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ABSTRACT Chronic kidney disease ( CKD ) is a syndrome caused by the progressive reduction of renal function . This study aim ed to systematic ally examine the effects of supplementation with probiotics in the treatment of CKD . Search es were carried out on data bases MEDLINE ( PubMed ) , SciELO , Cochrane , and Clinical Trials . Two independent review ers selected the studies from which data was extracted . The search included papers written in English and Portuguese published in the 2012 - 2016 period describing r and omized clinical trials . Eight of the 82 eligible articles met the inclusion criteria . Sample size ranged from 18 to 101 individuals with CKD . The duration of the included studies varied from four to 24 weeks . Most of the included articles reported positive effects in renal function and decreased levels of urea , blood urea nitrogen , ammonia , plasma p-cresol , p-cresyl sulfate , and indoxyl sulfate
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"BACKGROUND AND OBJECTIVES The generation of key uremic nephrovascular toxins , indoxyl sulfate ( IS ) , and p-cresyl sulfate ( PCS ) , is attributed to the dysbiotic gut microbiota in CKD . The aim of our study was to evaluate whether synbiotic ( pre- and probiotic ) therapy alters the gut microbiota and reduces serum concentrations of microbiome-generated uremic toxins , IS and PCS , in patients with CKD . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Predialysis adult participants with CKD ( eGFR=10 - 30 ml/min per 1.73 m(2 ) ) were recruited between January 5 , 2013 and November 12 , 2013 to a r and omized , double-blind , placebo-controlled , crossover trial of synbiotic therapy over 6 weeks ( 4-week washout ) . The primary outcome was serum IS . Secondary outcomes included serum PCS , stool microbiota profile , eGFR , proteinuria-albuminuria , urinary kidney injury molecule-1 , serum inflammatory biomarkers ( IL-1β , IL-6 , IL-10 , and TNF-α ) , serum oxidative stress biomarkers ( F2-isoprostanes and glutathione peroxidase ) , serum LPS , patient-reported health , Gastrointestinal Symptom Score , and dietary intake . A prespecified subgroup analysis explored the effect of antibiotic use on treatment effect . RESULTS Of 37 individuals r and omized ( age = 69±10 years old ; 57 % men ; eGFR=24±8 ml/min per 1.73 m(2 ) ) , 31 completed the study . Synbiotic therapy did not significantly reduce serum IS ( -2 μmol/L ; 95 % confidence interval [ 95 % CI ] , -5 to 1 μmol/L ) but did significantly reduce serum PCS ( -14 μmol/L ; 95 % CI , -27 to -2 μmol/L ) . Decreases in both PCS and IS concentrations were more pronounced in patients who did not receive antibiotics during the study ( n=21 ; serum PCS , -25 μmol/L ; 95 % CI , -38 to -12 μmol/L ; serum IS , -5 μmol/L ; 95 % CI , -8 to -1 μmol/L ) . Synbiotics also altered the stool microbiome , particularly with enrichment of Bifidobacterium and depletion of Ruminococcaceae . Except for an increase in albuminuria of 38 mg/24 h ( P=0.03 ) in the synbiotic arm , no changes were observed in the other secondary outcomes . CONCLUSION In patients with CKD , synbiotics did not significantly reduce serum IS but did decrease serum PCS and favorably modified the stool microbiome . Large-scale clinical trials are justified",
"Background The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively . However , its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood . To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals . Methods A r and omized , double-blind , parallel-group , controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30 - 70 years old in a teaching hospital in Kuala Lumpur , Malaysia . Subjects were r and omly assigned to receive microbial cell preparation ( N = 68 ) or a placebo ( N = 68 ) for 12 weeks . The outcomes measured at baseline , week 6 , and week 12 and included changes in renal profile ( Sodium , Potassium , Urea , Creatinine , Glomerular Filtration Rate ) , and liver function tests ( Albumin , Total Protein , Alkaline Phosphatase , Alanine Aminotransferase , Aspartate Aminotransferase ) . Intention to treat ( ITT ) analysis was performed on all the recruited subjects , while per protocol ( PP ) analysis was conducted on those who completed the trial with good compliance . Result The urea levels significantly declined in the probiotic group . Serum urea levels reduced from 4.26 mmol/L to 4.04 mmol/L in Probiotic Group while it increased in Placebo Group from 4.03 mmol/L to 4.24 mmol/L. These changes were significant between groups in ITT analysis ( p = 0.018 ) . Other parameters did not change significantly between groups . Conclusion 12 weeks supplementation with daily dosage of 6 × 1010 Colony Forming Units of multi-strain microbial cell preparation significantly improved urea levels . Trial registration ( Clinical trials : # NCT01752803",
"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 Patients with chronic kidney disease ( CKD ) show an increase in bowel aerobic bacteria that produce uremic toxins and decreased anaerobic bacteria as bifidobacteria and lactobacillus . The latter can be used as probiotics . The probiotic with greater availability in Mexico , is the lactobacillus casei shirota ( LcS ) , currently there is no known LcS specified dose that produces a benefit to the patient with CKD . OBJECTIVE To determine the effectiveness of two different LcS doses in achieving a decrease in urea concentrations of at least 10 % in patients with KDOQI stage 3 and stage 4 CKD . METODOLOGY : A simple r and omized , controlled clinical trial . Out patients treated at the National Institute of Medical Sciences and Nutrition Salvador Zubirán in México D.F. Patients were provided the LcS , as follows : Group A : 8 x 10(9 ) colony-forming units ( CFU ) and Group B : 16 x 10(9 ) CFU . Patients were followed-up for eight weeks , and baseline and final sample s were obtained to calculate the basal and final concentrations , respectively , of blood urea and serum creatinine ( CrS ) . During the follow-up , both groups consumed a diet of 30 kcal/kg/weight and 0.8 g/kg/weight of protein , and a food diary was made to assess both the adherence to the diet and LcS. RESULTS Thirty patients with CKD were evaluated . When analyzing the percentage change between the different doses , a decrease > 10 % was found in the blood urea concentrations for patients treated with the 16 x 109 dose , which was significant with respect to the baseline measurement . CONCLUSION There was a > 10 % decrease in the serum urea concentrations with LcS in patients with stage 3 and 4 CRF",
"INTRODUCTION Chronic kidney disease ( CKD ) is a progressive and irreversible impairment of kidney function ; if it progresses to the end-stage of CKD , dialysis or kidney transplant is needed . In general , there are no definitive treatment to slow the progression of CKD . This study aim ed to determine the effect of synbiotic supplementations on azotemia in patients with CKD . MATERIAL S AND METHODS A r and omized controlled trial was conducted on 66 patients with CKD ( stages 3 and 4 ) . The participants were r and omly divided into 2 groups to receive synbiotic supplement , 1000 mg/d , and placebo ( 2 capsules a day ) for 6 weeks . At the beginning and end of the study , blood parameters and kidney function were evaluated . RESULTS Of the 66 patients studied , 16 patients ( 24.2 % ) were women and 50 ( 75.8 % ) were men . The mean age and body mass index of the participants were 61 ± 7.65 years and 28.52 ± 4.06 kg/m2 , respectively . The level of blood urea nitrogen showed a significant reduction following the intake of synbiotic supplement ( from 40.80 ± 22.11 mg/dL to 36.14 ± 20.52 mg/dL , P = .01 ) . Serum creatinine , uric acid , and other indicators of kidney function showed no significant change . CONCLUSIONS The intake of synbiotic supplement could reduce blood urea nitrogen in patients with CKD in stages 3 and 4 ; however , it had no effect on the other markers of kidney function",
"OBJECTIVES Gut microbiota provides beneficial effects under physiological conditions , but is able to contribute to inflammatory diseases in susceptible individuals . Thus , we design ed this study to test whether additional intake of symbiotic gel affects specific modifications of gut microbiota in patients with end-stage renal disease ( ESRD ) . METHODS Eighteen patients with ESRD diagnosis with renal replacement therapy ( hemodialysis ) were included in this study . They were r and omly assigned to 2 treatment groups : ( 1 ) test group ( nutritional counseling + symbiotic ) and ( 2 ) control group ( nutritional counseling + placebo ) . Clinical history and the evaluation of Gastrointestinal Symptom Rating Scale were performed . Gut microbiota composition was analyzed by real-time polymerase chain reaction from fecal sample s. All subjects were followed for 2 months . RESULTS Bifidobacterial counts were higher in the second sample s ( mean : 5.5 ± 1.72 log10 cells/g ) than in first sample s ( 4.2 ± 0.88 log 10 cells/g ) in the patients of the test group ( P = .0344 ) . Also , lactobacilli counts had a little decrease in the test group ( 2.3 ± 0.75 to 2.0 ± 0.88 log 10 cells/g ) and the control group ( 2.2 ± 0.90 to 1.8 ± 1.33 log 10 cells/g ) , between the first and the second sample s. Gastrointestinal symptoms scores ( scale 8 - 40 ) were reduced in the test group ( start 12 [ 10 - 14 ] and end 9 [ 8 - 10 ] ) compared with control group ( start 11 [ 8 - 21 ] and end 11 [ 9 - 15 ] ) . CONCLUSIONS Short-term symbiotic treatment in patients with ESRD can lead to the increase of Bifidobacterium counts , maintaining the intestinal microbial balance",
"Inflammatory markers such as interleukin (IL)-6 and tumour necrosis factor-alpha ( TNF-α ) are elevated in dialysis patients and can predict cardiovascular events and all-cause mortality . Endotoxin is an important source and also another marker of inflammation in patients with chronic kidney disease . The aim of this study was to evaluate the impact of oral probiotics on serum levels of endotoxemia and cytokines in peritoneal dialysis ( PD ) patients . The decline of residual renal function , peritonitis episodes , and cardiovascular events were also recorded . From July 2011 to June 2012 , a r and omised , double-blind , placebo-controlled trial was conducted in PD patients . The intervention group received one capsule of probiotics containing 10(9 ) cfu Bifobacterium bifidum A218 , 10(9 ) cfu Bifidobacterium catenulatum A302 , 10(9 ) cfu Bifidobacterium longum A101 , and 10(9 ) cfu Lactobacillus plantarum A87 daily for six months , while the placebo group received similar capsules containing maltodextrin for the same duration . Levels of serum TNF-α , interferon gamma , IL-5 , IL-6 , IL-10 , IL-17 , and endotoxin were measured before and six months after intervention . 39 patients completed the study ( 21 in the probiotics group and 18 in the placebo group ) . In patients receiving probiotics , levels of serum TNF-α , IL-5 , IL-6 , and endotoxin significantly decreased after six months of treatment , while levels of serum IL-10 significantly increased . In contrast , there were no significant changes in levels of serum cytokines and endotoxin in the placebo group after six months . In addition , the residual renal function was preserved in patients receiving probiotics . In conclusion , probiotics could significantly reduce the serum levels of endotoxin , pro-inflammatory cytokines ( TNF-α and IL-6 ) , IL-5 , increase the serum levels of anti-inflammatory cytokine ( IL-10 ) , and preserve residual renal function in PD patients"
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BACKGROUND The current paradigm for cardiovascular disease ( CVD ) emphasises absolute risk assessment to guide treatment decisions in primary prevention . Although the derivation and validation of multivariable risk assessment tools , or CVD risk scores , have attracted considerable attention , their effect on clinical outcomes is uncertain . OBJECTIVES To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes , risk factor levels , preventive medication prescribing , and health behaviours . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) in the Cochrane Library ( 2016 , Issue 2 ) , MEDLINE Ovid ( 1946 to March week 1 2016 ) , Embase ( embase .com ) ( 1974 to 15 March 2016 ) , and Conference Proceedings Citation Index-Science ( CPCI-S ) ( 1990 to 15 March 2016 ) . We imposed no language restrictions . We search ed clinical trial registers in March 2016 and h and search ed reference lists of primary studies to identify additional reports . SELECTION CRITERIA We included r and omised and quasi-r and omised trials comparing the systematic provision of CVD risk scores by a clinician , healthcare professional , or healthcare system compared with usual care ( i.e. no systematic provision of CVD risk scores ) in adults without CVD . DATA COLLECTION AND ANALYSIS Three review authors independently selected studies , extracted data , and evaluated study quality . We used the Cochrane ' Risk of bias ' tool to assess study limitations . The primary outcomes were : CVD events , change in CVD risk factor levels ( total cholesterol , systolic blood pressure , and multivariable CVD risk ) , and adverse events . Secondary outcomes included : lipid-lowering and antihypertensive medication prescribing in higher-risk people . We calculated risk ratios ( RR ) for dichotomous data and mean differences ( MD ) or st and ardised mean differences ( SMD ) for continuous data using 95 % confidence intervals . We used a fixed-effects model when heterogeneity ( I² ) was at least 50 % and a r and om-effects model for substantial heterogeneity ( I² > 50 % ) . We evaluated the quality of evidence using the GRADE framework . MAIN RESULTS We identified 41 r and omised controlled trials ( RCTs ) involving 194,035 participants from 6422 reports . We assessed studies as having high or unclear risk of bias across multiple domains . Low- quality evidence evidence suggests that providing CVD risk scores may have little or no effect on CVD events compared with usual care ( 5.4 % versus 5.3 % ; RR 1.01 , 95 % confidence interval ( CI ) 0.95 to 1.08 ; I² = 25 % ; 3 trials , N = 99,070 ) . Providing CVD risk scores may reduce CVD risk factor levels by a small amount compared with usual care . Providing CVD risk scores reduced total cholesterol ( MD -0.10 mmol/L , 95 % CI -0.20 to 0.00 ; I² = 94 % ; 12 trials , N = 20,437 , low- quality evidence ) , systolic blood pressure ( MD -2.77 mmHg , 95 % CI -4.16 to -1.38 ; I² = 93 % ; 16 trials , N = 32,954 , low- quality evidence ) , and multivariable CVD risk ( SMD -0.21 , 95 % CI -0.39 to -0.02 ; I² = 94 % ; 9 trials , N = 9549 , low- quality evidence ) . Providing CVD risk scores may reduce adverse events compared with usual care , but results were imprecise ( 1.9 % versus 2.7 % ; RR 0.72 , 95 % CI 0.49 to 1.04 ; I² = 0 % ; 4 trials , N = 4630 , low- quality evidence ) . Compared with usual care , providing CVD risk scores may increase new or intensified lipid-lowering medications ( 15.7 % versus 10.7 % ; RR 1.47 , 95 % CI 1.15 to 1.87 ; I² = 40 % ; 11 trials , N = 14,175 , low- quality evidence ) and increase new or increased antihypertensive medications ( 17.2 % versus 11.4 % ; RR 1.51 , 95 % CI 1.08 to 2.11 ; I² = 53 % ; 8 trials , N = 13,255 , low- quality evidence ) . AUTHORS ' CONCLUSIONS There is uncertainty whether current strategies for providing CVD risk scores affect CVD events . Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm . There were multiple study limitations in the identified studies and substantial heterogeneity in the interventions , outcomes , and analyses , so readers should interpret results with caution . New models for implementing and evaluating CVD risk scores in adequately powered studies are needed to define the role of applying CVD risk scores in primary CVD prevention
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"Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register",
"Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice . Recommendations for cardiovascular risk management , including lifestyle change , are clearly described in the Dutch national guideline . Although lifestyle interventions , such as advice on diet , physical exercise , smoking and alcohol , have moderate , but potentially relevant effects in these patients , adherence to lifestyle advice in general practice is not optimal . The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics . The aim of this paper is to describe the design and methods of a study to evaluate an intervention aim ed at involving patients in cardiovascular risk management . Methods A cluster-r and omised controlled trial in 20 general practice s , 10 practice s in the intervention arm and 10 in the control arm , starting on October 2005 . A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited . In both arms , the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management . Nurses in the intervention arm will receive an extended training in risk assessment , risk communication , the use of a decision aid and adapted motivational interviewing . This communication technique will be used to support the shared decision-making process about risk reduction . The intervention comprises 2 consultations and 1 follow-up telephone call . The nurses in the control arm will give usual care after the risk estimation , according to the national guideline . Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment . Secondary outcome measures are the patients ' perception of risk and their motivation to change their behaviour . The measurements will take place at baseline and after 12 and 52 weeks . Clinical endpoints will not be measured , but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year . Discussion The combined use of risk communication , a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention . Trial registration Current Controlled Trials IS RCT",
"Background — Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited . Methods and Results — Using a parallel arm cluster-r and omized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline -indicated risk factor measurements and ( 2 ) guideline -indicated medications for those at high cardiovascular disease risk . Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Isl and er people aged ≥35 years and others aged ≥45 years ) . Patient-level analyses were conducted using generalized estimating equations to account for clustering . Median follow-up for 38 725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months . Mean monthly staff support was improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04–1.50 ; P=0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n=10 308 ; 56.8 % versus 51.2 % ; P=0.12 ) . There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 4.3 % versus 2.7 % ; P=0.01 ) , and BP lowering ( 18.2 % versus 11.0 % ; P=0.02 ) but not lipid-lowering medications . Conclusions — In Australian primary healthcare setting s , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group . Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management . Clinical Trial Registration — URL : https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=336630 . Australian New Zeal and Clinical Trials Registry No. 12611000478910",
"Background Patient-centered diabetes care requires shared decision making ( SDM ) . Decision aids promote SDM , but their efficacy in nonacademic and rural primary care clinics is unclear . Methods We cluster-r and omized 10 practice s in a concealed fashion to implement either a decision aid ( DA ) about starting statins or one about choosing antihyperglycemic agents . Each practice served as a control group for another practice implementing the other type of DA . From April 2011 to July 2012 , 103 ( DA=53 ) patients with type 2 diabetes participated in the trial . We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes ( patient knowledge and comfort with decision making , patient and clinician satisfaction ) . Medical records provided data on metabolic control . Pharmacy fill profiles provided data for estimating adherence to therapy . Results Compared to usual care , patients receiving the DA were more likely to report discussing medications ( 77 % vs. 45 % , p answer knowledge questions correctly ( risk reduction with statins 61 % vs. 33 % , p=.07 ; knowledge about options 57 % vs. 33 % , p=.002 ) and were more engaged by their clinicians in decision making ( 50 . vs. 28 , difference 21.4 ( 95 % CI 6.4 , 36.3 ) , p=.01 ) . We found no significant impact on patient satisfaction , medication starts , adherence or clinical outcomes , in part due to limited statistical power . Conclusion DAs improved decisional outcomes without significant effect on clinical outcomes . DAs design ed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practice s . Trial Registration",
"Background There is currently much interest in encouraging individuals to increase physical activity in order to reduce CVD risk . This study has been design ed to determine if personalised CVD risk appreciation can increase physical activity in adults at high risk of CVD . Methods / Design In a 2 × 2 factorial design participants are allocated at r and om to a personalised 10-year CVD risk estimate or numerical CVD risk factor values ( systolic blood pressure , LDL cholesterol and fasting glucose ) and , simultaneously , to receive a brief lifestyle advice intervention targeting physical activity , diet and smoking cessation or not . We aim to recruit 200 participants from Oxfordshire primary care practice s. Eligibility criteria include adults age 40–70 years , estimated 10-year CVD risk ≥20 % , ability to read and write English , no known CVD and no physical disability or other condition reducing the ability to walk . Primary outcome is physical activity measured by ActiGraph accelerometer with biochemical , anthropometrical and psychological measures as additional outcomes . Primary analysis is between group physical activity differences at one month powered to detect a difference of 30,000 total counts per day of physical activity between the groups . Additional analyses will seek to further eluci date the relationship between the provision of risk information , and intention to change behaviour and to determine the impact of both interventions on clinical and anthropometrical measures including fasting and 2 hour plasma glucose , fructosamine , serum cotinine , plasma vitamin C , body fat percentage and blood pressure . Discussion This is a pilot trial seeking to demonstrate in a real world setting , proof of principal that provision of personalised risk information can contribute to behaviour changes aim ed at reducing CVD risk . This study will increase our underst and ing of the links between the provision of risk information and behaviour change and if successful , could be used in clinical practice with little or no modification",
"Background A healthy diet , low in saturated fat and high in fiber , is a popular medical recommendation in preventing cardiovascular disease ( CVD ) . One approach to motivating healthier eating is to raise individuals ’ awareness of their CVD risk and then help them form specific plans to change . Objectives The aim was to explore the combined impact of a Web-based CVD risk message and a fully automated planning tool on risk perceptions , intentions , and saturated fat intake changes over 4 weeks . Methods Of the 1187 men and women recruited online , 781 were r and omly allocated to one of four conditions : a CVD risk message , the same CVD risk message paired with planning , planning on its own , and a control group . All outcome measures were assessed by online self-reports . Generalized linear modeling was used to analyze the data . Results Self-perceived consumption of low saturated fat foods ( odds ratio 11.40 , 95 % CI 1.86–69.68 ) and intentions to change diet ( odds ratio 21.20 , 95 % CI 2.6–172.4 ) increased more in participants allocated to the planning than the control group . No difference was observed between the four conditions with regard to percentage saturated fat intake changes . Contrary to our expectations , there was no difference in perceived and percentage saturated fat intake change between the CVD risk message plus planning group and the control group . Risk perceptions among those receiving the CVD risk message changed to be more in line with their age ( change in slopeindividual = 0.075 , P = .01 ; change in slopecomparative = 0.100 , P = .001 ) , whereas there was no change among those who did not receive the CVD risk message . Conclusion There was no evidence that combining a CVD risk message with a planning tool reduces saturated fat intake more than either alone . Further research is required to identify ways in which matching motivational and volitional strategies can lead to greater behavior changes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 91154001 ; http://www.controlled-trials.com/IS RCT N91154001 ( Archived by WebCite at http://www.webcitation.org/62sBoGeOO",
"Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the intervention group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months . The primary outcome is the mean change in systolic BP from baseline to 12 months . The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months . All outcomes will be assessed at baseline , six months and 12 months . Trained community health nurses will deliver the intervention as part of Ghana ’s community-based health planning and services ( CHPS ) program . Discussion Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in re source -poor setting s . Trial registration NCT01802372",
"Background We examined the effectiveness of a structured collaboration in general practice between a practice nurse , a peer health educator , the general practitioner ( GP ) and a GP assistant in providing intensified preventive care for patients at high risk of developing cardiovascular diseases . Design A r and omized controlled trial in three healthcare centres ( 18 GPs ) in deprived neighbourhoods of two major Dutch cities . Methods Two hundred seventy-five high-risk patients ( 30 - 70 years ) from various ethnic groups were r and omized to intervention ( n = 137 ) or usual care group ( n = 138 ) . We determined group differences in outcomes [ 10-year absolute risk ( Framingham risk equation ) , blood pressure , lipids and body mass index ] at 12-month follow-up . Results The 10-year absolute risk was reduced by 1.76 % ( st and ard error : 0.81 ) in intervention and by 2.27 % ( st and ard error : 0.69 ) in usual care group ; the difference in mean change was 0.88 % [ 95 % confidence interval : −1.16 to 2.93 ] . In both groups significant reductions were observed in the following individual risk factors : total cholesterol , total cholesterol/high-density lipoprotein cholesterol , and low-density lipoprotein cholesterol , with no relevance between group differences . Conclusion The cardiovascular risk profile of intervention and control patients improved after 1-year follow-up . However , no extra effect of the structured preventive care on the risk for cardiovascular diseases was achieved . Eur J Cardiovasc Prev Rehabil 15:488 - 493 © 2008 The European Society of",
"Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century . The Department of Health in Engl and has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk . The aims of this study were to monitor population changes in cardiovascular disease ( CVD ) risk factors over the first year of the new service and to assess the value of tailored lifestyle support , including motivational interview with ongoing support and referral to other services . Methods R and omised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent , Engl and . Thirty eight general practice s and 601 ( 365 usual care , 236 additional lifestyle support ) patients were recruited and r and omised independently between September 2009 and February 2010 . Changes in population CVD risk between baseline and one year follow-up were compared , using intention-to-treat analysis . The primary outcome was the Framingham 10 year CVD risk score . Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories . Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for : weight management , physical activity , cook and eat and positive thinking . Results Average population CVD risk decreased from 32.9 % to 29.4 % ( p Health Check only group and from 31.9 % to 29.2 % ( p NHS Health Check plus additional lifestyle support group . There was no significant difference between the two groups at either measurement point . Prevalence of high blood pressure , high cholesterol and smoking were reduced significantly ( p Prevalence of central obesity was reduced significantly ( p additional lifestyle support but not in the NHS Health Check only group . Conclusions The NHS Health Check service in Stoke on Trent result ed in significant reduction in estimated population CVD risk . There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction",
"BACKGROUND It is important that patients are well-informed about risks and benefits of therapies to help them decide whether to accept medical therapy . Different numerical formats can be used in risk communication but It remains unclear how the different formats affect decisions made by real-life patients . AIM To compare the impact of using Prolongation Of Life ( POL ) and Absolute Risk Reduction ( ARR ) information formats to express effectiveness of cholesterol-lowering therapy on patients ' redemptions of statin prescriptions , and on patients ' confidence in their decision and satisfaction with the risk communication . DESIGN AND SETTING Cluster-r and omised clinical trial in general practice s. Thirty-four Danish GPs from 23 practice s participated in a primary care-based clinical trial concerning use of quantitative effectiveness formats for risk communication in health prevention consultations . METHOD GPs were cluster-r and omised ( treating practice s as clusters ) to inform patients about cardiovascular mortality risk and the effectiveness of statin treatment using either POL or ARR formats . Patients ' redemptions of statin prescriptions were obtained from a regional prescription data base . The COMRADE question naire was used to measure patients ' confidence in their decision and satisfaction with the risk communication . RESULTS Of the 240 patients included for analyses , 112 were allocated to POL information and 128 to ARR . Patients redeeming a statin prescription totalled six ( 5.4 % ) when informed using POL , and 32 ( 25.0 % ) when using ARR . The level of confidence in decision and satisfaction with risk communication did not differ between the risk formats . CONCLUSION Patients redeemed statin prescriptions less often when their GP communicated treatment effectiveness using POL compared with ARR",
"Objective To derive a new cardiovascular disease risk score ( QRISK ) for the United Kingdom and to vali date its performance against the established Framingham cardiovascular disease algorithm and a newly developed Scottish score ( ASSIGN ) . Design Prospect i ve open cohort study using routinely collected data from general practice . Setting UK practice s contributing to the Q RESEARCH data base . Participants The derivation cohort consisted of 1.28 million patients , aged 35 - 74 years , registered at 318 practice s between 1 January 1995 and 1 April 2007 and who were free of diabetes and existing cardiovascular disease . The validation cohort consisted of 0.61 million patients from 160 practice s. Main outcome measures First recorded diagnosis of cardiovascular disease ( incident diagnosis between 1 January 1995 and 1 April 2007 ) : myocardial infa rct ion , coronary heart disease , stroke , and transient ischaemic attacks . Risk factors were age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol to high density lipoprotein , body mass index , family history of coronary heart disease in first degree relative aged less than 60 , area measure of deprivation , and existing treatment with antihypertensive agent . Results A cardiovascular disease risk algorithm ( QRISK ) was developed in the derivation cohort . In the validation cohort the observed 10 year risk of a cardiovascular event was 6.60 % ( 95 % confidence interval 6.48 % to 6.72 % ) in women and 9.28 % ( 9.14 % to 9.43 % ) in men . Overall the Framingham algorithm over-predicted cardiovascular disease risk at 10 years by 35 % , ASSIGN by 36 % , and QRISK by 0.4 % . Measures of discrimination tended to be higher for QRISK than for the Framingham algorithm and it was better calibrated to the UK population than either the Framingham or ASSIGN models . Using QRISK 8.5 % of patients aged 35 - 74 are at high risk ( 20 % risk or higher over 10 years ) compared with 13 % when using the Framingham algorithm and 14 % when using ASSIGN . Using QRISK 34 % of women and 73 % of men aged 64 - 75 would be at high risk compared with 24 % and 86 % according to the Framingham algorithm . UK estimates for 2005 based on QRISK give 3.2 million patients aged 35 - 74 at high risk , with the Framingham algorithm predicting 4.7 million and ASSIGN 5.1 million . Overall , 53 668 patients in the validation data set ( 9 % of the total ) would be reclassified from high to low risk or vice versa using QRISK compared with the Framingham algorithm . Conclusion QRISK performed at least as well as the Framingham model for discrimination and was better calibrated to the UK population than either the Framingham model or ASSIGN . QRISK is likely to provide more appropriate risk estimates to help identify high risk patients on the basis of age , sex , and social deprivation . It is therefore likely to be a more equitable tool to inform management decisions and help ensure treatments are directed towards those most likely to benefit . It includes additional variables which improve risk estimates for patients with a positive family history or those on antihypertensive treatment . However , since the validation was performed in a similar population to the population from which the algorithm was derived , it potentially has a “ home advantage . ” Further validation in other population s is therefore required",
"OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . FINDINGS The study included 2397 patients with baseline hypertension : 1191 in 20 intervention facilities and 1206 in 20 control facilities . Systolic and diastolic blood pressure decreased more in intervention patients than in controls . However , at 12 months more than half of patients still had uncontrolled hypertension ( systolic blood pressure > 140 mmHg and /or diastolic blood pressure > 90 mmHg ) . Behavioural risk factors had improved among intervention patients in Nigeria but not in China . Only about 2 % of hypertensive patients required referral to the next level of care . CONCLUSION Even in low-re source setting s , hypertensive patients can be effectively assessed and managed in primary care facilities",
"Objectives Hypertension is common among patients with dyslipidemia but is often poorly treated . The objective of this analysis was to evaluate how a decision aid , used by primary care physicians to improve lipid therapy , impacted on the treatment of hypertension . Study Design Data were analyzed from patients enrolled in a r and omized trial focusing primarily on the treatment of dyslipidemia . Patients received usual care or a coronary risk profile every three months to monitor the risk reduction following lifestyle changes and /or pharmacotherapy to treat dyslipidemia . Hypertension management was assessed based on a post hoc analysis of individuals whose blood pressure exceeded current national hypertension guidelines . Results There were 2,631 subjects who completed the study . Among 1,352 patients without diagnosed hypertension , 30 % were above target on at least three consecutive visits . Among 1,279 individuals with known hypertension , 69 % were above target on at least two consecutive visits . Overall , patients receiving risk profiles were more likely to receive appropriate antihypertensive therapy ( OR = 1.40 , 95 % CI 1.11 – 1.78 ) compared to those receiving usual care . After adjustment for inter-physician variability and potential confounders , the use of the risk profile was associated with an increased likelihood of starting therapy ( OR = 1.78 , 95 % CI 1.06 – 3.00 ) or modifying therapy ( OR = 1.40 , 95 % CI 1.03 – 1.91 ) . Conclusions In this clinical trial of dyslipidemia management , inadequately controlled hypertension was common , occurring in nearly 50 % of individuals . Ongoing coronary risk assessment was associated with more appropriate blood pressure management . Cardiovascular risk assessment decision aids should be further evaluated in a r and omized trial of hypertension therapy",
"Background Cardiovascular disease ( including coronary heart disease and stroke ) is a major cause of death and disability in the United Kingdom , and is to a large extent preventable , by lifestyle modification and drug therapy . The recent st and ardisation of electronic codes for cardiovascular risk variables through the United Kingdom 's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals . This r and omised controlled trial will test the benefits of an automated system of alert messages and practice search es to identify those at highest risk of cardiovascular disease in primary care data bases . Design Patients over 50 years old in practice data bases will be r and omised to the intervention group that will receive the alert messages and search es , and a control group who will continue to receive usual care . In addition to those at high estimated risk , potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made . Further groups identified will be those with possible undiagnosed diabetes , based either on elevated past recorded blood glucose measurements , or an absence of recent blood glucose measurement in those with established cardiovascular disease . Outcome measures The intervention will be applied for two years , and outcome data will be collected for a further year . The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study . Secondary measures include the proportion of patients at high estimated cardiovascular risk , the proportion of patients with missing data for a risk estimate , and the proportion with undefined diabetes status at the end of the trial",
"OBJECTIVE To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse . METHODS The IMPALA study ( 2006 , the Netherl and s ) was a cluster-r and omised controlled trial involving 25 general practice s and 615 patients who were eligible for cardiovascular risk management . The intervention consisted of ( 1 ) individual 10-year cardiovascular risk assessment , ( 2 ) risk communication , ( 3 ) use of a decision aid and ( 4 ) adapted motivational interviewing , applied by practice nurses in two consultations . Outcomes were smoking , alcohol , diet , physical activity and the secondary outcomes risk perception , anxiety , confidence about the decision and satisfaction with the communication , measured at baseline and after 12 weeks . RESULTS Patients of both groups improved their lifestyle , but no relevant significant differences between the groups were found . Intervention group patients improved in terms of the appropriateness of risk perception , although not significantly . Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients . CONCLUSION The intervention seems to have improved the patients ' risk perception , anxiety and satisfaction with the communication , which are important conditions for shared decision making . However , we found no additional effect of the intervention on lifestyle ",
"OBJECTIVE To evaluate the effectiveness of a population -based multi-factorial lifestyle intervention on long-term changes in dietary habits compared to a non-intervention control group . METHODS The study was a r and omized controlled lifestyle intervention study , Inter99 ( 1999 - 2006 ) , Copenhagen , Denmark , using a high-risk strategy . Participants in the intervention group ( n=6 091 ) had at baseline a medical health-examination and a face-to-face lifestyle counselling . Individuals at high risk of ischemic heart disease were repeatedly offered both individual and group-based counselling . The control group ( n=3 324 ) was followed by question naires . Dietary habits were measured by a vali date d 48-item food frequency question naire and changes were analyzed by multilevel analyses . RESULTS At the 5-year follow-up the intervention group compared to the control group had significantly increased their intake of vegetables ( men : net-change : 23 g/week ; p=0.04 ; women : net-change : 27 g/week ; p=0.005 ) and decreased the intake of highly saturated fats used on bread and for cooking ( men : OR=0.59 ( 0.41 - 0.86 ) ; women : OR=0.42 ( 0.30 - 0.59 ) ) . Significant effects on fruit and fish intake were found at the 3-year follow-up but the effect attenuated at the 5-year follow-up . CONCLUSION A population -based multi-factorial lifestyle intervention promoted significant greater beneficial long-term dietary changes compared to the control group , especially the intake of vegetables and saturated fat was improved",
"Background —Many eligible primary cardiovascular disease prevention c and i date s are not treated with statins . Electronic health record data can identify patients with increased cardiovascular disease risk . Methods and Results —We performed a pragmatic r and omized controlled trial at community health centers in 2 states . Participants were men aged ≥35 years and women ≥45 years , without cardiovascular disease or diabetes mellitus , and with a 10-year risk of coronary heart disease of at least 10 % . The intervention group received telephone and mailed outreach , individualized based on patients ’ cardiovascular disease risk and uncontrolled risk factors , provided by lay health workers . Main outcomes included : documented discussion of medication treatment for cholesterol with a primary care clinician , receipt of statin prescription within 6 months , and low-density lipoprotein (LDL)-cholesterol repeated and at least 30 mg/dL lower than baseline within 1 year . Six hundred forty-six participants ( 328 and 318 in the intervention and control groups , respectively ) were included . At 6 months , 26.8 % of intervention and 11.6 % of control patients had discussed cholesterol treatment with a primary care clinician ( odds ratio , 2.79 ; [ 95 % confidence interval , 2.25–3.46 ] ) . Statin prescribing occurred for 10.1 % in the intervention group and 6.0 % in the control group ( odds ratio , 1.76 ; [ 95 % confidence interval , 0.90–3.45 ] ) . The cholesterol outcome did not differ , and the majority of patients did not repeat lipid levels during follow-up . Conclusions —Risk communication and lay outreach increased cholesterol treatment discussion s with primary care clinicians . However , most discussion s did not result in statin prescribing . For outreach to be successful , it should be combined with interventions to encourage clinicians to follow contemporary risk-based cholesterol treatment guidelines . Clinical Trial Registration —URL : http://www.clincialtrials.gov . Unique identifier : NCT01610609",
"Abstract BACKGROUND : Little is known about how interventions motivate individuals to change multiple health risk behaviors . Self-determination theory ( SDT ) proposes that patient autonomy is an essential factor for motivating change . OBJECTIVE : An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested . DESIGN : The Smokers ’ Health Study is a r and omized multiple risk behavior change intervention trial . SETTING : Smokers were recruited to a tobacco treatment center . PATIENTS : A total of 1,006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements . INTERVENTIONS : A 6-month clinical intervention ( 4 contacts ) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care . Clinicians elicited patient perspectives and life strivings , provided absolute coronary artery disease risk estimates , enumerated effective treatment options , supported patient initiatives , minimized clinician control , assessed motivation for change , and developed a plan for change . MAIN OUTCOME MEASURES : Twelve-month prolonged tobacco abstinence , and change in percent calories from fat and low-density lipoprotein-cholesterol ( LDL-C ) from baseline to 18 months . RESULTS : Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence ( 6.2 % vs 2.4 % ; odds ratio [OR]=2.7,P=.01 , number needed to treat [NNT]=26 ) , and reduced LDL-C ( −8.9 vs −4.1 mg/dL;P=.05 ) . There was no effect on percent calories from fat . CONCLUSIONS : An intervention focused on supporting smokers ’ autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence",
"BACKGROUND Poor quality of information transfer about the benefits and risks of statin drug use may result in patients not making informed decisions that they can act on in a timely fashion . METHODS The effect of a decision aid about statin drugs on treatment decision making in 98 patients with diabetes was determined in a cluster r and omized trial of decision aid vs control pamphlet , with concealed allocation , blinding of participants to study goals , and adherence to the intention-to-treat principle . Twenty-one endocrinologists conducted specialty outpatient metabolic consultations . Patients in the intervention group received Statin Choice , a tailored decision aid that presents the estimated 10-year cardiovascular risk , the absolute risk reduction with use of statin drugs , and the disadvantages of using statin drugs . Patients in the control group received the institution 's pamphlet about cholesterol management . We measured acceptability , knowledge about options and cardiovascular risk , and decisional conflict immediately after the visit , and adherence to pill taking was measured 3 months later . RESULTS Patients favored using the decision aid ( odds ratio [ OR ] , 2.8 ; 95 % confidence interval [ CI ] , 1.2 - 6.9 ) ; patients who received the decision aid ( n = 52 ) knew more ( difference , 2.4 of 9 points ; 95 % CI , 1.5 - 3.3 ) , had better estimated cardiovascular risk ( OR , 22.4 ; 95 % CI , 5.9 - 85.6 ) and potential absolute risk reduction with statin drugs ( OR , 6.7 ; 95 % CI , 2.2 - 19.7 ) , and had less decisional conflict ( difference , -10.6 ; 95 % CI , -15.4 to -5.9 on a 100-point scale ) than did patients in the control group ( n = 46 ) . Of 33 patients in the intervention group taking statin drugs at 3 months , 2 reported missing 1 dose or more in the last week compared with 6 of 29 patients in the control group taking statin drugs ( OR , 3.4 ; 95 % CI , 1.5 - 7.5 ) . CONCLUSIONS A decision aid enhanced decision making about statin drugs and may have favorably affected drug adherence",
"Objective To develop and vali date version two of the QRISK cardiovascular disease risk algorithm ( QRISK2 ) to provide accurate estimates of cardiovascular risk in patients from different ethnic groups in Engl and and Wales and to compare its performance with the modified version of Framingham score recommended by the National Institute for Health and Clinical Excellence ( NICE ) . Design Prospect i ve open cohort study with routinely collected data from general practice , 1 January 1993 to 31 March 2008 . Setting 531 practice s in Engl and and Wales contributing to the national Q RESEARCH data base . Participants 2.3 million patients aged 35 - 74 ( over 16 million person years ) with 140 000 cardiovascular events . Overall population ( derivation and validation cohorts ) comprised 2.22 million people who were white or whose ethnic group was not recorded , 22 013 south Asian , 11 595 black African , 10 402 black Caribbean , and 19 792 from Chinese or other Asian or other ethnic groups . Main outcome measures First ( incident ) diagnosis of cardiovascular disease ( coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records or linked Office for National Statistics death certificates . Risk factors included self assigned ethnicity , age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol : high density lipoprotein cholesterol , body mass index , family history of coronary heart disease in first degree relative under 60 years , Townsend deprivation score , treated hypertension , type 2 diabetes , renal disease , atrial fibrillation , and rheumatoid arthritis . Results The validation statistics indicated that QRISK2 had improved discrimination and calibration compared with the modified Framingham score . The QRISK2 algorithm explained 43 % of the variation in women and 38 % in men compared with 39 % and 35 % , respectively , by the modified Framingham score . Of the 112 156 patients classified as high risk ( that is , ≥20 % risk over 10 years ) by the modified Framingham score , 46 094 ( 41.1 % ) would be reclassified at low risk with QRISK2 . The 10 year observed risk among these reclassified patients was 16.6 % ( 95 % confidence interval 16.1 % to 17.0%)—that is , below the 20 % treatment threshold . Of the 78 024 patients classified at high risk on QRISK2 , 11 962 ( 15.3 % ) would be reclassified at low risk by the modified Framingham score . The 10 year observed risk among these patients was 23.3 % ( 22.2 % to 24.4%)—that is , above the 20 % threshold . In the validation cohort , the annual incidence rate of cardiovascular events among those with a QRISK2 score of ≥20 % was 30.6 per 1000 person years ( 29.8 to 31.5 ) for women and 32.5 per 1000 person years ( 31.9 to 33.1 ) for men . The corresponding figures for the modified Framingham equation were 25.7 per 1000 person years ( 25.0 to 26.3 ) for women and 26.4 ( 26.0 to 26.8 ) for men ) . At the 20 % threshold , the population identified by QRISK2 was at higher risk of a CV event than the population identified by the Framingham score . Conclusions Incorporating ethnicity , deprivation , and other clinical conditions into the QRISK2 algorithm for risk of cardiovascular disease improves the accuracy of identification of those at high risk in a nationally representative population . At the 20 % threshold , QRISK2 is likely to be a more efficient and equitable tool for treatment decisions for the primary prevention of cardiovascular disease . As the validation was performed in a similar population to the population from which the algorithm was derived , it potentially has a “ home advantage . ” Further validation in other population s is therefore advised",
"Background Elevated low-density lipoprotein ( LDL ) cholesterol is a leading risk factor for cardiovascular disease . Despite the availability of proven interventions to lower LDL cholesterol , their use remains subobtimal . Many websites provide interactive , tailored advice on cardiovascular risk in an attempt to help bridge this evidence - practice gap , yet there is little evidence that provision of such a tool is effective in changing practice . Objectives The objective was to define the effects on use of cholesterol-lowering interventions of a consumer-targeted tailored advice website . Methods This was a prospect i ve , double-blind , r and omized controlled trial open to any adult Australian with access to the Internet . A total of 2099 participants were r and omized . Of these , 45 % were male , the mean age of all participants was 56 , and 1385 ( 66 % ) self-reported hypercholesterolemia . Follow-up information was obtained for 1945 ( 93 % ) . Participants completed a brief online question naire . Individuals assigned to intervention received immediate , fully automated , personally tailored advice ( based on current guidelines ) regarding the need for commencement of statin therapy , increased statin therapy in those already on treatment , and nondrug intervention strategies . Control group participants were directed to static Web pages providing general information about cholesterol management . Results The primary outcome was the proportion of participants that commenced or increased use of prescribed cholesterol-lowering therapy . Of the total 2099 r and omized participants , 304 ( 14 % ) met eligibility criteria for cholesterol-lowering therapy but were not prescribed treatment , and 254 ( 12 % ) were prescribed treatment but were not achieving the recommended target level . Treatment was commenced or increased in 64 ( 6.0 % ) of the 1062 intervention group participants and 79 ( 7.6 % ) of the 1037 control group participants ( % difference = -1.6 % , 95 % confidence interval [ CI ] -3.75 to 0.57 , P = .15 ) . No differences were found between the r and omized groups for the secondary outcomes of “ discussed treatment with a health professional ” ( % difference = -3.8 % , 95 % confidence interval [ CI ] -8.16 to 0.19 , P = .08 ) , “ had their cholesterol checked ” ( % difference = -1.5 % , 95 % CI -5.79 to 2.71 , P = .48 ) , “ had their blood pressure checked ” ( % difference = 1.4 % , 95 % CI -2.55 to 5.34 , P = .49 ) or made a lifestyle change ( P values between .49 and .96 ) . Conclusions Despite providing specific carefully tailored advice , this website had no detectable effect on cholesterol management strategies . This finding raises considerable uncertainty about the value of Internet-based tools providing tailored advice directly to consumers . Trial Registration NCT00220974 ; http:// clinical trials.gov/ct2/show/NCT00220974 ( Archived by WebCite at http://www.webcitation.org/5sdq63rrY",
"OBJECTIVE Statin choice , an encounter decision aid ( DA ) , was developed in the USA to facilitate shared decision making between patients and clinicians about the use of statins to reduce cardiovascular risk . We aim ed to assess the efficacy of this DA , compared to usual primary care , in Spanish patients with type 2 diabetes . METHODS Cluster r and omized trial with 29 clinicians and 168 patients . Knowledge of statins , cardiovascular risk perception , decisional conflict , anxiety and satisfaction with the decision making process were assessed immediately after intervention , and self-reported adherence at three months . RESULTS Intervention significantly improved knowledge ( p=0.01 ) , perception of the 10-year risk of myocardial infa rct ion without ( p=0.01 ) and with statins ( p=0.08 ) , and satisfaction ( p=0.01 ) . There were no significant differences in decisional conflict , anxiety , consultation time or adherence , although more intervention patients reported taking all pills during the last week ( 92.7 % vs. 81 % ; p=0.19 ) . CONCLUSION The statin choice DA improved the quality of decision making about statins . PRACTICE IMPLICATION S This trial contributes to the body of evidence substantiating the efficacy of statin choice and extending it to Spanish clinicians and their patients with type 2 diabetes . TRIAL REGISTRATION This trial is registered with the European Union Clinical Trials Register ( EudraCT : 2010 - 023912 - 14 )",
"Abstract Background Low utilization of effective coronary heart disease ( CHD ) prevention strategies may be due to many factors , but chief among them is the lack of patient involvement in prevention decisions . We undertook this study to test the effectiveness of an individually-tailored , computerized decision aid about CHD on patients ' discussion s with their doctor and their plans for CHD prevention . Methods We conducted a pilot r and omized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored , computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor . Results We enrolled 75 adults . Mean age was 53 . 59 % were female , 73 % white , and 23 % African-American . 66 % had some college education . 43 % had a 10-year CHD risk of 0–5 % , 25 % a risk of 6–10 % , 24 % a risk of 11–20 % , and 5 % a risk of > 20 % . 78 % had at least one option to reduce their CHD risk , but only 45 % accurately identified the strategies best supported by evidence . 41 patients received the decision aid , 34 received usual care . In unadjusted analysis , the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24 % to 40 % ( absolute difference 16 % ; 95 % CI -4 % to + 37 % ) and increased the proportion who had a specific plan to reduce their risk from 24 % to 37 % ( absolute difference 13 % ; 95 % CI -7 % to + 34 % ) . In pre-post testing , the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk ( absolute increase ranging from 21 % to 47 % for planned medication use and 5 % to 16 % for planned behavioral interventions ) . Conclusion Our study confirms patients ' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients ' discussion s about CHD prevention with their doctor and their plans for CHD risk reduction . These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD . Trial Registration : Clinical Trials.gov",
"BACKGROUND The objective of this study was to examine the association of Joint National Committee ( JNC-V ) blood pressure and National Cholesterol Education Program ( NCEP ) cholesterol categories with coronary heart disease ( CHD ) risk , to incorporate them into coronary prediction algorithms , and to compare the discrimination properties of this approach with other noncategorical prediction functions . METHODS AND RESULTS This work was design ed as a prospect i ve , single-center study in the setting of a community-based cohort . The patients were 2489 men and 2856 women 30 to 74 years old at baseline with 12 years of follow-up . During the 12 years of follow-up , a total of 383 men and 227 women developed CHD , which was significantly associated with categories of blood pressure , total cholesterol , LDL cholesterol , and HDL cholesterol ( all P accuracy of this categorical approach was found to be comparable to CHD prediction when the continuous variables themselves were used . After adjustment for other factors , approximately 28 % of CHD events in men and 29 % in women were attributable to blood pressure levels that exceeded high normal ( > or = 130/85 ) . The corresponding multivariable-adjusted attributable risk percent associated with elevated total cholesterol ( > or = 200 mg/dL ) was 27 % in men and 34 % in women . CONCLUSIONS Recommended guidelines of blood pressure , total cholesterol , and LDL cholesterol effectively predict CHD risk in a middle-aged white population sample . A simple coronary disease prediction algorithm was developed using categorical variables , which allows physicians to predict multivariate CHD risk in patients without overt CHD",
"Background Multi-factorial intervention studies have been found to be successful in the initiation of lifestyle changes . However , little is known about the longer-term maintenance of health behavior improvements . The purpose of this study was to investigate whether improvements in physical activity and dietary habits achieved in a population -based multi-factorial lifestyle intervention of five years duration were maintained five years after intervention activities have ended . Methods The study was a population -based r and omized controlled trial , Inter99 ( 1999–2006 ) , Copenhagen , Denmark . Over five years , all participants in the intervention group ( n = 6,091 ) received individual lifestyle counseling ; participants at high risk of ischemic heart disease – according to pre-specified criteria – were also offered group-based counseling . The control group ( n = 3,324 ) was followed by question naires . Both groups were followed one , three , five , and ten years after baseline . Changes in physical activity and dietary habits ( intake of vegetables , fruit , fish , and saturated fat ) during and after the intervention were investigated using r and om-coefficient models . Results Five years after the intervention , women in the intervention group reported greater improvements in the intake of fruit ( MΔ = 90.2 g/week , p = 0.041 ) and less intake of saturated fat ( OR = 0.30 , 95 % CI : 0.17–0.54 ) than the control group . Men in the intervention group reported greater improvements in physical activity ( MΔ = 19.6 min/week , p = 0.003 ) and less intake of saturated fat ( OR = 0.31 , 95 % CI : 0.17–0.56 ) than the control group . Improvements in the intake of vegetables and fish achieved during the intervention were not maintained in the longer-term . Conclusions Screening and lifestyle counseling had sustained effects on physical activity and dietary habits five years after its discontinuation . The patterns of long-term changes in lifestyle differed across behaviors and between men and women . Trial registration Clinical Trials.gov ( NCT00289237",
"UNLABELLED Pilot study to vali date a Computerized Decision Support Systems ( CDS ) ( HTE-DLP ) for improving treatment of hyperlipidemia . METHODS HTE-DLP was programmed to offer automatic specific reminders for lipid treatment . Seventy-seven patients with high cardiovascular risk were r and omized . 10 expert physicians in cardiovascular-risk management were recruited . We assessed number of patients at LDL after 12 weeks of treatment . RESULTS A greater proportion of intervention group reached the LDL-C 70 mg/ml [ 55.0 % vs 12.5 % , p = 0.003 ; OR : 3.26 IC ( 1.16 - 9.15 ) ] . \" High potency statins \" and combined therapy were used more frequently in the intervention group than the control group ( p = 0.001 ) . Seven adverse effects were documented in the intervention group and two in the control group . An acceptable relationship was observed with regard to costeffectiveness in the intervention group . Physicians expressed good agreement with HTE-DLP ( 86.1 % ) and comfortable ease-of-use ( 85 % ) . CONCLUSIONS Use of a CDSS in high-risk cardiovascular patients result ed in a significant reduction in LDL-C levels",
"Background To improve risk factor management in diabetes , we need to support effective interactions between patients and healthcare providers . Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes , and is intended to empower patients in taking a proactive role in their disease management . Important features are : ( 1 ) involving patients in setting goals together with their provider ; ( 2 ) encourage them to prioritise on treatments that maximise relevant outcomes ; and ( 3 ) integration of the decision aid in the practice setting and workflow . As secondary aim , we want to evaluate the impact of different presentation formats , and learn more from the experiences of the healthcare providers and patients with the decision aid . Methods and design We will conduct a r and omised trial comparing four formats of the decision aid in a 2 × 2 factorial design with a control group . Patients with type 2 diabetes managed in 18 to 20 primary care practice s in The Netherl and s will be recruited . Excluded are patients with a recent myocardial infa rct ion , stroke , heart failure , angina pectoris , terminal illness , cognitive deficits , > 65 years at diagnosis , or not able to read Dutch . The decision aid is offered to the patients immediately before their quarterly practice consultation . The same decision information will be available to the healthcare provider for use during consultation . In addition , the providers receive a set of treatment cards , which they can use to discuss the benefits and risks of different options . Patients in the control group will receive care as usual . We will measure the effect of the intervention on patient empowerment , satisfaction with care , beliefs about medication , negative emotions , health status , prescribed medication , and predicted cardiovascular risk . Data will be collected with question naires and automated extraction from medical records in 6 months before and after the intervention . Discussion This decision aid is innovative in supporting patients and their healthcare providers to make shared decisions about multiple treatments , using the patient ’s data from electronic medical records . The results can contribute to the further development and implementation of electronic decision support tools for the management of chronic diseases . Trial registration Dutch Trial register NTR1942",
"Cardiovascular disease causes the death of around 80 % of patients with type 2 diabetes.1 However , risk factors for cardiovascular disease in such patients are often untreated2 despite the proved benefits of intervention . 3 4 One way to help clinicians identify patients at high risk of cardiovascular disease is to use cardiovascular primary prevention risk tables . These tables integrate the multiple risk factors into a single score . We did a pilot study to test the hypothesis that documentation of a cardiovascular risk score in the case notes would improve the management of cardiovascular risk factors . We recruited patients with type 2 diabetes who had no history of cardiovascular disease or renal disease . All patients were aged 35–75 years and attending a hospital",
"OBJECTIVES To investigate the impact of general health screenings and discussion s with general practitioners on the cardiovascular risk profile of a r and om population of patients . STUDY DESIGN A population -based , r and omized , controlled , 5-year follow-up trial conducted in a primary care setting . POPULATION The study group consisted of 2000 patients , r and omly selected middle-aged men and women aged 30 to 50 years from family practice s in the district of Ebeltoft , Denmark . Of these patients , 1507 ( 75.4 % ) agreed to participate . Patients were r and omized into ( 1 ) a control group who did not receive health screenings , ( 2 ) an intervention group that received 2 health screenings , ( 3 ) an intervention group that received both the 2 screenings and a 45-minute follow-up consultation annually with their general practitioner . OUTCOMES MEASURED Cardiovascular risk score ( CRS ) , body mass index ( BMI ) , blood pressure , serum cholesterol , carbon monoxide in expiratory air , and tobacco use . RESULTS After 5 years , the CRS , BMI , and serum cholesterol levels were lower in the intervention groups compared with the control group . The improved outcome was greater in the baseline risk groups . The number of patients with elevated CRS in the intervention groups was approximately half the number of patients with elevated CRS in the control group . The difference was not a result of medication use . There was no difference between the group that received consultations after the screenings and the group that had health screenings alone . CONCLUSIONS Health screenings reduced the CRS in the intervention groups . After 5 years of follow-up , the number of persons at elevated cardiovascular risk was about half that expected , based on the prevalence/proportion in a population not receiving the health checks ( the control group ) . The impact of intervention was higher among at-risk individuals . Consultations about health did not appear to improve the cardiovascular profile of the study population",
"BACKGROUND The Coronary Health Assessment Study ( CHAS ) was developed to determine the feasibility of using patient-specific , multifactorial computerized coronary risk profiles as a clinical decision aid to support primary prevention of CHD . METHODS Study participants included 253 community based physicians , r and omized into profile and control groups , and 958 of their patients . The profile group physicians received coronary risk profiles for their patients within 10 working days after the baseline patient assessment providing early feedback . The control group received their profiles only if the patient was clinical ly reevaluated during a 3-month follow-up visit . Patients ' coronary risk factors were evaluated at baseline and at follow-up . RESULTS The profile group had a significantly higher ( P ratio of high-risk/low-risk patients who returned for a follow-up visit compared to the control group ( 1.23 vs 0.77 ) . The patients in the profile group also had significantly ( P reductions in total cholesterol ( -0.5 vs -0.1 mmol/L ) , LDL cholesterol ( -0.4 vs 0.0 mmol/L ) , the total cholesterol/ HDL ratio ( -0.6 vs -0.2 ) , and the predicted 8-year coronary risk ( -1.8 vs -0.3 % ) . CONCLUSIONS Computer-generated coronary risk profiles can be effective in assisting physicians to identify high-risk patients . Their use is also associated with significantly greater improvements in the serum lipid profiles and the overall coronary risk of these patients",
"OBJECTIVE To analyze mental distress in relation to participation in lifestyle intervention . METHODS In 2000 - 2001 a total of 1948 consecutive participants , living in the suburbs of Copenhagen , were asked to complete a short version of SCL-90-R ( anxiety , depression , and somatization ) before screening , immediately after screening , and one and 10 months after screening . The screening classified participants into high or low risk individuals . High risk individuals received personal lifestyle counselling and were r and omized to either group-based counselling ( A ) or referred care ( B ) . Multilevel regression models taking into account repeated measurements and missing data at follow-up were performed . RESULTS Before screening , high risk individuals had higher scores on anxiety , depression , and somatization than low risk individuals . All categories of participants decreased in scores after screening . The scores increased after 1 month , but were still significantly lower than before screening . After 10 months , low risk individuals and high risk individuals in group A still had significantly lower scores ( except for depression ) compared with pre-screening levels , whereas high risk individuals in group B reached the pre-screening level ( except for anxiety ) . CONCLUSION Screening for risk of cardiovascular disease followed by health counselling does not give rise to mental distress , but has a temporary beneficial effect",
"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",
"BACKGROUND The multiprofessional teams in Finnish health centres are well placed to carry out interventions aim ed at the prevention of cardiovascular diseases . AIM To evaluate the effectiveness of an individually tailored multifactorial lifestyle intervention in primary care for individuals at high risk for cardiovascular disease . DESIGN OF STUDY A r and omised controlled trial was conducted over 24 months with interim assessment s at six and 12 months . SETTING A health centre in Finl and with a patient population of 11,000 . METHOD One hundred and fifty adults aged 18 to 65 years old with existing cardiovascular disease or multiple risk factors were r and omised to active multiprofessional risk factor intervention or to st and ard care . The main outcome measure was a change in cardiovascular risk-factor score . Secondary outcomes were changes in blood pressure , weight , body-mass index , serum cholesterol , blood glucose , smoking cessation , and exercise habits . RESULTS The cardiovascular risk score decreased by 28 % in the intervention group ( 23 % in the control group ) , body weight decreased by 3.7 % ( 2 % ) and total cholesterol decreased by 10.8 % ( 6.5 % ) , while time engaged in exercise increased by 39 % ( 43 % ) . Differences were not significant . CONCLUSIONS Cardiovascular risk levels of high-risk individuals decreased in both intervention and control groups . Primary care prevention should be targeted to high-risk persons . Long-term follow-up studies are needed",
"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 Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk ( CVR ) rather than by blood pressure levels alone . However , this paradigm change has not yet arrived in German General Practice . We have evaluated the effect of an educational outreach visit with general practitioners ( GPs ) , encouraging them to consider CVR in treatment decisions for patients with hypertension . Methods Prospect i ve cluster-r and omised trial comprising 3443 patients with known hypertension treated by 87 GPs . Practice s were r and omly assigned to complex ( A ) or simple ( B ) intervention . Both groups received a guideline by mail ; group A also received complex peer intervention promoting the concept of global CVR . Clinical data were collected at baseline and 6 - 9 months after intervention . Main outcome was improvement of calculated CVR in the predefined sub population of patients with a high CVR ( 10-year mortality ≥5 % ) , but no manifest cardiovascular disease . Results Adjusted for baseline the follow-up CVR were 13.1 % ( 95 % CI 12.6%-13.6 % ) ( A ) and 12.6 % ( 95 % CI 12.2%-13.1 % ) ( B ) with a group difference ( A vs. B ) of 0.5 % ( -0.2%-1.1 % ) , p = 0.179 . The group difference was -0.05 % in patients of GPs familiar with global CVR and 1.1 % in patients of GPs not familiar with with global CVR . However , this effect modification was not significant ( p = 0.165 ) . Pooled over groups , the absolute CVR reduction from baseline was 1.0 % , p 0.001 . The ICC was 0.026 ( p = 0.002 ) . Hypertension control ( BP 140/90 mmHg ) improved in the same sub population from 38.1 to 45.9 % in the complex intervention group , and from 35.6 to 46.5 % in the simple intervention group , with adjusted follow-up control rates of 46.7 % ( 95 % CI 40.4%-53.1 % ) ( A ) and 46.9 % ( 95 % CI 40.3%-53.5 % ( B ) and an adjusted odds ratio ( A vs B ) of 0.99 ( 95 % CI 0.68 - 1.45 ) , p = 0.966 . Conclusions Our complex educational intervention , including a clinical outreach visit , had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention . Trial registration IS RCT N44478543",
"Abstract Objectives : To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk , blood pressure , and prescribing of cardiovascular drugs in hypertensive patients . Design : Cluster r and omised controlled trial . Setting : 27 general practice s in Avon . Participants : 614 patients aged between 60 and 79 years with high blood pressure . Interventions : Patients were r and omised to computer based clinical decision support system plus cardiovascular risk chart ; cardiovascular risk chart alone ; or usual care . Main outcome measures : Percentage of patients in each group with a five year cardiovascular risk≥10 % , systolic blood pressure , diastolic blood pressure , prescribing of cardiovascular drugs . Results : Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10 % than patients receiving usual care . Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk≥10 % than chart only patients , odds ratio 2.3 ( 95 % confidence interval 1.1 to 4.8 ) . The chart only group had significantly lower systolic blood pressure compared with the usual care group ( difference in means−4.6 mm Hg ( 95 % confidence interval−8.4 to−0.8 ) . Reduction of diastolic blood pressure did not differ between the three groups . The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups . Conclusions : The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended . Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure ",
"BACKGROUND Computerized decision support systems ( CDSSs ) linked with electronic medical records ( EMRs ) are promoted as an effective means of improving patient care . However , very few high- quality studies are set in routine , community-based clinical care , and no consistent evidence of an effect on patient outcomes has been found . METHODS A r and omized controlled trial among EMR-using primary care practice s in Ontario , Canada . Patients 55 years or older with previous vascular events , diabetes mellitus , hypertension , or hypercholesterolemia were r and omized to the Computerization of Medical Practice s for the Enhancement of Therapeutic Effectiveness ( COMPETE III ) CDSS intervention or to usual care . The intervention included personally tailored electronic vascular risk monitoring and treatment advice shared between the physician and patient , risk calculation , and a clinical re source . The primary outcome was a composite score of 8 recommended process outcomes at 1 year . Data collectors were blinded to group allocation . Analysis used the intention-to-treat principle with multiple imputation for missing data . RESULTS We r and omized and included in the analysis 1102 patients in 49 community-based physician practice s ( 53.4 % female ; mean age , 69.1 years ; 28.0 % with a previous vascular event ) . The intervention group ( 545 [ 49.5 % ] ) had a significantly greater improvement in mean process composite , with a difference of 4.70 ( P continuity of care ( 4.18 ; P ability to improve their vascular health ( 3.07 ; P -vascular events , clinical variables , and quality of life-were not improved . CONCLUSION Despite favorable review s and important improvements in the complex processes required to reduce vascular risk , clinical outcomes remain unchanged",
"OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients",
"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 There is nonoptimal adherence of general practitioners ( GPs ) and patients to cardiovascular risk reducing interventions . GPs find it difficult to assimilate multiple risk factors into an accurate assessment of cardiovascular risk . In addition , communicating cardiovascular risk to patients has proved to be difficult . Aims Improving primary prevention of cardiovascular disease ( CVD ) in primary care by enhancing patient involvement in the use of a decision support tool . Design Cluster r and omized trial . Methods Thirty-four GPs included patients ( 40 - 75 years old ) without CVD . In an interactive , small group training session lasting 4h , the GPs in the intervention group were trained to use the guidelines on cardiovascular risk and a decision support tool . The control group received educational material s about the guidelines on paper . GPs ’ clinical performance and patients ’ risk perception and self-reported lifestyles were measured at baseline and after 6 months . Results Thirty-four GPs recorded 490 consultations , 276 in the intervention and 214 in the control group . After 6 months , no significant effect of the intervention on the GPs ’ performance or the patients ’ risk perception was found . There was only an effect on self-reported lifestyle , in that more men in the intervention group than in the control group increased their physical activity ( odds ratio 3.8 , 95 % confidence interval 1.7–8.7 ) . Conclusion The 4-h interactive , small group training did not guarantee correct application of the decision support tool and as such failed to improve GPs ’ performance or correct patients ’ risk perception . The positive effect on physical activity justifies further research on patient involvement . Eur J Cardiovasc Prev Rehabil 14 : 44 - 50 © 2007 The European Society of",
"Background The periodic health check-up has been a fundamental part of routine medical practice for decades , despite a lack of consensus regarding its value in health promotion and disease prevention . A large-scale Danish population -based preventive programme ‘ Check your health ’ was developed based on available evidence of screening and successive accepted treatment , prevention for diseases and health promotion , and is closely aligned with the current health care system . The objective of the ‘ Check your health ’ [ CORE ] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population -level to all individuals aged 30–49 years , and to establish the cost-effectiveness . Methods / Design The trial will be conducted as a pragmatic household-cluster r and omised controlled trial involving 10,505 individuals . All individuals within a well-defined geographical area in the Central Denmark Region , Denmark ( DK ) were r and omised to be offered a preventive health check ( Intervention group , n = 5250 ) or to maintain routine access to healthcare until a delayed intervention ( Comparison group , n = 5255 ) . The programme consists of a health examination which yields an individual risk profile , and according to this participants are assigned to one of the following interventions : ( a ) referral to a health promoting consultation in general practice , ( b ) behavioural programmes at the local Health Centre , or ( c ) no need for follow-up . The primary outcomes at 4 years follow-up are : ten-year-risk of fatal cardiovascular event ( Heart-SCORE model ) , physical activity level ( self-report and cardiorespiratory fitness ) , quality of life ( SF12 ) , sick leave and labour market attachment . Cost-effectiveness will be evaluated according to life years gained , direct costs and total health costs . Intention to treat analysis will be performed . Discussion Results from the largest Danish health check programme conducted within the current healthcare system , spanning the sectors which share responsibility for the individual , will provide a scientific basis to be used in the development of systems to optimise population health in the 21st century . Trial registration The trial has registered at Clinical Trials.gov with an ID : NCT02028195 ( 7 . March 2014 )",
"Primary care facilities may be a natural setting for delivering interventions that focus on behaviors that improve cardiovascular disease ( CVD ) risk factors . The purpose of this study was to examine the 24-month effects of the Activity Counseling Trial ( ACT ) on CVD risk factors , to examine whether changes in CVD risk factors differed according to baseline risk factor status , and to examine whether changes in fitness were associated with changes in CVD risk factors . ACT was a 24-month multicenter r and omized controlled trial to increase physical activity . Participants were 874 inactive men and women aged 35–74 years . Participants were r and omly assigned to one of three arms that varied by level of counseling , intensity , and re source requirements . Because there were no significant differences in change over time between arms on any of the CVD risk factors examined , all arms were combined , and the effects of time , independent of arm , were examined separately for men and women . Time × Baseline risk factor status interactions examined whether changes in CVD risk factors differed according to baseline risk factor status . Significant improvements in total cholesterol , high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol , the ratio of total cholesterol to HDL-C , and triglycerides were seen in both men and women who had high ( or low for HDL-C ) baseline levels of risk factors , whereas significant improvements in diastolic blood pressure were seen only in those men with high baseline levels . There were no improvements in any risk factors among participants with normal baseline levels . Changes in fitness were associated with changes in a number of CVD risk factors . However , most relationships disappeared after controlling for changes in body weight . Improvements in lipids from the ACT interventions could reduce the risk of coronary heart disease in people with already high levels of lipids by 16%–26 % in men and 11%–16 % in women . Interventions that can be implemented in health care setting s nationwide and result in meaningful population -wide changes in CVD risk factors are needed . The ACT physical activity interventions produced substantial improvements among men and women with elevated CVD risk factors",
"Background There is a need to find innovative approaches for translating best practice s for chronic disease care into daily primary care practice routines . Primary care plays a crucial role in the prevention and management of cardiovascular disease . There is , however , a substantive care gap , and many challenges exist in implementing evidence -based care . The Improved Delivery of Cardiovascular Care ( IDOCC ) project is a pragmatic trial design ed to improve the delivery of evidence -based care for the prevention and management of cardiovascular disease in primary care practice s using practice outreach facilitation . Methods The IDOCC project is a stepped-wedge cluster r and omized control trial in which Practice Outreach Facilitators work with primary care practice s to improve cardiovascular disease prevention and management for patients at highest risk . Primary care practice s in a large health region in Eastern Ontario , Canada , were eligible to participate . The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period . Starting with audit and feedback , consensus building , and goal setting , the practice s are supported in changing practice behavior by incorporating chronic care model elements . These elements include ( a ) evidence -based decision support for providers , ( b ) delivery system re design for practice s , ( c ) enhanced self-management support tools provided to practice s to help them engage patients , and ( d ) increased community re source linkages for practice s to enhance referral of patients . The primary outcome is a composite score measured at the level of the patient to represent each practice 's adherence to evidence -based guidelines for cardiovascular care . Qualitative analysis of the Practice Outreach Facilitators ' written narratives of their ongoing practice interactions will be done . These textual analyses will add further insight into underst and ing critical factors impacting project implementation . Discussion This pragmatic , stepped-wedge r and omized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence -based approaches to care delivery . This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality -improvement program in primary care . It is anticipated that through the evaluation of IDOCC , we will demonstrate an effective , practical , and sustainable means of improving the cardiovascular health of patients across Canada . Trial Registration Clinical Trials.gov :",
"Abstract Background Cardiovascular disease ( CVD ) is an important worldwide cause of mortality . In The Netherl and s , CVD is the leading cause of death for women and the second cause of death for men . Recommendations for diagnosis and treatment of CVD are not well implemented in primary care . In this study , we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with ( high risk for ) CVD . Methods / design A two-arm cluster r and omized trial is planned . We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values , risk profiling and lifestyle advice . Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management ( CVRM ) . They are also advised to screen for the presence and severity of depressive symptoms in patients . We also advise practice nurses to use selected E-health options ( selected websites and Twitter-consult ) in patients without symptoms of depression . Patients with mild depressive symptoms are referred to a physical exercise group . We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM . Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practice s in several geographical areas in The Netherl and s. The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients . Patients ’ health-related lifestyles ( physical exercise , diet and smoking status ) will be measured with vali date d question naires and medical record audit will be performed to document estimated CVD risk . Additionally , we will survey and interview participating healthcare professionals for exploration of processes of change . The control practice s will provide usual care . Discussion Tailored interventions can improve healthcare . An underst and ing of the methods to reach the improved healthcare can be improved . This research contributes a share of it . Identification of the determinants of practice and developing implementation interventions were two steps which were completed . The subsequent step was implementation of the tailored intervention program . Trial registration Name trial register : Nederl and s trial registerWeb address of trial register : http://www.trialregister.nl Data of registration : 11 July 2013Number of registration :",
"Background The underlying reasons for differences between clinical practice and systematic ally developed guidelines vary from one clinical problem to another . It is therefore logical to tailor strategies to support the implementation of guidelines to address identified barriers to change . The objective of this trial is to evaluate the effects of a tailored intervention to support the implementation of systematic ally developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease . Methods / Design Unblinded , cluster-r and omised trial . 150 general practice s will be recruited from two geographical areas in Norway , and r and omised to the intervention or control group ( passive dissemination of guidelines ) . Outcomes will be measured for all eligible patients seen in the participating practice s during one year after the intervention . A multifaceted intervention has been tailored to address identified barriers to change . Key components are an educational outreach visit with audit and feedback , and computerised reminders . Pharmacists will conduct the visits . During the outreach visit the main recommendations will be presented and software will be installed that links to the electronic medical record systems used in the participating practice s. The software will perform an audit that will be fed back during the visit , present pop-up reminders for patients with high blood pressure or cholesterol , and provide a cardiovascular risk calculator and patient education material . The main outcomes are the proportions of 1 ) first time prescriptions for hypertension where thiazides are not prescribed , 2 ) patients not assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs , and 3 ) patients treated for hypertension or high cholesterol for three months or more who have not achieved recommended treatment goals",
"Aim : To examine the effect of a r and omized multiple risk factor intervention study for prevention of ischaemic heart disease ( IHD ) on the development in physical activity over a 36-month period . Methods : Two r and om sample s ( high intensity intervention , group A , n=11,708 ; low intensity intervention , group B , n=1,308 ) were invited for a health examination , an assessment of absolute risk of developing IHD , and an individualized lifestyle intervention . The participation rate was 52.5 % . High-risk persons in group A were also offered diet/physical activity and /or smoking cessation group counselling . High-risk persons in group B were referred to their GP . High-risk persons were re-counselled after 12 and 36 months . The control group ( group C , n=5,264 , response rate=61.3 % ) answered a mailed question naire . Data were analysed using longitudinal linear regression models with r and om effects . Main outcome : Change in physical activity from baseline to 12- and 36-month follow-up . Results : In men , the high-intensity ( group A ) intervention had a beneficial effect at 12-month follow-up , whereas after 36 months both the high-intensity and the low-intensity ( group B ) intervention had a beneficial effect on the development in physical activity when compared with group C. This was regardless of baseline physical activity level . At 36-month follow-up there was no significant difference between groups A and B. There was no intervention effect among women . Conclusions : Only men seemed to benefit from the intervention",
"Background Cardiovascular diseases ( CVD ) are the leading cause of death and the third cause of disability in Europe . Prevention programmes should include interventions aim ed at a reduction of medical risk factors ( hypertension , hypercholesterol , hyperglycemia , overweight and obesity ) as well as behavioural risk factors ( sedentary lifestyle , high fat intake and low fruit and vegetable intake , smoking ) . The aim of this study is to investigate the effects of a multifaceted , multidisciplinary electronic prevention programme on cardiovascular risk factors . Methods / Design In a r and omized controlled trial , one group will receive a maximal intervention (= intervention group ) . The intervention group will be compared to the control group receiving a minimal intervention . An inclusion of 350 patients in total , with a follow-up of 3 years is foreseen . The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas , insuring for guaranteed income in case of illness for self-employed . The maximal intervention group receives several prevention consultations by their general practitioner ( GP ) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors . These patients receive a follow-up with intensive support of health behaviour change via different methods , i.e. a tailored website and personal advice of a multidisciplinary team ( psychologist , physiotherapist and dietician ) . The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines . The primary outcome measures will be cardiovascular risk factors . The secondary outcome measures are cardiovascular events , quality of life , costs and incremental cost effectiveness ratios . The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback . Discussion This trial incorporates interventions by GPs and other health professionals aim ing at a reduction of medical and behavioural cardiovascular risk factors . An assessment of clinical , psychological and economical outcome measures will be performed . Trial registration IS RCT",
"Background Community-based programs are being widely adopted in the struggle to prevent cardiovascular diseases . No study has been conducted in Japan to evaluate the effects of a community-based health promotion program by using the Framingham risk score and 10-year CHD risk as outcome variables . The aim of the present study was to assess the effects of a program involving 6-month intervention and 18-month follow-up using such outcomes . Methods Participants ( n = 1,983 , 39.5 % women , mean age 63.4 years ) were selected for the study in 2008 . Of these 1,983 , 347 ( 42.4 % women ) subjects received the 6-month intervention . The intervention included individual counseling and group sessions , among others . After 18 months , 1,278 participants ( intervention group : 238 , control group : 1,040 ) were followed up . Changes in the Framingham risk score and 10-year coronary heart disease ( CHD ) risk were evaluated . ANCOVA and multiple logistic models adjusted for baseline value , age , sex and intervention times were used . Results The results showed that the differences in the Framingham risk score and mean 10-year CHD risk were significant in the intervention group compared with the control group after 6-month follow-up ( -0.46 and -1.12 , respectively ) and were also significant after 18-month follow-up ( -0.39 and -0.85 , respectively ) . The proportion of those with intermediate 10-year CHD risk ( > = 10 % ) was significantly lower at 6 months ( OR 0.30 , 95 % CI 0.12 - 0.74 ) and at 18 months ( OR 0.41 , 95 % CI 0.19 - 0.92 ) . Conclusions The six-month intervention program effectively decreased estimated 10-year CHD risk and the effects were still present at 18-month follow-up . Trial registration UMIN-CTR :",
"Background Decision aids offer promise as a practical solution to improve patient decision making about coronary heart disease ( CHD ) prevention medications and help patients choose medications to which they are likely to adhere . However , little data is available on decision aids design ed to promote adherence . Methods In this paper , we report on secondary analyses of a r and omized trial of a CHD adherence intervention ( second generation decision aid plus tailored messages ) versus usual care in an effort to underst and how the decision aid facilitates adherence . We focus on data collected from the primary study visit , when intervention participants presented 45 minutes early to a previously scheduled provider visit ; viewed the decision aid , indicating their intent for CHD risk reduction after each decision aid component ( individualized risk assessment and education , values clarification , and coaching ) ; and filled out a post-decision aid survey assessing their knowledge , perceived risk , decisional conflict , and intent for CHD risk reduction . Control participants did not present early and received usual care from their provider . Following the provider visit , participants in both groups completed post-visit surveys assessing the number and quality of CHD discussion s with their provider , their intent for CHD risk reduction , and their feelings about the decision aid . Results We enrolled 160 patients into our study ( 81 intervention , 79 control ) . Within the decision aid group , the decision aid significantly increased knowledge of effective CHD prevention strategies ( + 21 percentage points ; adjusted p accuracy of perceived CHD risk ( + 33 percentage points ; adjusted p decreased decisional conflict ( -0.63 ; adjusted p CHD prevention discussion s with providers ( + 31 percentage points ; adjusted p improved perceptions of some features of patient-provider interactions . Further , it increased participants ’ intentions for any effective CHD risk reducing strategies ( + 21 percentage points ; 95 % CI 5 to 37 percentage points ) , with a majority of the effect from the educational component of the decision aid . Ninety-nine percent of participants found the decision aid easy to underst and and 93 % felt it easy to use . Conclusions Decision aids can play an important role in improving decisions about CHD prevention and increasing patient-provider discussion s and intent to reduce CHD risk",
"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",
"Background Large gaps exist in the implementation of guideline recommendations for cardiovascular disease ( CVD ) risk management . Electronic decision support ( EDS ) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia . We have developed HealthTracker , a multifaceted EDS and quality improvement intervention to improve the management of CVD risk . Methods / design It is hypothesised that the use of HealthTracker over a 12-month period will result in : ( 1 ) an increased proportion of patients receiving guideline -indicated measurements of CVD risk factors and ( 2 ) an increased proportion of patients at high risk will receive guideline -indicated prescriptions for lowering their CVD risk . Sixty health services ( 40 general practice s and 20 Aboriginal Community Controlled Health Services ( ACCHSs ) will be r and omised in a 1:1 allocation to receive either the intervention package or continue with usual care , stratified by service type , size and participation in existing quality improvement initiatives . The intervention consists of point-of-care decision support ; a risk communication interface ; a clinical audit tool to assess performance on CVD-related indicators ; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance . The control arm will continue with usual care without access to these intervention components . Quantitative data will be derived from cross-sectional sample s at baseline and end of study via automated data extraction . Detailed process and economic evaluations will also be conducted . Ethics and dissemination The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee ( HREC ) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC . Formal agreements with each of the participating sites have been signed . In addition to the usual scientific forums , results will be disseminated via newsletters , study websites , face-to-face feedback forums and workshops . Trial registration The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910",
"Background . Statin Choice is a decision aid about taking statins . The optimal mode of delivering Statin Choice ( or any other decision aid ) in clinical practice is unknown . Methods . To investigate the effect of mode of delivery on decision aid efficacy , the authors further explored the results of a concealed 2 × 2 factorial clustered r and omized trial enrolling 21 endocrinologists and 98 diabetes patients and r and omizing them to 1 ) receive either the decision aid or pamphlet about cholesterol , and 2 ) have these delivered either during the office visit ( by the clinician ) or before the visit ( by a research er ) . We estimated between-group differences and their 95 % confidence intervals ( CI ) for acceptability of information delivery ( 1—7 ) , knowledge about statins and coronary risk ( 0—9 ) , and decisional conflict about statin use ( 0—100 ) assessed immediately after the visit . Follow-up was 99 % . Results . The relative efficacy of the decision aid v. pamphlet interacted with the mode of delivery . Compared with the pamphlet , patients whose clinicians delivered the decision aid during the office visit showed significant improvements in knowledge ( difference of 1.6 of 9 questions , CI 0.3 , 2.8 ) and nonsignificant trends toward finding the decision aid more acceptable ( odds ratio 3.1 , CI 0.9 , 11.2 ) and having less decisional conflict ( difference of 7 of 100 points , CI -4 , 18 ) than when a research er delivered the decision aid just before the office visit . Conclusions . Delivery of decision aids by clinicians during the visit improves knowledge and shows a trend toward better acceptability and less decisional conflict",
"BACKGROUND Current guidelines recommend global risk assessment to guide vascular risk factor management ; however , most provider-patient communication focuses on individual risk factors in isolation . We sought to evaluate the impact of personalized coronary heart disease and stroke risk communication on patients ' knowledge , beliefs , and health behavior . METHODS We conducted a r and omized controlled trial testing personalized risk communication based on Framingham stroke and coronary heart disease risk scores compared with a st and ard risk factor education . A total of 89 patients were recruited from primary care clinics and followed up for 3 months . Outcomes included the following : risk perception and worry , risk factor knowledge , risk reduction preferences and decision conflict , medication adherence , health behaviors , and blood pressure . RESULTS Participants had a very low underst and ing of numeric information , high perceived risk for stroke or myocardial infa rct ion , and high proportion of medication nonadherence . Patients ' ability to identify vascular risk factors increased with personalized risk communication ( mean 1.8 additional risk factors , 95 % CI 1.3 - 2.2 ) and st and ard risk factor education ( mean 1.6 additional risk factors , 95 % CI 1.1 - 2.1 ) immediately after the intervention but was not sustained at 3 months . Patients in the personalized group had less decision conflict than the st and ard risk factor education group over intended risk reduction strategies ( 5.9 vs 10.1 , P = .003 ) . There was no appreciable impact of either communication strategy on medication adherence , exercise , smoking cessation , or blood pressure . CONCLUSIONS Personalized risk communication was preferred by patients and had a small impact on risk reduction preferences and decision conflict but had no impact on patient beliefs or behavior compared with st and ard risk factor education",
"Background To evaluate the efficacy of Counselling and Advisory Care for Health ( COACH ) programme in managing dyslipidaemia among primary care practice s in Malaysia . This open-label , parallel , r and omised controlled trial compared the COACH programme delivered by primary care physicians alone ( PCP arm ) and primary care physicians assisted by nurse educators ( PCP-NE arm ) . Methods This was a multi-centre , open label , r and omised trial of a disease management programme ( COACH ) among dyslipidaemic patients in 21 Malaysia primary care practice s. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia ; 149 were r and omised to the COACH programme delivered by primary care physicians assisted by nurse educators ( PCP-NE ) and 148 to care provided by primary care physicians ( PCP ) alone . The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms . Secondary endpoints included mean percentage change from baseline of lipid profile ( TC , LDL-C , HDL-C , TG , TC : HDL ratio ) , Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24 . The study also assessed the sustainability of programme efficacy at week 36 . Results Both study arms demonstrated improvement in LDL-C from baseline . The least squares ( LS ) mean change from baseline LDL-C were −30.09 % and −27.54 % for PCP-NE and PCP respectively . The difference in mean change between groups was 2.55 % ( p=0.288 ) , with a greater change seen in the PCP-NE arm . Similar observations were made between the study groups in relation to total cholesterol change at week 24 . Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups , 3.01 % , 95 % CI 0.12 - 5.90 , p=0.041 , at week 24 . There was no significant difference in lipid outcomes between 2 study groups at week 36 ( 12 weeks after the programme had ended ) . Conclusion Patients who received coaching and advice from primary care physicians ( with or without the assistance by nurse educators ) showed improvement in LDL-cholesterol . Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone ; however , the improvements were not maintained when the services were withdrawn . Trial registration National Medical Research Registration ( NMRR ) Number : NMRR-08 - 287 - 1442Trial Registration Number ( Clinical Trials.gov Identifier ) :",
"Aim : To compare the effects of information pamphlets with those of group counselling on cardiovascular risk among individuals from a community with low socioeconomic status . Methods : Risk factors for coronary heart disease were assessed in 1131 men and women from a community with low socioeconomic status in suburban Melbourne . Individuals deemed to be at moderate risk , on the basis of an integrated risk score greater than 65 , were asked to participate in a r and omized trial comparing two simple interventions design ed to reduce cardiovascular risk . One hundred and sixty-four individuals were r and omly assigned to group A ( n = 85 ) and participated in a single group counselling session lasting between 1.5 and 2.0 h. Group B ( n = 79 ) received a specially prepared pamphlet that provided brief written information concerning risk-factor modification . Both groups were asked to attend a follow-up assessment of risk factors 3 and 6 months after entry . Results : There was no significant difference in the change in risk-factor levels between those receiving information pamphlets and those attending the group counselling session after 3 or 6 months of follow-up . Small but significant decreases ( P in systolic and diastolic blood pressures ( −−5/4 mmHg for group A , −−5/3 mmHg for group B ) , total plasma cholesterol level ( −−0.30 mmol/l for groups A and B ) and overall coronary risk score ( −14.4 and −13.9 for groups A and B , respectively ) . Body weight remained unchanged during the study period in both groups . Conclusion : Screening together with 1.5−2 h group counselling had no more influence on cardiovascular risk factors than screening together with provision of information pamphlets in a population with low socioeconomic status",
"OBJECTIVE The Diabetes Care Protocol ( DCP ) , a multifaceted computerized decision support diabetes management intervention , reduces cardiovascular risk of type 2 diabetic patients . We performed a cost-effectiveness analysis of DCP from a Dutch health care perspective . RESEARCH DESIGN AND METHODS A cluster r and omized trial provided data of DCP versus usual care . The 1-year follow-up patient data were extrapolated using a modified Dutch microsimulation diabetes model , computing individual lifetime health-related costs , and health effects . Incremental costs and effectiveness ( quality -adjusted life-years [ QALYs ] ) were estimated using multivariate generalized estimating equations to correct for practice -level clustering and confounding . Incremental cost-effectiveness ratios ( ICERs ) were calculated and cost-effectiveness acceptability curves were created . Stroke costs were calculated separately . Subgroup analyses examined patients with and without cardiovascular disease ( CVD+ or CVD− patients , respectively ) . RESULTS Excluding stroke , DCP patients lived longer ( 0.14 life-years , P = NS ) , experienced more QALYs ( 0.037 , P = NS ) , and incurred higher total costs ( € 1,415 , P = NS ) , result ing in an ICER of € 38,243 per QALY gained . The likelihood of cost-effectiveness given a willingness-to-pay threshold of € 20,000 per QALY gained is 30 % . DCP had a more favorable effect on CVD+ patients ( ICER = € 14,814 ) than for CVD− patients ( ICER = € 121,285 ) . Coronary heart disease costs were reduced ( € −587 , P CONCLUSIONS DCP reduces cardiovascular risk , result ing in only a slight improvement in QALYs , lower CVD costs , but higher total costs , with a high cost-effectiveness ratio . Cost-effective care can be achieved by focusing on cardiovascular risk factors in type 2 diabetic patients with a history of CVD",
"OBJECTIVE To determine whether nurse case management with a therapeutic algorithm could effectively improve rates of control for hypertension , hyperglycemia , and hyperlipidemia compared with usual care among veterans with diabetes . RESEARCH DESIGN AND METHODS A r and omized controlled trial of diabetic patients that had blood pressure ( BP ) > 140/90 mmHg , hemoglobin A1c ( HbA1c ) > 9.0 % , or LDL > 100 mg/dL. Intervention patients received case management ( n = 278 ) versus usual care ( n = 278 ) over a 1-year period . The primary outcome was the percentage of patients achieving simultaneous control of all three parameters ( defined by BP included improvements within each individual component of the composite primary outcome . Differences between groups were analyzed using t tests , Pearson χ2 tests , and linear and logistic regression . RESULTS A greater number of individuals assigned to case management achieved the primary study outcome of having all three outcome measures under control ( 61 [ 21.9 % ] compared with 28 [ 10.1 % ] in the usual care group [ P individual treatment goals of HbA1c and BP LDL patients with diabetes , nurse case managers using a treatment algorithm can effectively improve the number of individuals with control of multiple cardiovascular risk factors at 1 year",
"BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor . METHODS We recruited 68 primary care family and internal medicine practice s ; 66 were r and omly allocated to a study arm ; 5 practice s withdrew , result ing in 29 receiving the Third Adult Treatment Panel ( ATP III ) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC-7 ) . The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment . All practice s received copies of each clinical practice guideline , an introductory lecture , 1 performance feedback report , and 4 visits for intervention-specific academic detailing . Data were abstract ed at 61 practice s from r and om sample s of medical records of patients treated from June 1 , 2001 , through May 31 , 2003 ( baseline ) , and from May 1 , 2004 , through April 30 , 2006 ( follow-up ) . The proportion screened with subsequent appropriate decision making ( primary outcome ) was calculated . Generalized estimating equations were used to compare results by arm , accounting for clustering of patients within practice s. RESULTS We examined 5057 baseline and 3821 follow-up medical records . The screening rate for lipid levels increased from 43.6 % to 49.0 % ( ATP III practice s ) and from 40.1 % to 50.8 % ( control practice s ) ( net difference , -5.3 % [ P = .22 ] ) . Appropriate management of lipid levels decreased slightly ( 73.4 % to 72.3 % ) in ATP III practice s and more markedly ( 79.7 % to 68.9 % ) in control practice s. The net change in appropriate management favored the intervention ( + 9.7 % ; 95 % confidence interval [ CI ] , 2.8%-16.6 % [ P Appropriate drug prescription within 4 months decreased in both arms ( 38.8 % to 24.8 % in ATP III practice s and 45.3 % to 24.1 % in control practice s ; net change , + 7.2 % [ P = .37 ] ) Overtreatment declined from 6.6 % to 3.9 % in ATP III and rose from 4.2 % to 6.4 % in control practice s ( net change , -4.9 % [ P = .01 ] ) . CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines . Trial Registration clinical trials.gov Identifier : NCT00224848",
"Background : “ CardioTest ® ” is a tool for cardiovascular risk assessment . The aim of this study was to evaluate if this test used in Swiss pharmacies provides risk stratification and if it had impact on individual behaviour . Methods : Individuals were evaluated ( blood pressure , body waist circumference , r and om blood sample s and coronary artery disease risk factors ) . The cardiovascular risk was calculated ( AGLA Risk Score ( ARS ) a modified PROCAM Score ) and participants were informed about their result . One year after the initial testing individuals were followed up by question naire with respect to the action they had taken based upon the ARS results . The relation between ARS results and events during follow-up were assessed . Events were defined as cardiovascular events due to chest pain , myocardial infa rct ion or stroke . Result : A total of 1415 individuals were contacted for follow-up , 746 ( 53 % ) with a mean age of 62.7 ( ±12.8 ) years ( 60 % were male ) returned their question naire . The cardiovascular risk throughout the study - population turned out to be low : 73.9 % had a low ARS 20 % . Significantly more participants with ARS > 20 % consulted their family doctor ( 46.2 % ) than those with ARS 10 - 20 % ( 25.2 % ) and ARS suffered a cardiovascular event . The event rates increased as a function of ARS . Conclusion : The overall cardiovascular risk of individuals participating in a pharmacy based risk assessment program seems to be low . CardioTest ® provided risk stratification with respect to future cardio-vascular events . CardioTest ® seems to have impact on individual behavior and lifestyle modification . Other setting s and locations for screening might be considered to reach higher risk individuals at an earlier stage",
"BACKGROUND Treatment of cardiovascular risk factors based on disease risk depends on valid risk prediction equations . We aim ed to develop , and apply in example countries , a risk prediction equation for cardiovascular disease ( consisting here of coronary heart disease and stroke ) that can be recalibrated and up date d for application in different countries with routinely available information . METHODS We used data from eight prospect i ve cohort studies to estimate coefficients of the risk equation with proportional hazard regressions . The risk prediction equation included smoking , blood pressure , diabetes , and total cholesterol , and allowed the effects of sex and age on cardiovascular disease to vary between cohorts or countries . We developed risk equations for fatal cardiovascular disease and for fatal plus non-fatal cardiovascular disease . We vali date d the risk equations internally and also using data from three cohorts that were not used to create the equations . We then used the risk prediction equation and data from recent ( 2006 or later ) national health surveys to estimate the proportion of the population at different levels of cardiovascular disease risk in 11 countries from different world regions ( China , Czech Republic , Denmark , Engl and , Iran , Japan , Malawi , Mexico , South Korea , Spain , and USA ) . FINDINGS The risk score discriminated well in internal and external validations , with C statistics generally 70 % or more . At any age and risk factor level , the estimated 10 year fatal cardiovascular disease risk varied substantially between countries . The prevalence of people at high risk of fatal cardiovascular disease was lowest in South Korea , Spain , and Denmark , where only 5 - 10 % of men and women had more than a 10 % risk , and 62 - 77 % of men and 79 - 82 % of women had less than a 3 % risk . Conversely , the proportion of people at high risk of fatal cardiovascular disease was largest in China and Mexico . In China , 33 % of men and 28 % of women had a 10-year risk of fatal cardiovascular disease of 10 % or more , whereas in Mexico , the prevalence of this high risk was 16 % for men and 11 % for women . The prevalence of less than a 3 % risk was 37 % for men and 42 % for women in China , and 55 % for men and 69 % for women in Mexico . INTERPRETATION We developed a cardiovascular disease risk equation that can be recalibrated for application in different countries with routinely available information . The estimated percentage of people at high risk of fatal cardiovascular disease was higher in low-income and middle-income countries than in high-income countries . FUNDING US National Institutes of Health , UK Medical Research Council , Wellcome Trust",
"Background High blood pressure ( HBP ) is a major risk factor for cardiovascular disease ( CVD ) . European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method , the modification of lifestyles to prevent CVD , and achieving good control over risk factors . The EDUCORE ( Education and Coronary Risk Evaluation ) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD ; Methods / Design This work describes a protocol for a clinical trial , r and omised by clusters and involving 22 primary healthcare clinics , to test the effectiveness of the EDUCORE method . The number of patients required was 736 , all between 40 and 65 years of age ( n = 368 in the EDUCORE and control groups ) , all of whom had been diagnosed with HBP at least one year ago , and all of whom had poorly controlled hypertension ( systolic blood pressure ≥ 140 mmHg and /or diastolic ≥ 90 mmHg ) . All personnel taking part were explained the trial and trained in its methodology . The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action , plus the receipt of a pamphlet explaining how to better maintain cardiac health . The main outcome variable was the control of blood pressure ; secondary outcome variables included the SCORE score , therapeutic compliance , quality of life , and total cholesterol level . All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months . Information on sex , age , educational level , physical activity , body mass index , consumption of medications , change of treatment and blood analysis results was also recorded ; Discussion The EDUCORE method could provide a simple , inexpensive means of improving blood pressure control , and perhaps other health problems , in the primary healthcare setting ; Trial registration The trial was registered with Clinical Trials.gov , number NCT01155973 [ http:// Clinical Trials.gov ]",
"Objective To evaluate the effectiveness of the community based Cardiovascular Health Awareness Program ( CHAP ) on morbidity from cardiovascular disease . Design Community cluster r and omised trial . Setting 39 mid-sized communities in Ontario , Canada , stratified by location and population size . Participants Community dwelling residents aged 65 years or over , family physicians , pharmacists , volunteers , community nurses , and local lead organisations . Intervention Communities were r and omised to receive CHAP ( n=20 ) or no intervention ( n=19 ) . In CHAP communities , residents aged 65 or over were invited to attend volunteer run cardiovascular risk assessment and education sessions held in community based pharmacies over a 10 week period ; automated blood pressure readings and self reported risk factor data were collected and shared with participants and their family physicians and pharmacists . Main outcome measure Composite of hospital admissions for acute myocardial infa rct ion , stroke , and congestive heart failure among all community residents aged 65 and over in the year before compared with the year after implementation of CHAP . Results All 20 intervention communities successfully implemented CHAP . A total of 1265 three hour long sessions were held in 129/145 ( 89 % ) pharmacies during the 10 week programme . 15 889 unique participants had a total of 27 358 cardiovascular assessment s with the assistance of 577 peer volunteers . After adjustment for hospital admission rates in the year before the intervention , CHAP was associated with a 9 % relative reduction in the composite end point ( rate ratio 0.91 , 95 % confidence interval 0.86 to 0.97 ; P=0.002 ) or 3.02 fewer annual hospital admissions for cardiovascular disease per 1000 people aged 65 and over . Statistically significant reductions favouring the intervention communities were seen in hospital admissions for acute myocardial infa rct ion ( rate ratio 0.87 , 0.79 to 0.97 ; P=0.008 ) and congestive heart failure ( 0.90 , 0.81 to 0.99 ; P=0.029 ) but not for stroke ( 0.99 , 0.88 to 1.12 ; P=0.89 ) . Conclusions A collaborative , multi-pronged , community based health promotion and prevention programme targeted at older adults can reduce cardiovascular morbidity at the population level . Trial registration Current controlled trials IS RCT N50550004",
"Background Although hypercholesterolemia is considered a cardiovascular risk factor , in isolation it is not necessarily sufficient cause for a cardiovascular event . To improve event prediction , cardiovascular risk calculators have been developed ; the REGICOR calculator has been vali date d for use in our population . The objective of this project is to develop an intervention with general practitioners ( GPs ) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease . Methods This nonblinded , cluster-r and omized clinical trial analyzes data from primary care electronic medical records ( ECAP ) and other data bases . Inclusion criteria are patients aged 35 to 74 years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period . Dependent variables include the following : RETIRA , defined as new cholesterol-lowering drugs initiated during the year preceding the intervention , considered inadequate , and withdrawn during the study period ; EVITA , defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate ; COST , defined as the total cost of inadequate new treatments prescribed ; and REGISTER , defined as the recording of cardiovascular risk factors . Independent variables include the GP ’s quality -of-care indicators and r and omly assigned study group ( intervention vs control ) , patient demographics , and clinical variables . Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect , adjusted for individual and GP variables . Discussion The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care . The goal is to improve the prescription adequacy of lipid-lowering therapies for primary prevention . Trial registration Clinical Trials.gov Identifier : NCT01997671 . November 28 , 2013",
"Aims We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease ( CHD ) risk could lower patients ' predicted Framingham CHD risk vs. usual care . Methods The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospect i ve , controlled , cluster-r and omised trial in nine European countries , among patients at moderate cardiovascular risk . Following baseline assessment s , physicians in the intervention group calculated patients ' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme . Usual care physicians did not calculate patients ' risk and provided usual care only . The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care . Results Of 1103 patients across 100 sites , 524 patients receiving intervention , and 461 receiving usual care , were analysed for efficacy . After 6 months , mean predicted risks were 12.5 % with intervention , and 13.7 % with usual care [ odds ratio = 0.896 ; p = 0.001 , adjusted for risk at baseline ( 17.2 % intervention ; 16.9 % usual care ) and other covariates ] . The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention ( 25.4 % ) than usual care ( 14.1 % ; p physician-implemented CHD risk evaluation/communication programme improved patients ' modifiable risk factor profile , and lowered predicted CHD risk compared with usual care . By combining this strategy with more intensive treatment to reduce residual modifiable risk , we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice",
"Background The format or frame in which the results of r and omized trials are presented has been shown to influence health professional 's self-reported practice . We sought to investigate the effect of framing cardiovascular risk as two different formats in a r and omized trial . Methods We recruited 457 patients aged between 60 and 79 years with high blood pressure from 20 family practice s in Avon , UK . Patients were r and omized to cardiovascular risk presented either as 1 ) an absolute risk level ( AR ) or as 2 ) the number needed to treat to prevent an adverse event ( NNT ) . The main outcome measures were : 1 ) percentage of patients in each group with a five-year cardiovascular risk ≥ 10 % , 2 ) systolic and diastolic blood pressure , 3 ) intensity of prescribing of cardiovascular medication . Results Presenting cardiovascular risk as either an AR or NNT had no impact reducing cardiovascular risk at 12 month follow up , adjusted odds ratio 1.53 ( 95%CI 0.76 to 3.08 ) . There was no difference between the two groups in systolic ( adjusted difference 0.97 mmHg , 95%CI -2.34 mmHg to 4.29 mmHg ) or diastolic ( adjusted difference 0.70 mmHg , 95%CI -1.05 mmHg to 2.45 mmHg ) blood pressure . Intensity of prescribing of blood pressure lowering drugs was not significantly different between the two groups at six months follow up . Conclusions Presenting cardiovascular risk in clinical practice guidelines as either an AR or NNT had a similar influence on patient outcome and prescribing intensity . There is no difference in patient outcomes when these alternative formats of risk are used in clinical practice guidelines",
"OBJECTIVE Patients with type 2 diabetes mellitus ( T2DM ) underestimate their risk of developing severe complications , and they do not always underst and the risk communication by their caregivers . The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease ( CVD ) in patients with T2DM . RESEARCH DESIGN AND METHODS A r and omized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System ( DCS ) West-Friesl and , a managed-care system in the Netherl and s. The intervention group ( n = 131 ) received a six-step CVD risk communication . Control subjects ( n = 130 ) received st and ard managed care . The primary outcome measure was appropriateness of risk perception ( difference between actual CVD risk calculated by the UK Prospect i ve Diabetes Study risk engine and risk perception ) . Secondary outcome measures were illness perceptions , attitude and intention to change behavior , satisfaction with the communication , and anxiety and worry about CVD risk . Patients completed question naires at baseline , at 2 weeks ( immediately after the intervention ) , and at 12 weeks . RESULTS Appropriateness of risk perception improved between the intervention and control groups at 2 weeks . This effect disappeared at 12 weeks . No effects were found on illness perceptions , attitude and intention to change behavior , or anxiety and worry about CVD risk . Patients in the intervention group were significantly more satisfied with the communication . CONCLUSIONS This risk communication method improved patients ’ risk perception at 2 weeks but not at 12 weeks . Negative effects were not found , as patients did not become anxious or worried after the CVD risk communication",
"Background Whether disclosure of a genetic risk score ( GRS ) for a common disease influences relevant clinical outcomes is unknown . We describe design of the Myocardial Infa rct ion Genes ( MI-GENES ) Study , a r and omized clinical trial to assess whether disclosing a GRS for coronary heart disease ( CHD ) leads to lowering of low-density lipoprotein cholesterol ( LDL-C ) levels . Methods and design We performed an initial screening genotyping of 28 CHD susceptibility single-nucleotide polymorphisms ( SNPs ) that are not associated with blood pressure or lipid levels , in 1000 individuals from Olmsted County , Minnesota who were participants in the Mayo Clinic BioBank and met eligibility criteria . We calculated GRS based on 28 SNPs and will enroll 110 patients each in two CHD genomic risk categories : high ( GRS ≥1.1 ) , and average/low ( GRS measurement of fasting lipid levels and assessment of changes in dietary fat intake and physical activity levels . Psychosocial measures will be assessed at baseline and after disclosure of CHD risk . Discussion The proposed trial will provide insights into the clinical utility of genetic testing for CHD risk assessment . Clinical trial registration Clinical Trials.gov registration number : NCT01936675",
"Background Risk communication is an integral part of shared decision-making in health care . In the context of interventions for chronic diseases it represents a particular challenge for all health practitioners . By using two different quantitative formats to communicate risk level and effectiveness of a cholesterol-lowering drug , we posed the research question : how does the format of risk information influence patients ’ decisions concerning therapy , patients ’ satisfaction with the communication as well as confidence in the decision . We hypothesise that patients are less prone to accept therapy when the benefits of long-term intervention are presented in terms of prolongation of life ( POL ) in months compared to the absolute risk reduction ( ARR ) . We hypothesise that patients presented with POL will be more satisfied with the communication and confident in their decision , suggesting underst and ing of the time-related term . Methods / Design In 2009 a sample of 328 general practitioners ( GPs ) in the Region of Southern Denmark was invited to participate in a primary care-based clinical trial among patients making real-life clinical decisions together with their GP . Interested GPs were cluster-r and omised to inform patients about cardiovascular disease ( CVD ) risk and the effectiveness of statin therapy using either POL or ARR . The GPs attended a training session before informing their patients . Before training and after the trial period they received a question naire about their attitudes to risk communication and the use of numerical information . Patients ’ redemptions of statin prescriptions will be registered in a regional prescription data base to evaluate a possible association between redemption rates and effectiveness format . The Combined Outcome Measure for Risk Communication And Treatment Decision Making Effectiveness ( COMRADE ) question naire will be used to measure patients ’ confidence and satisfaction with the risk communication immediately after the conversation with their GPs . Discussion This r and omised clinical trial compares the impact of two effectiveness formats on real-life risk communication between patients and GPs , including affective patient outcomes and actual choices about acceptance of therapy . Though we found difficulties in recruiting GPs , according to the study protocol we have succeeded in engaging sufficient GPs for the trial , enabling us to perform the planned analyses . Trial registration Clinical Trials.gov Protocol Registration System http://ww . clinical",
"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 Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 . Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care . Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed . Methods We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare . This intervention will be implemented as a stepped wedge , cluster r and omised controlled trial in 18 primary health centres and 54 villages in rural And hra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk ( approximately 15,000 people ) . Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension ’s region-specific risk charts . Cluster r and omisation will occur at the level of the primary health centres . Outcome analyses will be conducted blinded to intervention allocation . Expected outcomes The primary study outcome is the difference in the proportion of people meeting guideline -recommended blood pressure targets in the intervention period vs. the control period . Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) . Trial outcomes will be accompanied by detailed process and economic evaluations . Significance The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served population s in low and middle income country setting s . Trial registration Clinical Trial Registry India CTRI/2013/06/003753",
"Background A gap exists between evidence and practice regarding the management of cardiovascular risk factors . This gap could be narrowed if systematic ally developed clinical practice guidelines were effectively implemented in clinical practice . We evaluated the effects of a tailored intervention to support the implementation of systematic ally developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease . Methods and Findings We conducted a cluster-r and omized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practice s in two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders linked to the medical record system . Pharmacists conducted the visits . Outcomes were measured for all eligible patients seen in the participating practice s during 1 y before and after the intervention . The main outcomes were the proportions of ( 1 ) first-time prescriptions for hypertension where thiazides were prescribed , ( 2 ) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs , and ( 3 ) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals . The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug . Thiazides were prescribed to 17 % of patients in the intervention group versus 11 % in the control group ( relative risk 1.94 ; 95 % confidence interval 1.49–2.49 , adjusted for baseline differences and clustering effect ) . Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals . Conclusions Our tailored intervention had a significant impact on prescribing of antihypertensive drugs , but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care",
"Background In re source -poor areas of China and India , the cardiovascular disease burden is high , but availability of and access to quality healthcare is limited . Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management . The study aims to develop , implement , and evaluate the feasibility and effectiveness of a simplified , evidence -based cardiovascular management program delivered by community healthcare workers in re source -constrained areas in Tibet , China and Haryana , India . Methods / design This yearlong cluster-r and omized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana . R and omization of villages to usual care or intervention will be stratified by country . High cardiovascular disease risk individuals ( aged 40 years or older , history of heart disease , stroke , diabetes , or measured systolic blood pressure of 160 mmHg or higher ) will be screened at baseline . Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified ‘ 2 + 2 ’ intervention model involving two lifestyle recommendations and the appropriate prescription of two medications . A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management . Baseline and follow-up surveys will be conducted in a st and ardized fashion in all villages . The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention . Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure . Process and economic evaluations will also be conducted . Discussion To our knowledge , this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients . If effective , this intervention strategy can serve as a model that can be implemented , where applicable , in rural China , India , and other re source -constrained areas .Trial registration The trial was registered in the clinical trials.gov data base on 30 December , 2011 and the registration number is NCT01503814",
"Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level . Design R and omised controlled community based trial . Setting Suburbs of Copenhagen , Denmark Participants 59 616 people aged 30 - 60 years r and omised with different age and sex r and omisation ratios to an intervention group ( n=11 629 ) and a control group ( n=47 987 ) . Intervention The intervention group was invited for screening , risk assessment , and lifestyle counselling up to four times over a five year period . All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits ( at baseline and after one and three years ) ; those at high risk of ischaemic heart disease , according to predefined criteria , were furthermore offered six sessions of group based lifestyle counselling on smoking cessation , diet , and physical activity . After five years all were invited for a final counselling session . Participants were referred to their general practitioner for medical treatment , if relevant . The control group was not invited for screening . Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group . Secondary outcome measures were stroke , combined events ( ischaemic heart disease , stroke , or both ) , and mortality . Results 6091 ( 52.4 % ) people in the intervention group participated at baseline . Among 5978 people eligible at five year follow-up ( 59 died and 54 emigrated ) , 4028 ( 67.4 % ) attended . A total of 3163 people died in the 10 year follow-up period . Among 58 308 without a history of ischaemic heart disease at baseline , 2782 developed ischaemic heart disease . Among 58 940 without a history of stroke at baseline , 1726 developed stroke . No significant difference was seen between the intervention and control groups in the primary end point ( hazard ratio for ischaemic heart disease 1.03 , 95 % confidence interval 0.94 to 1.13 ) or in the secondary endpoints ( stroke 0.98 , 0.87 to 1.11 ; combined endpoint 1.01 , 0.93 to 1.09 ; total mortality 1.00 , 0.91 to 1.09 ) . Conclusion A community based , individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease , stroke , or mortality at the population level after 10 years . Trial registration Clinical trials NCT00289237",
"Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015",
"Aims Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory . In the absence of long-term data on hard outcomes , we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis , and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years . Methods In a pragmatic , cluster-r and omized , parallel-group trial in Denmark , the Netherl and s and the UK , 3057 people with screen-detected Type 2 diabetes were r and omized by general practice to receive ( 1 ) routine care of diabetes according to national guidelines ( 1379 patients ) or ( 2 ) intensive multifactorial target-driven management ( 1678 patients ) . Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospect i ve Diabetes Study Risk Engine ( version 3β ) . Results Among 2101 individuals with complete data at follow up ( 73.4 % ) , 10-year modelled cardiovascular disease risk was 27.3 % ( sd 13.9 ) at baseline and 21.3 % ( sd 13.8 ) at 5-year follow-up ( intensive treatment group difference –6.9 , sd 9.0 ; routine care group difference –5.0 , sd 12.2 ) . Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years , after adjustment for baseline cardiovascular disease risk and clustering ( –2.0 ; 95 % CI –3.1 to –0.9 ) . Conclusions Despite increasing age and diabetes duration , there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis . Compared with routine care , 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years . Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory , where the rate of cardiovascular disease risk progression may be slowed",
"OBJECTIVES The aim of this study was to determine adults ' Willingness To Pay ( WTP ) for CardioVascular Disease ( CVD ) intervention programs of different intensities . METHODS Three hundred fourteen participants were r and omized to two study conditions : ( i ) CVD risk assessment /communication ; ( ii ) CVD risk assessment /communication + a behavior change program . The behavior change program was aim ed at increasing physical activity , reducing saturated fat intake and smoking cessation . It consisted of a tailored Web site and individual coaching with a self-selected dose . At post- assessment , WTP and perceived autonomy support items were included . The intervention dose was registered throughout the trial and post-hoc intervention dose groups were created . Pearson Chi-Square tests , Student 's t-tests , one-way analyses of variance were used to examine WTP-differences between the study conditions and intervention dose groups . RESULTS Twenty-four months after baseline , 61 and 135 participants of the control and intervention condition , respectively , completed the question naires . No WTP difference was found between the study conditions . However , participants that selected a higher intervention dose were willing to pay significantly more for their program ( p pay the same amount of money for a CVD prevention program , irrespective of the inclusion of a behavior change program . However , there seems to be an association between the self-selected dose of the latter program and the WTP",
"Abstract BACKGROUND : Integrative medicine is an individualized , patient-centered approach to health , combining a whole-person model with evidence -based medicine . Interventions based in integrative medicine theory have not been tested as cardiovascular risk-reduction strategies . Our objective was to determine whether personalized health planning ( PHP ) , an intervention based on the theories and principles underlying integrative medicine , reduces 10-year risk of coronary heart disease ( CHD ) . METHODS : We conducted a r and omized , controlled trial among 154 out patients age 45 or over , with 1 or more known cardiovascular risk factors . Subjects were enrolled from primary care practice s near an academic medical center , and the intervention was delivered at a university Center for Integrative Medicine . Following a health risk assessment , each subject in the intervention arm worked with a health coach and a medical provider to construct a personalized health plan . The plan identified specific health behaviors important for each subject to modify ; the choice of behaviors was driven both by cardiovascular risk reduction and the interests of each individual subject . The coach then assisted each subject in implementing her/his health plan . Techniques used in implementation included mindfulness meditation , relaxation training , stress management , motivational techniques , and health education and coaching . Subjects r and omized to the comparison group received usual care ( UC ) without access to the intervention . Our primary outcome measure was 10-year risk of CHD , as measured by a st and ard Framingham risk score , and assessed at baseline , 5 , and 10 months . Differences between arms were assessed by linear mixed effects modeling , with time and study arm as independent variables . RESULTS : Baseline 10-year risk of CHD was 11.1 % for subjects r and omized to UC ( n=77 ) , and 9.3 % for subjects r and omized to PHP ( n=77 ) . Over 10 months of the intervention , CHD risk decreased to 9.8 % for UC subjects and 7.8 % for intervention subjects . Based on a linear mixed-effects model , there was a statistically significant difference in the rate of risk improvement between the 2 arms ( P=.04 ) . In secondary analyses , subjects in the PHP arm were found to have increased days of exercise per week compared with UC ( 3.7 vs 2.4 , P=.002 ) , and subjects who were overweight on entry into the study had greater weight loss in the PHP arm compared with UC ( P=.06 ) . CONCLUSIONS : A multidimensional intervention based on integrative medicine principles reduced risk of CHD , possibly by increasing exercise and improving weight loss ",
"BACKGROUND Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been \" identified\"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India",
"Objective To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care . Design Pragmatic multicentre r and omised controlled trial . Setting General practice s throughout Australia , except Northern Territory , 2009 - 11 . Participants Of 2185 patients from 119 general practice s who were eligible for drug treatment for hypertension according to national guidelines 416 ( 19.0 % ) achieved their individual blood pressure target during a 28 day run-in period of monotherapy . After exclusions , 1562 participants not at target blood pressure ( systolic 150 ( SD 17 ) mm Hg , diastolic 88 ( SD 11 ) mm Hg ) were r and omised ( 1:2 ratio ) to usual care ( n=524 ) or the intervention ( n=1038 ) . Intervention Computer assisted clinical profiling and risk target setting ( all participants ) with intensified follow-up and stepwise drug titration ( initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers ) for those r and omised to the intervention . The control group received usual care . Main outcome measures The primary outcome was individual blood pressure target achieved at 26 weeks . Secondary outcomes were change in mean sitting systolic and diastolic blood pressure , absolute risk for cardiovascular disease within five years based on the Framingham risk score , and proportion and rate of adverse events . Results On an intention to treat basis , there was an 8.8 % absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group ( 358/988 ( 36.2 % ) v 138/504 ( 27.4 % ) ) : adjusted relative risk 1.28 ( 95 % confidence interval 1.10 to 1.49 , P=0.0013 ) . There was also a 9.5 % absolute difference in favour of the intervention group for achieving the classic blood pressure target of ≤140/90 mm Hg ( 627/988 ( 63.5 % ) v 272/504 ( 54.0 % ) ) : adjusted relative risk 1.18 ( 1.07 to 1.29 , P mean adjusted reduction in systolic blood pressure of 13.2 mm Hg ( 95 % confidence interval −12.3 to −14.2 mm Hg ) and diastolic blood pressure of 7.7 mm Hg ( −7.1 to −8.3 mm Hg ) v 10.1 mm Hg ( −8.8 to 11.3 mm Hg ) and 5.5 mm Hg ( −4.7 to −6.2 mm Hg ) in the usual care group ( P 1141 participants in whom five year absolute cardiovascular risk scores were calculated from baseline to the 26 week follow-up , the reduction in risk scores was greater in the intervention group than usual care group ( 14.7 % ( SD 9.3 % ) to 10.9 % ( SD 8.0 % ) ; difference −3.7 % ( SD 4.5 % ) and 15.0 % ( SD 10.1 % ) to 12.4 % ( SD 9.4 % ) ; −2.6 % ( SD 4.5 % ) : adjusted mean difference −1.13 % ( 95 % confidence interval −0.69 % to −1.63 % ; P of blood pressure control , with clinical ly lower blood pressure and absolute risk of future cardiovascular events overall and with more people achieving their target blood pressure . An important gap in treatment remains though and applying intensive management and achieving currently advocated risk based blood pressure targets is challenging",
"AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 )",
"OBJECTIVE To assess the impact of a decision aid on perceived risk of heart attacks and medication adherence among urban primary care patients with diabetes . METHODS We r and omly allocated 150 patients with diabetes to participate in a usual primary care visit either with or without the Statin Choice tool . Participants completed a question naire at baseline and telephone follow-up at 3 and 6 months . RESULTS Intervention patients were more likely to accurately perceive their underlying risk for a heart attack without taking a statin ( OR : 1.9 , CI : 1.0 - 3.8 ) and with taking a statin ( OR : 1.4 , CI : 0.7 - 2.8 ) ; a decline in risk overestimation among patients receiving the decision aid accounts for this finding . There was no difference in statin adherence at 3 or 6 months . CONCLUSION A decision aid about using statins to reduce coronary risk among patients with diabetes improved risk communication , beliefs , and decisional conflict , but did not improve adherence to statins . PRACTICE IMPLICATION S Decision aid enhanced communication about the risks and benefits of statins improved patient risk perceptions but did not alter adherence among patients with diabetes",
"BACKGROUND Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular ( CV ) guidelines , medication adherence , and risk factor control . However , there is limited information on whether these models can be successfully implemented more widely in diverse setting s and population s. The purpose of this study is to evaluate whether a central ized , web-based cardiovascular risk service ( CVRS ) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics . METHODS This study is a prospect i ve trial in 20 primary care offices stratified by the percent of under-represented minorities and then r and omized to either the CVRS intervention or usual care . The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months . The primary outcome is the difference in guideline adherence between groups . Data will also be abstract ed from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued . CONCLUSIONS Patient enrollment will continue through 2016 , with results expected in 2019 . This study will provide information on whether a distant , central ized CVRS can be implemented in large numbers of medical offices , if it is effective in diverse population s , and if there is a long-term sustained effect",
"OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care",
"BACKGROUND There is increasing political pressure on the medical profession to approach welfare diseases , such as coronary heart disease and diabetes , through prevention . General practitioners are required to offer regular health checks to healthy people , in spite of the lack of scientific evidence for the universal need , usefulness and side effects of such an intervention . R and omized controlled trials are needed . AIM A study was carried out to investigate people 's interest in participating in health checks and in discussion s about health with their own general practitioner , participants ' health status , the proportion who received health advice following health checks , and the lifestyle goals they set following discussion with their general practitioner . This study reports the baseline data from a five-year r and omized , controlled , prospect i ve , population -based study in general practice s in Ebeltoft , Denmark . METHOD All general practitioners from the four practice s in Ebeltoft and a r and om sample of 2000 people aged between 30 and 50 years were invited to participate . Participants were r and omly divided into three groups -- one control group and two intervention groups . One intervention group were given a health check which included being screened for cardiovascular risk factors , lung and liver function , fitness , sight and hearing and an optional test for the human immunodeficiency virus ( HIV ) ; this group received written feedback from the general practitioner . The other intervention group were also given a health check and written feedback ; in addition , they were given the opportunity to attend their general practitioner to discuss preventive health . RESULTS A total of 1370 people participated in the study ( 69 % response rate ) . Health advice was given to 76 % of 905 participants following health checks . Almost all of the 456 participants ( 96 % ) who were offered the opportunity of discussing their health with their general practitioner took up the offer ; 64 % of the 456 participants reported that they had decided to undertake lifestyle changes . Eleven of those who discussed their health with the doctor were referred to a specialist ( 2 % ) . CONCLUSION There was considerable interest in participating in health promotion . Three out of four of those having a health check were given health advice . Two out of three of those offered a health talk with the general practitioner appeared willing to make relevant lifestyle changes . Long-term follow up is needed to determine effects and side effects of health checks and health talks",
"PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines . METHODS A 1-year cluster r and omized controlled trial was performed using 30 primary care practice s ( 4,105 patients ) in southeastern New Engl and . The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein ( LDL ) and non – high-density lipoprotein ( HDL ) cholesterol goals . RESULTS After 1 year of intervention , both r and omized practice groups improved screening ( 89 % screened ) , and 74 % of patients in both groups were at their LDL and non-HDL cholesterol goals ( P screening or percentage of patients who achieved LDL and non-HDL cholesterol goals . Post hoc analysis showed practice s who made high use of the patient activation kiosk were more likely to have patients screened ( odds ratio [ OR ] = 2.54 ; 95 % confidence interval [ CI ] , 1.97–3.27 ) compared with those who made infrequent or no use . Additionally , physicians who made high use of decision support tools were more likely to have their patients at their LDL cholesterol goals ( OR = 1.27 ; 95 % CI , 1.07–1.50 ) and non-HDL goals ( OR = 1.23 ; 95 % CI , 1.04–1.46 ) than low-use or no-use physicians . CONCLUSION This study showed None results with the intent-to-treat analysis regarding the benefits of a patient activation and a decision support tool in improving cholesterol management in primary care practice s. Post hoc analysis showed a potential benefit in practice s that used the e-health tools more frequently in screening and management of dyslipidemia . Further research on how to incorporate and increase adoption of user-friendly , patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted",
"BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of global mortality . Risk factor management in clinical practice often relies on relative risk modification rather than the more appropriate absolute risk assessment . AIM To determine whether patients receiving more-frequently design ated GP visits had increased benefit in terms of their absolute CVD risk assessment , as compared with patients in receipt of their usual GP care . DESIGN AND SETTING Prospect i ve , open , pragmatic block r and omised study in a 1:1 group allocation ratio in three Western Australian general practice s. METHOD A convenience sample ( n = 1200 ) of patients aged 40 - 80 years were r and omised to 3-monthly GP visits ( five in total for the intensive ) or usual GP care ( two in total for the opportunistic ) , with 12 months ' follow-up . The main outcome was absolute CVD risk scores based on the New Zeal and Cardiovascular Risk Calculator . Others outcome measures were weight , height , waist circumference , blood pressure , and fasting blood lipids and glucose . RESULTS There were 600 patients per group at baseline . At 12 months ' analysis there were 543 in the intensive group and 569 in the opportunistic group . Mean ( st and ard deviation [ SD ] ) absolute CVD risk reduced significantly between baseline and 12 months in the intensive group ( 6.28 % [ 5.11 ] to 6.10 % [ 4.94 ] ) but not in the opportunistic group ( 6.27 % [ 5.10 ] to 6.24 % [ 5.38 ] ) . There was a significant reduction between baseline and 12 months in mean ( SD ) total cholesterol ( 5.28 mmol/l [ 0.94 ] to 5.08 mmol/l [ 0.96 ] ) ; low-density lipoprotein cholesterol ( 3.08 mmol/l [ 0.87 ] to 2.95 mmol/l [ 0.89 ] ) ; triglyceride ( 1.45 mmol/l [ 0.86 ] to 1.36 mmol/l [ 0.84 ] ) ; and in mean ( SD ) waist circumference in men ( 98.74 cm [ 10.70 ] to 97.13 cm [ 10.20 ] ) and females ( 90.64 cm [ 14.62 ] to 88.96 cm [ 14.00 ] ) in the intensive group . CONCLUSION A targeted approach using absolute risk calculators can be used in primary care to modify global CVD risk assessment",
"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 ] .",
"INTRODUCTION We investigated the impact of general health screenings and discussion s with general practitioners on the cardiovascular risk profile of the population . MATERIAL AND METHODS A population -based , r and omised , controlled , 5-year follow-up trial conducted in a primary care setting . In total 2000 r and omly selected men and women , aged 30 - 50 years , from family practice s in the district of Ebeltoft , Denmark . Of these persons , 1507 ( 75.4 % ) agreed to participate , and were r and omised into : ( 1 ) a control group who did not receive health screenings ; ( 2 ) an intervention group that received two health screenings ; or ( 3 ) an intervention group that received both the two screenings and a 45-minute follow-up consultation annually with their general practitioner . All were followed up after 5 years by question naires and health screenings . The outcome measures were : cardiovascular risk score ( CRS ) , body mass index ( BMI ) , blood pressure , serum cholesterol , carbon monoxide in expiratory air , and use of tobacco . RESULTS After 5 years , the CRS , BMI , and serum cholesterol levels were lower in the intervention groups , as compared with the control group . The improved outcome was greater in the baseline risk groups . The number of persons with elevated CRS in the intervention groups was about half the number of persons with elevated CRS in the control group . The difference was not a result of medication use . There was no difference between the group that received consultations after the screenings and the group that had health screenings alone . DISCUSSION Systematic health screenings reduce the cardiovascular risk score in a middle-aged population . After 5 years of follow-up , the number of persons at elevated cardiovascular risk was about half the expected . The impact of intervention is higher in at-risk individuals . Planned consultations about health did not appear to improve the cardiovascular profile of the study population",
"BACKGROUND Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk ( CVAR ) to manage patients . This r and omized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk , including prescription of antihypertensive and lipid-lowering medication . METHODS A cluster r and omized controlled trial was conducted from 2008 to 2010 in Sydney , Australia . Family practice s were r and omized , and patients aged 45 to 69 years were invited to participate . Intervention family physicians ( FP ) were trained in use of CVAR , provided with an electronic CVAR calculator , and assessed their patients ' absolute risk in a dedicated consultation . Control practice patients received a general health check . Primary outcome analyzed was the proportion of patients in each group on antihypertensive and /or lipid-lowering medication at 12 months . Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy . RESULTS The study recruited 36 FPs from 34 practice s and 1,074 patients , of which 906 ( 84.4 % ) completed 12-month follow-up . At 12 months , there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives ( 31.2 % vs 34.3 % , P = .31 ) , but control group patients were more likely to be on lipid-lowering medications ( 30.2 % vs 22.7 % , P = .01 ) . After multilevel analysis , this difference was not present . Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group . CONCLUSIONS Single-risk factor management remains a strong influence on FP prescribing practice s. Shifting to an approach based on CVAR will require more intensive intervention",
"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 ",
"OBJECTIVE To test the primary study hypothesis that a physician-delivered coronary heart disease risk evaluation and communication program can lower patients ' predicted 10-year risk of myocardial infa rct ion or death due to coronary heart disease by 10 % within 6 months compared to usual care . DESIGN Prospect i ve , parallel group , open-label , controlled , cluster-r and omized multinational trial ; the study site is the unit of r and omization . SETTING Patients were recruited from 106 general practice s located in nine European countries . PATIENTS Men and women aged 45 to 64 ( N=1500 ) with a documented history of hypertension ( treated or untreated ) , systolic blood pressure > or = 140 mmHg ( or > or = 130 mmHg in the presence of renal or kidney disease ) , no history of cardiovascular disease , and a predicted 10-year risk of myocardial infa rct ion or death due to coronary heart disease > or = 10 % . INTERVENTION Sites were r and omized to deliver a physician-directed coronary heart disease risk communication and education program or usual care . The intervention program included informing patients of their 10-year risk of myocardial infa rct ion or death due to coronary heart disease , educating patients about modifiable risk factors and their control , and three follow-up phone calls by a physician or study nurse . MAIN OUTCOME MEASURE Predicted 10-year risk of myocardial infa rct ion or death due to coronary heart disease at 6 months . CONCLUSIONS REACH OUT will evaluate a novel , patient-focused , physician-implemented application of coronary heart disease risk equations . Results of the study will be of practical relevance to physicians , health care organizations , and those who issue clinical guidelines for the reduction of cardiovascular risk",
"Background : Evidence on the effectiveness of educational interventions on prescribing behaviour modification in prevention of cardiovascular disease is still insufficient . We evaluated the effects of a brief educational intervention on prescription of hydroxymethylglutaryl-CoA reductase inhibitors ( statins ) , inhibitors of platelet aggregation ( IPA ) , and antihypertensive agents ( AH ) . Design : Cluster r and omised controlled trial with continuous medical education ( CME ) groups of general practitioners ( GPs ) . Methods : Prescription of statins , IPA , and AH were verified prior to study start ( BL ) , immediately after index consultation ( IC ) , and at follow-up after 6 months ( FU ) . Prescription in patients at high risk ( > 15 % risk of a cardiovascular event in 10 years , based on the Framingham equation ) and no prescription in low-risk patients ( ≤ 15 % ) were considered appropriate . Results : An intervention effect on prescribing could only be found for IPA . Generally , changes in prescription over time were all directed towards higher prescription rates and persisted to FU , independent of risk status and group allocation . Conclusions : The active implementation of a brief evidence -based educational intervention on global risk in CVD did not lead directly to risk-adjusted changes in prescription . Investigations on an extended time scale would capture whether decision support of this kind would improve prescribing risk-adjusted sustainably",
"This study describes the attitudes and practice s of patients and GPs 12 months after participating in a trial of absolute cardiovascular risk assessment in general practice . It involved a qualitative design using semistructured interviews with 12 Sydney GPs from the intervention arm of a cluster r and omised controlled trial of cardiovascular absolute risk ( CVAR ) assessment and 15 of their moderate to high risk patients who participated in the assessment s. Most GPs had sustained CVAR assessment in their practice , using it primarily to motivate patients to change their behaviour and adhere to management rather than to make decisions about pharmacotherapy or referral . Time was a barrier to its use . Patients who sustained changes to their behaviour had internalised the benefits to their health and received support from family and friends . Those who relapsed attributed this to their own lack of motivation and extrinsic factors . CVAR assessment needs to be incorporated into practice information systems and long-term planned preventive care if it is to be sustained in general practice and have long-term impacts on patient behaviour",
"Background : Preventive guidelines on cardiovascular risk management recommend lifestyle changes . Support for lifestyle changes may be a useful task for practice nurses , but the effect of such interventions in primary prevention is not clear . We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk . Methods : We performed a cluster r and omized controlled trial in 25 practice s that included 615 patients . The intervention consisted of nurse-led cardiovascular risk management , including risk assessment , risk communication , a decision aid and adapted motivational interviewing . The control group received a minimal nurse-led intervention . The self-reported outcome measures at one year were smoking , alcohol use , diet and physical activity . Nurses assessed 10-year cardiovascular mortality risk after one year . Results : There were no significant differences between the intervention groups . The effect of the intervention on the consumption of vegetables and physical activity was small , and some differences were only significant for subgroups . The effects of the intervention on the intake of fat , fruit and alcohol and smoking were not significant . We found no effect between the groups for cardiovascular 10-year risk . Interpretation : Nurse-led risk communication , use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk , despite significant within-group differences",
"Background Although percentage risk formats are commonly used to convey cardiovascular disease ( CVD ) risk , people find it difficult to underst and these representations . Aims To compare the impact of providing a CVD risk message in either a traditional format ( % risk ) or using an analogy of risk ( Heart-Age ) on participants ' risk perceptions and intention to make lifestyle changes . Methods Four hundred and thirteen men and women were r and omly allocated to one of two conditions ; CVD risk as a percentage or as a Heart-Age score ( a cardiovascular risk adjusted age ) . Results There was a grade d relationship between perceived and actual CVD risk only in those participants receiving a Heart-Age message ( P Heart-Age was more emotionally impactful in younger individuals at higher actual CVD risk ( P Self-reported emotional reactions further mediated the relationship between risk perception and intention to make lifestyle changes . Conclusion This study found that the Heart-Age message significantly differed from percentage CVD risk score in risk perceptions and was more emotionally impactful in those participants at higher actual CVD risk levels",
"The objective of this r and omised controlled trial was to compare the effects and expense of three approaches to care ( 1 ) proactive cardiovascular risk reduction ( CaRR ) clinic ; ( 2 ) nurse telephone calls ; or ( 3 ) usual care for people with cardiovascular risk factors in a Primary Care , Health Service Organisation ( HSO ) in Ontario , Canada . Subjects included consenting patients with an identified cardiovascular disease ( CVD ) risk factor identified from the HSO computerised patient information system in 2004 . Patients were excluded if they were mentally incompetent , Of 1570 eligible subjects , 523 ( 33.3 % ) verbally declined , 145 ( 9.2 % ) could not be contacted , and 249 ( 15.9 % ) were not needed . The final sample size was 653 ( 41.6 % ) , 634 completed the follow-up ( 97 % ) . The Cardiovascular Risk Score , Health and Social Service Utilisation , Montgomery-Asberg Depression Rating , Billings and Moos Indices of Coping , Personal Re source and Self-Efficacy Question naires were measured at baseline and 1-year follow-up by clinical examination and telephone interview . Cardiovascular risk scores were reduced in all treatment groups after 1 year . The proportions of subjects showing reduction in risk score greater than or equal to 10 % was greatest in the CaRR group ( 69.2 % ) compared with Nurse Phone intervention ( 57.8 % ) and Usual Care ( 59.0 % ) ( M-Hchi(2 ) = 4.33 , df = 1 , P = 0.037 , CaRR-Usual Care ) . Self-efficacy scores showed the greatest improvements in the CaRR clinic . This effect was achieved with no significant difference in total person per annum costs for direct and indirect health and social service utilisation between all three groups . A CaRR clinic is more effective in reducing CVD risk after 1 year compared with nurse phone intervention and usual care with no additional expense found",
"BACKGROUND AND AIM This cluster r and omized trial evaluated the efficacy of a disease and care management ( D&CM ) model in cardiovascular ( CVD ) prevention in primary care . METHODS AND RESULTS Eligible subjects had ≥ 1 among : blood pressure ≥ 140/90 mmHg ; glycated hemoglobin ≥ 7 % ; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL ( primary or secondary prevention , respectively ) ; BMI ≥ 30 ; current smoking . The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans . Control group was allocated to usual-care . The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month . During 2008 - 2009 we enrolled 920 subjects in the Abruzzo/Marche regions , Italy . Following the exclusion of L'Aquila due to 2009 earthquake , final analyses included 762 subjects . The primary outcome was achieved by 39.1 % ( 95%CI : 34.2 - 44.2 ) and 25.2 % ( 95%CI : 20.9 - 29.9 ) of subjects in the intervention and usual-care group , respectively ( p The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension , with no differences in hypercholesterolemia , smoking status and obesity . CONCLUSIONS The D&CM intervention was effective in controlling cardiovascular risk factors , in particular hypertension and diabetes . Numbers needed to treat were small . Such intervention may deserve further consideration in clinical practice . REGISTRATION NUMBER ACTRN12611000813987",
"BACKGROUND Evidence of the value of systematic ally collecting family history in primary care is limited . OBJECTIVE To evaluate the feasibility of systematic ally collecting family history of coronary heart disease in primary care and the effect of incorporating these data into cardiovascular risk assessment . DESIGN Pragmatic , matched-pair , cluster r and omized , controlled trial . ( International St and ardized R and omized Controlled Trial Number Register : IS RCT N 17943542 ) . SETTING 24 family practice s in the United Kingdom . PARTICIPANTS 748 persons aged 30 to 65 years with no previously diagnosed cardiovascular risk , seen between July 2007 and March 2009 . INTERVENTION Participants in control practice s had the usual Framingham-based cardiovascular risk assessment with and without use of existing family history information in their medical records . Participants in intervention practice s also completed a question naire to systematic ally collect their family history . All participants were informed of their risk status . Participants with high cardiovascular risk were invited for a consultation . MEASUREMENTS The primary outcome was the proportion of participants with high cardiovascular risk ( 10-year risk ≥ 20 % ) . Other measures included question naire completion rate and anxiety score . RESULTS 98 % of participants completed the family history question naire . The mean increase in proportion of participants classified as having high cardiovascular risk was 4.8 percentage points in the intervention practice s , compared with 0.3 percentage point in control practice s when family history from patient records was incorporated . The 4.5-percentage point difference between groups ( 95 % CI , 1.7 to 7.2 percentage points ) remained significant after adjustment for participant and practice characteristics ( P = 0.007 ) . Anxiety scores were similar between groups . LIMITATIONS Relatively few participants were from ethnic minority or less-educated groups . The potential to explore behavioral change and clinical outcomes was limited . Many data were missing for anxiety scores . CONCLUSION Systematic ally collecting family history increases the proportion of persons identified as having high cardiovascular risk for further targeted prevention and seems to have little or no effect on anxiety . PRIMARY FUNDING SOURCE Genetics Health Services Research program of the United Kingdom Department of Health",
"ABSTRACT Objective : The use of Framingham equations to determine 10-year absolute coronary risk ( “ global risk ” ) represents an accepted strategy to target coronary prevention measures and enhance clinical outcomes . The aim of this study was to determine the effects of providing global risk scores to physicians on the prescription of lipid-lowering therapy for patients at increased coronary risk . Research design and methods : This prospect i ve , r and omized controlled trial enrolled 368 primary -care patients without a history of coronary heart disease and not on therapy with a hydroxymethylglutaryl coenzyme A reductase inhibitor ( i.e. statin ) . The study was conducted in the general medical clinics of an academic US teaching hospital . In the intervention group ( n = 186 ) patients ’ charts were review ed , 10‐year absolute coronary risk computed , and this information conveyed via a simple educational tool appended to charts . In the control group ( n = 182 ) , charts were accompanied by a form with general information on coronary prevention goals and strategies . Main outcome measure : The primary endpoint was the proportion of high-risk patients receiving a new statin prescription . Secondary and tertiary endpoints included ( 1 ) the proportion of moderate-risk patients receiving a statin prescription ; and ( 2 ) the proportion of patients in the whole cohort who had other coronary prevention measures recommended . Results : There was no significant difference in statin prescription to high-risk individuals in the intervention group ( 40.0 % ) compared with the control group ( 37.9 % ; p = 0.86 ) . Moderate-risk individuals who were not eligible for treatment according to the National Cholesterol Education Program Adult Treatment Panel II guidelines were more likely to receive a statin prescription in the intervention group versus the control group ( 28.8 % vs. 12.5 % . p = 0.036 ) Conclusions : Although a simple global risk educational tool did not improve the targeting of statin therapy to patients at high absolute coronary risk , it may be of benefit in targeting moderate-risk individuals who do not have markedly elevated low-density lipoprotein cholesterol ( LDL‐C ) levels . Future research should evaluate the effects of physicians performing their own Framingham risk calculations on statin prescribing and on cholesterol goal attainment",
"African Americans have higher rates of cardiovascular disease ( CVD ) and poorer outcomes compared to others . The American Diabetes Association and the National Diabetes Education Program have promoted use of the ABC approach ( glycated hemoglobin A1c , blood pressure , cholesterol ) for identifying and controlling the leading indicators of CVD risk . In the present study , research ers added a D factor , for depression , because this disorder is common and also predictive of CVD risk and of control of diabetes . Particularly among low-income African Americans , depression is frequently not targeted or treated . The current study tests the effectiveness of recruiting African Americans in churches and training community health workers ( CHWs ) to educate their peers about CVD and risk reduction . For the intervention group , CHWs participated in a 16-hour training session and delivered a 6-week tailored educational program with counseling sessions and demonstrations . The control group received a weekly lecture by clinical experts . The CHW active-learning intervention was more effective than lectures by clinical experts in increasing the knowledge of CVD risk . The only significant difference in clinical measures reflected a worsening of HbA1c levels in the control group ; the CHW intervention group showed a slight improvement . Participants also learned self-management skills , such as taking blood pressure , measuring glucose , and reading labels . Nevertheless , more longitudinal research and a larger sample size are needed to confirm the impact of CHWs in community setting s to change factors associated with CVD risk",
"BACKGROUND Although lifestyle and medications are effective for coronary heart disease ( CHD ) risk reduction , few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction . In this paper , we report on the design and baseline characteristics of participants for just such a trial . METHODS We conducted a r and omized trial of the same lifestyle and medication intervention delivered in two alternate formats : counselor-delivered or web-based . The trial was conducted at 5 diverse practice s in a family medicine research network and included men and women age 35 - 79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10 % or a known history of cardiovascular disease . After individual-level r and omization , participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months . The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease . Secondary outcomes , measured among all participants , included changes in CHD risk factors , cost-effectiveness , and acceptability at 4 and 12-month follow-up . RESULTS We r and omized 489 eligible patients : 389 without and 100 with a known history of cardiovascular disease . Mean age was 62.3 . 75 % were white , 25 % African-American . 45 % had a college education . 88 % had health insurance . Mean 10-year predicted CHD risk was 16.9 % . CONCLUSION We have successfully recruited a diverse sample of practice s and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention",
"BACKGROUND Although cardiovascular absolute risk ( CVAR ) assessment has been recommended for use in Australian general practice for a number of years , there is continuing uncertainty about its implementation and impact . Our previous work has developed a multifaceted implementation model . This study aims to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care . STUDY DESIGN This cluster r and omized controlled trial will be conducted in general practice s in Sydney , involving general practitioners ( GPs ) , other practice staff , and patients aged 45 to 69 years without existing cardiovascular disease . METHODS A total of 32 practice s ( 40 GPs ) and 1,320 patients will be recruited . R and omization will be conducted at the practice level . The intervention group of GPs will be trained to use a CVAR implementation model , whereas the control group of GPs will continue usual care . Study outcomes include clinical processes , patient risk , use of lifestyle intervention , and prescription of antihypertensive and lipid-lowering medications . Data will be collected and analyzed using mixed methods . Study outcomes before and after the intervention will be compared , and the 2 groups will also be compared after adjusting for baseline difference and clustering factors . DISCUSSION This trial will be the first study in Australian general practice and one of few international studies to evaluate the impact of implementing CVAR assessment and management . Results of this study will help improve the primary prevention of cardiovascular disease and inform guidelines for clinical practice and the implementation of other health initiatives",
"Background —Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes , the implementation of risk-reducing practice s remains poor . This report describes the results of a r and omized , controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /community health worker ( NP/CHW ) teams versus enhanced usual care ( EUC ) to improve lipids , blood pressure , glycated hemoglobin ( HbA1c ) , and patient perceptions of the quality of their chronic illness care in patients in urban community health centers . Methods and Results —A total of 525 patients with documented cardiovascular disease , type 2 diabetes , hypercholesterolemia , or hypertension and levels of LDL cholesterol , blood pressure , or HbA1c that exceeded goals established by national guidelines were r and omly assigned to NP/CHW ( n=261 ) or EUC ( n=264 ) groups . The NP/CHW intervention included aggressive pharmacological management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control . Compared with EUC , patients in the NP/CHW group had significantly greater 12-month improvement in total cholesterol ( difference , 19.7 mg/dL ) , LDL cholesterol ( difference,15.9 mg/dL ) , triglycerides ( difference , 16.3 mg/dL ) , systolic blood pressure ( difference , 6.2 mm Hg ) , diastolic blood pressure ( difference , 3.1 mm Hg ) , HbA1c ( difference , 0.5 % ) , and perceptions of the quality of their chronic illness care ( difference , 1.2 points ) . Conclusions —An intervention delivered by an NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illness care in high-risk patients . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00241904",
"OBJECTIVE Adopting features of the Chronic Care Model may reduce coronary heart disease risk and blood pressure in vulnerable population s. We evaluated a peer and practice team intervention on reduction in 4-year coronary heart disease risk and systolic blood pressure . DESIGN AND SUBJECTSA single blind , r and omized , controlled trial in two adjacent urban university-affiliated primary care practice s. Two hundred eighty African-American subjects aged 40 to 75 with uncontrolled hypertension . INTERVENTIONThree monthly calls from trained peer patients with well-controlled hypertension and , on alternate months , two practice staff visits to review a personalized 4-year heart disease risk calculator and slide shows about heart disease risks . All subjects received usual physician care and brochures about healthy cooking and heart disease . MAIN MEASURES Change in 4-year coronary heart disease risk ( primary ) and change in systolic blood pressure , both assessed at 6 months . KEY RESULTS At baseline , the 136 intervention and 144 control subjects ’ mean 4-year coronary heart disease risk did not differ ( intervention = 5.8 % and control = 6.4 % , P = 0.39 ) , and their mean systolic blood pressure was the same ( 140.5 mmHg , p = 0.83 ) . Endpoint data for coronary heart disease were obtained for 69 % of intervention and 82 % of control subjects . After multiple imputation for missing endpoint data , the reduction in risk among all 280 subjects favored the intervention , but was not statistically significant ( difference −0.73 % , 95 % confidence interval : -1.54 % to 0.09 % , p = 0.08 ) . Among the 247 subjects with a systolic blood pressure endpoint ( 85 % of intervention and 91 % of control subjects ) , more intervention than control subjects achieved a > 5 mmHg reduction ( 61 % versus 45 % , respectively , p = 0.01 ) . After multiple imputation , the absolute reduction in systolic blood pressure was also greater for the intervention group ( difference −6.47 mmHg , 95 % confidence interval : −10.69 to −2.25 , P = 0.003 ) . One patient died in each study arm . CONCLUSIONS Peer patient and office-based behavioral support for African-American patients with uncontrolled hypertension did not result in a significantly greater reduction in coronary heart disease risk but did significantly reduce systolic blood pressure",
"Background Many studies have demonstrated a gap between guidelines for the prevention of cardiovascular disease ( CVD ) and their implementation in clinical practice . Aim The PEGASE education program has been devised with an aim to improve the management of patients at high risk of CVD . Methods In a multicentre study carried out from 2001–2004 in France , 96 participating physicians were r and omized into a “ trained ” group , which included 398 “ educated ” patients , and a “ non-trained ” group , which included 242 “ non-educated ” patients . Educated patients received six hospital-based educational sessions , four collective and two individual . Framingham score , smoking , lipid levels , glycaemia , blood pressure , dietary intake and drug compliance , as well as quality of life , were evaluated at baseline ( M0 ) and 6 months ( M6 ) . The primary endpoint of the study was the efficacy of the PEGASE program in reducing global CVD risk in high-risk patients . Results The Framingham score was calculated for 473 patients . The Framingham score improved significantly at M6 vs M0 in the educated group ( 13.0 ± 8.21 vs 13.6 ± 8.48 , d = −0.658 , p = 0.016 ) , but not in the non-educated group ( 12.5 ± 8.19 vs 12.4 ± 7.81 , d = + 0.064 , p = 0.836 ) ; the mean change between the two groups did not reach significance . Quality of life , LDL-c level and diet scores improved in the “ educated ” group only . Conclusions The PEGASE education program improved risk factors for CVD , although global assessment by Framingham score was not significantly different between groups . This program , aim ed at meeting needs and expectations of patients and physicians , was easily implemented in all hospital centres",
"OBJECTIVES To compare antihypertensive therapeutic strategies and efficacy whether the physicians were aware or not of the calculated cardiovascular risk at 10 years obtained from the Framingham equation . It was also possible to evaluate the concordance of the general physicians estimation of the cardiovascular risk with the calculated percentage . METHODS The participation of 953 general physicians to the study allowed to achieve an estimation of the absolute cardiovascular risk for 1,243 hypertensives . Patients were r and omised in 2 groups according to the knowledge or not by the physicians of the calculated risk . The therapeutic strategy included a monotherapy ( Fosinopril 20 mg/days ) for a follow up of 8 weeks , with the possibility to increase the treatment after 4 weeks ( Fosinopril + hydrochlorotiazide ) . To be included , patients had to be more than 18 and less than 75 years , and a blood pressure above 140/90 mmHg . Estimated and calculated cardiovascular risk at 10 years , were classified according to the 1999 WHO-ISH guidelines : low risk 30 % . RESULTS In this population , aged 60 + /- 10 years , with 54 % of men , the concordance between estimated risk and calculated risk was of 35 % . This concordance was better for the \" low risk \" and \" very high risk \" , but remains inferior to 50 % . The determinants of concordance were : gender ( male ) , smoking and a low HDL cholesterol . After 8 weeks of treatment , no difference was observed between the 2 groups concerning final blood pressure level , percentage of normalised patients and number of patients with bi-therapy . CONCLUSIONS General physicians estimation of cardiovascular risk at 10 years of hypertensive subjects has a bad concordance with the calculated risk according to Framingham equation . The results of this study indicate that the estimation of cardiovascular risk of hypertensive subjects does not modify the management of hypertension",
"OBJECTIVE The ability to accurately identify articles about therapy in large bibliographic data bases such as EMBASE is important for research ers and clinicians . Our study aim ed to develop optimal search strategies for detecting sound treatment studies in EMBASE in the year 2000 . METHODS H and search es of journals were compared with retrievals from EMBASE for c and i date search strategies . Six trained research assistants review ed fifty-five journals indexed in EMBASE and rated articles using purpose and quality indicators . C and i date search strategies were developed for identifying treatment articles and then tested , and the retrievals were compared with the h and - search data . The operating characteristics of the strategies were calculated . RESULTS Three thous and eight hundred fifty articles were original studies on treatment , of which 1,256 ( 32.6 % ) were method ologically sound . Combining search terms revealed a top performing strategy ( r and om:.tw . OR clinical trial:.mp . OR exp health care quality ) with sensitivity of 98.9 % and specificity of 72.0 % . Maximizing specificity , a top performing strategy ( double-blind:.mp . OR placebo:.tw . OR blind : .tw . ) achieved a value over 96.0 % , but with compromised sensitivity at 51.7 % . A 3-term strategy achieved the best optimization of sensitivity and specificity ( r and om:.tw . OR placebo:.mp . OR double-blind:.tw . ) , with both these values over 92.0 % . CONCLUSION Search strategies can achieve high performance for retrieving sound treatment studies in EMBASE",
"BACKGROUND Despite increasing evidence that treating dyslipidemia reduces cardiovascular events , many patients do not achieve recommended lipid targets . METHODS To determine whether showing physicians and patients the patient 's calculated coronary risk can improve the effectiveness of treating dyslipidemia in a primary care setting , patients were r and omized to receive usual care or ongoing feedback regarding their calculated coronary risk and the change in this risk after lifestyle changes , pharmacotherapy , or both to treat dyslipidemia . Outcomes , based on intention-to-treat analysis , included changes in blood lipid levels , coronary risk , and the frequency of reaching lipid targets . RESULTS Two hundred thirty primary care physicians enrolled 3,053 patients . After 12 months of follow-up , 2,687 patients ( 88.0 % ) remained in the study . After adjustment for baseline lipid values , significantly greater mean reductions in low-density lipoprotein cholesterol levels and the total cholesterol to high-density lipoprotein cholesterol ratio were observed in patients receiving risk profiles ( 51.2 mg/dL [ to convert to millimoles per liter , multiply by 0.0259 ] and 1.5 , respectively ) vs usual care ( 48.0 mg/dL and 1.3 , respectively ) , but the differences were small ( -3.3 mg/dL ; 95 % confidence interval [ CI ] , -5.4 to -1.1 mg/dL ; and -0.1 ; 95 % CI , -0.2 to -0.1 , respectively ) . Patients in the risk profile group were also more likely to reach lipid targets ( odds ratio , 1.26 ; 95 % CI , 1.07 to 1.48 ) . A significant dose-response effect was also noted when the impact of the risk profile was stronger in those with worse profiles . CONCLUSIONS Discussing coronary risk with the patient is associated with a small but measurable improvement in the efficacy of lipid therapy . The value of incorporating risk assessment in preventive care should be further evaluated",
"Abstract Objectives : To determine the effectiveness of a health check and assess any particular benefits result ing from feedback of plasma cholesterol concentration or coronary risk score , or both Design : R and omised controlled trial in two Glasgow work sites Subjects:1632 employees ( 89 % male ) aged 20 to 65 years . Interventions : At the larger work site , ( a ) health education ; ( b ) health education and feedback on cholesterol concentration ; ( c ) health education and feedback on risk score ; ( d ) health education with feedback on cholesterol concentration and risk score ( full health check ) ; ( e ) no health intervention ( internal control ) . At the other work site there was no health intervention ( external control ) . Main outcome measures Changes in Dundee risk score , plasma cholesterol concentration , diastolic blood pressure , body mass index , and self reported behaviours ( smoking , exercise , alcohol intake , and diet ) in comparison with internal and external control groups Results : Comparisons between the full health check and the internal control groups showed a small difference ( 0.13 mmol/l ) in the change in mean cholesterol concentration ( 95 % confidence interval 0.02 to 0.22 , P=0.02 ) but no significant differences for changes in Dundee risk score ( P=0.21 ) , diastolic blood pressure ( P=0.71 ) , body mass index ( P=0.16 ) , smoking ( P=1.00 ) , or exercise ( P=0.41 ) . Significant differences between the two groups were detected for changes in self reported consumption of alcohol ( 41 % in group with full health check v 17 % in internal control group , P=0.001 ) , fruit and vegetables ( 24 % v 12 % , P fat ( 30 % v 9 % , P cholesterol concentration or risk score , or both . Conclusions : The health check only had a small effect on reversible coronary risk . It was effective in influencing self reported alcohol consumption and diet . Feedback on cholesterol concentration and on risk score did not provide additional motivation for a change in behaviour",
"OBJECTIVE Web-based patient information is widespread and information on the benefits and risks of treatments is often difficult to underst and . We therefore evaluated different risk presentation formats - numerical , graphical and others - addressing the pros and cons of tight control versus usual treatment approaches for diabetes . METHOD DESIGN R and omised controlled trial . SETTING Online . Publicity disseminated via Diabetes UK . PARTICIPANTS People with diabetes or their carers . INTERVENTIONS Control group information based on British Medical Journal ' Best Treatments ' . Four intervention groups received enhanced information re sources : ( 1 ) detailed numerical information ( absolute/relative risk , numbers-needed-to-treat ) ; ( 2 ) ' anchoring ' to familiar risks or descriptions ; ( 3 ) graphical ( bar charts , thermometer scales , crowd figure formats ) ; ( 4 ) combination of 1 - 3 . OUTCOMES Decision conflict scale ( DCS , a measure of uncertainty ) ; satisfaction with information ; further free text responses for qualitative content analysis . RESULTS Seven hundred and ten people visited the website and were r and omised . Five hundred and eight completed the question naire for quantitative data . Mean DCS scores ranged from 2.12 to 2.24 for the five r and omisation groups , indicating neither clear delay or vacillation about decisions ( usually DCS>2.5 ) nor tending to make decisions ( usually DCS DCS , or satisfaction with information . Two hundred and fifty-six participants provided responses for qualitative analysis : most found graphical representations helpful , specifically bar chart formats ; many found other graphic formats ( thermometer style , crowd figures/smiley faces ) and ' anchoring ' information unhelpful , and indicated information overload . Many negative experiences with healthcare indicate a challenging context for effective information provision and decision support . CONCLUSION Online evaluation of different risk representation formats was feasible . There was a lack of intervention effects on quantitative outcomes , perhaps reflecting already well-informed participants from the Diabetes UK patient organisation . The large qualitative data set included many comments about what participants found helpful as formats for communicating risk information . PRACTICE IMPLICATION S These findings assist the design of online decision aids and the representation of risk information . The challenge is to provide more information , in appropriate and clear formats , but without risking information overload . Interactive web design s hold much promise to achieve this",
"We investigated whether disclosure of coronary heart disease ( CHD ) genetic risk influences perceived personal control ( PPC ) and genetic counseling satisfaction ( GCS ) . Participants ( n = 207 , age : 45–65 years ) were r and omized to receive estimated 10‐year risk of CHD based on a conventional risk score ( CRS ) with or without a genetic risk score ( GRS ) . Risk estimates were disclosed by a genetic counselor who also review ed how GRS altered risk in those r and omized to CRS+GRS . Each participant subsequently met with a physician and then completed surveys to assess PPC and GCS . Participants who received CRS+GRS had higher PPC than those who received CRS alone although the absolute difference was small ( 25.2 ± 2.7 vs 24.1 ± 3.8 , p = 0.04 ) . A greater proportion of CRS+GRS participants had higher GCS scores ( 17.3 ± 5.3 vs 15.9 ± 6.3 , p = 0.06 ) . In the CRS+GRS group , PPC and GCS scores were not correlated with GRS . Within both groups , PPC and GCS scores were similar in patients with or without family history ( p = NS ) . In conclusion , patients who received their genetic risk of CHD had higher PPC and tended to have higher GCS . Our findings suggest that disclosure of genetic risk of CHD together with conventional risk estimates is appreciated by patients . Whether this results in improved outcomes needs additional investigation",
"Aims To test whether communicating cardiovascular diseases ( CVD ) risk using a novel risk assessment tool ( Heart Age ) will be able to motivate a population to adopt healthier lifestyles and improve CVD risk profile over the use of a traditional percentage-based tool . Methods A single-blind r and omized intervention study was carried out in a Caucasian population . A total of 3153 subjects were r and omly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , Framingham REGICOR ( 10-year percentage risk score , calibrated to Spanish population was given to the subjects ) , or Heart Age group ( Heart Age tool was administered to the subjects ) . Anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and 12-months post intervention . Results Both the Framingham REGICOR and the Heart Age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the Heart Age group . No differences per gender were observed in the Heart Age group . Conclusions Informing patients about their CVD risk expressed as the new Heart Age tool results in a reduction in their CVD risk higher than the one observed when the Framingham REGICOR risk score was used",
"Using perceived risk of a heart attack , we examined the relative importance of perceived risk factors and sociodemographic variables on subjects ' perception of heart attack risk , the relationship between perceived and objective ly measured heart attack risk , and the effect of health risk appraisal ( HRA ) feedback on risk perceptions . Data derive from a r and om sample of 732 Greater Boston , Massachusetts area men and women ages 25 - 65 years , who participated in a field trial of health risk appraisal instruments . At baseline and approximately two months later , all respondents completed a question naire assessing their own health-related behavior , risk factors , and perception of heart attack risk . At baseline , respondents also completed one of four HRA instruments . Physiologic measures of cholesterol , blood pressure , and weight were taken at either baseline or follow-up visit . Results showed that respondents used established risk factors in estimating overall risk ; that compared to objective measures of risk , a high percentage of respondents displayed an optimistic bias ; and that HRA feedback had some effect on perception of heart attack risk for those at high risk . Implication s of these results for health promotion are discussed",
"Objective To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions . Design Pragmatic r and omised controlled trial . Setting 18 general practice s in the north of the Netherl and s. Participants 344 patients with type 2 diabetes aged ≤65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012 : 225 were allocated to the intervention group and 119 to the usual care group . Intervention The intervention comprised a decision aid for people with diabetes , with individually tailored risk information and treatment options for multiple risk factors . The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions . It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation . Four different formats of the decision aid were included for additional explorative analyses . Main outcome measures The primary outcome was the effects on patient empowerment for setting and achieving goals . The secondary outcomes were changes in the prescribing of drugs to regulate glucose , blood pressure , lipids , and albuminuria . Data were collected through structured question naires and automated data extraction from electronic health records during six months before and after the intervention . Results Of all intervention participants , 103 ( 46 % ) reported to have received the basic elements of the intervention . For the primary outcome analysis , 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included . The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group , which was not significantly different from that of the control group ( mean difference after adjusting for baseline 0.039 , 95 % confidence interval −0.056 to 0.134 ) . Lipid regulating drug treatment was intensified in 25 % of intervention and 12 % of control participants with increased cholesterol levels , which did not reach significance when the intervention was compared with the usual care group ( odds ratio 2.54 , 95 % confidence interval 0.89 to 7.23 ) . Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care ( 3.90 , 1.29 to 11.80 ) . No relevant or significant changes were seen for other treatments . Conclusion We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount . The aid was not used to its full extent in a substantial number of participants . Trial registration Dutch trial register NTR1942",
"We conducted a feasibility study of a web-based intervention , which provided personalized cardiovascular disease ( CVD ) risk information , behavioural risk reduction strategies and educational re sources . Participants were block-r and omized to the 3-month intervention ( n = 47 ) or to usual care ( n = 49 ) . Participants in the intervention group were presented with their CVD risk based on the Framingham risk score , and in three subsequent online encounters could select two behavioural/lifestyle modules , giving them an opportunity to complete six modules over the course of the study . Because it was self-guided , participants had differing levels of engagement with intervention material s. Most intervention group participants ( 77 % , n = 36 ) completed all modules . After 3 months there were no significant differences between the intervention and usual care groups for systolic blood pressure , body-mass index , CVD risk , smoking cessation or medication non-adherence . The study suggests that modest clinical improvements can be achieved by interventions that are entirely web-administered . However , web-based interventions do not replace the need for human interaction to communicate CVD risk and assist with decision-making",
"IMPORTANCE Most primary care clinicians lack the skills and re sources to offer effective lifestyle and medication ( L&M ) counseling to reduce coronary heart disease ( CHD ) risk . Thus , effective and feasible CHD prevention programs are needed for typical practice setting s. OBJECTIVE To assess the effectiveness , acceptability , and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats . DESIGN , SETTING , AND PARTICIPANTS A comparative effectiveness trial in 5 diverse family medicine practice s in North Carolina . Participants were established patients , aged 35 to 79 years , with no known cardiovascular disease , and at moderate to high risk for CHD ( 10-year Framingham Risk Score [ FRS ] , ≥10 % ) . INTERVENTIONS Participants were r and omized to counselor-delivered or web-based format , each including 4 intensive and 3 maintenance sessions . After r and omization , both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies . Participants chose the risk-reducing strategies they wished to follow . MAIN OUTCOMES AND MEASURES The primary outcome was within-group change in FRS at 4-month follow-up . Other measures included st and ardized assessment s of blood pressure , blood lipid levels , lifestyle behaviors , and medication adherence . Acceptability and cost-effectiveness were also assessed . Outcomes were assessed at 4 and 12 months . RESULTS Of 2274 screened patients , 385 were r and omized ( 192 counselor ; 193 web ) : mean age , 62 years ; 24 % African American ; and mean FRS , 16.9 % . Follow-up at 4 and 12 months included 91 % and 87 % of the r and omized participants , respectively . There was a sustained reduction in FRS at both 4 months ( primary outcome ) and 12 months for both counselor-based ( -2.3 % [ 95 % CI , -3.0 % to -1.6 % ] and -1.9 % [ 95 % CI , -2.8 % to -1.1 % ] , respectively ) and web-based groups ( -1.5 % [ 95 % CI , -2.2 % to -0.9 % ] and -1.7 % [ 95 % CI , -2.6 % to -0.8 % ] respectively ) . At 4 months , the adjusted difference in FRS between groups was -1.0 % ( 95 % CI , -1.8 % to -0.1 % ) ( P = .03 ) , and at 12 months , it was -0.6 % ( 95 % CI , -1.7 % to 0.5 % ) ( P = .30 ) . The 12-month costs from the payer perspective were $ 207 and $ 110 per person for the counselor- and web-based interventions , respectively . CONCLUSIONS AND RELEVANCE Both intervention formats reduced CHD risk through 12-month follow-up . The web format was less expensive . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01245686",
"METHODS Case-management ( CM ) can positively influence chronic disease care by facilitating guideline -concordant interventions that improve outcomes through intensive , individualized , longitudinal care . Implementation of CM , however , is difficult . We have identified lessons learned from a cardiovascular risk reduction CM program that may aid future CM implementation . INTRODUCTION Heart to Heart is both a clinical trial and program dissemination project implementing CM for persons at elevated risk of coronary heart disease ( CHD ) events in a multiethnic , low-income population in a county health system . Patients were r and omized to CM plus usual primary care ( N = 212 ) or primary care alone ( N = 207 ) . CM patients received face-to-face nurse and dietitian visits ( mean of 14 hours ) over 17 months . Visits emphasized behavior change , risk-factor monitoring , and guideline -based pharmacotherapy . A total of 341 patients ( 81 % ) were available for follow-up . This CM model is currently transitioning to a County-run program . RESULTS Findings demonstrated statistically significant reductions in mean Framingham Risk for CM versus usual primary care ( 1.56 % absolute decrease in 10-year CHD risk , P = 0.007 ) . Favorable changes were noted across most major CHD risk factors . Lessons learned are the need for the following : ( 1 ) Strategies for implementing CM in low-income , ethnically-diverse population s , ( 2 ) Methods for developing clinical ly more effective CM , and ( 3 ) Approaches to increase the efficiency of cardiovascular CM . CONCLUSIONS CM for cardiac risk factors faces notable implementation barriers , particularly in County health systems . Specific implementation solutions recommended may help confront these barriers and improve diffusion of this evidence -based and patient centered model of care",
"BACKGROUND There is a lack of evidence regarding the value of tools design ed to aid decision making in patients with newly diagnosed hypertension . AIM To evaluate two interventions for assisting newly diagnosed hypertensive patients in the decision whether to start drug therapy for reducing blood pressure . DESIGN OF STUDY Factorial r and omised controlled trial . SETTING Twenty-one general practice s in south-west Engl and , UK . METHOD Adults aged 32 to 80 years with newly diagnosed hypertension were r and omised to receive either : ( a ) computerised utility assessment interview with individualized risk assessment and decision analysis ; or ( b ) information video and leaflet about high blood pressure ; or ( c ) both interventions ; or ( d ) neither intervention . Outcome measures were decisional conflict , knowledge , state anxiety , intentions regarding starting treatment , and actual treatment decision . RESULTS Of 217 patients r and omised , 212 ( 98 % ) were analysed at the primary follow-up ( mean age = 59 years , 49 % female ) . Decision analysis patients had lower decisional conflict than those who did not receive this intervention ( 27.6 versus 38.9 , 95 % confidence interval [ CI ] for adjusted difference = -13.0 to -5.8 , P knowledge about hypertension ( 73 % versus 67 % , adjusted 95 % CI = 2 % to 9 % , P = 0.003 ) and no evidence of increased state anxiety ( 34.8 versus 36.8 , adjusted 95 % CI = -5.6 to 0.1 , P = 0.055 ) . Video/leaflet patients had lower decisional conflict than corresponding controls ( 30.3 versus 36.8 , adjusted 95 % CI = -7.4 to -0.6 , P = 0.021 ) , greater knowledge ( 75 % versus 65 % , adjusted 95 % CI = 6 % to 13 % , P increased state anxiety ( 35.7 versus 36.1 , adjusted 95 % CI = -3.9 to 1.7 , P = 0.46 ) . There were no differences between either of the interventions and their respective controls in the proportion of patients prescribed antihypertensive medication ( 67 % ) . CONCLUSIONS This trial demonstrates that , among patients facing a real treatment decision , interventions to inform patients about hypertension and to clarify patients ' values concerning outcomes of treatment are effective in reducing decisional conflict and increasing patient knowledge , while not result ing in any increases in state anxiety",
"BACKGROUND Exposure to combination antiretroviral therapy ( cART ) can lead to important metabolic changes and increased risk of coronary heart disease ( CHD ) . Computerized clinical decision support systems have been advocated to improve the management of patients at risk for CHD but it is unclear whether such systems reduce patients ' risk for CHD . METHODS We conducted a cluster trial within the Swiss HIV Cohort Study ( SHCS ) of HIV-infected patients , aged 18 years or older , not pregnant and receiving cART for > 3 months . We r and omized 165 physicians to either guidelines for CHD risk factor management alone or guidelines plus CHD risk profiles . Risk profiles included the Framingham risk score , CHD drug prescriptions and CHD events based on biannual assessment s , and were continuously up date d by the SHCS data centre and integrated into patient charts by study nurses . Outcome measures were total cholesterol , systolic and diastolic blood pressure and Framingham risk score . RESULTS A total of 3,266 patients ( 80 % of those eligible ) had a final assessment of the primary outcome at least 12 months after the start of the trial . Mean ( 95 % confidence interval ) patient differences where physicians received CHD risk profiles and guidelines , rather than guidelines alone , were total cholesterol -0.02 mmol/l ( -0.09 - 0.06 ) , systolic blood pressure -0.4 mmHg ( -1.6 - 0.8 ) , diastolic blood pressure -0.4 mmHg ( -1.5 - 0.7 ) and Framingham 10-year risk score -0.2 % ( -0.5 - 0.1 ) . CONCLUSIONS Systemic computerized routine provision of CHD risk profiles in addition to guidelines does not significantly improve risk factors for CHD in patients on cART",
"Background R and omised , controlled trials focusing on long-term psychological reactions to information about increased risk of coronary heart disease are scarce . Design A population -based r and omised , controlled , 5-year follow-up trial was conducted in general practice . Methods In 1991 , invitations were sent to 2,000 middle-aged people registered in the general practice s in the district of Ebeltoft , Denmark . A total of 1,507 ( 75.4 % ) agreed to participate and were r and omised into a control group and two intervention groups : one included health screening , a written feedback and an optional follow-up visit with the general practitioner ; the other included health screening , written feedback and a planned 45-min follow-up visit with the general practitioner . The participants were informed at screening about their risk of developing coronary heart disease . Psychological distress was measured by the GHQ-12 before screening and at the 1 and the 5-year follow-up . Results Before the screening ( 0 year ) , 1 and 5 years after there were no significant differences in the GHQ-12 score between the control group and the two intervention groups . Nor were there any differences related to information about increased risk of coronary heart disease between scores obtained at the 1 and the 5-year follow-up . Conclusion Middle-aged persons had no long-term psychological reaction after information about increased risk of developing coronary heart disease following a health screening in general practice evaluated by the GHQ-12,1 year and 5 years after the examinations",
"OBJECTIVE To determine in primary care patients at high risk for a cardiovascular event , the effects on biomedical risk factors for and incidence of cardiovascular events , of a brief cardiovascular prevention program executed by a health advisor . METHOD DESIGN cluster r and omized controlled trial with 1275 patients ( 24 general practice s ) in and around Maastricht , the Netherl and s ( 1999 - 2004 ) . INTERVENTION health advisors were to complete computerized cardiovascular risk profiles , provide multi-factorial tailored health education and advice , and communicate with GP 's to optimize treatment . OUTCOME differences in changes in risk factors between baseline and follow up at 6 , 18 , and 36 months and incidence of cardiovascular events at 36 months . RESULTS PROCESS Because of logistic reasons risk profiles were put on paper instead of in the computerized patient files . On average patients attended 2.3 counseling sessions . Interaction with GPs was less productive than expected . OUTCOME Effect after six months on BMI ( -0.20 kg/m(2 ) ( 95 % CI -0.38 to -0.01 , p=0.039 ) , Cohen 's d : -0.18 ) , and after 18 months on HDL-cholesterol ( + 0.05 mmol/l ( 95 % CI + 0.01 to + 0.09 , p=0.014 ) , Cohen 's d : 0.14 ) . No other ( subgroup ) effects were found . CONCLUSION Given the lack of clinical ly meaningful effects , implementation of this intervention in its present form is not justified",
"BACKGROUND Pharmacist- or nurse-led team care decreases patient blood pressure ( BP ) and cardiovascular disease ( CVD ) risk . PURPOSE To evaluate whether a Web-based dietitian-led ( WD ) team care intervention was feasible and result ed in decreased BP , CVD risk , and weight compared to usual care ( UC ) . METHODS Electronic health record ( EHR ) data identified patients aged 30 - 69 years with BMI > 26 , elevated BP , and 10%-25 % 10-year Framingham CVD risk who were registered patient website users . Patients with uncontrolled BP at screening were r and omized to UC or WD , which included a home BP monitor , scale , and dietitian team care . WD participants had a single in-person dietitian visit to obtain baseline information and create a plan to reduce CVD risk . Planned follow-up occurred via secure messaging to report BP , weight , and fruit and vegetable intake and receive ongoing feedback . If needed , dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications . Primary outcomes were change in systolic BP and weight loss ≥4 kg at 6 months . Feasibility outcomes included intervention utilization and satisfaction . RESULTS Between 2010 and 2011 , a total of 90 of 101 participants completed 6-month follow-ups . The WD group had higher rates of secure messaging utilization and patient satisfaction . The WD group lost significantly more weight than the UC group ( adjusted net difference=-3.2 kg , 95 % CI=-5.0 , -1.5 , p lose ≥4 kg ( adjusted relative risk [RRadj]=2.96 , 95 % CI=1.16 , 7.53 ) . BP control and CVD risk reduction were greater in WD than UC , but differences were not statistically significant . CONCLUSIONS WD intervention was feasible and result ed in decreased weight , BP , and CVD risk . A larger trial is justified . TRIAL REGISTRATION NUMBER Trial Registration Number : NCT01077388",
"STUDY OBJECTIVE To evaluate whether a simple pharmacist protocol , consisting of patient screening and cardiovascular risk stratification , identification and reminders about uncontrolled risk factors , and drug adherence support , can significantly reduce cardiovascular risk . DESIGN Prospect i ve , r and omized , controlled pilot study . SETTING Large primary care medical clinic in Saskatoon , Saskatchewan , Canada . PATIENTS One hundred seventy-six adult patients ( mean age 60 yrs ) who exhibited a 10-year Framingham risk score of 15 % or greater , or a coronary artery disease risk equivalent ( coronary artery disease , peripheral artery disease , cerebrovascular disease , or diabetes mellitus ) . INTERVENTION Eligible patients initially met with the pharmacist to receive general counselling about cardiovascular disease and were then r and omly assigned to receive ongoing follow-up by the pharmacist ( follow-up group [ 88 patients ] ) or to return to usual care ( single-contact group [ 88 patients ] ) for a minimum of 6 months . MEASUREMENTS AND MAIN RESULTS The primary end point was mean reduction in the 10-year Framingham risk score . Secondary end points included individual modifiable risk factors ( systolic and diastolic blood pressures ; total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol [ HDL ] , and triglyceride levels ; total cholesterol : HDL ratio ; and hemoglobin A(1c ) value ) , as well as statin utilization , initiation , and adherence rates . Baseline characteristics were similar across both groups . Neither the mean reduction in 10-year risk ( -2.68 for the follow-up group and -1.25 for the single-contact group , one-tailed p=0.098 ) nor individual risk factors were significantly different between groups . The proportion of patients exhibiting statin adherence of 80 % or greater did not significantly differ between groups at study end ( 73.1 % [ 57/78 ] and 80.0 % [ 52/65 ] , respectively , p=0.333 ) . However , 85.2 % ( 75/88 ) in the follow-up group continued with statin therapy at the end of the study compared with 67.0 % ( 59/88 ) in the single-contact group ( p=0.005 ) . Statin initiations were more frequent in the follow-up group than in the single-contact group ( 75.0 % [ 30/40 ) vs 48.9 % [ 22/45 ] , p=0.013 ) . CONCLUSION This simple cardiovascular care protocol for nonspecialist pharmacists did not result in a clear improvement to cardiovascular risk reduction success among patients in a primary care medical clinic . The intervention did , however , appear to improve statin utilization",
"This study is a 3-year follow-up of a factorial r and omised controlled trial of two decision aids - decision analysis and information video plus leaflet - for newly diagnosed hypertensive patients . We found no evidence of differences for either of the two decision aids compared with controls for the primary outcome of blood pressure control at follow-up . There were also no differences in any of the secondary outcomes measured - the proportion taking blood pressure lowering drugs , self-reported medication adherence , or consulting behaviour . The r and omised controlled trial cohort as a whole , irrespective of r and omised group , demonstrated substantial reductions in blood pressure and 10-year cardiovascular risk over the follow-up period",
"PURPOSE We wanted to determine the effect of promoting the effective communication of absolute cardiovascular disease ( CVD ) risk and shared decision making through disseminating a simple decision aid for use in family practice consultations . METHODS The study was based on a pragmatic , cluster r and omized controlled trial ( phase III ) with continuing medical education ( CME ) groups of family physicians as the unit of r and omization . In the intervention arm , 44 physicians ( 7 CME groups ) consecutively recruited 550 patients in whom cholesterol levels were measured . Forty-seven physicians in the control arm ( 7 CME groups ) similarly included 582 patients . Four hundred sixty patients ( 83.6 % ) of the intervention arm and 466 patients ( 80.1 % ) of the control arm were seen at follow-up . Physicians attended 2 interactive CME sessions and received a booklet , a paper-based risk calculator , and individual summary sheets for each patient . Control physicians attended 1 CME-session on an alternative topic . Main outcome measures were patient satisfaction and participation after the index consultation , change in CVD risk status , and decisional regret at 6 months ’ follow-up . RESULTS Intervention patients were significantly more satisfied with process and result ( Patient Participation Scale , difference 0.80 , P Decisional regret was significantly lower at follow-up ( difference 3.39 , P = .02 ) . CVD risk decreased in both groups without a significant difference between study arms . CONCLUSION A simple transactional decision aid based on calculating absolute individual CVD risk and promoting shared decision making in CVD prevention can be disseminated through CME groups and may lead to higher patient satisfaction and involvement and less decisional regret , without negatively affecting global CVD risk",
"The purpose of the present study was to examine general practitioners ' abilities to make a correct estimation of the risk of coronary heart disease ( CHD ) . A 10 % r and om sample of Norwegian primary care physicians ( n = 288 ) received a question naire that presented 10 case histories containing information about five CHD risk factors . The respondents ' risk estimation was compared with a composite score computed from epidemiologic data . The observed general tendency was towards underestimating the CHD risk . However , ' high-risk ' histories were recognized as CHD risk persons . Assessment of CHD risk due to multiple marginal abnormalities was only exceptionally correct . Hypercholesterolaemia and hypertension in men were acknowledged as contributing to clinical ly significant CHD risk only by a minority of GPs . Heavy smoking and a positive family history were associated with a more accurate estimation of CHD risk . Forty per cent of the physicians did not recognize the sex dependency of cholesterol as a CHD risk factor . None of the physician characteristics could predict variation in correct risk assessment",
"Electronic decision-support tools may help to improve management of hyperlipidemia and other chronic diseases . This study examined the impact of lipid management tools integrated into an electronic medical record ( EMR ) in primary care practice s. This r and omized controlled trial was conducted in a national network of physicians who use an outpatient EMR . Adult primary care physicians were r and omized by office to receive an electronic form that was embedded in the EMR . The form contained prompts regarding suboptimal care based on Adult Treatment Panel-III ( ATP-III ) guidelines , as well as reporting tools to identify patients outside of office visits whose lipid management was suboptimal . All active patients , ages 20 - 79 years , whose physicians participated in the study , were categorized as high , moderate , or low cardiovascular risk , and the proportion who were tested for hyperlipidemia , at lipid goal , and on lipid-lowering medications if not at goal were measured according to ATP-III guidelines . A total of 105 physicians from 25 offices and 64,150 patients were included in the study . Outcomes improved for most measures from before to 1 year after the intervention ( November 1 , 2005 to October 31 , 2006 ) . However , after controlling for confounding variables and for clustering in multilevel modeling , only up-to- date lipid testing for high-risk patients was statistically better in the intervention group as compared to the control group ( adjusted odds ratio 15.0 , P quality of lipid management after implementing an EMR-based disease management intervention in primary care setting s. Future studies may need to examine more comprehensive interventions that include office staff in a team approach to care",
"Background — Whether knowledge of genetic risk for coronary heart disease ( CHD ) affects health-related outcomes is unknown . We investigated whether incorporating a genetic risk score ( GRS ) in CHD risk estimates lowers low-density lipoprotein cholesterol ( LDL-C ) levels . Methods and Results — Participants ( n=203 , 45–65 years of age , at intermediate risk for CHD , and not on statins ) were r and omly assigned to receive their 10-year probability of CHD based either on a conventional risk score ( CRS ) or CRS + GRS ( + GRS ) . Participants in the + GRS group were stratified as having high or average/low GRS . Risk was disclosed by a genetic counselor followed by shared decision making regarding statin therapy with a physician . We compared the primary end point of LDL-C levels at 6 months and assessed whether any differences were attributable to changes in dietary fat intake , physical activity levels , or statin use . Participants ( mean age , 59.4±5 years ; 48 % men ; mean 10-year CHD risk , 8.5±4.1 % ) were allocated to receive either CRS ( n=100 ) or + GRS ( n=103 ) . At the end of the study period , the + GRS group had a lower LDL-C than the CRS group ( 96.5±32.7 versus 105.9±33.3 mg/dL ; P=0.04 ) . Participants with high GRS had lower LDL-C levels ( 92.3±32.9 mg/dL ) than CRS participants ( P=0.02 ) but not participants with low GRS ( 100.9±32.2 mg/dL ; P=0.18 ) . Statins were initiated more often in the + GRS group than in the CRS group ( 39 % versus 22 % , P in dietary fat intake and physical activity levels were noted . Conclusions — Disclosure of CHD risk estimates that incorporated genetic risk information led to lower LDL-C levels than disclosure of CHD risk based on conventional risk factors alone . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01936675",
"ABSTRACT BACKGROUND Many individuals at higher risk for cardiovascular disease ( CVD ) do not receive recommended treatments . Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness . OBJECTIVE AND DESIGN To perform a 9-month cluster-r and omized trial , comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care . PARTICIPANTS Patients of participating physicians with a Framingham Risk Score of at least 5 % , low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment , and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis .INTERVENTION Patients of physicians r and omized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin ( and controlling hypertension or quitting smoking when relevant).MAIN MEASURES The primary outcome was occurrence of a LDL-cholesterol level , repeated in routine practice , that was at least 30 mg/dl lower than prior . A secondary outcome was lipid-lowering drug prescribing . Clinical trials.gov identifier : NCT01286311.KEY RESULTS Fourteen physicians with 218 patients were r and omized to intervention , and 15 physicians with 217 patients to control . The mean patient age was 60.7 years and 77 % were male . There was no difference in the primary outcome ( 11.0 % vs. 11.1 % , OR 0.99 , 95 % CI 0.56–1.74 , P = 0.96 ) , but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication ( 11.9 % , vs. 6.0 % , OR 2.13 , 95 % CI 1.05–4.32 , p = 0.038 ) . In post hoc analysis with extended follow-up to 18 months , the primary outcome occurred more often in the intervention group ( 22.5 % vs. 16.1 % , OR 1.59 , 95 % CI 1.05–2.41 , P = 0.029 ) . CONCLUSIONS In this effectiveness trial , individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions , but we observed no difference in proportions lowering LDL-cholesterol after 9 months . With longer follow-up , the intervention ’s effect on LDL-cholesterol levels was apparent",
"AIM Informing a person of their individual risk of developing a disease in the future may be sufficient to provide the person with the impetus to adopt risk reducing behaviours . The aim of this study was to determine if a personalised 10-year cardiovascular disease ( CVD ) risk estimate can increase physical activity and other risk reduction behaviours in adults at high risk of CVD . METHODS Pilot 2 × 2 factorial r and omised controlled trial conducted in Oxfordshire , UK including 194 adults at increased CVD risk ( 10-year CVD risk ≥ 20 % ) recruited from four general practice s. Main outcome measure at one month was physical activity measured by accelerometer . RESULTS Median ( IQR ) age was 62.3 ( 54.9 , 66.1 ) years , 67 % were men and 19 % had known diabetes . Mean ( SD ) total accelerometer counts per day was 297 × 10(-3 ) ( 110 × 10(-3 ) ) and activity of moderate or greater intensity was undertaken for 53 ( 22 ) minutes per day . In the 185 ( 95 % ) participants attending follow-up an increase in physical activity was not seen . There was a non-significant 0.5 % ( p = 0.56 ) greater increase in accelerometer counts in those receiving personalised CVD risk estimates . No significant within or between group changes were seen at one month in estimated 10-year CVD risk . A net 7 % decrease in mean LDL cholesterol ( p = 0.004 ) was seen in the intervention group despite similar increases in new prescriptions for lipid lowering therapies . CONCLUSION In adults at increased risk of CVD provision of personalised 10-year CVD risk estimates did not appear to increase physical activity or estimated CVD risk over a one-month period",
"OBJECTIVE High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated . Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in population s. The present study is a community cluster-r and omised trial testing the effectiveness of CHAP ( Cardiovascular Health Awareness Program ) on the cardiovascular health of older adults . METHODS Thirty-nine mid-sized communities in Ontario , Canada were stratified by geographic location and size of the population aged > or=65 years and r and omly allocated to receive CHAP or no intervention . In CHAP communities , residents aged > or=65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall , 2006 . Sessions included blood pressure measurement and feedback to family physicians . Trained volunteers delivered the program with support from pharmacists , community nurses and local organisations . RESULTS The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infa rct ion , congestive heart failure and stroke ( composite end-point ) among residents aged > or=65 years in intervention and control communities , using routinely collected , population -based administrative health data . CONCLUSION This paper highlights considerations in design , implementation and evaluation of a large-scale , community-wide cardiovascular health promotion initiative"
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OBJECTIVES High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices . The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage . We aim ed to identify vali date d surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty ( THA ) . METHODS We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA . Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines . We conducted a search of Medline and Embase ( OVID ) data bases . Separate search strategies were devised for the Cochrane data base and Google Scholar . Each search was performed to include articles from the date of their inception to June 8 , 2015 . RESULTS Our search strategy identified 1082 studies of which 115 studies were included for full article review . Following review , 17 articles were found that investigated surrogate markers of long-term outcome . These included one systematic review , one r and omised control trial ( RCT ) , one case control study and 13 case series . Vali date d surrogate markers included Radiostereometric Analysis ( RSA ) and Einzel-Bild-Röntgen-Analyse ( EBRA ) , each measuring implant migration and wear . We identified five RSA studies ( one systematic review and four case series ) and four EBRA studies ( one RCT and three case series ) . Patient Reported Outcome Measures ( PROMs ) at six months have been investigated but have not been vali date d against long-term outcomes . CONCLUSIONS This systematic review identified two vali date d surrogate markers of long-term primary THA outcome : RSA and EBRA , each measuring implant migration and wear . We recommend the consideration of RSA in the pre-market testing of new implants . EBRA can be used to investigate acetabular wear but not femoral migration . Further studies are needed to vali date the use of PROMs for post-market surveillance . Cite this article : T. T. Malak , J. A. J. Broomfield , A. J. R. Palmer , S. Hopewell , A. Carr , C. Brown , D. Prieto-Alhambra , S. Glyn-Jones . Surrogate markers of long-term outcome in primary total hip arthroplasty : A systematic review . Bone Joint Res 2016;5:206 - 214 . DOI : 10.1302/2046 - 3758.56.2000568
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"Surgery and other invasive therapies are complex interventions , the assessment of which is challenged by factors that depend on operator , team , and setting , such as learning curves , quality variations , and perception of equipoise . We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process . We also encourage the widespread use of prospect i ve data bases and registries . Reports of new techniques should be registered as a professional duty , anonymously if necessary when outcomes are adverse . Case series studies should be replaced by prospect i ve development studies for early technical modifications and by prospect i ve research data bases for later pre-trial evaluation . Protocol s for these studies should be registered publicly . Statistical process control techniques can be useful in both early and late assessment . R and omised trials should be used whenever possible to investigate efficacy , but adequate pre-trial data are essential to allow power calculations , clarify the definition and indications of the intervention , and develop quality measures . Difficulties in doing r and omised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems . Alternative prospect i ve design s , such as interrupted time series studies , should be used when r and omised trials are not feasible . Established procedures should be monitored with prospect i ve data bases to analyse outcome variations and to identify late and rare events . Achievement of improved design , conduct , and reporting of surgical research will need concerted action by editors , funders of health care and research , regulatory bodies , and professional societies",
"We report a prospect i ve , stratified study of 60 PCA-cups and 60 RM-polyethylene cups which have been followed for a median time of 90 months , with annual radiography . The radiological migration of cups was measured by the computer-assisted EBRA method . A number of threshold migration rates from 1 mm in the first year to 1 mm in five years have been assessed and related to clinical ly determined revision rates . A total of 28 cups showed a total migration of 1 mm or more within the first two years ; 13 of these cups have required revision and been exchanged . The survival curves of cups which had previously shown early migration were considerably different from those without early migration . For cups with a migration of less than 1 mm within the first two years the mean survival at 96 months was 0.96 + /- 0.02 ; for migrating cups , it was 0.63 + /- 0.11 ( log-rank test , p=0.0001 ; chi-square value=39.4 ) . Early migration is a good predictor for late loosening of hip sockets",
"The IDEAL framework describes the stages of evaluation for surgical innovations . This paper considers the role of observational studies in the exploration and assessment stages . At the exploration stage , the surgical intervention is usually more widely used , and observational studies should collect prospect i ve data from multiple surgeons , deal with factors such as case mix and learning , and prepare for a definitive evaluation at the next stage of assessment . Although a r and omised controlled trial is preferable , a high quality observational study would be acceptable if a r and omised trial is not feasible or , on rare occasions , deemed unnecessary",
"The complexity of surgical procedures often poses challenges for conducting a rigorous and comprehensive evaluation . This paper considers the final two IDEAL stages of surgical innovation . Surgical r and omised controlled trials are often challenging to undertake and require careful consideration of the intervention definition , who should deliver it , and the impact of surgeon and patient preferences . In the long term study stage , better monitoring of surgical procedures is needed , along with improved surveillance of devices",
"Background Due to its collarless , double-tapered polished design , the Exeter femoral stem is known to migrate distally in the first 5 years after implantation . However , its long-term migration pattern has not been investigated . Patients and methods 39 consecutive patients ( 41 total hip arthroplasties ) received a cemented Exeter stem and had prospect i ve clinical and RSA follow-up . Patients were evaluated postoperatively at 6 , 12 , 26 , and 52 weeks , and annually thereafter . Short-term results have been reported . In this study , the mean length of follow-up was 9.4 years ( SD 3.2 years ) . No patients were lost to follow-up . 15 patients died during follow-up . Results No stems were revised . In 4 stems , fractures of the cement mantle were noted within the first 3 postoperative years . In 3 stems , this result ed in a complete circumferential cement mantle discontinuity . For the 37 well-performing stems , continuous but small migration was measured between 2 and 12 years of follow-up . Continued subsidence of 0.08 mm/year ( 95 % CI : 0.05–0.12 , p continued rotation in retroversion of 0.07 ° /year ( 95 % CI : 0.02–0.12 , p = 0.01 ) . At 10 years of follow-up , mean subsidence was 2.1 ( SD 1.2 ) mm and mean retroversion was 1.8 ° ( SD 2.0 ) . Two-thirds of this occurred during the first 2 postoperative years . In the 3 stems with a complete circumferential cement fracture , a sudden and disproportionately high increase in subsidence was measured in the time period of occurrence . Interpretation The Exeter femoral stem continues to migrate during the first decade after implantation . Absolute stability is not required for good long-term survival if this is compatible with the design of the implant",
" The vertical migration of four configurations of a proximal femoral prosthesis , followed for up to nine years , was measured on st and ard radiographs . The same implant was used without cement ( group 1 ) and with cement ( group 2 ) . The migration of both groups was linear from six months onwards . The mean migration rate and the incidence of late aseptic loosening were both greater in group 1 . Survival analysis of the two groups , however , showed no statistically significant difference . In both groups , hips later destined for revision migrated more rapidly from the initial postoperative period onwards , than did the remainder . A threshold migration of 1.2 mm/year during the first two years after implantation detected hips likely to fail with a specificity of 86 % and a sensitivity of 78 % . This ' migration test ' was applied to the results in two further groups of patients in which a modified femoral prosthesis had been implanted without hydroxyapatite coating ( group 3 ) and with hydroxyapatite coating ( group 4 ) . The test distinguished between the four groups and suggested that at least two fixation procedures should be ab and oned . We conclude that vertical migration measured on st and ard radiographs in the first two years after implantation can be used to predict late aseptic loosening . New prosthetic configurations should be evaluated by migration measurements before their general release . Our observations support the view that one cause of late aseptic loosening is imperfect initial fixation",
"BACKGROUND The use of highly cross-linked polyethylene is now commonplace in total hip arthroplasty . Hip simulator studies and short-term in vivo measurements have suggested that the wear rate of highly cross-linked polyethylene is significantly less than that of conventional ultra-high molecular weight polyethylene . However , long-term data to support its use are limited . The aim of this study was to compare the intermediate-term steady-state wear of highly cross-linked polyethylene compared with that of conventional ultra-high molecular weight polyethylene acetabular liners in a prospect i ve , double-blind , r and omized controlled trial with use of radiostereometric analysis . METHODS Fifty-four patients were r and omized to receive hip replacements with either conventional ultra-high molecular weight polyethylene acetabular liners ( Zimmer ) or highly cross-linked polyethylene liners ( Longevity ; Zimmer ) . All patients received a cemented , collarless , polished , tapered femoral component ( CPT ; Zimmer ) and an uncemented acetabular component ( Trilogy ; Zimmer ) . Clinical outcomes were assessed and the three-dimensional penetration of the head into the socket was determined for a minimum of seven years . Linear regression was used to calculate the steady-state wear rate following the creep-dominated penetration seen during the first year . RESULTS At a minimum of seven years postoperatively , the mean total femoral head penetration was significantly lower in the highly cross-linked polyethylene group ( 0.33 mm ; 95 % confidence interval [ CI ] , ±0.10 mm ) than it was in the ultra-high molecular weight polyethylene group ( 0.55 mm ; 95 % CI , ±0.10 mm ) ( p = 0.005 ) . The mean steady-state wear rate of highly cross-linked polyethylene was 0.005 mm/yr ( 95 % CI , ±0.015 mm/yr ) , compared with 0.037 mm/yr ( 95 % CI , ±0.019 mm/yr ) for conventional ultra-high molecular weight polyethylene ( p = 0.007 ) . No patient in the highly cross-linked polyethylene group had a wear rate above the osteolysis threshold of 0.1 mm/yr , compared with 9 % of patients in the ultra-high molecular weight polyethylene group . CONCLUSIONS This study demonstrates that highly cross-linked polyethylene has a significantly lower steady-state wear rate compared with that of conventional ultra-high molecular weight polyethylene . Longer-term follow-up is required to determine if this will translate into improved clinical performance and longevity of these implants",
"BACKGROUND Excessive early migration of femoral stems following total hip arthroplasty and tibial components following total knee arthroplasty is associated with their long-term survival and allows reliable early evaluation of implant performance . However , a similar relationship involving acetabular components following hip arthroplasty has not been evaluated . This prospect i ve , long-term study with clinical and Roentgen stereophotogrammetric analysis ( RSA ) follow-up establishes the existence of this relationship and its associated diagnostic performance . METHODS Thirty-nine consecutive patients ( forty-one hips ) who underwent total hip arthroplasty with a cemented Exeter stem and a cemented Exeter all-polyethylene cup had prospect i ve clinical and RSA follow-up . Patients were evaluated postoperatively at six weeks , at three , six , and twelve months , and annually thereafter . Conventional anteroposterior and lateral radiographs were made at six weeks and at two , five , and ten years postoperatively as well as when indicated . The mean duration of follow-up ( and st and ard deviation ) was 9.4 ± 3.2 years . No patients were lost to follow-up ; fifteen patients died during the follow-up period . RESULTS Eleven acetabular components were observed to be loose on conventional radiographs after a mean of seventy-six months ( range , twelve to 140 months ) . During the first two postoperative years , the failed acetabular components showed markedly greater and more rapid cranial translation and sagittal rotation . Both cranial translation ( hazard ratio = 19.9 [ 95 % confidence interval , 4.94 to 80.0 ] , p and sagittal rotation ( hazard ratio = 11.1 [ 95 % confidence interval , 2.83 to 43.9 ] , p = 0.001 ) were strong risk factors for late aseptic loosening . Eight of the eleven failed components showed a distinctive pattern of excessive cranial translation combined with excessive sagittal rotation . The associated diagnostic performance of two-year cranial translation and /or sagittal rotation for predicting late aseptic loosening of the acetabular component was good ( area under the receiver operating characteristic curve , 0.88 [ 95 % confidence interval , 0.74 to 1.00 ; p performance of new implants or implant-related changes ",
"Background Acetabular screw cups seem to give high primary stability . We analyzed the migration and loosening behavior of a first-generation screw cup in a longterm follow-up . Patients and methods We examined 92 uncemented titanium alloy conical screw cups prospect ively . Implant migration was assessed with a digital high-precision method ( EBRA ) with an accuracy of 1.0 mm . Results After mean 11 ( 0.5–18 ) years , 87 patients were available for examination and 5 patients had died . 32 implants had been revised and 7 cases showed radiographic evidence of loosening . The 10-year survival rate was 71 % . Migration of more than 1 mm occurred in 53 hips . Implant survival was strongly associated with an annual migration of greater than 0.2 mm . Interpretation The long-term behavior of this cup is not satisfactory . In spite of extraordinarily high primary implant stability , secondary osseointegration of this cup often fails . The annual migration rate represents a valid parameter for prediction of implant survival ",
"Roentgen stereophotogrammetry was used to measure the migration of the centre of the femoral head in 84 cemented Lubinus SP I hip arthroplasties ( 58 primary operations , 26 revisions ) . Four to seven years later , seven femoral components had been revised because of painful loosening . These implants showed greater subsidence , medial migration and posterior migration during the first two postoperative years than did the hips which had not been revised . Six months after operation , subsidence of more than 0.33 mm combined with a total migration of more than 0.85 mm predicted an increased risk of subsequent revision ; the amount of subsidence at two years was an even better predictor . The probability of revision was greater than 50 % if the subsidence at two years was 1.2 mm or more"
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Due to the positive effects demonstrated in r and omized clinical trials on cardiovascular surrogate markers and bone metabolism , a positive effect of growth hormone ( GH ) treatment on clinical ly relevant end-points seems feasible . In this review , we discuss the long-term efficacy and safety of GH treatment in adult patients with growth hormone deficiency ( GHD ) with emphasis on morbidity : fatal and nonfatal cardiovascular disease ( CVD ) and stroke , fractures , fatal and nonfatal malignancies and recurrences , and diabetes mellitus . A positive effect of GH treatment on CVD and fracture risk could be concluded , but study design limitations have to be considered . Stroke and secondary brain tumours remained more prevalent . However , other contributing factors have to be taken into account . Regrowth and recurrences of (peri)pituitary tumours were not increased in patients with GH treatment compared to similar patients without GH treatment . All fatal and nonfatal malignancies were not more prevalent in GH-treated adults compared to the general population . However , follow-up time is still relatively short . The studies on diabetes are difficult to interpret , and more evidence is awaited . In clinical practice , a more individualized assessment seems appropriate , taking into consideration the underlying diagnosis of GHD , other treatment regimens , metabolic profile and the additional beneficial effects of GH set against the possible risks . Large and thoroughly conducted observational studies are needed and seem the only feasible way to inform the ongoing debate on health care costs , drug safety and clinical outcomes
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[
"Objective Few studies have determined the effects of more than 5–10 years of GH replacement in adults on bone mineral content ( BMC ) and bone mineral density ( BMD ) . Design / patients In this prospect i ve , single-centre , open-label study , the effects of 15 years of GH replacement on BMC and BMD , measured using dual-energy X-ray absorptiometry , were determined in 126 hypopituitary adults ( 72 men ) with adult-onset GH deficiency ( GHD ) . Mean age was 49.4 ( range 22–74 ) years at the initiation of the study . Results The mean initial GH dose of 0.63 ( s.e.m . 0.03 ) mg/day was gradually lowered to 0.41 ( 0.01 ) mg/day after 15 years . The mean serum IGF1 SDS increased from −1.69 ( 0.11 ) at baseline to 0.63 ( 0.16 ) at the study end ( P GH replacement induced a sustained increase in total body BMC ( + 5 % , P ) and BMD ( + 2 % , P increased by 9 % ( P peak increase in BMC and BMD of 7 and 3 % , respectively , was observed after 7 years ( both P years , femur neck BMC was 5 % above the baseline value ( P whereas femur neck BMD had returned to the baseline level . In most variables , men had a more marked response to GH replacement than women . Conclusions Fifteen-year GH replacement in GHD adults induced a sustained increase in total body and lumbar ( L2–L4 ) spine BMC and BMD . In femur neck , BMC and BMD peaked at 7 years and then decreased towards baseline values",
"Context : In clinical practice , the safety profile of GH replacement therapy for GH-deficient adults compared with no replacement therapy is unknown . Objective : The objective of this study was to compare adverse events ( AEs ) in GH-deficient adults who were GH-treated with those in GH-deficient adults who did not receive GH replacement . Design and Setting : This was a prospect i ve observational study in the setting of US clinical practice s. Patients and Outcome Measures : AEs were compared between GH-treated ( n = 1988 ) and untreated ( n = 442 ) GH-deficient adults after adjusting for baseline group differences and controlling the false discovery rate . The st and ardized mortality ratio was calculated using US mortality rates . Results : After a mean follow-up of 2.3 years , there was no significant difference in rates of death , cancer , intracranial tumor growth or recurrence , diabetes , or cardiovascular events in GH-treated compared with untreated patients . The st and ardized mortality ratio was not increased in either group . Unexpected AEs ( GH-treated vs untreated , P ≤ .05 ) included insomnia ( 6.4 % vs 2.7 % ) , dyspnea ( 4.2 % vs 2.0 % ) , anxiety ( 3.4 % vs 0.9 % ) , sleep apnea ( 3.3 % vs 0.9 % ) , and decreased libido ( 2.1 % vs 0.2 % ) . Some of these AEs were related to baseline risk factors ( including obesity and cardiopulmonary disease ) , higher GH dose , or concomitant GH side effects . Conclusions : In GH-deficient adults , there was no evidence for a GH treatment effect on death , cancer , intracranial tumor recurrence , diabetes , or cardiovascular events , although the follow-up period was of insufficient duration to be conclusive for these long-term events . The identification of unexpected GH-related AEs reinforces the fact that patient selection and GH dose titration are important to ensure safety of adult GH replacement",
"We recently observed that among patients with GH deficiency due to adult-onset hypopituitarism , men responded with a greater increase in serum levels of insulin-like growth factor I ( IGF-I ) and biochemical markers of bone metabolism than women when the same dose of recombinant human GH ( rhGH ) per body surface area was administered for 9 months . In the present study , 33 of the 36 patients in the previous trial ( 20 men and 13 women ) continued therapy for up to 45 months . The dose of rhGH was adjusted according to side-effects and to maintain serum IGF-I within the physiological range . This result ed in a significant dose reduction in the men ; consequently , the women received twice as much rhGH as the men ( mean + /- SD , 1.9 + /- 1.1 vs. 1.0 + /- 0.6 U/day ; P serum IGF-I levels and serum biochemical markers of bone metabolism were similar in men and women with these doses . The total bone mineral content ( BMC ) was increased after 33 and 45 months of treatment up to 5.1 % ( P = 0.004 and 0.0001 ) . Bone mineral density ( BMD ) , BMC , and the area of the femoral neck and the lumbar spine were also significantly increased after 33 and 45 months of treatment . When analyzed by gender , total body BMC , femoral neck BMD and BMC , and spinal BMC were significantly increased in males , but not in females ( P rhGH treatment continued to have an effect on bone metabolism and bone mass for up to 45 months of therapy . The changes in bone mass were greater in the men , although they received lower doses of rhGH than the women . The results indicate that the sensitivity to GH in adult patients with GH deficiency is gender dependent",
"BACKGROUND Four retrospective studies have reported premature mortality in patients with hypopituitarism with st and ard mortality ratios ( SMRs ) varying between 1.20 and 2.17 . Patients with hypopituitarism have complex endocrine deficiencies , and the mechanisms underpinning any excess mortality are unknown . Furthermore , the suggestion has emerged that endogenous growth-hormone deficiency might account for any excess mortality . We aim ed to clarify these issues by doing a large prospect i ve study of total and specific-cause mortality in patients with hypopituitarism . METHODS We followed up 1014 UK patients ( 514 men , 500 women ) with hypopituitarism from January , 1992 , to January , 2000 . 573 ( 57 % ) patients had non-functioning adenomas , 118 ( 12 % ) craniopharyngiomas , and 93 ( 9 % ) prolactinomas . SMRs were calculated as the ratio of observed deaths to the number of deaths in an age-matched and sex-matched UK population . FINDINGS The number of observed deaths was 181 compared with the 96.7 expected ( SMR 1.87 [ 99 % CI 1.62 - 2.16 ] , p Univariate analysis indicated that mortality was higher in women ( 2.29 [ 1.86 - 2.82 ] ) than men ( 1.57 [ 1.28 - 1.93 ] , p=0.002 ) , in younger patients , in patients with an underlying diagnosis of craniopharyngioma ( 9.28 [ 5.84 - 14.75 ] vs 1.61 [ 1.30 - 1.99 ] , p Excess mortality was attributed to cardiovascular ( 1.82 [ 1.30 - 2.54 ] , p respiratory ( 2.66 [ 1.72 - 4.11 ] , p cerebrovascular ( 2.44 [ 1.58 - 4.18 ] , p mortality , except for gonadotropin deficiency , which , if untreated was associated with excess mortality ( untreated 2.97 [ 2.13 - 4.13 ] vs treated 1.42 [ 0.97 - 2.07 ] , p Patients with hypopituitarism have excess mortality , predominantly from vascular and respiratory disease . Age at diagnosis , female sex , and above all , craniopharyngioma were significant independent risk factors . Specific endocrine-axis deficiency , with the exception of untreated gonadotropin deficiency , does not seem to have a role",
"OBJECTIVE Hypopituitary GH-deficient patients have an increased cardiovascular mortality and GH replacement in this population has result ed in considerable therapeutic benefit . GH replacement involves administration of a potentially mitogenic substance to patients with a previous or residual pituitary tumour . Our objective was to evaluate whether GH replacement results in an increase in the size of pituitary tumours . METHODS This was a non-r and omised observational study on patients recruited from the endocrine clinic . All subjects had GH deficiency , proven on an insulin tolerance test and were divided into those who were or were not receiving long-term GH replacement . Comparison of change in pituitary size was made with interval radiological imaging of the pituitary . RESULTS Seventy-five patients ( 40 men and 35 women ) were in the study , 47 were on long-term GH replacement and there were 28 controls . The average length of treatment for the treated group was 3.6 patient years . Thirty-nine patients in the treated group had at least 2 years of GH treatment between imaging studies of the pituitary . Two patients in the treated group had an increase in pituitary size ( non-functioning adenomas ) and two in the control group ( one functioning and one non-functioning adenoma adenoma ) . None of these four patients required further treatment . There was no statistically significant difference between the two groups . CONCLUSION Using a representative cohort of hypopituitary patients attending an endocrine clinic , GH replacement was not associated with an increased pituitary tumour recurrence rate . Although the results are not conclusive , in the period of observation GH had little adverse effect but longer studies are required to be certain",
"OBJECTIVE Adult growth hormone deficiency ( AGHD ) is characterized by abnormalities in body composition and a poor perceived quality of life ( QoL ) . Weight‐based high‐dose growth hormone replacement ( GHR ) results in improvements in body composition and QoL in AGHD . However , a high patient percentage reported side‐effects on high‐dose GHR result ing in a high rate of patient withdrawal from growth hormone ( GH ) treatment . High‐dose GH therapy also leads to supraphysiological serum insulin‐like growth factor‐I ( IGF‐I ) concentrations that have been associated with breast and prostate cancer , raising major concerns over the use of such high‐dose GH regimen in AGHD . The aim of this study was to assess the effects of low‐dose growth hormone replacement ( GHR ) on body composition and QoL as early as 1 and 3 months",
"Abstract Background The French Safety and Appropriateness of Growth Hormone treatments in Europe ( SAGhE ) cohort has raised concern of increased mortality risk during follow-up into adulthood in certain patients who had received growth hormone ( GH ) treatment during childhood . The Hypopituitary Control and Complications Study monitored mortality and morbidity of adult GH-deficient patients including those with childhood-onset GH deficiency ( COGHD ) who received GH treatment as children . Purpose Evaluate risk of mortality , cancer , myocardial infa rct ion ( MI ) and stroke in a prospect i ve observational study . Methods COGHD patients [ n = 1,204 , including 389 diagnosed with idiopathic COGHD ( ICOGHD ) ] had received pediatric GH treatment . St and ardized mortality ratios ( SMRs ) , and cancer st and ardized incidence ratios ( SIRs ) in patients without a prior cancer were estimated relative to reference population s. Crude incidence rates were estimated for MI and stroke . Results No increased mortality or cancer incidence was observed , as compared with reference population s , during a follow-up of 3.7 ± 3.3 years ( mean ± SD ) . The overall SMR for COGHD was 1.14 [ 95 % confidence interval ( CI ) 0.55–2.10 ] , and for ICOGHD , 0.33 ( 0.01–1.84 ) . The overall cancer SIR for COGHD was 0.27 ( 0.01–1.50 ) , and for ICOGHD , 0.00 ( 0.00–2.45 ) . No incident case of MI was reported . The crude stroke incidence rate [ 181.3 per 100,000 person-years ] in COGHD patients was consistent with the rates reported in reference population s. No incident case of stroke was identified in ICOGHD patients who are presumed to have no increased stroke risk factors . Conclusions The results indicate no increased risk of mortality or incidence of cancer , stroke , or MI in adult GH-deficient patients who had previously received pediatric GH treatment ",
"CONTEXT GH secretion and response to GH replacement are gender-related . OBJECTIVE The objective of this study was to investigate the effects of GH deficiency ( GHD ) and replacement on the cardiovascular system according to gender . DESIGN The design was open and prospect i ve . SETTING The study was conducted at a university hospital . SUBJECTS Subjects included 36 severe adult-onset GHD patients ( 18 men , 20 women , aged INTERVENTIONS Subjects received GH replacement at a median dose of 6.5 microg/kg.d in men and 7.7 microg/kg.d in women for 2 yr . MAIN OUTCOME MEASURES Homeostasis model assessment index , total to HDL cholesterol ratio , fibrinogen and C-reactive protein levels , left ventricular mass index , blood pressure , heart rate , diastolic filling , and systolic function at rest and at peak exercise and intima-media thickness ( IMT ) at common carotid arteries were measured . RESULTS Basal prevalence and /or degree of insulin resistance , lipid alterations , compromised cardiac function , and IMT were similar in women and men . Diastolic dysfunction was more prevalent in men ( 61 vs. 25 % , P = 0.036 ) . After GH replacement , IGF-I levels normalized in all patients . Lipid profile , fibrinogen , and C-reactive protein levels normalized in all cases . The total to HDL ratio ( P = 0.04 ) was higher in women than men . The homeostasis model assessment index persisted higher in GHD patients than controls and decreased only in GHD men ( P = 0.017 ) . Left ventricular mass index normalized during treatment in both women and men , abnormal diastolic function persisted in three women ( P = 0.031 ) , and abnormal systolic performance persisted in six women and one man ( P = 0.13 ) . IMT decreased similarly in women and men , persisting higher than in controls . Exercise performance normalized in all . CONCLUSIONS Two-year GH replacement has similar beneficial effects on cardiac and exercise performance and atherosclerosis in women and men with severe GHD",
"OBJECTIVE Several studies documented metabolic and psychological benefits of GH substitution in deficient adults , most of them suffering from benign pituitary adenomas . Since GH substitution is considered to promote tumour regrowth , adequate treatment is performed with some reservation . Therefore , we aim ed to eluci date the effect of GH replacement therapy on tumour recurrence following surgery . METHODS In patients with hormonally inactive pituitary adenomas undergoing tumour surgery , a retrospective case-control study was performed . Pre- and postoperative magnetic resonance ( MR ) images of GH-treated and untreated patients were matched for best fit by two independent observers . The treated patients were retrieved from the surveillance programme of the German KIMS data base and the untreated from the data base of the Department of Neurosurgery , University of Erlangen . A total of 55 matched pairs were followed for at least 5 years . Tumour recurrence and progression rates were determined according to the postoperative MR . RESULTS There were 16 tumour progressions in the treatment group and 12 in the control group . Statistical analysis revealed no significant increase in either recurrence ( P = 0.317 ) or progression ( P = 0.617 ) within the follow-up period of 5 years when GH was adequately replaced . CONCLUSIONS This study provides further observational data of substitution therapy in GH-deficient adults with pituitary adenomas . Comparing long-term surgical results , we found no evidence that GH substitution should be withheld in deficient patients . Even residual tumour does not constitute a contraindication to GH replacement . However , since pituitary tumours are slow growing , an observational period of 5 years may not have been long enough to verify any absolute influence on recurrence potential",
"GH deficiency is associated with increased cardiovascular morbidity , which may be determined by alterations in vascular risk factors . We report the effect of partially treated hypopituitarism and subsequent GH replacement ( mean dose , 0.2 IU/kg.week ) on putative cardiovascular risk factors in 22 nondiabetic hypopituitary subjects in a 6-month , double blind , controlled study ( active/placebo ratio , 11:11 ) . All patients were subsequently treated with GH for a further 6 months . Total fat , percent body fat , and central fat were measured by dual energy x-ray absorptiometry . The hypopituitary patients had increased percent fat ( P = 0.03 ) and central fat ( P GH treatment , fasting ( total ) and specific insulin positively correlated with body mass index ( P = 0.02 and P waist/hip ratio ( P = 0.05 and P = 0.01 ) , and central fat ( P = 0.03 and P = 0.003 ) . Specific insulin and insulin sensitivity ( IS ) , calculated by homeostatic model of assessment , were related to total fat ( P GH treatment for 6 months led to a reduction in total fat ( P percent fat ( P = 0.002 ) , central fat ( P = 0.012 ) , waist/hip ratio ( P total cholesterol ( P = 0.03 ) , and apolipoprotein-B ( P = 00001 ) , as well as a decrease in the IS from 36.9 % ( range , 12 - 100 % ) to 25 % ( range , 2.5 - 55 % ; P = 0.0002 ) . This was paralleled by a rise in fasting ( total ) and specific insulin ( P = 0.016 and P = 0.002 ) . The degree of correlation among indices of IS , body composition , and fat distribution increased after GH treatment . Fasting plasma glucose rose significantly , but was within the reference range . During 12 months of GH therapy , a significant increase in serum lipoprotein-(a ) was observed ( P GH has beneficial effects on central adiposity and lipid fractions , it is also associated with a decrease in IS ; these effects may vary between individuals",
"A double-blind , placebo-controlled , crossover study on the effects of 4 months ' growth hormone ( GH ) treatment was carried out in 22 GH-deficient adults ( 8 women , 14 men ; mean [ SEM ] age 23.8 [ 1.2 ] years ) . 1 patient was withdrawn because of oedema . Mean total body weight of the other 21 did not change , whereas mean muscle volume of the thigh , estimated by computerised tomography ( CT ) , was significantly higher after GH than after placebo ( 70.0 [ 3.7 ] vs 66.3 [ 3.1 ] ml/0.8 cm cross-sectional slice ) . The mean adipose tissue volume of the thigh and subscapular skinfold thickness fell significantly during GH treatment . Growth hormone caused a small increase in the isometric strength of the quadriceps muscles and a significant rise in exercise capacity ( 60.8 [ 7.2 ] vs 54.2 [ 6.6 ] kJ ) . The heart rate both at rest and after maximum exercise was low during the placebo period and increased significantly during GH treatment . Blood pressure and echocardiographic wall mass of the left ventricle did not change during the study . Growth hormone increased both mean glomerular filtration rate and renal plasma flow from a subnormal level on placebo to a level comparable with that of an age-matched control group . The filtration fraction did not change . Urinary albumin excretion was in the low normal range and was not affected by GH treatment . Finally , GH treatment normalised mean circulating levels of insulin-like growth factor 1 ( IGF-1 ) , which were low after the placebo period ( 96 [ 9 ] micrograms/l placebo ; 224 [ 28 ] micrograms/l GH ) . These findings suggest that GH , in a conventional replacement dose , has several potentially beneficial effects in GH-deficient adults and therefore encourage future long-term trials",
"CONTEXT Patients with hypopituitarism have an increased st and ardized mortality rate . The basis for this has not been fully clarified . OBJECTIVE To investigate in detail the cause of death in a large cohort of patients with hypopituitarism subjected to long-term follow-up . DESIGN AND METHODS All-cause and cause-specific mortality in 1286 Swedish patients with hypopituitarism prospect ively monitored in KIMS ( Pfizer International Metabolic Data base ) 1995 - 2009 were compared to general population data in the Swedish National Cause of Death Registry . In addition , events reported in KIMS , medical records , and postmortem reports were review ed . MAIN OUTCOME MEASURES St and ardized mortality ratios ( SMR ) were calculated , with stratification for gender , attained age , and calendar year during follow-up . RESULTS An excess mortality was found , 120 deaths vs 84.3 expected , SMR 1.42 ( 95 % confidence interval : 1.18 - 1.70 ) . Infections , brain cancer , and sudden death were associated with significantly increased SMRs ( 6.32 , 9.40 , and 4.10 , respectively ) . Fifteen patients , all ACTH-deficient , died from infections . Eight of these patients were considered to be in a state of adrenal crisis in connection with death ( medical reports and post-mortem examinations ) . Another 8 patients died from de novo malignant brain tumors , 6 of which had had a benign pituitary lesion at baseline . Six of these 8 subjects had received prior radiation therapy . CONCLUSION Two important causes of excess mortality were identified : first , adrenal crisis in response to acute stress and intercurrent illness ; second , increased risk of a late appearance of de novo malignant brain tumors in patients who previously received radiotherapy . Both of these causes may be in part preventable by changes in the management of pituitary disease",
"A retrospective comparison was performed between 1411 hypopituitary adults without GH replacement [ mean age , 56.9 ( sd 18.6 ) yr ] and the normal population in terms of fatal and nonfatal morbidity . A similar prospect i ve comparison was then made in 289 hypopituitary patients on long-term GH replacement [ mean age , 47.6 ( sd 14.8 ) yr ; mean duration of GH treatment , 60 months ] . In the 1411 hypopituitary patients without GH replacement , overall mortality ( P rates of myocardial infa rct ions ( P cerebrovascular events ( P malignancies ( P Colorectal cancer was the most common malignancy in this cohort ( P 289 hypopituitary patients on GH replacement , overall mortality and the rate of malignancies were similar to the normal population . In the hypopituitary adults on GH therapy , the rate of myocardial infa rct ions was lower than that in the background population ( P rate of cerebrovascular events . In conclusion , overall mortality and the rate of myocardial infa rct ions were increased in hypopituitary patients without GH replacement . An increased rate of malignancies was observed in the hypopituitary adults without GH therapy , with a predominance of colorectal cancer . GH replacement appeared to provide protection from myocardial infa rct ions . The rate of cerebrovascular events tended to be increased also in hypopituitary adults on GH therapy",
"The prevalence of clinical signs and symptoms related to fluid retention is high in most studies evaluating the efficacy of GH treatment in GH-deficient ( GHD ) adults . This may be a consequence of supraphysiological GH replacement . To examine whether fluid retention is a dose-related phenomenon , we evaluated the impact of various GH substitution doses on body fluid status in 46 GHD men participating in a 1-yr , double blind , and placebo-controlled study . The patients were r and omized to receive either placebo ( n = 13 ) or GH in a dose of 1 ( n = 11 ) , 2 ( n = 10 ) , or 3 ( n = 12 ) IU/m2.day , respectively . Treatment was started at one third of the predetermined dose and was subsequently increased by another third every month until the maintenance dose was reached . Tissue hydration was assessed by means of electrical impedance measurements . Normal values were obtained from 128 age- and sex-matched controls . In the untreated GHD state , whole body resistance was abnormally high ( observed , 642 + /- 82 omega ; predicted , 550 + /- 31 omega ; P specific resistance of the lean body as a consequence of a reduction in extracellular water ( ECW ) . The first month of GH treatment was associated with a sharp decline in electrical resistance that was attributed to an increase in ECW . Whole body resistance reached its nadir after 3 months of treatment ( 517 + /- 72 omega , i.e. 19.6 + /- 6.5 % lower than before treatment ; P changes in body resistance were dose dependent . A significant decrease was observed with a dose as low as 0.33 IU/m2.day ( P whole body resistance remained higher than normal in patients receiving less than 0.67 IU/m2.day ( P = 0.05 ) . Abnormally low resistance values , indicative of overhydration , were observed in patients receiving doses equal to or higher than 2 IU/m2.day ( P GH replacement in a dose of 1.10 IU/m2.day ( 95 % confidence interval , 0.85 - 1.45 IU/m2.day ) result ed in a normalization of whole body resistance . In conclusion , GH replacement therapy in adults rapidly corrects the preexisting deficit in ECW . This rehydration process is dose dependent and may result in a substantial weight gain . ( ABSTRACT TRUNCATED AT 400 WORDS",
"BACKGROUND Severe GH deficiency ( GHD ) is associated with , increased cardiovascular risk and intima-media thickness ( IMT ) at major arteries . OBJECTIVE The objective of the study was to investigate the 5-yr effects of GH replacement on common carotid IMT and insulin resistance syndrome ( IRS ) ( at least two of the following : triglycerides levels > or = 1.7 mmol/liter , high-density lipoprotein-cholesterol levels Patients included 35 men with severe GHD and 35 age-matched healthy men as controls . INTERVENTION All patients received st and ard replacement therapy ; GH replacement was added in 22 patients ( group A ) and refused by 13 others ( group B ) . MEASUREMENTS Five-year changes in IMT and IRS prevalence were measured . RESULTS At baseline , IMT was higher in the patients with ( P . At study end , use of lipid-lowering drugs ( 92.3 , vs. 13.6 and 34.3 % , P glucose-lowering drugs ( 69.2 vs. 31.4 and 22.7 % ; P = 0.016 ) , and antihypertensive drugs ( 61.5 vs. 20.0 and 4.5 % ; P IGF-I levels normalized in all group A patients and remained lower than -1 sd score in 77 % of group B patients . IMT significantly decreased only in group A and significantly increased in controls and nonsignificantly in group B patients . IRS prevalence significantly reduced only in group A patients . CONCLUSIONS Severely hypopituitary GHD men have more frequently increased IMT at common carotid arteries and IRS than controls . After 5 years , only in GH replaced patients , IMT and prevalence of IRS decreased",
"The consequences of GH deficiency may differ if the disease is childhood onset or adulthood onset . In this single-center , prospect i ve study , 21 consecutive adults with childhood onset GH deficiency and 21 adults with adulthood onset GH deficiency , matched for age , gender , body mass index , and number of anterior pituitary hormonal deficiencies , were included . Baseline differences and differences in the responses in body composition , muscle strength , bone mass , and metabolic indices during 5-yr GH replacement were determined . The duration of GH deficiency was longer and serum IGF-I level and body height were lower in the childhood onset patients than in the adulthood onset patients . Body fat ( observed/predicted ratio ) was increased , and lean mass and muscle strength were decreased , in the childhood onset patients . Total body and lumbar ( L2-L4 ) bone mineral content and bone mineral density were lower in the childhood onset patients . Serum total cholesterol level was higher in the adulthood onset patients . The childhood onset and adulthood onset patients received a similar dose of GH . After adjustment for body weight , however , the dose of GH was higher in the childhood onset patients . The treatment responses were more marked in the childhood onset patients in lean mass , knee extensor strength , left-h and grip strength , and in total body and lumbar ( L2-L4 ) bone mineral content and bone mineral density . The reduction in serum total cholesterol concentration was more marked in the adulthood onset patients . At study end , no differences remained between the two study groups after the correction for body height in the statistical analysis . In conclusion , the baseline analysis suggests more decreased lean mass , muscle strength , and bone mass in the childhood onset patients whereas the lipid profile was more disturbed in the adulthood onset patients . The 5-yr GH replacement eliminated all the anthropodometric and metabolic differences between the two groups",
"OBJECTIVE Childhood cancer survivors are commonly treated with GH for GH deficiency that develops either as a result of primary malignancy or its treatment . One study --the Childhood Cancer Survivor Study (CCSS)--demonstrated increased risk of second neoplasm ( SN ) in GH-treated childhood cancer survivors compared with non-GH treated , after adjusting for key risk factors . We assessed the incidence of SN in GH-treated childhood cancer survivors in outpatient observational studies of GH replacement . DESIGN Retrospective analysis of two prospect i ve cohort studies that collected data on safety of GH replacement as prescribed in clinical practice . METHODS Childhood cancer survivors enrolled in Eli Lilly and Company 's pediatric ( Genetics and Neuroendocrinology of Short Stature International Study ( GeNeSIS ) ) and adult ( Hypopituitary Control and Complications Study ( HypoCCS ) ) observational studies of GH treatment were assessed for incidence of SN . RESULTS The percentage of childhood cancer survivors treated with GH who developed a SN was 3.8 % in pediatric GeNeSIS participants and 6.0 % in adult HypoCCS participants . The estimated cumulative incidence of SN at 5 years of follow-up in these studies was 6.2 and 4.8 % respectively . CONCLUSIONS The incidence of SN in GeNeSIS and HypoCCS GH-treated participants is similar to the published literature and is thus consistent with increased risk of SN in childhood cancer survivors treated with GH . As follow-up times were relatively short ( risk of SN in childhood cancer survivors treated with GH and continue chronic surveillance"
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Nootropics represent probably the first " smart drugs " used for the treatment of cognitive deficits . The aim of this paper is to verify , by a systematic analysis of the literature , the effectiveness of nootropics in this indication . The analysis was limited to nootropics with cholinergic activity , in view of the role played by acetylcholine in learning and memory . Acetylcholine was the first neurotransmitter identified in the history of neuroscience and is the main neurotransmitter of the peripheral , autonomic , and enteric nervous systems . We conducted a systematic review of the literature for the 5-year period 2006 - 2011 . From the data reported in the literature , it emerges that nootropics may be an effective alternative for strengthening and enhancing cognitive performance in patients with a range of pathologies . Although nootropics , and specifically the cholinergic precursors , already have a long history behind them , according to recent renewal of interest , they still seem to have a significant therapeutic role . Drugs with regulatory indications for symptomatic treatment of Alzheimer 's disease , such as cholinesterase inhibitors and memantine , often have transient effects in dementia disorders . Nootropics with a cholinergic profile and documented clinical effectiveness in combination with cognate drugs such as cholinesterase inhibitors or alone in patients who are not suitable for these inhibitors should be taken into account and evaluated further
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"Background and Purpose In a prospect i ve , double-blind , placebo-controlled study , it was investigated whether piracetam improves language recovery in poststroke aphasia assessed by neuropsychological tests and activation PET measurement of cerebral blood flow . Methods Twenty-four stroke patients with aphasia were r and omly allocated to 2 groups : 12 patients received 2400 mg piracetam twice daily , 12 placebo . Before and at the end of the 6-week treatment period in which both groups received intensive speech therapy , the patients were examined neuropsychologically and studied with H215O PET at rest and during activation with a word-repetition task . Blood flow was analyzed in 14 language -activated brain regions defined on reconstructed surface views from MRI coregistered to the PET images . Results Before treatment , both groups were comparable with respect to performance in language tasks and to type and severity of aphasia . In the piracetam group , increase of activation effect was significantly higher ( P placebo group showed an increase of activation effect only in the left vocalization area . In the test battery , the piracetam group improved in 6 language functions , the placebo group only in 3 subtests . Conclusions Piracetam as an adjuvant to speech therapy improves recovery of various language functions , and this effect is accompanied by a significant increase of task-related flow activation in eloquent areas of the left hemisphere",
"Twenty-four carefully assessed patients with probable Alzheimer 's disease were enrolled in a double-blind , placebo-controlled treatment study of oxiracetam , a nootropic agent reported to improve memory performance in patients with dementia . A broad battery of neuropsychological tests failed to reveal any improvement in the treated group or in any treated patient when individual test scores were analyzed . These findings indicate that oxiracetam is ineffective in reducing cognitive impairment due to Alzheimer 's disease",
"BACKGROUND Piracetam is widely used as a purported means of improving cognitive function in children with Down syndrome . Its efficacy , however , has not been rigorously assessed . OBJECTIVE To determine whether 4 months of piracetam therapy ( 80 - 100 mg/kg per day ) enhances cognitive function in children with Down syndrome . DESIGN A r and omized , double-blind , placebo-controlled crossover study . PARTICIPANTS AND METHODS Twenty-five children with Down syndrome ( aged 6.5 - 13 years ) and their caregivers participated . After undergoing a baseline cognitive assessment , children were r and omly assigned to 1 of 2 treatment groups : piracetam-placebo or placebo-piracetam . MAIN OUTCOME MEASURE The difference in performance while taking piracetam vs while taking placebo on tests assessing a wide range of cognitive functions , including attention , learning , and memory . RESULTS Eighteen children completed the study , 4 withdrew , and 3 were excluded at baseline . Piracetam therapy did not significantly improve cognitive performance over placebo use but was associated with central nervous system stimulatory effects in 7 children : aggressiveness ( n = 4 ) , agitation or irritability ( n = 2 ) , sexual arousal ( n = 2 ) , poor sleep ( n = 1 ) , and decreased appetite ( n = 1 ) . CONCLUSION Piracetam therapy did not enhance cognition or behavior but was associated with adverse effects",
"In this study , the protective effect of piracetam on select aspects of cognitive function in patients undergoing bypass surgery was investigated . Male patients ( n = 64 ) with an indication for a surgical revascularization using artificial extracorporal circuits were r and omly assigned in a double-blind fashion to receive a single challenge of 12-g piracetam infusion or placebo ( sterile saline ) prior to the bypass surgery . A brief battery of neuropsychological tests for verbal and non-verbal short-term memory and attention was administered 1 day before and 3 days after the surgical intervention . There was a significant difference in short-term memory and attention , with the piracetam-treated patients producing a better level of performance 3 days after surgery compared to the placebo group . The overall postoperative cognitive function ( z-transformation of all 6 test results ) was more significantly ( p piracetam infusion prior to surgical intervention might offer a short-term neuroprotective effect for patients undergoing cardiac bypass surgery . Whether this effect persists for a longer period of time requires further investigation",
"OBJECTIVES Reduction of cognitive function is a possible side effect after the use of cardiopulmonary bypass ( CPB ) during cardiac surgery . Since it has been proven that piracetam is cerebroprotective in patients undergoing coronary bypass surgery , we investigated the effects of piracetam on the cognitive performance of patients undergoing open heart surgery . METHODS Patients scheduled for elective open heart surgery were r and omized to the piracetam or placebo group in a double-blind study . Patients received 12 g of piracetam or placebo at the beginning of the operation . Six neuropsychological subtests from the Syndrom Kurz Test and the Alzheimer 's Disease Assessment Scale were performed preoperatively and on day 3 , postoperatively . To assess the overall cognitive function and the degree of cognitive decline across all tests after the surgery , we combined the six test-scores by principal component analysis . RESULTS A total of 88 patients with a mean age of 67 years were enrolled into the study . The mean duration of CPB was 110 minutes . Preoperative clinical parameters and overall cognitive functions were not significantly different between the groups . The postoperative combined score of the neuropsychological tests showed deterioration of cognitive function in both groups ( piracetam : preoperative 0.19 ± 0.97 vs. postoperative -0.97 ± 1.38 , p and placebo : preoperative -0.14 ± 0.98 vs. postoperative -1.35 ± 1.23 , p taking piracetam did not perform better than those taking placebo , and both groups had the same decline of overall cognitive function ( p = 0.955 ) . CONCLUSION Piracetam had no cerebroprotective effect in patients undergoing open heart surgery . Unlike the patients who underwent coronary surgery , piracetam did not reduce the early postoperative decline of neuropsychological abilities in heart valve patients",
"Minimal hepatic encephalopathy ( MHE ) is characterized by disturbance of mental state and neuromuscular function . To assess the clinical efficacy of acetyl-l-carnitine ( ALC ) in the treatment of MHE , we performed a r and omized , double-blind , placebo-controlled study administering ALC in cirrhotic patients with this disease and evaluating their cognitive functions . One hundred and twenty-five cirrhotic patients , of whom 21 were infected by hepatitis B virus , 75 by hepatitis C virus and 29 with cryptogenic cirrhosis , were enrolled in our study . Patients were r and omly divided into two groups , and using double-blind administration , group A was treated with ALC and group B with placebo for 90 days . The two groups were similar in demographic characteristics , aetiology of cirrhosis , duration and Child-Pugh grade . Minimal hepatic encephalopathy was diagnosed with the Trail Making Test ( TMT ) , Symbol Digit Modalities Test ( SDMT ) and Auditory Verbal Learning Test ( AVL ) and cognitive function with the Mini Mental State Examination ( MMSE ) . After 90 days in group A treated with ALC , we observed a significant decrease in prothrombin time ( P ) , bilirubin serum levels ( P 0.01 ) , AST ( P fasting NH4 serum levels ( P Trail Making Test-A ( P Trail Making Test-B ( P albumin serum levels ( P MMSE test ( P Symbol Digit Modalities Test ( P BDT ( P AVL long-term test ( P AVL total test ( P No significant differences were observed in EEG in either group of patients treated with ALC or placebo . The benefits of ALC in comparison with placebo are demonstrated in greater reductions in serum ammonia levels , as well as in improvements of neuropsychological functioning",
"The maintenance of the effects of Cerebrolysin , a peptidergic compound with neurotrophic activity , on cognitive performance and qEEG activity was investigated through a 12-week , open-label extension of a 4-week , r and omised , placebo-controlled pilot study . Thirty-three out of 41 patients with mild-to-moderate severe probable vascular dementia ( VaD ) according to NINDS-AIREN participating in the double-blind phase of the study were also assessed at the follow-up visit at week 16 . Patients received i.v . infusions of Cerebrolysin ( 10 or 30 mL ) or placebo ( saline ) 5 days/week for 4 weeks . Neuropsychological evaluations and qEEG recordings were done at baseline , week 4 and week 16 . The mean change in score from baseline in the ADAS-cog+ and the slow-to-fast qEEG power ratio ( PR ) , used as an index of qEEG slowing , were the two primary endpoints . Correlations between changes in cognition and qEEG induced by the treatment were also assessed . At the week 16 follow-up visit , Cerebrolysin improved ( p cognitive performance at the 10-mL and 30-mL doses and reduced qEEG slowing significantly ( p placebo . In addition , a significant ( p from the baseline qEEG PR and ADAS-cog+ variables was observed at week 16 . These results indicate a persistence of the beneficial effects of Cerebrolysin on cognition and qEEG activity in VaD patients for at least 12 weeks after treatment cessation , and they suggest the potential utility of qEEG parameters as biomarkers for VaD clinical trials",
"Rationale There is increasing evidence to suggest the possible efficacy of Crocus sativus ( saffron ) in the management of Alzheimer ’s disease ( AD ) . Objective The purpose of the present investigation was to assess the efficacy of C. sativus in the treatment of patients with mild-to-moderate AD . Methods Fifty-four Persian-speaking adults 55 years of age or older who were living in the community were eligible to participate in a 22-week , double-blind study of parallel groups of patients with AD . The main efficacy measures were the change in the Alzheimer ’s Disease Assessment Scale — cognitive subscale and Clinical Dementia Rating Scale — Sums of Boxes scores compared with baseline . Adverse events ( AEs ) were systematic ally recorded . Participants were r and omly assigned to receive a capsule saffron 30 mg/day ( 15 mg twice per day ) or donepezil 10 mg/day ( 5 mg twice per day ) . Results Saffron at this dose was found to be effective similar to donepezil in the treatment of mild-to-moderate AD after 22 weeks . The frequency of AEs was similar between saffron extract and donepezil groups with the exception of vomiting , which occurred significantly more frequently in the donepezil group . Conclusion This phase II study provides preliminary evidence of a possible therapeutic effect of saffron extract in the treatment of patients with mild-to-moderate Alzheimer ’s disease . This trial is registered with the Iranian Clinical Trials Registry ( I RCT 138711051556N1 )",
"The effectiveness of Oxiracetam ( 1600 mg/day ) versus placebo was assessed in a group of 96 out- patients suffering from cognitive disorders secondary to primary degenerative dementia . The study lasted twelve months and was performed in two stage , a ) double-blind ( 26 weeks ) and b ) open study ( 26 weeks ) . The assessment of the results obtained at two , six and twelve months was carried out following both the methodology based on neuropsychological tests and scales , and the study of the simple reaction time by any of a computerized portable tachystoscope . The patients treated with Oxiracetam showed a statistically significant improvement of simple reaction time and cognitive function detected by the Attention matrix . In the placebo group after twelve months a significant worsening of cognitive and global function was observed in comparison with baseline scores . The patients themselves appeared in favor of Oxiracetam . The drug tolerability proved to be very good for the whole duration of the treatment . The authors believe that Oxiracetam favorably acts on the symptoms of senile cerebral deterioration and can improve the capability of information processing , as suggested by the better performances obtained at the reaction time test and at the Attentional Matrix test",
"BACKGROUND Cognitive deficits have been reported in patients after coronary artery bypass grafting , but the incidence of these deficits varies widely . We studied prospect ively the incidence of cognitive change and whether the changes persisted over time . METHODS Cognitive testing was done preoperatively and 1 month and 1 year postoperatively in 127 patients undergoing coronary artery bypass grafting . Tests were grouped into eight cognitive domains . A change of 0.5 st and ard deviation or more at 1 month and 1 year from patient 's preoperative Z score was the outcome measure . RESULTS We identified four main outcomes for each cognitive domain : no decline ; decline and improvement ; persistent decline ; and late decline . Only 12 % of patients showed no decline across all domains tested ; 82 % to 90 % of patients had no decline in visual memory , psychomotor speed , motor speed , and executive function ; 21 % and 26 % had decline and improvement in verbal memory and language ; approximately 10 % had persistent decline in the domains of verbal memory , visual memory , attention , and visuoconstruction ; and 24 % had late decline ( between 1 month and 1 year ) in visuoconstruction . CONCLUSIONS This study establishes that the incidence of cognitive decline varies according to the cognitive domain studied and that some patients have persistent and late cognitive changes in specific domains after coronary artery bypass grafting",
"We studied correlations of serial changes in local cerebral blood flow ( LCBF ) after single intravenous ( i.v . ) injection of cytidine diphosphate choline ( CDP-choline ) to changes in cognitive function in demented subjects after its daily administration for one week . The study group consisted of 7 patients with dementia of vascular origin ( VD group ; mean age 65.0 years ) and 3 patients with dementia of non-vascular origin ( non-VD group ; 64.7 years ) . Cognitive function was evaluated with the Japanese version of the Cross Cultural Cognitive Examination ( CCCE ) . After i.v . injection of CDP-choline , mean supratentorial LCBF increased with the maximum value at 40 minutes post-injection in the VD-group , but decreased in the non-VD group ( Type , n.s . ; Time , n.s . ; Type x Time , p number of the pass-tasks in CCCE increased significantly after the 7 days-injection of CDP-choline only in the VD group ( p 15 control patients , who were matched in age and severity of dementia to the study patients . In this group , a change in the number of pass-tasks was significantly correlated with those in LCBF at ROIs in the left and right temporal cortices and the right thalamus . In the non-VD group , there were no significant changes of mean supratentorial LCBF and of the number of pass-tasks in CCCE . These results may be attributable to difference in availability of the acetylcholine neurotransmitter system in the brain between VD- and non-VD patients",
"BACKGROUND Reduction of cognitive function is a possible side effect after cardiac surgery using cardiopulmonary bypass . We investigated the cerebroprotective effect of piracetam on cognitive performance in patients undergoing coronary artery bypass surgery under cardiopulmonary bypass . MATERIAL / METHODS Patients scheduled for elective , primary and isolated coronary bypass surgery were r and omised either to piracetam or placebo group . The study was performed in a double blind fashion . Patients received either 12 g piracetam or placebo at the beginning of the operation . Six neuropsychological subtests from the Syndrom Kurz Test and the Alzheimer 's Disease Assessment Scale were performed preoperatively and on the third postoperative day . To assess the overall cognitive function and the degree of cognitive decline across all tests after surgery we combined the six test-scores by principal component analysis . RESULTS A total number of 120 patients were enrolled into the study . Preoperative overall cognitive function were not significantly different between the groups . The postoperative combined score of the neuropsychological tests showed a deterioration of cognitive function in both groups ( placebo-pre : -0.06+/-0.99 vs placebo-post : -1.38+/-1.11 ; p piracetam-pre : 0.06+/-1.02 vs piracetam-post : -0.65+/-0.93 ; p overall cognitive function ( p Piracetam has a cerebroprotective effect in patients undergoing coronary artery bypass surgery with the use of cardiopulmonary bypass . It reduces an early postoperative substantial decline of neuropsychological abilities",
"BACKGROUND Coronary artery bypass grafting ( CABG ) can be associated with postoperative cognitive impairment and ischemic stroke . No effective treatment is currently available . The aim of this study was to evaluate the effectiveness of piracetam to treat the cognitive impairment after CABG in an investigator-initiated , double-blind , placebo-controlled , r and omized clinical trial . METHODS Patients undergoing CABG ( n = 98 ) were r and omized to placebo ( n = 48 ) or piracetam ( n = 50 ) . Study drugs were administered intravenously ( 150 mg/kg daily ; 300 mg/kg on the day of surgery ) from the day before surgery to 6 days after surgery , then orally ( 12 g/day ) up to 6 weeks after surgery . Cognitive function was assessed before surgery ( baseline ) and 6 weeks after surgery ( outcome ) by using a battery of 12 neuropsychologic tests . The Spielberger Anxiety Inventory and the Beck Depression Inventory were also administered . The combined score derived from the st and ardized neuropsychologic assessment s was analyzed by using an analysis of covariance with baseline and education as covariates . RESULTS Six weeks after surgery , the combined score indicated a statistically significant treatment effect in the per protocol population ( 1.848 , p = 0.041 ) and a tendency towards statistical significance in the intent-to-treat population ( 1.624 , p = 0.064 ) in the group treated with piracetam , but no statistically significant treatment effect was seen in the placebo . The state of anxiety measured by the Spielberger Anxiety Inventory was decreased in both groups ( -9.27 and -6.37 in the placebo and piracetam groups , respectively ) . CONCLUSIONS Six weeks after CABG , cognition was significantly improved in patients treated with piracetam . Additional trials are required to confirm these effects",
"Abstract Background . Minimal hepatic encephalopathy ( MHE ) represents a common complication present in well-compensated cirrhotic patients that impairs patients ' daily functioning and health-related quality of life ( HRQL ) . Acetyl-l-carnitine ( ALC ) has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with MHE . Objective . This study evaluated the effects of ALC treatment on HRQL and depression in patients with MHE . Study design . This was a r and omized , double-blind , placebo-controlled study . Sixty-seven patients with MHE were recruited to the study . They were r and omly assigned to two groups and received either 2 g acetyl-l-carnitine twice a day ( n = 33 ) or placebo ( n = 34 ) for 90 days . The primary efficacy measures were changes in aspartate aminotransferase , alanine aminotransferase , γ-glutamyl-transpeptidase , albumin , alkaline phosphatase , prothrombin time , and ammonia . Clinical and laboratory assessment s , psychometric tests and automated electroencephalogram ( EEG ) analysis were performed for all patients . Results . At the end of the study period , between the two groups , we observed a significant difference in physical function ( p role physical ( p general health ( p , social function ( p role emotional ( p , mental health ( p Beck Depression Inventory ( p TMT-B s ( p 0.001 ) , State Trait Inventory ( p urea ( p NH4 + ( p and bilirubin ( p that ALC treatment is associated with significant improvement in patient energy levels , general functioning and well-being . The improvement of quality of life is associated with reduction of anxiety and depression ",
"BACKGROUND Surgery and anaesthesia may account for postoperative complications including cognitive impairment . The purpose of the study was to assess the influence of general anaesthetics on children 's memory and effectiveness of piracetam for prevention of postoperative cognitive dysfunction . METHODS The study included patients receiving different kinds of anaesthesia for various surgical procedures , r and omly allocated to two groups . According to immediate postoperative treatment , the study group received intravenous piracetam 30 mg kg(-1 ) and the control group -- placebo . The cognitive functions were examined preoperatively and within 10 consecutive postoperative days using the ten-word memory test . RESULTS The study group consisted of 123 children , the control one -- of 127 . Declines in memory indexes were observed in all anaesthetized patients . The most injured function was long-term memory . The intravenous administration of piracetam improved this cognitive function . CONCLUSIONS The study results confirm that general anaesthesia affects the memory function in children . Piracetam is effective for prevention of postoperative cognitive dysfunction after anaesthesia"
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4116cfcc-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Fibromyalgia ( FMS ) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services . Exercise training is commonly recommended as a treatment . This is an up date of a review published in Issue 2 , 2002 . OBJECTIVES The primary objective of this systematic review was to evaluate the effects of exercise training including cardiorespiratory ( aerobic ) , muscle strengthening , and /or flexibility exercise on global well-being , selected signs and symptoms , and physical function in individuals with FMS . SEARCH STRATEGY We search ed MEDLINE , EMBASE , CINAHL , SportD iscus , PubMed , PEDro , and the Cochrane Central Register for Controlled Trials ( CENTRAL , Issue 3 , 2005 ) up to and including July 2005 . We also review ed reference lists from review s and meta-analyses of treatment studies . SELECTION CRITERIA R and omized trials focused on cardiorespiratory endurance , muscle strength and /or flexibility as treatment for FMS were selected . DATA COLLECTION AND ANALYSIS Two of four review ers independently extracted data for each study . All discrepancies were rechecked and consensus achieved by discussion . Method ological quality was assessed by two instruments : the van Tulder and the Jadad method ological quality criteria . We used the American College of Sport Medicine ( ACSM ) guidelines to evaluate whether interventions had provided a training stimulus that would effect changes in physical fitness . Due to significant clinical heterogeneity among the studies we were only able to meta-analyze six aerobic-only studies and two strength-only studies . MAIN RESULTS There were a total of 2276 subjects across the 34 included studies ; 1264 subjects were assigned to exercise interventions . The 34 studies comprised 47 interventions that included exercise . Effects of several disparate interventions on global well-being , selected signs and symptoms , and physical function in individuals with FMS were summarized using st and ardized mean differences ( SMD ) . There is moderate quality evidence that aerobic-only exercise training at recommended intensity levels has positive effects global well-being ( SMD 0.44 , 95 % confidence interval ( CI 0.13 to 0.75 ) and physical function ( SMD 0.68 , 95 % CI 0.41 to 0.95 ) and possibly on pain ( SMD 0.94 , 95 % CI -0.15 to 2.03 ) and tender points ( SMD 0.26 , 95 % CI -0.28 to 0.79 ) . Strength and flexibility remain under-evaluated . AUTHORS ' CONCLUSIONS There is ' gold ' level evidence ( www.cochranemsk.org ) that supervised aerobic exercise training has beneficial effects on physical capacity and FMS symptoms . Strength training may also have benefits on some FMS symptoms . Further studies on muscle strengthening and flexibility are needed . Research on the long-term benefit of exercise for FMS is needed
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[
"OBJECTIVE To determine the prevalence and characteristics of fibromyalgia in the general population . METHODS A r and om sample of 3,006 persons in Wichita , KS , were characterized according to the presence of no pain , non-widespread pain , and widespread pain . A sub sample of 391 persons , including 193 with widespread pain , were examined and interviewed in detail . RESULTS The prevalence of fibromyalgia was 2.0 % ( 95 % confidence interval [ 95 % CI ] 1.4 , 2.7 ) for both sexes , 3.4 % ( 95 % CI 2.3 , 4.6 ) for women , and 0.5 % ( 95 % CI 0.0 , 1.0 ) for men . The prevalence of the syndrome increased with age , with highest values attained between 60 and 79 years ( > 7.0 % in women ) . Demographic , psychological , dolorimetry , and symptom factors were associated with fibromyalgia . CONCLUSION Fibromyalgia is common in the population , and occurs often in older persons . Characteristic features of fibromyalgia -- pain threshold and symptoms -- are similar in community and clinic population s , but overall severity , pain , and functional disability are more severe in the clinic population",
"& NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies",
"OBJECTIVE To measure mood and physical function of individuals with fibromyalgia , 6 and 12 months following 23 weeks of supervised aerobic exercise . METHODS This is a followup report of individuals who were previously enrolled in 23 weeks of l and -based and water-based aerobic exercise classes . Outcomes included the 6-minute walk test , Beck Depression Inventory ( BDI ) , State-Trait Anxiety Inventory , Arthritis Self-Efficacy Scale ( ASES ) , Fibromyalgia Impact Question naire ( FIQ ) , tender point count , patient global assessment score , and exercise compliance . Outcomes were measured at the start and end of the exercise classes and 6 and 12 months later . RESULTS Analyses were conducted on 29 ( intent-to-treat ) or 18 ( efficacy ) subjects . Six-minute walk distances and BDI total scores were improved at followup ( all analyses ) . BDI cognitive/affective scores were improved at the end of 23 weeks of exercise ( both analyses ) and at the 12-month followup ( efficacy analysis only ) . BDI somatic scores were improved at 6-month ( both analyses ) and 12-month followup ( intent-to-treat only ) . FIQ and ASES function were improved at all followup points . ASES pain was improved in efficacy analyses only ( all followup points ) . Tender points were unchanged after 23 weeks of exercise and at followup . Exercise duration at followup ( total minutes of aerobic plus anaerobic exercise in the preceding week ) was related to gains in physical function ( 6- and 12-month followup ) and mood ( 6-month followup ) . CONCLUSION Exercise can improve physical function , mood , symptom severity , and aspects of self efficacy for at least 12 months . Exercising at followup was related to improvements in physical function and perhaps mood",
"Objective . To follow patients with fibromyalgia six and 24 months after they finished a six-month treatment programme . The programme comprised pool exercise therapy , adjusted to the patients ' limitations , and education based on their health problems . Methods . Twenty-six patients were examined six and 24 months after the completion of the treatment programme with the Fibromyalgia Impact Question naire ( FIQ ) , SF-36 , the 6-minute walk test , and the Grippit measure . The values obtained at the follow-up examinations were compared with the baseline and post-treatment values . Results . As compared with baseline , symptom severity ( FIQ , SF-36 ) , physical function ( FIQ , SF-36 , 6-minute walk test ) and quality of life ( SF-36 ) still showed improvements six months after the completion of treatment ( p Pain ( FIQ , SF-36 ) , fatigue ( FIQ , SF-36 ) , walking ability , and social function ( SF-36 ) still showed improvements 2 years after the completion of the programme as compared with the baseline values ( p symptom severity , physical function and social function were still found six and 24 months after the completed treatment programme",
"Within the context of a double blind r and omized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs , we vali date d WOMAC , a new multidimensional , self-administered health status instrument for patients with osteoarthritis of the hip or knee . The pain , stiffness and physical function subscales fulfil conventional criteria for face , content and construct validity , reliability , responsiveness and relative efficiency . WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials",
"OBJECTIVE To determine the effects of moderate-intensity exercise training on self-rated ( subjective ) sleep quality among healthy , sedentary older adults reporting moderate sleep complaints . DESIGN R and omized controlled trial of 16 weeks ' duration . SETTING General community . PARTICIPANTS Volunteer sample of 29 women and 14 men ( of 67 eligible subjects ) aged 50 to 76 years who were sedentary , free of cardiovascular disease , and reported moderate sleep complaints . No participant was withdrawn for adverse effects . INTERVENTION R and omized to 16 weeks of community-based , moderate-intensity exercise training or to a wait-listed control condition . Exercise consisted primarily of four 30- to 40-minute endurance training sessions ( low-impact aerobics ; brisk walking ) prescribed per week at 60 % to 75 % of heart rate reserve based on peak treadmill exercise heart rate . MAIN OUTCOME MEASURE Pittsburgh Sleep Quality Index ( PSQI ) . RESULTS Compared with controls ( C ) , subjects in the exercise training condition ( E ) showed significant improvement in the PSQI global sleep score at 16 weeks ( baseline and posttest values in mean [ SD ] for C=8.93 [ 3.1 ] and 8.8 [ 2.6 ] ; baseline and posttest values for E=8.7 [ 3.0 ] and 5.4 [ 2.8 ] ; mean posttest difference between conditions=3.4 ; P sleep parameters of rated sleep quality , sleep-onset latency ( baseline and posttest values for C=26.1 [ 20.0 ] and 23.8 [ 15.3 ] ; for E=28.4 [ 20.2 ] and 14.6 [ 13.0 ] ; net improvement=11.5 minutes ) , and sleep duration baseline and posttest scores for C=5.8 [ 1.1 ] and 6.0 [ 1.0 ] ; for E=6.0 [ 1.1 ] and 6.8 [ 1.2 ] ; net improvement=42 minutes ) assessed via PSQI and sleep diaries ( P=.05 ) . CONCLUSIONS Older adults with moderate sleep complaints can improve self-rated sleep quality by initiating a regular moderate-intensity exercise program",
"OBJECTIVE To assess the responsiveness of the Fibromyalgia Impact Question naire ( FIQ ) , patient ratings of pain intensity , number of tender points , and total tender point pain intensity score to perceived changes in clinical status in patients with fibromyalgia ( FM ) . METHODS Using data from a r and omized placebo controlled study evaluating efficacy of magnetic therapy in patients with FM , the ability of primary outcomes to detect clinical ly meaningful changes over a 6 month period was assessed by : ( 1 ) degree of association between outcome change scores and patient global ratings of symptom change ( Spearman rank-order correlations ) ; ( 2 ) ability of these scores to discriminate among groups of patients whose perceived health status had changed to varying degrees ( ANOVA ) ; ( 3 ) ability of these scores , individually and jointly , to discriminate between patients who had reported improvement and those who did not ( logistic regression ) ; ( 4 ) effect size , st and ardized response mean , and Guyatt 's statistic were calculated to quantify responsiveness . RESULTS Correlations showed the outcome measures were moderately responsive to perceived symptomatic change . For FIQ , pain intensity ratings and number of tender points , differences in change scores between globally improved and unchanged groups and between globally improved and worsened groups were significant ; for total tender point pain intensity , the globally improved differed from worsened group . FIQ outperformed the other measures in discriminating between patients who reported improvement from those who did not . Summary statistics were consistent with discriminatory analyses , indicating the measures were sensitive to improvement , but relatively unresponsive to decline . CONCLUSION The FIQ was the most responsive measure to perceived clinical improvement and we recommend its inclusion as a primary endpoint in FM clinical trials"
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4116d008-06ff-11f0-808a-c43d1ab1c353
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Background : Enhanced recovery following surgery can be achieved through the introduction of evidence -based perioperative maneuvers . This review aims to present a consensus for optimal perioperative management of patients undergoing breast reconstructive surgery and to provide evidence -based recommendations for an enhanced perioperative protocol . Methods : A systematic review of meta-analyses , r and omized controlled trials , and large prospect i ve cohorts was conducted for each protocol element . Smaller prospect i ve cohorts and retrospective cohorts were considered only when higher level evidence was unavailable . The available literature was grade d by an international panel of experts in breast reconstructive surgery and used to form consensus recommendations for each topic . Each recommendation was grade d following a consensus discussion among the expert panel . Development of these recommendations was endorsed by the Enhanced Recovery after Surgery Society . Results : High- quality r and omized controlled trial data in patients undergoing breast reconstruction informed some of the recommendations ; however , for most items , data from lower level studies in the population of interest were considered along with extrapolated data from high- quality studies in non – breast reconstruction population s. Recommendations were developed for a total of 18 unique enhanced recovery after surgery items and are discussed in the article . Key recommendations support use of opioid-sparing perioperative medications , minimal preoperative fasting and early feeding , use of anesthetic techniques that decrease postoperative nausea and vomiting and pain , use of measures to prevent intraoperative hypothermia , and support of early mobilization after surgery . Conclusion : Based on the best available evidence for each topic , a consensus review of optimal perioperative care for patients undergoing breast reconstruction is presented . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic ,
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"Background A recent development in gastrointestinal surgery is the implementation of enhanced recovery after surgery ( ERAS ) programs . Evidence regarding the benefit of these programs in patients undergoing esophageal surgery is scarce . We investigated the feasibility and possible benefit of a perioperative ERAS program in patients undergoing esophagectomy for malignant disease . Methods The ERAS program was initiated in 2009 . Patients who underwent esophagectomy and were treated according to the ERAS program were included . Items of ERAS included preoperative nutrition , early extubation , early removal of nasogastric tube , and early mobilization . Primary outcome parameters were hospital stay and the incidence of postoperative complications . Outcome parameters in the ERAS cohort were compared to a cohort of patients who underwent surgical resection in the year prior to the implementation of the ERAS protocol . A feasibility analysis was performed among a sample of ERAS patients to determine the number of achieved items per patient . Results Between 2008 and August 2010 , 181 patients in our department underwent esophagectomy . Of these , 103 patients were included in the ERAS program ( ERAS+ group ) and were compared to 78 patients who had undergone an esophagectomy in 2008 ( ERAS– group ) . Overall hospital stay was 14 days versus 15 days ( ERAS+ and ERAS– , respectively ; p = 0.013 ) . There were no significant differences in the incidence of postoperative complications in either group . The percentage of achieved items varied between 42 and 93 % per item . Conclusions The implementation of an ERAS program in esophageal surgery was feasible and result ed in a small but significant reduction in overall hospital stay , whereas overall morbidity was not affected",
"This study explores the experiences of and the nursing care for nine women with breast cancer undergoing immediate breast reconstruction ( IBR ) with a TRAM-flap . The study was prospect i ve and descriptive and source and method triangulation was used . Source triangulation consisted of the patients ' and nurses ' perspectives , whilst method triangulation combined interviews , question naires and medical records . One result is that the meaning of IBR for the women operated is related to feelings of hope , normality and ' wholeness ' . Another result is that not all the needs of the patients are assessed and met ; the nursing care during admission is mainly focused on the physical care and after dismissal the patients are left in a situation characterized by vulnerability and a sense of emptiness . The study points to some implication s in the means of quality development and rehabilitation",
"BACKGROUND Surgical complications after breast reconstruction can be associated with significant morbidity , dissatisfaction , and cost . We used the ACS-NSQIP data sets from 2005 to 2011 to derive predictors of morbidity and to stratify risk after immediate breast reconstruction ( IBR ) . STUDY DESIGN Surgical complications after implant and autologous reconstruction were assessed using the ACS-NSQIP 2005 to 2011 data sets . Patient demographics , clinical characteristics , and operative factors were associated with the likelihood of experiencing a surgical complication . A \" model cohort \" of 12,129 patients was r and omly selected from the study cohort to derive predictors . Weighted odds ratios derived from logistic regression analysis were used to create a composite risk score and to stratify patients . The remaining one-third of the cohort ( n = 6,065 ) were used as the \" validation cohort \" to assess the accuracy value of the risk model . RESULTS On adjusted analysis , autologous reconstruction ( odds ratio [ OR ] 1.41 , p American Society of Anesthesiologists physical status ≥ 3 ( OR 1.25 , p = 0.004 ) , class I obesity ( OR 1.38 , p accurate prediction of risk across groups : low ( 7.1 % vs 7.1 % , respectively , p = 0.9 ) , intermediate ( 10.9 % vs 12.0 % , respectively , p = 0.38 ) , high ( 16.7 % vs 16.8 % , respectively , p = 0.95 ) , and very high ( 27.0 % vs 30.0 % , respectively , p = 1.0 ) . CONCLUSIONS Surgical complications after IBR are related to preoperatively identifiable factors that can be used to accurately risk stratify patients , which may assist with counseling , selection , and perioperative decision-making",
"BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations",
"Background The effectiveness of antibiotic prophylaxis for prevention of surgical site infection ( SSI ) following specific types of breast cancer surgery remains uncertain . This study assessed the effectiveness of prophylaxis in modified radical mastectomy ( MRM ) . Methods Women undergoing MRM for breast cancer were recruited . Women were excluded who had diabetes mellitus , severe malnutrition or known allergy to cephalosporins ; were receiving corticosteroid therapy or were treated with antibiotics within one week prior to surgery ; were scheduled for simultaneous breast reconstruction or bilateral oophorectomy ; had existing local infection . Participants were r and omized to receive either intravenous cefazolin 1 g or placebo within 30 min prior to skin incision . St and ard skin preparation and operative technique for MRM were carried out . Wounds were assessed for SSI and other complications weekly for 30 days . Results A total of 254 women were recruited . Age , clinical stage , prior chemotherapy , and operative time were similar for antibiotic and placebo groups . The overall incidence of SSI was 14.2 % . There were no significant differences in the infection rate over the 30-day follow-up period between the placebo and antibiotic groups ( 15 % vs 13.4 % ; p = 0.719 ) or at each week . The majority of SSI were either cellulitis or superficial infection for both groups . There were no significant differences between groups in treatments required for SSI , incidence of hematoma or seroma . Conclusions The findings of this study , alone and when meta-analyzed with data from studies in similar surgical population s , do not support the use of antibiotic prophylaxis in MRM",
"Background : Pulsed electromagnetic fields have been shown to reduce postoperative pain , inflammation , and narcotic requirements after breast reduction and augmentation surgical procedures . This study examined whether pulsed electromagnetic field therapy could produce similar results in patients undergoing unilateral transverse rectus abdominis myocutaneous ( TRAM ) flap breast reconstruction , a significantly more complex and painful surgical procedure . Methods : In this double-blind , placebo-controlled , r and omized study , 32 patients undergoing unilateral TRAM flap breast reconstruction received active or sham pulsed electromagnetic field therapy . Pain levels were measured by using a visual analogue scale ; narcotic use and wound exu date volume were recorded starting 1 hour postoperatively . Wound exu date s were analyzed for interleukin-1&bgr;. Results : Mean visual analogue scale pain scores were 2-fold higher in the sham cohort at 5 hours and 4-fold higher at 72 hours ( p Wound exu date volume was 2-fold higher in the sham cohort at 24 hours ( p mean interleukin-1&bgr ; concentration in wound exu date s of sham patients was 5-fold higher at 24 hours ( p Pulsed electromagnetic field therapy significantly reduced postoperative pain , inflammation , and narcotic use following TRAM flap breast reconstruction , paralleling its effect in breast reduction patients . Both studies also report a significant reduction of interleukin-1&bgr ; in the wound exu date , supporting a mechanism involving a pulsed electromagnetic field effect on nitric oxide/cyclic guanosine monophosphate signaling , which modulates the body ’s antiinflammatory pathways . Adjunctive pulsed electromagnetic field therapy could impact the speed and quality of wound repair in many surgical procedures . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic ,",
"UNLABELLED Infusions of carbohydrates before surgery reduce postoperative insulin resistance . We in-vestigated the effects of a carbohydrate drink , given shortly before surgery , on postoperative metabolism . METHOD Insulin sensitivity , glucose turnover ( [ 6,6 , 2H2]-D-glucose ) and substrate utilization were measured using hyperinsulinemic normoglycemic clamps and indirect calorimetry in two matched groups of patients before and after elective colorectal surgery . The drink group ( n = 7 ) received 800 ml of an isoosmolar carbohydrate rich beverage the evening before the operation ( 100 g carbohydrates ) , as well as another 400 ml ( 50 g carbohydrates ) 2 h before the initiation of anesthesia . The fasted group ( n = 7 ) was operated after an overnight fast . RESULTS After surgery , energy expenditure increased in both groups . Endogenous glucose production was higher after surgery and the difference was significant during low insulin infusion rates in both groups ( P endogenous glucose production by the two step insulin infusion was similar pre- and postoperatively in both groups . At the high insulin infusion rate postoperatively , whole body glucose disposal was more reduced in the fasted group ( -49 + /- 6 % vs -26 + /- 8 % , P insulin infusion rates , glucose oxidation decreased postoperatively only in the fasted group ( P postoperative levels of fat oxidation were greater in the fasted group ( P changes in cortisol and glucagon were found and no differences were found between the treatment groups . CONCLUSIONS Patients given a carbohydrate drink shortly before elective colorectal surgery displayed less reduced insulin sensitivity after surgery as compared to patients who were operated after an overnight fast",
"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",
"Background Major colorectal surgery usually requires a hospital stay of more than 12 days . Inadequate pain management , intestinal dysfunction and immobilisation are the main factors associated with delay in recovery . The present work assesses the short and medium term results achieved by an enhanced recovery program based on previously published protocol s. Methods This prospect i ve study , performed at 12 Spanish hospitals in 2008 and 2009 , involved 300 patients . All patients underwent elective colorectal resection for cancer following an enhanced recovery program . The main elements of this program were : preoperative advice , no colon preparation , provision of carbohydrate-rich drinks one day prior and on the morning of surgery , goal directed fluid administration , body temperature control during surgery , avoiding drainages and nasogastric tubes , early mobilisation , and the taking of oral fluids in the early postoperative period . Perioperative morbidity and mortality data were collected and the length of hospital stay and protocol compliance recorded . Results The median age of the patients was 68 years . Fifty-two % of the patients were women . The distribution of patients by ASA class was : I 10 % , II 50 % and III 40 % . Sixty-four % of interventions were laparoscopic ; 15 % required conversion to laparotomy . The majority of patients underwent sigmoidectomy or right hemicolectomy . The overall compliance to protocol was approximately 65 % , but varied widely in its different components . The median length of postoperative hospital stay was 6 days . Some 3 % of patients were readmitted to hospital after discharge ; some 7 % required repeat surgery during their initial hospitalisation or after readmission . The most common complications were surgical ( 24 % ) , followed by septic ( 11 % ) or other medical complications ( 10 % ) . Three patients ( 1 % ) died during follow-up . Some 31 % of patients suffered symptoms that delayed their discharge , the most common being vomiting or nausea ( 12 % ) , dyspnoea ( 7 % ) and fever ( 5 % ) . Conclusion The following of this enhanced recovery program posed no risk to patients in terms of morbidity , mortality and shortened the length of their hospital stay . Overall compliance to protocol was 65 % . The following of this program was of benefit to patients and reduces costs by shortening the length of hospital stay . The implantation of such programmes is therefore highly recommended",
"BACKGROUND Surgical site infection ( SSI ) is the fourth commonest healthcare-associated infection and complicates at least 5 % of open operations . In a r and omized clinical trial , antimicrobial-coated sutures were compared with their conventional counterparts , polyglactin and poliglecaprone , for skin closure after breast cancer surgery to assess their role in reducing the rate of SSI . METHODS Between November 2008 and February 2011 , 150 female patients presenting with breast cancer to a single center were r and omized to skin closure with antimicrobial-coated or plain sutures . Postoperatively , SSI was defined using the U.S. Centers for Disease Control and Prevention ( CDC ) definitions and scored using the ASEPSIS or Southampton systems by trained , blinded observers with close post-discharge surveillance and patient diaries . Surgeons and patients were blinded to the type of suture used . RESULTS Using CDC criteria , the overall rate of SSI was 18.9 % at six weeks . Six patients ( 4.7 % ) needed intervention or readmission for SSI . Skin closure with antimicrobial sutures showed a non-statistically significant reduction in the SSI rate , to 15.2 % , compared with conventional sutures ( 22.9 % ) . A uniform tendency for fewer SSIs in the antimicrobial-coated suture group was found using ASEPSIS and Southampton scores , but again , the difference was not statistically significant . CONCLUSION The previously reported high rate of SSI related to breast surgery was confirmed . Using statistical modeling and earlier reports , the study was powered to show a difference using ASEPSIS scores , but the modification used in this trial failed to find a difference . Finding a statistically significant difference would have needed two to three times the number of patients recruited . Further evaluation of antimicrobial-coated sutures is merited , particularly if used as part of a care bundle to reduce SSI after breast cancer surgery",
"Summary Background In this prospect i ve , r and omized , placebo-controlled , double-blinded clinical trial we tested the hypothesis that preemptive analgesia with bupivacaine applied in the area of the surgical incision in patients undergoing mastectomy for breast cancer would reduce post-operative acute pain and would reduce the amount of analgesics used during surgery and in the post-operative period . Material / Methods Participants were assigned into 1 of 2 groups – with bupivacaine applied in the area of surgical incision or with placebo . We assessed the intraoperative consumption of fentanyl , the postoperative consumption of morphine delivered using a PCA method , and the subjective pain intensity according to VAS score reported by patients in the early post-operative period . Results Out of 121 consecutive cases qualified for mastectomy , 112 women were allocated r and omly to 1 of 2 groups – group A ( bupivacaine ) and group B ( placebo ) . The final study group comprised 106 breast cancer cases . Between the groups , a statistically significant difference was observed with respect to : lower fentanyl consumption during surgery ( p=0.011 ) , lower morphine ( delivered by means of a PCA ) consumption between the 4–12th postoperative hours ( p=0.02 ) and significantly lower pain intensity assessed according to VAS score at the 4th and 12th hours after surgery ( p=0.004 and p=0.02 respectively ) for the group A patients . Conclusions Preemptive analgesia application in the form of infiltration of the area of planned surgical incisions with bupivacaine in breast cancer patients undergoing mastectomy decreases post-operative pain sensation , limits the amount of fentanyl used during surgery , and reduces the dem and for opiates in the hours soon after surgery",
"BACKGROUND : Postoperative nausea and vomiting ( PONV ) occur commonly after craniotomy . In patients receiving prophylaxis with ondansetron and dexamethasone , vomiting occurred in 45 % of patients at 48 hours . In addition to causing patient discomfort , the physical act of vomiting may increase intracranial pressure or cerebral intravascular pressure , jeopardizing hemostasis and cerebral perfusion . Aprepitant is a neurokin-1 receptor antagonist with a long duration of action and no sedative side effect . In a large multicenter study in patients undergoing abdominal surgery , aprepitant was significantly more effective than was ondansetron in preventing vomiting at 24 and 48 hours postoperatively . We hypothesized that the combination of aprepitant with dexamethasone will decrease the incidence of postoperative vomiting when compared with the combination of ondansetron and dexamethasone in patients undergoing craniotomy under general anesthesia . METHODS : Patients scheduled to undergo craniotomy under general anesthesia were enrolled in this prospect i ve , double-blind , r and omized study . Patients were r and omized to receive oral aprepitant 40 mg ( or matching placebo ) 1 to 3 hours before induction of anesthesia or ondansetron 4 mg IV ( or placebo ) within 30 minutes of the end of surgery . All patients received dexamethasone 10 mg after induction of anesthesia . The anesthetic technique was st and ardized . Data were collected at regular intervals by blinded personnel for 48 hours after surgery . Statistical analysis was performed using Wilcoxon 's ranked sum test and & khgr;2 test . P One hundred four patients completed the study . The cumulative incidence of vomiting at 48 hours was 16 % in the aprepitant group and 38 % in the ondansetron group ( P = 0.0149 ) . The incidence of vomiting was also decreased in the aprepitant group at 2 hours ( 6 % vs. 21 % , P = 0.0419 ) and 24 hours ( 14 % vs. 36 % , P = 0.0124 ) . From 0 to 48 hours , there was no difference between the aprepitant and ondansetron groups in the incidence of nausea ( 69 % vs. 60 % ) , nausea scores , need for rescue antiemetics ( 65 % vs. 60 % ) , complete response ( no PONV and no rescue , 22 % vs. 36 % ) , or patient satisfaction with the management of PONV . CONCLUSION : The combination of aprepitant and dexamethasone was more effective than was the combination of ondansetron and dexamethasone for prophylaxis against postoperative vomiting in adult patients undergoing craniotomy under general anesthesia . However , there was no difference between the groups in the incidence or severity of nausea , need for rescue antiemetics , or in complete response between the groups",
"PURPOSE To evaluate the accuracy of magnetic resonance angiography ( MRA ) for preoperative mapping of rectus and gluteal muscle perforating arteries prior to autologous flap breast reconstruction . MATERIAL S AND METHODS Preoperative MRA on 25 consecutive patients undergoing perforator artery-based autologous breast reconstruction was performed at 1.5 T using 3D liver accelerate volume acquisition ( LAVA ) of abdominal or gluteal regions acquired during injection of 20 mL of gadobenate dimeglumine with bolus timing optimized using MR fluoroscopy or SmartPrep . Perforator artery size and coordinates relative to umbilicus or top of gluteal crease on 3D MRA were compared to findings at surgery . Reconstructed breast volume estimates from MRA were also compared to weights at harvesting . RESULTS In all , 132 perforator arteries were found at surgery to be located within 1 cm of the coordinates measured on MRA and were surgically verified to be suitable for flap perfusion . Surgery verified the arterial course and caliber through the rectus and gluteal muscles visualized on MRA in 48 of 49 arteries . Volume rendering of 3D MRA predicted a breast reconstruction volume with a mean difference of 47 g compared to measurements at harvesting . CONCLUSION MRA accurately maps rectus and gluteal muscle perforator arteries for preoperative planning of autologous flaps for breast reconstruction",
"BACKGROUND Obesity is a growing epidemic in the United States ( US ) affecting more than 33 % of adults . We aim ed to use the World Health Organization ( WHO ) obesity stratification scheme to assess the overall risk of obese patients undergoing breast reconstruction using the ACS-NSQIP data base from 2005 to 2010 . STUDY DESIGN We review ed the 2005 to 2010 ACS-NSQIP data bases identifying encounters for Current Procedural Terminology ( CPT ) codes including either implant-based reconstruction ( immediate , delayed , and tissue exp and er ) or autologous reconstruction ( pedicled transverse rectus abdominis myocutaneous [ pTRAM ] , free TRAM , and latissimus dorsi flap with or without implant ) . Patients were classified and compared based on WHO obesity criteria : nonobese ( body mass index [ BMI ] = 20 to 29.9 kg/m(2 ) ) , class I ( BMI = 30 to 34.9 kg/m(2 ) ) , class II ( BMI = 35 to 39.9 kg/m(2 ) ) , and class III ( BMI > 40 kg/m(2 ) ) . RESULTS During the study period 15,937 breast reconstructions were performed . The majority of reconstructions were immediate reconstructions ( 85.0 % ) and implant-based ( 79.1 % ) . The incidence of obesity was 27.1 % , with 16.3 % defined as class I obese , 6.9 % defined as class II obese , and 4.0 % defined as class III obese . The WHO-classified obese patients tended to have a progressively higher incidence of comorbid conditions , higher American Society of Anesthesiologists ( ASA ) physical status ( p longer operative times ( p = 0.0001 ) , and greater lengths of hospital stay ( p = 0.0001 ) . Progressively higher BMI s were associated with higher rates of complications , including wound ( p medical ( p infections ( p major surgical ( p graft and prosthesis loss ( p return to the operating room ( p reconstruction using a large , prospect i ve multicenter data set . Increasing obesity is associated with increased perioperative morbidity . Data derived from this cohort study can be used to risk-stratify patients , enhance risk counseling , and advocate for institutional reimbursement in obese patients undergoing breast reconstruction",
"Background This review aims to present a consensus for optimal perioperative care in rectal/pelvic surgery , and to provide grade d recommendations for items for an evidence d-based enhanced recovery protocol . Methods Studies were selected with particular attention paid to meta-analyses , r and omized controlled trials and large prospect i ve cohorts . For each item of the perioperative treatment pathway , available English- language literature was examined , review ed and grade d. A consensus recommendation was reached after critical appraisal of the literature by the group . Results For most of the protocol items , recommendations are based on good- quality trials or meta-analyses of good- quality trials ( evidence grade : high or moderate ) . Conclusions Based on the evidence available for each item of the multimodal perioperative care pathway , the Enhanced Recovery After Surgery ( ERAS ) Society , European Society for Clinical Nutrition and Metabolism ( ESPEN ) and International Association for Surgical Metabolism and Nutrition ( IASMEN ) present a comprehensive evidence -based consensus review of perioperative care for rectal surgery",
"OBJECTIVE To explore whether perioperative intravenous flurbiprofen axetil can reduce the incidence and intensity of chronic pain for breast cancer after surgical treatment . METHODS This r and omized , double-blind , controlled trial enrolled 60 patients undergoing mastectomy and axillary lymph node dissection under general anesthesia . All patients accepted Hospital Anxiety and Depression Scale ( HAD ) tests the day before the surgery to evaluate depression and anxiety . The patients were r and omly assigned to receive either 50 mg flurbiprofen axetil intravenously 15 minutes before the surgical incision and 6 hours later ( group F ) or intravenous 5 mL intralipid as a control ( group C ) . All patients received patient-controlled intravenous analgesia ( PCIA ) with fentanyl postoperatively . Peripheral venous blood sample s were drawn before the surgery , at 4 and 24 h after the surgery to detect the plasma level of PGE2 and tumor necrosis factor-α ( TNF-α ) . Postoperative fentanyl consumption , Numerical Rating Scale ( NRS ) scores and adverse effects were recorded at 2 , 6 , 12 , 24 and 48 h after the surgery . The duration and intensity of pain were followed up by telephone at the 2nd-12th month after the surgery . RESULTS The incidence of pain at 2 , 4 , 6 , and 12 months after the breast surgery was 33 % , 20 % , 15 % , and 10 % , respectively , and the average pain score was 0.77 , 0.57 , 0.28 , and 0.18 , respectively . Compared with group C , the scores of pain in group F were significantly lower at 2 , 4 , 6 and 12 months postoperatively ( F=7.758 , P=0.007 ) . The incidence of pain in group F was significantly lower at 2 , 4 and 6 months postoperatively ( P the incidence of pain between the groups at 12 months postoperatively ( P>0.05 ) . Preoperatively and at 4 and 24 h after the surgery , there was no significant difference in the level of TNF-α between the two groups ( F=0.530 , P=0.470 ) ; but plasma concentration of PGE2 in group F was significantly lower than that in group C ( F=5.646 , P=0.021 ) . No patients developed abnormal bleeding , peptic ulcer , impaired liver or renal function and respiratory depression . CONCLUSION Perioperative intravenous infusion of 100 mg flurbiprofen axetil can decrease the intensity and incidence of chronic pain for breast cancer after surgical treatment",
"Background and Objectives Patients undergoing breast cancer surgery frequently experience chronic postoperative pain . The primary objective of this r and omized study was to determine if thoracic paravertebral block ( TPVB ) reduced the incidence of chronic pain after a modified radical mastectomy ( MRM ) when compared with general anesthesia ( GA ) . Methods One hundred eighty women undergoing MRM were r and omized to 1 of 3 study groups : group 1 : st and ardized GA , group 2 : GA with a single-injection TPVB and placebo paravertebral infusion , and group 3 : GA with a continuous TPVB . Outcomes assessed postoperatively included acute postoperative pain and analgesic consumption and , at 3 and 6 months , the incidence and severity of chronic pain and physical and mental health-related quality of life ( HRQOL ) . Results There was no significant difference in the incidence of chronic pain at 3 months ( P = 0.13 ) and 6 months ( P = 0.79 ) after the MRM between the study groups . The relative risk of developing chronic pain ( P = 0.25 ) was also similar between the groups . There was no difference in acute pain ( P = 0.22 ) or postoperative analgesic consumption ( P = 0.67 ) between the groups . Nevertheless , differences were observed in chronic pain – related secondary outcome variables . The TPVB groups reported lower chronic pain scores ( P signs of chronic pain ( P ⩽ 0.01 ) , and also experienced better physical and mental HRQOL than did the GA group . Chronic pain scores also decreased with time in all study groups ( P chronic pain at 3 and 6 months after an MRM when TPVB is used in conjunction with GA . Nevertheless , patients who receive a TPVB report less severe chronic pain , exhibit fewer symptoms and signs of chronic pain , and also experience better physical and mental HRQOL ",
" Enhanced recovery programmes ( ERPs ) have been shown to reduce length of hospital stay ( LOS ) and complications in colorectal surgery . Whether ERPs have the same benefits in open liver resection surgery is unclear , and r and omized clinical trials are lacking",
"Background : Technological innovations are often adopted before scientific comparison to an accepted st and ard . The authors ' study compared suture with a new coaptive film device , 3 M Steri-Strip S Surgical Skin Closure , on linear incisions . Methods : Patients undergoing Wise-pattern breast reduction or abdominal procedures had paired incisions r and omly assigned to Steri-Strip S or suture closure . Key outcome measures were closure time , patient comfort , and scar quality at 6 months by patients and surgeons using a new scar evaluation tool , visual assessment of linear scars . Statistical differences between the two closure techniques were assessed by Wilcoxon signed rank test . Results : Of 59 patients , eight were excluded from r and omization ( a surgeon judged Steri-Strip S to be a nonviable closure technique for mismatched wound edges ) . Fifty-one patients ( breast , n = 24 ; abdomen , n = 27 ) were r and omized . Operative time with Steri-Strip S for breast was 2.0 minutes ( SD = 1.1 ) versus suture closure at 4.6 minutes ( SD = 1.5 ; p Steri-Strip S versus suture for the abdomen was faster ( p Comfort scores did not differ between closures [ 5.8 ( SD = 2.7 ) versus 6.9 ( SD = 2.0 ) , respectively , on breast ( p = 0.142 ) and 7.7 ( SD = 1.8 ) versus 7.7 ( SD = 2.3 ) on abdomen ( p = 0.903 ) ] . Complication rates did not differ between closure types . Patients ' visual assessment of linear scars rating of breasts was 3.8 ( SD = 2.9 ) for Steri-Strip S and better at 2.6 ( SD = 2.9 ) for suture ( p = 0.008 ) . One surgeon rated breast Steri-Strip S scars worse than suture scars ( 4.3 versus 3.7 ; p = 0.014 ) . For abdominal scars , there was no difference in the patient or surgeon ratings . Conclusions : Steri-Strip S permits faster wound closure than suture . On the basis of patient reports of comfort and scar quality , surgeons increase efficiency and maintain quality with the use of Steri-Strip S on abdominal wounds but not on breast wounds",
"PURPOSE To compare the clinical efficacy of warmed irrigation fluid and room-temperature fluid in decreasing perioperative hypothermia during arthroscopic rotator cuff surgery . METHODS In this prospect i ve , r and omized , comparative study , warmed ( 36 ° C ) arthroscopic irrigation fluid ( group W , n = 36 ) or room-temperature irrigation fluid ( group RT , n = 36 ) was used without intraoperative warming devices during arthroscopic shoulder surgery in 72 patients . The serial core body temperature and the last and lowest core body temperatures were measured by use of an esophageal stethoscope with a thermometer and a digital tympanic thermometer at 15-minute intervals during the operation and recovery period , respectively . When patients arrived in the postanesthesia care unit ( PACU ) after surgery , they were warmed immediately and monitored thereafter for body temperature and development of hypothermia-related adverse effects such as postoperative shivering and cardiac events . We evaluated the changes in the patients ' weight and prothrombin time on postoperative day 1 and the hemoglobin level and visual analog scale pain score immediately after the operation and on postoperative day 1 . RESULTS The 2 groups did not differ in demographic and surgical data and incidence of intraoperative hypothermia ( 33 of 36 [ 91.6 % ] in group RT and 34 of 36 [ 94.4 % ] in group W , P = .276 ) . The core body temperatures decreased throughout the surgery and increased linearly in the PACU , without any intergroup differences ( P > .05 ) . All patients were normothermic within 1 hour of arrival in the PACU . The 2 groups did not differ in postoperative weight change , prothrombin time , hemoglobin level , or postoperative visual analog scale pain score ( all P > .05 ) . Postoperative shivering occurred in 3 patients and 1 patient in group RT and group W , respectively . No cardiac events occurred in either group . CONCLUSIONS Warmed irrigation fluid was not superior to room-temperature irrigation fluid in reducing the occurrence of perioperative hypothermia during arthroscopic shoulder surgery . LEVEL OF EVIDENCE Level I , r and omized controlled trial",
"BACKGROUND The primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy . A secondary objective was to assess the incidence of surgical site infection ( SSI ) . METHODS Patients undergoing modified radical mastectomy were r and omly assigned to coated VICRYL Plus antibacterial ( Polyglactin 910 ) suture or Chinese silk suture . Cosmetic outcomes were evaluated postoperatively at days 12 ( ± 2 ) and 30 ( ± 5 ) , and the evidence of SSI was assessed at days 3 , 5 , 7 , 12 ( ± 2 ) , 30 ( ± 5 ) , and 90 ( ± 7 ) . Cosmetic outcomes were independently assessed via visual analogue scale ( VAS ) score evaluations of blinded incision photographs ( primary endpoint ) and surgeon-assessed modified Holl and er Scale ( mHCS ) scores ( secondary endpoint ) . SSI assessment s used both CDC criteria and ASEPSIS scores . RESULTS Six Chinese hospitals r and omized 101 women undergoing modified radical mastectomy to closure with coated VICRYL Plus suture ( n = 51 ) or Chinese silk suture ( n = 50 ) . Mean VAS cosmetic outcome scores for antibacterial suture ( 67.2 ) were better than for Chinese silk ( 45.4 ) at day 30 ( P 0.0001 ) ) . Mean mHCS cosmetic outcome total scores , were also higher for antibacterial suture ( 5.7 ) than for Chinese silk ( 5.0 ) at day 30 ( P = 0.002 ) . CONCLUSIONS Patients using coated VICRYL Plus suture had significantly better cosmetic outcomes than those with Chinese silk sutures . Patients using coated VICRYL Plus suture had a lower SSI incidence compared to the Chinese silk sutures , although the difference did not reach statistical significance",
"The authors report the results of a multicenter prospect i ve study evaluating a novel technology : dermal suture using absorbable staples composed of polylactic and polyglycolic acids . From January to June 2009 , 59 dermal sutures were performed with Insorb absorbable staples and 41 with absorbable thread . All patients in the study underwent abdominal dermolipectomy ( N = 65 ) or surgery for breast hypertrophy ( N = 35 ) . The purpose of the study was to compare the closure time and healing quality obtained with the 2 methods . Ninety-five patients were reexamined by the surgeon after 1 year of follow-up to assess scar width , suppleness , inflammation , and hypertrophy . The overall results were good and quite similar for the 2 groups . Thus , the use of Insorb staples reduced closure time while ensuring good healing quality",
"We conducted a r and omised controlled trial to compare the efficacy of underbody forced‐air warming ( Arizant Healthcare Inc , Eden Prairie , MN , USA ) with an underbody resistive heating mattress ( Inditherm Patient Warming System , Rotherham , UK ) and passive insulation in 129 patients having hypothermic cardiac surgery with cardiopulmonary bypass . Patients were separated from cardiopulmonary bypass at a core temperature of 35 ° C and external warming continued until the end of surgery . Before cardiopulmonary bypass , the temperature‐vs‐time slopes were significantly greater in both active warming groups than in the passive insulation group ( p the rate of rewarming was significantly greater with forced‐air than with resistive warming or passive insulation ( p However , absolute temperature differences among the groups were small",
"Purpose Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals . We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction . Methods We conducted a pilot r and omized controlled trial ( RCT ) where participants were r and omly assigned to the intervention with routine education or routine education alone . The outcomes evaluated were decisional conflict , decision self-efficacy , satisfaction with information , perceived involvement in care , and uptake of reconstruction following surgical consultation . Trial feasibility and acceptability were evaluated , and effect sizes were calculated to determine the primary outcome for the full-scale RCT . Results Of the 41 patients enrolled , recruitment rate was 72 % , treatment fidelity was 98 % , and retention rate was 95 % . The Cohen ’s d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education ( 0.69 , 95 % CI = 0.02–1.42 ) , while the effect sizes of increase in decision self-efficacy ( 0.05 , 95 % CI = −0.60–0.71 ) and satisfaction with information ( 0.11 , 95 % CI = −0.53–0.76 ) were small . A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction ( 14/20 or 70 % ) compared to the intervention group ( 8/21 or 38 % ) P = 0.06 . Conclusions A pre-consultation educational group intervention improves patients ’ shared decision-making quality compared to routine preoperative patient education . A full-scale definitive RCT is warranted based on high feasibility outcomes , and the primary outcome for the main trial will be decisional conflict",
"Increased experience with free-tissue transfer has minimized flap loss secondary to microvascular thrombosis , yet pharmacologic antithrombotic prophylaxis continues to be used routinely . Currently there is no consensus on the ideal pharmacologic agent , dosing , or efficacy . Low-molecular-weight dextran has been widely used for prophylaxis due to its properties of volume expansion and enhanced microrheology . Significant systemic morbidity ( pulmonary morbidity , cardiac morbidity , anaphylaxis ) is known to occur with use of low-molecular-weight dextran . The purpose of this study was to evaluate morbidity associated with postoperative low-molecular-weight dextran and aspirin prophylaxis in head and neck microsurgery patients . This study was a r and omized prospect i ve analysis of 100 consecutive patients undergoing microvascular reconstruction for head and neck malignancy during a 2-year period . Patients were r and omized into one of three postoperative antithrombotic prophylaxis treatment groups : low-molecular-weight dextran 20 cc/hour for 48 hours ( n = 35 ) , low-molecular-weight dextran 20 cc/hour for 120 hours ( n = 32 ) , or aspirin 325 mg/day for 120 hours ( n = 27 ) . Six patients were excluded intraoperatively due to the need for systemic heparin therapy . Treatment groups were compared for age , sex , prior medical problems , duration of anesthesia , and intraoperative fluid intake . Flap outcome and the incidence of local and systemic complications were evaluated in the treatment groups . Patient ages ranged from 12 to 84 years ( mean age , 58 years ) . No significant difference was found among the treatment groups with respect to age , sex , prior medical problems , duration of anesthesia , intraoperative fluid intake , and the distribution of donor and recipient sites . There were no total flap losses and two partial flap losses in this series . Three flaps were reexplored and all were salvaged . The incidence of systemic complications ( congestive heart failure , myocardial infa rct ion , pulmonary edema , pleural effusion , and pneumonia ) was as follows : low-molecular-weight dextran 120 hours , 51 percent ; low-molecular-weight dextran 48 hours , 29 percent ; and aspirin , 7 percent . Analysis of these data suggests that the method of prophylaxis had no effect on overall flap survival . However , the incidence of systemic complications was significantly related to the method of prophylaxis , with patients receiving low-molecular-weight dextran 120 hours and 48 hours at a 7.2 and 3.9 times greater relative risk , respectively , of developing a systemic complication compared with patients receiving aspirin . The results of this study have eliminated the routine use of low-molecular-weight dextran prophylaxis at our institution in an effort to reduce morbidity in head and neck microsurgical reconstruction",
"Objectives Postmastectomy pain syndrome is a neuropathic pain syndrome that is known to develop after breast surgery . Preemptive analgesia has been shown to be efficacious in reducing postoperative pain , and may be effective in reducing the incidence of certain types of neuropathic pain . We investigated the analgesic efficacy of Venlafaxine and gabapentin on acute and chronic pain associated with cancer breast surgery . Patients and Methods The study was carried out on 150 patients scheduled for either partial or radical mastectomy with axillary dissection . They were r and omized in a double-blinded manner to receive , extended release Venlafaxine 37.5 mg/d , gabapentin 300 mg/d , or placebo for 10 days starting the night before operation . Pain scores were recorded at rest and movement ( visual analog scale ) at 4 , 12 , and 24 hours on the first day postoperatively , daily from the second to tenth day postoperatively and visual analog scale in addition to pain character 6 months later . Analgesic requirements were compared between the 3 groups . Results Pain after movement was reduced by gabapentin from the second to tenth postoperative day and venlafaxine group in the last 3 days but no difference was found between the groups regarding pain during rest . Gabapentin reduced morphine consumed in the first 24 hours postoperatively . The analgesic requirements from the second to tenth days for codeine and paracetamol were reduced in venlafaxine and gabapentin groups compared to the control group . Six months later , the incidence of chronic pain , its intensity , and need for analgesics were reduced in venlafaxine compared to gabapentin and the placebo group . However , burning pain was more frequent in the control groups than in the gabapentin . Conclusion Venlafaxine 37.5 mg/d extended release or gabapentin 300 mg/d have equipotent effects ( except on the first day in venlafaxine group ) in reducing analgesic requirements , although gabapentin is more effective in reducing pain after movement . Venlafaxine significantly reduced the incidence of postmastectomy pain syndromes ( chronic pain ) 6 months in women having breast cancer surgery . Gabapentin had no effect on chronic pain except decreasing incidence of burning pain",
"Abstract Immediate breast implant reconstruction has among the highest incidence of infections in plastic surgery . A literature search returned key articles that showed a significant decrease in surgical-site infections by performing nasal swab evaluation to treat methicillin-sensitive and methicillin-resistant Staphylococcus aureus before surgery with mupirocin nasal ointment and 5 days of chlorhexidine scrub to the surgical area . Additional Level 1 data supported the use of chlorhexidine-alcohol over povidone-iodine solutions for skin preparation . Intraoperative data on breast pocket irrigation showed the benefits of povidone-iodine as well as a triple antibiotic solution . Nasal swabs from 120 patients showed no methicillin-resistant S. aureus but did identify 10 patients with methicillin-sensitive S. aureus , 1 with streptococcus , and 3 with gram-negative rods , which changed perioperative antibiotic management . On the basis of the previously mentioned data , an evidence -based protocol for infection control was developed to potentially decrease infection rates . Further cost and efficacy data are warranted",
"Background : Post‐operative insulin resistance and hyperglycaemia are associated with an impaired outcome after surgery . Pre‐operative oral carbohydrate loading ( CHO ) reduces post‐operative insulin resistance with a reduced risk of hyperglycaemia during post‐operative nutrition . Insulin‐resistant diabetic patients have not been given CHO because the effects on pre‐operative glycaemia and gastric emptying are unknown",
"Introduction Despite recent interest in measurement of central venous oxygen saturation ( ScvO2 ) , there are no published data describing the pattern of ScvO2 changes after major general surgery or any relationship with outcome . Methods ScvO2 and other biochemical , physiological and demographic data were prospect ively measured for 8 hours after major surgery . Complications and deaths occurring within 28 days of enrolment were included in the data analysis . Independent predictors of complications were identified with the use of logistic regression analysis . Optimum cutoffs for ScvO2 were identified by receiver operator characteristic analysis . Results Data from 118 patients was analysed ; 123 morbidity episodes occurred in 64 these patients . There were 12 deaths ( 10.2 % ) . The mean ± SD age was 66.8 ± 11.4 years . Twenty patients ( 17 % ) underwent emergency surgery and 77 patients ( 66 % ) were male . The mean ± SD P-POSSUM ( Portsmouth Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity ) score was 38.6 ± 7.7 , with a predicted mortality of 16.7 ± 17.6 % . After multivariate analysis , the lowest cardiac index value ( odds ratio ( OR ) 0.58 ( 95 % confidence intervals 0.37 to 0.9 ) ; p = 0.018 ) , lowest ScvO2 value ( OR 0.94 ( 0.89 to 0.98 ) ; p = 0.007 ) and P-POSSUM score ( OR 1.09 ( 1.02 to 1.15 ) ; p = 0.008 ) were independently associated with post-operative complications . The optimal ScvO2 cutoff value for morbidity prediction was 64.4 % . In the first hour after surgery , significant reductions in ScvO2 were observed , but there were no significant changes in CI or oxygen delivery index during the same period . ConclusionS ignificant fluctuations in ScvO2 occur in the immediate post-operative period . These fluctuations are not always associated with changes in oxygen delivery , suggesting that oxygen consumption is also an important determinant of ScvO2 . Reductions in ScvO2 are independently associated with post-operative complications",
"Background Dexamethasone has been reported to reduce postoperative symptoms after different surgical procedures . We evaluated the efficacy of preoperative dexamethasone in ameliorating postoperative nausea and vomiting ( PONV ) , and pain after mastectomy . Methods In this prospect i ve , double-blind , placebo-controlled study , 70 patients scheduled for mastectomy with axillary lymph node dissection were analyzed after r and omization to treatment with 8 mg intravenous dexamethasone ( n = 35 ) or placebo ( n = 35 ) . All patients underwent st and ardized procedures for general anesthesia and surgery . Episodes of PONV and pain score were recorded on a visual analogue scale . Analgesic and antiemetic requirements were also recorded . Results Demographic and medical variables were similar between groups . The incidence of PONV was lower in the dexamethasone group at the early postoperative evaluation ( 28.6 % vs. 60 % ; p = 0.02 ) and at 6 h ( 17.2 % vs. 45.8 % ; p = 0.03 ) . More patients in the placebo group required additional antiemetic medication ( 21 vs. 8 ; p = 0.01 ) . Dexamethasone treatment significantly reduced postoperative pain just after surgery ( VAS score , 4.54 ± 1.55 vs. 5.83 ± 2.00 ; p = 0.004 ) , at 6 h ( 3.03 ± 1.20 vs. 4.17 ± 1.24 ; p 0.04 ) . Analgesics were required in more patients of the control group ( 21 vs. 10 ; p = 0.008 ) . There were no adverse events , morbidity or mortality . Conclusions Preoperative intravenous dexamethasone ( 8 mg ) can significantly reduce the incidence of PONV and pain in patients undergoing mastectomy with axillary dissection for breast cancer . Trial registration",
"Background One of the major risk variables for surgical site infection is wound management . Underst and ing infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes . The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization . Patients ’ perception at self- assessment will also be analyzed . Methods / Design This is a two-arm r and omized controlled trial . Two hundred breast cancer patients undergoing immediate or delayed breast reconstruction will be prospect ively enrolled . Patients will be r and omly allocated to group I ( dressing removed on postoperative day one ) or group II ( dressing removed on postoperative day six ) . Surgical site infections will be defined by st and ard criteria from the Centers for Disease Control and Prevention ( CDC ) . Skin colonization will be assessed by culture of sample s collected at predefined time points . Patients will score dressing wear time with regard to safety , comfort and convenience . Discussion The evidence to support dressing st and ards for breast surgery wounds is empiric and scarce . CDC recommends protecting , with a sterile dressing for 24 to 48 hours postoperatively , a primarily closed incision , but there is no recommendation to cover this kind of incision beyond 48 hours , or on the appropriate time to shower or bathe with an uncovered incision . The results of the ongoing trial may support st and ard recommendations regarding dressing wear time after breast reconstruction . Trial registration Clinical Trials.gov identifier : http://www . clinical trials.gov/ct2/ results ? term = NCT01148823",
"BACKGROUND In the immediate postoperative period surgical breast cancer patients can face many problems including functional limitation of the shoulder , edema , pain and depression . Although those symptoms can alleviate during the stages of the therapeutic route , most of the time concur significantly to the everyday life discomforts decreasing sharply the quality of life . Therefore , is essential to pay attention to the functional problems of breast cancer patients in order to ensure a quick and complete physical and psychosocial recovery . AIM Aim of this study , comparing 2 groups of patients , one that underwent to early physical rehabilitation program ( EPRP ) and one as a control group , is to evaluate : functional improvements of the glenohumeral joint mobility , antalgic effect of EPRP , improvements and /or worsening of quality of life . DESIGN R and omized controlled study . SETTING Inpatient and outpatient clinic , Breast Unit , \" San Giuseppe Moscati \" Hospital , Avellino , Italy . POPULATION Seventy women planned for Madden 's modified radical mastectomy or for segmental mastectomy with axillary dissection in the period from March 2010 to February 2011 . METHODS Patients were r and omly assigned to treated and control group . All participants were evaluated before surgery and postoperatively at fifth day , first , sixth and twelfth month . Patients of the treated group , underwent first , to assisted cautious mobilization of h and , wrist and elbow and after drainage removal , to twenty physiotherapy sessions under the guide of a physiotherapist . RESULTS Within group statistical analysis evidence d that TG regained normal function at 1 year after surgery while CG was unable to do so for flexion , abduction and internal rotation movements . TG manifested general and statistically significative improvements in QoL. Improvements in the grade of pain perceived were observed starting from the first postoperative month . CONCLUSION Postoperative early physical rehabilitation programme in surgical breast cancer patients surgically treated significantly improves glenohumeral joint mobility , reduces pain and widely improves the quality of life . CLINICAL REHABILITATION IMPACT Early rehabilitation plays a key role in the physical and psycho-social recovery for breast cancer patients surgically treated with axillary dissection",
"BACKGROUND Smokers are at higher risk of cardiopulmonary and wound-related postoperative complications than non-smokers . Our aim was to investigate the effect of preoperative smoking intervention on the frequency of postoperative complications in patients undergoing hip and knee replacement . METHODS We did a r and omised trial in three hospitals in Denmark . 120 patients were r and omly assigned 6 - 8 weeks before scheduled surgery to either the control ( n=60 ) or smoking intervention ( 60 ) group . Smoking intervention was counselling and nicotine replacement therapy , and either smoking cessation or at least 50 % smoking reduction . An assessor , who was masked to the intervention , registered the occurrence of cardiopulmonary , renal , neurological , or surgical complications and duration of hospital admittance . The main analysis was by intention to treat . FINDINGS Eight controls and four patients from the intervention group were excluded from the final analysis because their operations were either postponed or cancelled . Thus , 52 and 56 patients , respectively , were analysed for outcome . The overall complication rate was 18 % in the smoking intervention group and 52 % in controls ( p=0.0003 ) . The most significant effects of intervention were seen for wound-related complications ( 5 % vs 31 % , p=0.001 ) , cardiovascular complications ( 0 % vs 10 % , p=0.08 ) , and secondary surgery ( 4 % vs 15 % , p=0.07 ) . The median length of stay was 11 days ( range 7 - 55 ) in the intervention group and 13 days ( 8 - 65 ) in the control group . INTERPRETATION An effective smoking intervention programme 6 - 8 weeks before surgery reduces postoperative morbidity , and we recommend , on the basis of our results , this programme be adopted",
"Purpose Previous studies have demonstrated that amino acid infusions exert enhanced thermogenic effects during general anesthesia . This study was conducted to investigate whether amino acid infusions started after development of intraoperative core hypothermia can accelerate rewarming . Methods Twenty-two patients scheduled for major abdominal surgery were included in this study . When tympanic temperature reached 35.5 ° C , patients were r and omly assigned to receive amino acids ( amino acid group ; n = 11 ) or saline ( saline group ; n = 11 ) . A continuous infusion of a mixture of 18 amino acids or saline was started at 200 ml h−1 . Tympanic , forearm , and digit temperatures were recorded . Forearm minus fingertip skin-surface temperature gradients ( temperature gradient ) were calculated . Postoperative shivering was also evaluated . Results Tympanic membrane temperature and temperature gradient were similar between the two groups at each time point during the study period . Temperature gradient at extubation in the amino acid group was significantly lower than in the saline group although tympanic temperature at extubation was similar between the two groups . Postoperative shivering score was significantly lower in the amino acid group than in the saline group . Conclusions Amino acid infusions started after development of intraoperative core hypothermia failed to accelerate rewarming . However , amino acid infusions reduced the incidence of postoperative shivering . Use of amino acid infusions to reduce thermoregulatory vasoconstriction at emergence might contribute to a decrease in the development of postoperative shivering ",
"Not enough fluid and too much fluid are both bad . That is the one great irrefutable truth in fluid management in anaesthesia and in the critically ill . For almost every other question in fluid therapy there is ‘ current opinion ’ . The big questions are when , where , which and why but of greater moment than all of these is ‘ how much ’ . The current drift towards the use of smaller volumes of fluid in major surgery suggests that the right amount at the right time is probably the way to go , so volume and timing are seemingly linked . This ties in neatly with the rediscovery of the notion that early fluid resuscitation in the emergency room is better than late and dovetails with the concept that adequate resuscitation , or optimisation , improves outcome in high risk surgery . New gadgets that help to achieve this end abound since the pulmonary artery catheter fell from grace . The recent discovery of hyperchloraemic acidosis as a new iatrogenic disease entity has focused attention on the importance of the fundamental constituents of the fluids that are given [ 1 ] . The meta-analytical cloud that the Cochrane collaboration placed over albumin was dissipated by the SAFE study only to be replaced by a different evidential cloud drifting over the world of starches [ 2 ] . This has reawakened interest in the potentially malevolent nature of synthetic molecules . As the dynamics of the questions and current answers change , it is easy to become confused . The publication of the British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients could therefore not be more timely [ 3 ] . The authors have asked a very large number of relevant questions , assessed a vast array of available information and measured it with an evidence -based score to produce recommendations bundled into guidelines . There are no less than 28 evidence -scored recommendations to assist in fluid management . This major work should be m and atory reading for anyone involved in fluid management for a range of reasons that will come clear . The recommendations , all 28 of them , each has an evidence level of between 1 and 5 , although some have several evidence levels for different parts of the same question . In brief ; level 1 is very good , 1a – a systematic review or 1b a r and omised control trial , while level 4 is a case series and level 5 is expert opinion without critical appraisal , so ‘ 1 – good and 5 – bad ’ . The first recommendation dismisses normal saline from routine use because it causes hyperchloraemic acidosis , and advocates balanced solutions . The evidence level is 1b and appears to be very good using no fewer than seven papers . On closer scrutiny some of these are small r and omised controlled trials which demonstrate mild acidosis [ 4–9 ] . Saline and hyperchloraemic acidosis are associated and by implication this is harmful , although any evidence for harm is circumstantial and inconsequential [ 10 ] . The recommendation , supportive of balanced solutions , is inappropriate given the limited evidence ( this author ’s opinion – level 5 ) . Sensible maybe , but evidence -based ? To be fair , many of the recommendations have been st and ard practice for years and , paradoxically , several of these are level 5 . The pre-operative recommendations may raise eyebrows . Most anaesthetists know that fluids can be given orally up to 2 h pre-operatively but how many actively encourage it despite the evidence level of 1a ? The implication is there should be a general and active move to 2-h fluid fasting . These guidelines are based on three references , two of which are themselves guidelines and one being a Cochrane review . The fact that fluids make patients feel better is supported by trials and rates an evidence level of 2a . Curiously , the guidelines contain useful tips on the current position of bowel preparation , grade d level 1a , while the predicted fluid and electrolyte disturbance which it causes only achieves level 5 . Mind you , using a parachute when jumping out of an aircraft presumably only gets a score of 4 [ 11 ] . It is curious that the Geigy Scientific tables for the electrolyte content of secretions rates level 5 while the Hartmann ’s vs saline question in the replacement of gastric losses rates level 2a , again largely because saline is associated with hyperchloraemic acidosis . No-one would argue that balanced crystalloid or a colloid can be used for the treatment of hypovolaemia but , of the 11 references quoted , nine involve starches , a curious selection from a very extensive literature , while balanced crystalloid is once again recommended because of the supposed risks of hyperchloraemic acidosis , if such risks exist . The recommendations move on to the diagnosis of hypovolaemia and the use of incremental 200-ml boluses of either crystalloid or colloid . This is level 1b evidence based on two small trials [ 12 , 13 ] . While one must question whether this constitutes substantial evidence , it does make sense . Orthopaedic and abdominal surgery are singled out to recommend stroke volume measurement to guide fluid management peri-operatively ( level 1b ) . In orthopaedic surgery this is based on two well known studies , each of which can be interpreted either to indicate that the intervention reduced hospital stay or that the control group could have been better managed . The former is more widely accepted . In non-elective surgery , in the same specialities , this management should continue for 8 h and , in these circumstances , low dose dopexamine , which performed well in a meta- analysis , is Anaesthesia , 2009 , 64 , pages 235–238",
"OBJECTIVE To investigate the effect of a restricted intravenous fluid regimen versus a st and ard regimen on complications after colorectal resection . SUMMARY BACKGROUND DATA Current fluid administration in major surgery causes a weight increase of 3 - 6 kg . Complications after colorectal surgery are reported in up to 68 % of patients . Associations between postoperative weight gain and poor survival as well as fluid overload and complications have been shown . METHODS We did a r and omized observer-blinded multicenter trial . After informed consent was obtained , 172 patients were allocated to either a restricted or a st and ard intraoperative and postoperative intravenous fluid regimen . The restricted regimen aim ed at maintaining preoperative body weight ; the st and ard regimen resembled everyday practice . The primary outcome measures were complications ; the secondary measures were death and adverse effects . RESULTS The restricted intravenous fluid regimen significantly reduced postoperative complications both by intention-to-treat ( 33 % versus 51 % , P = 0.013 ) and per- protocol ( 30 % versus 56 % , P = 0.003 ) analyses . The numbers of both cardiopulmonary ( 7 % versus 24 % , P = 0.007 ) and tissue-healing complications ( 16 % versus 31 % , P = 0.04 ) were significantly reduced . No patients died in the restricted group compared with 4 deaths in the st and ard group ( 0 % versus 4.7 % , P = 0.12 ) . No harmful adverse effects were observed . CONCLUSION The restricted perioperative intravenous fluid regimen aim ing at unchanged body weight reduces complications after elective colorectal resection",
"Background Intermittent pneumatic compression ( IPC ) devices have been widely used for thrombosis prophylaxis in laparoscopic colorectal surgery . However , periodic compression using an IPC device may inject augmented boluses of cool blood from the lower limbs into the central circulation repetitively , thereby causing a reduction in core temperature . The authors therefore conducted a prospect i ve , r and omized , double-blind , controlled study to compare the effects of intraoperative IPC on core temperature in patients undergoing laparoscopic colorectal surgery . Methods For this study , 56 patients ages 18–60 years and scheduled to undergo laparoscopic resection for colorectal cancer under general anesthesia were r and omly assigned to receive either no IPC ( control group ) or calf-thigh-length IPC in both legs using the SCD Express ( IPC group ) . Anesthetic , thermal , and pneumoperitoneum management were st and ardized . Esophageal temperature , as an indicator of core temperature , was measured at 15-min intervals for 2 h after induction of anesthesia . Results A total of 47 subjects ( 23 control and 24 IPC subjects ) were included in the analysis . The core temperature drop in the IPC group was significantly greater than in the control group , starting from 45 min after induction of anesthesia ( P the total temperature drop during the 2-h study period was significantly greater in the IPC group ( 1.2 ± 0.3 ° C ) than in the control group ( 0.9 ± 0.3 ° C ) ( P = 0.004 ) . Conclusions Because intraoperative application of IPC carries an increased risk of a core temperature drop , appropriate temperature monitoring and active thermal management are required for surgical patients receiving IPC ",
"AIM To determine whether intravenous ketoprofen is effective as pre-emptive analgesia for breast surgery . DESIGN R and omised , controlled , double blind study . PATIENTS AND METHODS 50 patients undergoing breast surgery under general anaesthesia r and omised to receive either 100 mg intravenous ketoprofen 30 minutes before ( Group I ) , or immediately after surgical incision ( Group II ) . Postoperatively , pain scores ( Visual Analogue Scale , VAS ) and time to rescue analgesic were recorded by an independent , blinded observer . The study was terminated when rescue analgesic was required ( VAS > or = 4 or dem and for analgesic ) . STATISTICAL ANALYSIS Continuous variables were analysed by the unpaired ' t ' test , discrete variables with the chi square test , and survival curves by the log-rank test . RESULTS Pain scores were significantly lower in Group I till 10 hours after surgery . The number of patients requiring analgesia at 4 , 6 , 8 and 10 hours was significantly lower in group I ( 0 % vs. 47 % [ P mean time for rescue analgesic was 15.47 -/+ 2.87 hours in group I versus 4.22 -/+ 2.55 hours in group II ( P ketoprofen ( 100 mg ) produces better postoperative pain-relief in patients undergoing breast surgery",
"Background : Enhanced recovery after surgery was compared with traditional recovery after surgery for postmastectomy alloplastic breast reconstruction . Methods : Length of stay , emergency room visits , and complications within 30 days of surgery were compared among three groups : traditional recovery after surgery , transition ( some elements of enhanced recovery protocol , not transitioned to outpatient care ) , and enhanced recovery after surgery ( day surgery , provided with st and ardized perioperative education and multimodal analgesia ) . Prospect i ve data collection allowed quality -of-recovery assessment using a vali date d question naire for enhanced recovery/transition groups . Results were statistically analyzed ( analysis of variance/chi-square ) . Results : The traditional recovery , transition , and enhanced recovery cohorts comprised 29 , 11 , and 29 patients , respectively . No significant differences were present regarding age , smoking status , preoperative radiation , single stage direct-to-implant versus tissue exp and er , bilateral versus unilateral surgery , or immediate versus delayed reconstruction among groups . Average length of stay was 1.6 nights in both the traditional recovery and transition groups , compared with 0 nights in the enhanced recovery group ( p Enhanced recovery patients had less severe pain ( p = 0.02 ) and nausea ( p = 0.01 ) , and better enjoyed their food ( p = 0.0002 ) and felt more rested ( p = 0.02 ) than their transition counterparts . There were no differences in the number of emergency room visits among the three groups ( p = 0.88 ) . There was no difference in the rate of hematoma ( p = 0.36 ) , infection requiring intravenous antibiotics ( p = 0.36 ) , or infection requiring explantation ( p = 0.36 ) among the three groups . Conclusion : An enhanced recovery protocol for alloplastic breast reconstruction treated patients safely , with improved patient satisfaction and same-day discharge and with no increase in complications . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , III",
"Resistive heating is an alternative to forced‐air warming which is currently the most commonly used intra‐operative warming system . We therefore tested the hypothesis that rewarming rates are similar with Hot Dog ® ( Augustine Biomedical ) resistive and Bair Hugger ® ( Arizant ) forced‐air heating systems . We evaluated 28 patients having major maxillary tumour surgery . During the establishment of invasive monitoring , patients became hypothermic , dropping their core temperature to about 35 ° C . They were then r and omly assigned to rewarming with lower‐body resistive ( n = 14 ) or forced‐air ( n = 14 ) heating , with each system set to ‘ high ’ . Our primary outcome was the rewarming rate during active heating over a core temperature range from 35 to 37 ° C . Morphometric characteristics were comparable in both groups . Temperature increased at twice the rate in patients assigned to forced‐air warming , with an estimated mean ( SE ) slope of 0.49 ( 0.03 ) ° C.h−1 vs 0.24 ( 0.02 ) ° C.h−1 ( p < 0.001 ) . Resistive heating warmed at half the rate of forced air",
"Background : To plan abdominal perforator-based microsurgical breast reconstruction , duplex ultrasound is often employed to preoperatively identify the location of abdominal wall perforating vessels . Recently , several groups have published the use of computed tomography angiography for preoperative planning in perforator flap breast reconstruction . The purpose of this study was to compare the accuracy of computed tomography angiography in locating clinical ly useful abdominal wall perforators with that of duplex ultrasound . Methods : A prospect i ve study was conducted of 22 consecutive patients undergoing 30 abdomen-based microsurgical breast reconstructions using both preoperative computed tomography angiography and duplex ultrasound . Perforator data were obtained with both computed tomography angiography and ultrasound . The two largest perforators were chosen per abdominal side for comparison between studies . In addition , the locations of perforators were confirmed at surgery . Results : Computed tomography angiography preoperatively identified 83 of the largest perforators , while only 55 of these large perforators ( 66.3 percent ) were preoperatively identified on ultrasound . No superficial inferior epigastric arteries were identified by ultrasound . However , in all eight breast reconstructions performed with the superficial inferior epigastric system , the superficial inferior epigastric arteries were identified preoperatively as adequate size for microsurgical transfers , with an average diameter of 1.6 mm . Conclusions : There are many advantages to preoperative computed tomography angiography for planning abdominal perforator-based microsurgical breast reconstruction , including accurate identification of perforating vessels , the underlying branching pattern of the deep inferior epigastric artery , and the presence of the superficial inferior epigastric vessels . This study demonstrates the superiority of computed tomography angiography over duplex ultrasound as a tool for preoperative planning of perforator-based breast reconstruction",
"Background : A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner . To determine its clinical utility , a clinical investigation was undertaken to demonstrate equivalence of a new adhesive skin closure system ( Prineo Skin Closure System ) to intradermal sutures in wound closure . Methods : The investigation included 83 patients who underwent elective abdominoplasty , circumferential body lift procedures , and breast reconstruction with deep inferior epigastric perforator flaps . Incisions were divided in half , and each half was r and omized to wound closure with the new skin closure system , including a pressure-sensitive adhesive mesh tape for wound edge approximation and next-generation cyanoacrylate or intradermal sutures . Postoperative evaluations took place at 24 hours , 7 days , 12 to 25 days , 90 days , 6 months , and 12 months . Results : The new skin closure system was found to be equivalent to intradermal sutures for the continuous approximation of wounds . The upper limit of the two-sided 90 percent confidence interval for difference in proportions was 10.9 percent . The mean time to closure for the new skin closure system was 1.46 minutes , approximately 5 minutes faster than that for intradermal sutures ( p incision healing and cosmetic outcomes . No quantitative or qualitative differences of clinical significance were evident between the treatment groups . Conclusions : The Prineo Skin Closure System can be considered equivalent to intradermal sutures for full-thickness surgical incisions with regard to safety and effectiveness . The ease and speed of application contribute to shortened operative times ( 4.5 times faster than intradermal sutures ) . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , II",
"AIM Recent evidence suggests that the provision of energy-containing fluids is safe and may impact positively on markers of recovery . The aims of this study were to assess the tolerance of preoperative carbohydrate fluid administration and to determine its effect on postoperative metabolic and clinical responses . METHODS Patients admitted to the Royal Infirmary of Edinburgh for major , elective abdominal surgery were recruited to this double-blind , r and omised study and received either a placebo drink or carbohydrate ( 12.6g/100ml ) drink ( CHOD ) . Patients consumed 800 ml of their drink on the evening before surgery and 400 ml on the day of surgery 2 - 3 h before the induction of anaesthesia . Nutritional status was determined using body mass index ( BMI ) and upper arm anthropometry ; all measurements were taken preoperatively , postoperatively and at discharge . Blood glucose and insulin concentrations were also measured preoperatively and on the first post operative day . Length of hospital stay ( LOS ) and postoperative complications were recorded . RESULTS Seventy-two patients were recruited and 65 ( 34 male:31 female ) completed this study . Thirty-four patients were r and omised to receive the placebo drink ( control group ) and 31 patients to receive the carbohydrate drink ( CHOD group ) . Groups were well-matched in terms of gender and age . There were no differences between the two groups at baseline for BMI ( control : -25.1+/-1.7 kg/m2 ; CHOD -25.2+/-1.2 kg/m2 ) , upper arm anthropometry or surgical procedure . At discharge loss of muscle mass ( arm muscle circumference ) was significantly greater in the control group when compared with the CHOD group ( control : -1.1+/-0.15 cm ; CHOD : -0.5+/-0.16 cm ; P Baseline insulin ( control : 20.7+/-4.9 mU/l ; CHOD : 24.6+/-6.2 mU/l ) and glucose ( control : 6.0+/-1.4 mmol/l ; CHOD 5.7+/-1.4 mmol/l ) were comparable in the two groups and did not differ postoperatively . No complications were recorded as a result of preoperative fluid consumption . Postoperative morbidity occurred in six patients from each group . Median LOS in the control group was 10 days ( IQR=6 ) , and 8 days ( IQR=4 ) in the CHOD group . CONCLUSION Preoperative consumption of carbohydrate-containing fluids is safe . Provision of a carbohydrate energy source prior to surgery may attenuate depletion of muscle mass after surgery . Further studies are required to determine if this preservation of muscle mass is reflected in improved function and reduced rehabilitation time",
"BACKGROUND : The PerfecTemp is an underbody resistive warming system that combines servocontrolled underbody warming with viscoelastic foam pressure relief . Clinical efficacy of the system has yet to be formally evaluated . We therefore tested the hypothesis that intraoperative distal esophageal ( core ) temperatures with the PerfecTemp ( underbody resistive ) warming system are noninferior to upper-body forced-air warming in patients undergoing major open abdominal surgery under general anesthesia . METHODS : Adults scheduled for elective major open abdominal surgery ( liver , pancreas , gynecological , and colorectal surgery ) under general anesthesia were enrolled at 2 centers . Patients were r and omly assigned to underbody resistive or forced-air warming . Resistive heating started when patients were transferred to the operating room table ; forced-air warming started after patients were draped . The primary outcome was noninferiority of intraoperative time-weighted average core temperature , adjusted for baseline characteristics and using a buffer of 0.5 ° C . RESULTS : Thirty-six patients were r and omly assigned to underbody resistive heating and 34 to forced-air warming . Baseline and surgical characteristics were generally similar . We had sufficient evidence ( P = 0.018 ) to conclude that underbody resistive warming is not worse than ( i.e. , noninferior to ) upper-body forced-air warming in the time-weighted average intraoperative temperature , with a mean difference of −0.12 ° C [ 95 % confidence interval ( CI ) −0.37 to 0.14 ] . Core temperatures at the end of surgery averaged 36.3 ° C [ 95 % CI 36 to 36.5 ] in the resistive warming patients and 36.6 ° C [ 95 % CI 36.4 to 36.8 ] in those assigned to forced-air warming for a mean difference of −0.34 ° C [ 95 % CI −0.69 to 0.01 ] . CONCLUSIONS : Mean intraoperative time-weighted average core temperatures were no different , and significantly noninferior , with underbody resistive heating in comparison with upper-body forced-air warming . Underbody resistive heating may be an alternative to forced-air warming",
"CONTEXT We recently demonstrated that 28-d bed rest in healthy volunteers results in a moderate loss of lean leg mass and strength . OBJECTIVE The objective of this study was to quantify changes in muscle protein kinetics , body composition , and strength during a clinical bed rest model reflecting both physical inactivity and the hormonal stress response to injury or illness . DESIGN Muscle protein kinetics were calculated during a primed , continuous infusion ( 0.08 micromol/kg.min ) of 13C6-phenylalanine on d 1 and 28 of bed rest . SETTING The setting for this study was the General Clinical Research Center at the University of Texas Medical Branch . PARTICIPANTS Participants were healthy male volunteers ( n = 6 , 28 + /- 2 yr , 84 + /- 4 kg , 178 + /- 3 cm ) . INTERVENTION During bed rest , hydrocortisone sodium succinate was administered iv ( d 1 and 28 ) and orally ( d 2 - 27 ) to reproduce plasma cortisol concentrations consistent with trauma or illness ( approximately 22 microg/dl ) . MAIN OUTCOME MEASURES We hypothesized that inactivity and hypercortisolemia would reduce lean muscle mass , leg extension strength , and muscle protein synthesis . RESULTS Volunteers experienced a 28.4 + /- 4.4 % loss of leg extension strength ( P = 0.012 ) and a 3-fold greater loss of lean leg mass ( 1.4 + /- 0.1 kg ) ( P = 0.004 ) compared with our previous bed rest-only model . Net protein catabolism was primarily due to a reduction in muscle protein synthesis [ fractional synthesis rate , 0.081 + /- 0.004 ( d 1 ) vs. 0.054 + /- 0.007%/h ( d 28 ) ; P = 0.023 ] . There was no change in muscle protein breakdown . CONCLUSION Prolonged inactivity and hypercortisolemia represents a persistent catabolic stimulus that exacerbates strength and lean muscle loss via a chronic reduction in muscle protein synthesis",
"INTRODUCTION Pain control outcomes using local anesthetic delivery systems vs usual narcotics at our institution revealed that use of local anesthetic delivery systems decreased narcotic use greater than 40 % in patients with no reconstruction but had very little effect in patients receiving reconstruction . As part of our quality improvement program , the anesthesiology department trained and began offering paravertebral blocks ( PVBs ) to patients having reconstruction . We review ed pain control outcomes to underst and how the use of paravertebral nerve blocks affected narcotic use in reconstructed patients . METHODS Retrospective review of prospect ively collected data on patients undergoing mastectomy with or without reconstruction in the 6-month period after introduction of PVB analgesia . Patients received preoperative single-shot paravertebral nerve blocks at T2 to T3 and T5 to T6 with bupivacaine .5 % and epinephrine 1:200,000 ( 7.5 mL per injection ) . Patients who had a bilateral mastectomy with reconstruction received bilateral paravertebral nerve blocks at the same locations . Narcotic doses were converted to morphine equivalents ( MSEs ) to allow comparison . RESULTS There were 102 patients with mastectomy during that period and 91 were evaluable . Fifty-one had no reconstruction with an average MSE use of 37.9 . There were 40 with reconstruction , 33 had PVB with average MSE of 42.6 , and 7 patients had reconstruction with no PVB with average MSE of 71.1 . There were no major complications . CONCLUSIONS Institution of the PVB for patients undergoing mastectomy with reconstruction lowered average MSE use . We will continue to offer paravertebral blocks in this cohort of patients",
"Background A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner . To determine its clinical utility in breast procedures , a prospect i ve clinical investigation was undertaken to demonstrate equivalence of a new adhesive ( PRINEO ™ Skin Closure System ) to intradermal sutures in wound closure . Methods The investigation comprised 79 patients who underwent elective surgery for bilateral breast procedures . Each breast incision was r and omized to wound closure with the PRINEO ™ Skin Closure System or intradermal sutures ( used in accordance with st and ard local practice ) . Postoperative evaluations took place at 24 hours , 7 days , 12–25 days , 90 days , 6 months , and 12 months . Data were collected on the continuous approximation of the skin edges , the time required to close the include final skin layer , the evaluation of incision healing , and cosmesis outcomes . Safety evaluations were related to the incidence and extent of local acute inflammatory reactions , clinical infection , skin blistering , and adverse events . Results PRINEO ™ Skin Closure System was found to be equivalent to intradermal sutures for the continuous approximation of wounds associated with breast procedures . The upper limit of the one-sided 95 % confidence interval for difference in proportions was less than the predetermined 12 % , at 5.9 % . The mean time to closure for the PRINEO ™ Skin Closure System was 2.56 minutes , which was 13.66 minutes faster than that for intradermal sutures ( 16.22 minutes , P Time savings may be less if 2 operators close simultaneously . On the other h and , because the device can be applied by 1 operator , the assistant ’s time may be freed up to attend to other tasks . Both treatments had similar incision healing and cosmetic outcomes . No quantitative or qualitative differences of clinical significance were evident between the treatment groups for local acute inflammatory reactions , clinical infection , or skin blistering . The number of serious adverse events was low , although the number of adverse events was higher , with 54/79 patients experiencing at least 1 adverse event . Conclusion PRINEO ™ Skin Closure System can be considered equivalent to intradermal sutures for full-thickness surgical incisions associated with breast procedures , with regard to safety and effectiveness . It was also 6.3 times faster than intradermal sutures for wound closure",
"BACKGROUND The anticonvulsant gabapentin has proven effective for neuropathic pain in three large placebo-controlled clinical trials . Experimental and clinical studies have demonstrated antihyperalgesic effects in models involving central neuronal sensitization . It has been suggested that central neuronal sensitization may play an important role in postoperative pain . The aim of the study was to investigate the effect of gabapentin on morphine consumption and postoperative pain in patients undergoing radical mastectomy . METHODS In a r and omized , double-blind , placebo-controlled study , 70 patients received a single dose of oral gabapentin ( 1,200 mg ) or placebo 1 h before surgery . Patients received patient-controlled analgesia with morphine at doses of 2.5 mg with a lock-out time of 10 min for 4 h postoperatively . Pain was assessed on a visual analog scale at rest and during movement , and side effects were assessed on a four-point verbal scale 2 and 4 h postoperatively . RESULTS Thirty-one patients in the gabapentin group and 34 patients in the placebo group completed the study . Gabapentin reduced total morphine consumption from a median of 29 ( interquartile range , 21 - 33 ) to 15 ( 10 - 19 ) mg ( P Pain during movement was reduced from 41 ( 31 - 59 ) to 22 ( 10 - 38 ) mm at 2 h postoperatively ( P pain at rest or side effects . CONCLUSION A single dose of 1,200 mg oral gabapentin result ed in a substantial reduction in postoperative morphine consumption and movement-related pain after radical mastectomy , without significant side effects . These promising results should be vali date d in other acute pain models involving central neuronal sensitization",
"A study was conducted to assess the effect of intraoperatively administered inotropic agents on blood flow in the recipient and donor vessels , during breast reconstruction with a muscle sparing free TRAM flap . Twenty-one consecutive patients were r and omized into 3 groups receiving either dopamine , dobutamine , or placebo . When the flap and all vessels had been fully dissected but not yet divided , the study drug was administered intravenously for 15 minutes . Hemodynamic parameters and transit-time flow of the thoracodorsal and inferior epigastric arteries were monitored . Both dobutamine and dopamine infusions result ed in significant raises in cardiac output and mean arterial pressure . However , while dobutamine result ed in a higher cardiac output ( P = 0.001 ) and a decrease in systemic vascular resistance ( P = 0.028 ) , the increase in mean arterial pressure was greater with dopamine ( P = 0.002 ) . Only the dobutamine group showed increased blood flow , in both the thoracodorsal ( P = 0.043 ) and the inferior epigastric ( P = 0.043 ) arteries . If vasoactive agents are needed during microvascular anesthesia , dobutamine seems to be more advantageous than dopamine",
"STUDY OBJECTIVE To investigate the effects of preanesthetic oral clonidine on total propofol requirement for uniform minor surgery ( breast conservative surgery : breast cancer removal with axillary lymph node dissection ) , and to compare the action of clonidine with that of preanesthetic oral diazepam , a commonly used benzodiazepine . DESIGN R and omized double-blinded study . SETTING Operating room ASA physical status I and II room and recovery room of the cancer center . PATIENTS 80 breast cancer patients scheduled for surgery . INTERVENTIONS Patients were r and omized to one of four treatment groups ( placebo , clonidine 75 micrograms , or 150 micrograms of clonidine , or 10 mg of diazepam were orally administered 60 min before induction of anesthesia ) ; n = 20 per group . After evaluating the sedation and anxiety levels of patients using a visual analog scale , anesthesia was induced with propofol ( 1.5 mg/kg ) , and maintained with oxygen ( O2 ) : nitrous oxide ( N2O ) ( 30:70 ) with a continuous infusion of propofol . The propofol infusion was started at 10 mg/kg/h for 10 minutes , then decreased to 8 mg/kg/h , and 6 mg/kg/h thereafter , and the rate of infusion was adjusted to obtain adequate anesthesia ( maintaining hemodynamic parameters within 20 % of that prior to premedication ) . Fentanyl 0.2 mg ( each 0.1 mg was given for intubation and axillary lymph node dissection , respectively ) was administered . MEASUREMENTS AND MAIN RESULTS Preanesthetic oral clonidine ( 150 micrograms ) and diazepam ( 10 mg ) induced anxiolysis without sedation . The total requirement ( the mean infusion rates ) of propofol in placebo , clonidine 75 micrograms , clonidine 150 micrograms , and 10 mg of diazepam groups were 841 + /- 70 ( 9.0 + /- 0.3 ) , 720 + /- 63 ( 7.1 + /- 0.4 ) , 491 + /- 39 ( 5.6 + /- 0.2 ) , and 829 + /- 77 mg ( 7.9 + /- 0.4 mg/kg/h ) , respectively . The cost of propofol in these groups was $ 51.0 + /- 3.8 , $ 45.5 + /- 3.2 , $ 33.5 + /- 2.3 , and $ 50.5 + /- 4.4 , respectively . CONCLUSIONS Preanesthetic oral clonidine ( 150 micrograms ) but not diazepam ( 10 mg ) reduced the total requirement of propofol while stabilizing hemodynamic parameters . In addition , 150 micrograms of oral clonidine attenuates the hemodynamic responses associated with tracheal intubation",
"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",
"Background and objective : Data on the effectiveness of cyclooxygenase 2 inhibitors in postoperative pain therapy vary widely . We tested in a prospect i ve , placebo‐controlled , r and omized , double‐blind trial the hypotheses that perioperative ( i.e. preoperative and postoperative ) administration of the cyclooxygenase 2 inhibitor rofecoxib decreases pain scores and morphine consumption after spine , breast and orthopaedic surgery . Methods : Five hundred and forty patients scheduled for spine , breast or orthopaedic surgery were r and omly assigned to receive in combination with postoperative morphine via patient controlled analgesia pump for 4 days either rofecoxib 50 mg administered perioperatively , rofecoxib 50 mg administered only postoperatively , or placebo . Primary outcome criteria were pain score at rest ( numeric rating scale 0–4 ) and morphine consumption . Results : Perioperative rofecoxib significantly decreased pain score 0 ( 0–1 ) vs. 1 ( 0–2 ) ( median ( interquartile range ) ) , and morphine consumption 18 ( 6–33 ) vs. 22.5 ( 12–38 ) compared with placebo . In contrast , rofecoxib when administered only postoperatively did not significantly improve analgesic effects or side‐effects at time of assessment of the main criteria ( 24 h after skin closure ) , but during the follow‐up period at 48 h and 72 h after skin closure pain scores and morphine consumption were improved compared to placebo . The analgesic effects of rofecoxib were independent from the type of surgery . Conclusions : Perioperative administration of the cyclooxygenase 2 inhibitor rofecoxib decreases pain scores and morphine consumption after orthopaedic , breast and spine surgery . However , the benefit of preoperative administration of the cyclooxygenase 2 inhibitor seems to be only moderate , suggesting that early postoperative administration may be a useful alternative approach . There is no evidence that the type of surgery influences analgesic effects of cyclooxygenase 2 inhibitors",
"BACKGROUND Low concentrations of albumin in serum and long gastric emptying times have been returned to normal in dogs by salt and water restriction , or a high protein intake . We aim ed to determine the effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection in human beings . METHODS We r and omly allocated ten patients to receive postoperative intravenous fluids in accordance present hospital practice ( > or = 3 L water and 154 mmol sodium per day ) and ten to receive a restricted intake ( water and 77 mmol sodium per day ) . All patients had no disease other than colonic cancer . The primary endpoint was solid and liquid-phase gastric emptying time , measured by dual isotope radionuclide scintigraphy on the fourth postoperative day . Secondary endpoints included time to first bowel movement and length of postoperative hospital stay . Analysis was by intention to treat . FINDINGS Median solid and liquid phase gastric emptying times ( T(50 ) ) on the fourth postoperative day were significantly longer in the st and ard group than in the restricted group ( 175 vs 72.5 min , difference 56 [ 95 % CI 12 - 132 ] , p=0.028 ; and 110 vs 73.5 min , 52 [ 9 - 95 ] , p=0.017 , respectively ) . Median passage of flatus was 1 day later ( 4 vs 3 days , 2 [ 1 - 2 ] , p=0.001 ) ; median passage of stool 2.5 days later ( 6.5 vs 4 days , 3 [ 2 - 4 ] , p=0.001 ) ; and median postoperative hospital stay 3 days longer ( 9 vs 6 days , 3 [ 1 - 8 ] , p=0.001 ) in the st and ard group than in the restricted group . One patient in the restricted group developed hypokalaemia , whereas seven patients in the st and ard group had side-effects or complications ( p=0.01 ) . INTERPRETATION Positive salt and water balance sufficient to cause a 3 kg weight gain after surgery delays return of gastrointestinal function and prolongs hospital stay in patients undergoing elective colonic resection",
"BACKGROUND Gabapentin has been recently found to be useful for reducing acute postoperative pain when administered preoperatively . Although various dose regimens have been tried in different surgical setting s , the minimum effective dose is not established . AIMS We aim ed to evaluate the analgesic efficacy of single low dose gabapentin in patients undergoing total mastectomy and axillary dissection . SETTING S AND DESIGN Prospect i ve r and omized placebo-controlled double-blind trial in a tertiary care teaching hospital . MATERIAL S AND METHODS Fifty women scheduled for total mastectomy and axillary dissection were r and omized to receive either gabapentin 600 mg or placebo orally 1 h preoperatively . The intraoperative and postoperative management was st and ardized . Postoperative pain was assessed at rest and on movement for 12 h using the numerical rating scale ( NRS ) . Morphine was administered if NRS exceeded 30 . Primary outcome measure was total morphine consumption . STATISTICAL ANALYSIS The morphine consumption was compared using independent t test while pain and sedation scores were analyzed using Mann-Whitney U test . RESULTS Forty-six patients completed the trial . The postoperative morphine consumption was significantly less ( 5.8 + /- 4.2 vs. 11.0 + /- 3.4 mg ; P 0.001 ) and the median [ IQR ] time to first analgesic was significantly longer ( 90 [ 37.5 - 120 ] vs. 0 [ 0 - 90 ] min ; P 0.001 ) in the gabapentin group than in the placebo group . The incidence of side effects was similar in the two groups . CONCLUSIONS A single low dose of 600 mg gabapentin administered 1 h prior to surgery produced effective and significant postoperative analgesia after total mastectomy and axillary dissection without significant side effects",
"We studied the effects of different preoperative oral fluid protocol s on preoperative discomfort , residual gastric fluid volumes , and gastric acidity . Two-hundred-fifty-two elective abdominal surgery patients ( ASA physical status I – II ) were r and omized to preparation with a 12.5 % carbohydrate drink ( CHO ) , placebo ( flavored water ) , or overnight fasting . The CHO and Placebo groups were double-blinded and were given 800 mL to drink on the evening before and 400 mL on the morning of surgery . Visual analog scales were used to score 11 different discomfort variables . CHO did not increase gastric fluid volumes or affect acidity , and there were no adverse events . The visual analog scale scores in a control situation were not different between groups . During the waiting period before surgery , the CHO-treated group was less hungry and less anxious than both the other groups ( P ≤ 0.05 ) . CHO reduced thirst as effectively as placebo ( P decreasing thirst , hunger , anxiety , malaise , and unfitness in the CHO group ( P The Placebo group experienced decreasing unfitness and malaise , whereas nausea , tiredness , and inability to concentrate increased ( P group , hunger , thirst , tiredness , weakness , and inability to concentrate increased ( P conclusion , CHO significantly reduces preoperative discomfort without adversely affecting gastric contents",
"Clinical experience suggests that application of the fundamental principles of rehabilitation medicine can improve the care of patients with cancer . Despite the high incidence of neurological and functional deficits in patients affected by brain tumours ( BTs ) , rehabilitation treatment of this population is not as well established as it is for patients with other neurological conditions . To assess functional outcome in brain tumour in patients who underwent early rehabilitation after surgery . 75 patients who had undergone neurosurgery for primary BTs and 75 patients affected by stroke were enrolled in a case-control study . All patients were evaluated by means of a core set of clinical scales ( Functional Independence Measure , Sitting Balance score , St and ing Balance score , Hauser Index , Massachusetts General Hospital Functional Ambulation Classification ) . Patients were evaluated before the beginning ( T0 ) and at the end ( T1 ) of rehabilitation treatment . The neurorehabilitation programme consisted of individual 60-min sessions of treatment , administered once a day , six days a week , for four consecutive weeks . Speech therapy was included when aphasia was diagnosed . All the measures of outcome were indicative of substantial improvements for neuro-oncological and for stroke patients ( P = 0.000 ) . Analysis of subgroups showed that patients affected by meningioma achieved better results ( in efficiency terms ) as regards independence in activities of daily living ( P = 0.02 ) and mobility ( P = 0.04 ) compared with patients affected by glioblastoma or stroke . Rehabilitation after surgery can improve functional outcome , justifying the delivery of rehabilitation services , even during the acute phase , to BTs in patients , irrespective of tumour type",
"Background : A multidisciplinary patient care plan was developed to facilitate early discharge following autogenous breast reconstruction and included ( 1 ) preadmission patient education , ( 2 ) perioperative multimodal pain management , ( 3 ) intraoperative nerve blocks , and ( 4 ) postdischarge telephone advice . This study evaluated the success of this care plan in the first 18 months after its implementation . Methods : A retrospective cohort study of all consecutive women undergoing pedicled transverse rectus abdominis myocutaneous ( TRAM ) flap breast reconstruction ( November of 2009 to May of 2011 ) was performed . The primary outcome was time to discharge ; secondary outcomes included complications , readmission , and self-report pain at discharge . Predictors of discharge time were analyzed using stepwise multivariable regression modeling . Results : Ninety-one women ( mean age , 50.0 ± 8.5 years ) underwent pedicled TRAM flap reconstruction ( 76 percent unilateral and 81 percent delayed ) , with 77 percent receiving the intended multimodal analgesia protocol . Mean time to discharge was 38.7 ± 27.6 hours . Overall , 40 percent of patients were discharged within 24 hours , but successful early discharge increased significantly over the study period . Key predictors of shorter time to discharge were use of multimodal analgesia , lower American Society of Anesthesiologists class , and surgery more than 6 months after implementation of the care plan . Conclusions : The authors ’ initial experience has supported the safety and feasibility of expedited discharge following pedicled TRAM flap breast reconstruction , with adherence to the authors ’ care plan improving steadily over the study period . Multimodal pain management proved a key modifiable factor in facilitating early discharge . A prospect i ve study is currently underway to evaluate patient-reported quality of recovery following ambulatory surgery in this population . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , IV",
"Objective Clinical studies show that the incidence of postoperative wound complications is higher in smokers than nonsmokers . In this study , we evaluated the effect of abstinence from smoking on incisional wound infection . Methods Seventy-eight healthy subjects ( 48 smokers and 30 never-smokers ) were included in the study and followed for 15 weeks . In the first week of the study , the smokers smoked 20 cigarettes per day . Subsequently , they were r and omized to continuous smoking , abstinence with transdermal nicotine patch ( 25 mg per day ) , or abstinence with placebo patch . At the end of the first week and 4 , 8 , and 12 weeks after r and omization , incisional wounds were made lateral to the sacrum to excise punch biopsy wounds . At the same time identical wounds were made in 6 never-smokers . In 24 never-smokers a wound was made once . All wounds were followed for 2 weeks for development of wound complications . Results A total of 228 wounds were evaluated . In smokers the wound infection rate was 12 % ( 11 of 93 wounds ) compared with 2 % ( 1 of 48 wounds ) in never-smokers ( P Wound infections were significantly fewer in abstinent smokers compared with continuous smokers after 4 , 8 , and 12 weeks after r and omization . No difference between transdermal nicotine patch and placebo was found . Conclusions Smokers have a higher wound infection rate than never-smokers and 4 weeks of abstinence from smoking reduces the incidence of wound infections",
"Background : General anesthesia is used for most major surgeries , and the most common side effects include headache , nausea , vomiting , and sore throat . Major breast surgery is associated with a high incidence of postoperative nausea and vomiting ( PONV ) . We compared the postoperative nausea and vomiting of propofol-based total intravenous anesthesia ( TIVA ) and sevoflurane ( SEVO ) anesthesia under auditory evoked potential ( AEP ) monitoring in female patients undergoing breast surgery . Methods : A total of 84 patients scheduled to undergo elective breast surgery from 1 to 4 h in duration from March 2011 to December 2011 were prospect ively included in the study . All participants were r and omly assigned to TIVA or SEVO group . The AEP index was maintained at 15 - 25 . After completing the surgery , the duration of surgery , emergence time , and the side effects of PONV were recorded . Results : Patient characteristics , intraoperative and postoperative data , and the amounts of intraoperative analgesic drugs used were not significantly different between the TIVA and SEVO groups . The incidence of PONV was significantly higher in the SEVO group than in the TIVA group ( 50 % and 14.3 % , respectively ; p the total cost was significantly lower in the TIVA group than in the SEVO group ( 648 ± 185 and 850 ± 197 , respectively ) . Conclusion : We observed that when compared with sevoflurane , propofol given for the maintenance of general anesthesia improves the postoperative patient well-being and reduces the incidence of PONV . Furthermore , total intravenous anesthesia with propofol result ed in significant cost reductions ",
"UNLABELLED Breast surgery is classified among the procedures performed in clean surgery and is associated with a low incidence of wound infection ( 3 - 15 % ) . The objective of this study was to evaluate the advantages antibiotic prophylaxis in patients undergoing breast surgery . A multicenter r and omized controlled study was performed between January 2008 and November 2008 . One thous and four hundred patients were enrolled in prospect i ve r and omized study ; surgical wound infection was found in 41 patients ( 2.93 % ) . In our RCT we have shown that in breast surgery antibiotic prophylaxis does not present significant advantages in patients with potential risk of infection ( 17 patients , 2.42 % , subjected to antibiotic prophylaxis vs 24 patients , 3.43 % , without antibiotic prophylaxis ) ( P = 0.27 ) . In patients with drainage there is a significant minor incidence of wound infections in patients receiving antibiotic prophylaxis ( 5 patients , 0.92 % , subjected to antibiotic prophylaxis vs 14 patients , 3.09 % , without antibiotic prophylaxis ) ( P = 0.02 ) . CONCLUSION This study is only a preliminary RCT to be followed by a study which should be enrolled more patients in order to get the results as statistically significant",
"BACKGROUND Recent studies suggest that the use of tissue adhesive for closure of both traumatic lacerations and incisional surgical wounds leads to cosmetic outcome comparable to conventional sutures . To date , no studies have investigated tissue adhesive in breast surgery and costs . Our aim was to compare the tissue adhesive 2-octylcyanoacrylate ( OCA ) with st and ard suture in breast surgery . METHODS A prospect i ve r and omized study was conducted in which 151 patients were assessed for eligibility , and 133 were r and omly allocated to skin closure with OCA adhesive or monofilament suture . Cosmetic outcome with blinded assessment , wound management by the patients , complication rates , and economic outcome were recorded . RESULTS There was no difference in cosmetic score in the 2 groups , nor in complications at the early , 6-month , and 1-year follow-up . Patient satisfaction with the wound closed with OCA was rated significantly higher when compared with st and ard suture ( P application of the tissue adhesive was significantly faster than that for st and ard suture ( P economic terms total costs were less in the tissue adhesive group , mainly due to lower postoperative costs of physician and assistant services ( P OCA is effective and reliable in skin closure for breast surgery , yielding similar cosmetic results to st and ard suture . OCA is faster than st and ard wound closure and offers several practical advantages over suture repair for patients . Cost analysis has found that OCA adhesive can significantly decrease health care costs",
"This study aim ed to compare the efficiency of the thermal blanket and thermal mattress in the prevention of hypothermia during surgery . Thirty-eight r and omized patients were divided into two groups ( G1 - thermal blanket and G2 - thermal mattress ) . The variables studied were : length of surgery , length of stay in the post-anesthetic care unit , period without using the device after thermal induction , transport time from the operating room to post-anesthetic care unit , intraoperative fluid infusion , surgery size , anesthetic technique , age , body mass index , esophageal , axillary and operating room temperature . In G2 , length of surgery and starch infusion longer was higher ( both p=0.03 ) , but no hypothermia occurred . During the surgical anesthetic procedure , the axillary temperature was higher at 120 minutes ( p=0.04 ) , and esophageal temperature was higher at 120 ( p=0.002 ) and 180 minutes ( p=0.03 ) and at the end of the procedure ( p=0.002 ) . The thermal mattress was more effective in preventing hypothermia during surgery",
"Background : Regional anesthesia and analgesia attenuate or prevent perioperative factors that favor minimal residual disease after removal of the primary carcinoma . Therefore , the authors evaluated prostate cancer recurrence in patients who received either general anesthesia with epidural anesthesia/analgesia or general anesthesia with postoperative opioid analgesia . Methods : In a retrospective review of medical records , patients with invasive prostatic carcinoma who underwent open radical prostatectomy between January 1994 and December 2003 and had either general anesthesia – epidural analgesia or general anesthesia – opioid analgesia were evaluated through October 2006 . The endpoint was an increase in postoperative prostate-specific antigen . Results : After adjusting for tumor size , Gleason score , preoperative prostate-specific antigen , margin , and date of surgery , the epidural plus general anesthesia group had an estimated 57 % ( 95 % confidence interval , 17–78 % ) lower risk of recurrence compared with the general anesthesia plus opioids group , with a corresponding hazard ratio of 0.43 ( 95 % confidence interval , 0.22–0.83 ; P = 0.012 ) in a multivariable Cox regression model . Gleason score and tumor size ( percent of prostate involved ) were also independent predictors of recurrence ( hazards ratios of 1.19 [ 1.08 , 1.52 ] , P = 0.004 , and 1.17 [ 1.03 , 1.34 ] for 10 % size difference , P = 0.01 , respectively ) . A similar association between epidural use and recurrence was obtained by comparing patients matched on the propensity to receive epidural versus general anesthesia . Conclusions : Open prostatectomy surgery with general anesthesia , substituting epidural analgesia for postoperative opioids , was associated with substantially less risk of biochemical cancer recurrence . Prospect i ve r and omized trials to evaluate this association seem warranted",
"Purpose We hypothesized that oral rehydration therapy using an oral rehydration solution may be effective for preoperative fluid and electrolyte management in surgical patients before the induction of general anesthesia , and we investigated the safety and effectiveness of oral rehydration therapy as compared with intravenous therapy . Methods Fifty female patients who underwent breast surgery were r and omly allocated to two groups . Before entry to the operation room and the induction of general anesthesia , 25 patients drank 1000 ml of an oral rehydration solution ( “ oral group ” ) and 25 patients were infused with 1000 ml of an intravenous electrolyte solution ( “ intravenous group ” ) . Parameters such as electrolyte concentrations in serum and urine , urine volume , vital signs , vomiting and aspiration , volumes of esophageal-pharyngeal fluid and gastric fluid ( EPGF ) , and patient satisfaction with the therapy ( as surveyed by a question naire ) were assessed . Results After treatment , the serum sodium concentration and the hematocrit value , which both declined within the normal limits , were significantly higher in the oral group than in the intravenous group ( sodium , 140.8 ± 2.9 mEq·l−1 in the oral group and 138.7 ± 1.9 mEq·l−1 in the intravenous group ; P = 0.005 ; hematocrit , 39.03 ± 4.16 % in the oral group and 36.15 ± 3.41 % in the intravenous group ; P = 0.01 ) . No significant difference was observed in serum glucose values . Urine volume was significantly larger in the oral group ( 864.9 ± 211.5 ml ) than in the intravenous group ( 561.5 ± 216.0 ml ; P , as an index of renal blood flow , was increased in both groups following treatment ( 0.8 ± 0.5 in the oral group and 0.8 ± 0.3 in the intravenous group ) . Patient satisfaction with the therapy favored the oral rehydration therapy , as judged by factors such as “ feeling of hunger ” , “ occurrence of dry mouth ” , and “ less restriction in physical activity ” . The volume of EPGF collected following the induction of anesthesia was significantly smaller in the oral group than in the intravenous group ( 6.03 ± 9.14 ml in the oral group and 21.76 ± 30.56 ml in the intravenous group ; P in either group . Conclusion The results suggest that the oral rehydration therapy with an oral rehydration solution before surgery is superior to the current preoperative intravenous therapy for the provision of water , electrolytes , and carbohydrates , and this therapy should be considered as an alternative to the intravenous therapy for preoperative fluid and electrolyte management in selected surgical patients in whom there is no reason to suspect delayed gastric emptying",
"UNLABELLED We evaluated the preemptive analgesic effect of a small dose of ketamine given before or immediately after surgery in a r and omized , double-blinded study performed in 128 women undergoing total mastectomy . Group 1 patients received ketamine 0.15 mg/kg as a 5-mL i.v . injection 5 min before surgery and isotonic saline 5 mL i.v . at the time of skin closure . Group 2 received 5 mL i.v . of isotonic saline , then 0.15 mg/kg i.v . ketamine . A st and ard general anesthesia procedure including sufentanil was used . In the recovery room , patient-controlled analgesia i.v . morphine was used for postoperative analgesia . Postoperative pain was assessed by measuring morphine consumption and visual analog scale pain scores . No significant intergroup differences were seen in the pain scores . Patient-controlled analgesia morphine consumption was lower during the first 2 h after surgery in patients given ketamine at the time of skin closure . No patient complained of hallucinations or nightmares . The incidence of adverse effects was not different between the two groups . In conclusion , administering ketamine at the end of surgery is more effective in reducing morphine consumption than it is when given before surgery . IMPLICATION S We administered the same small dose of ketamine before or after surgery . The preoperative administration of 0.15 mg/kg ketamine in patients undergoing total mastectomy did not elicit a preemptive analgesic effect . Ketamine given at closure reduced the patient-controlled analgesia morphine requirement in the first 2 h after surgery",
"Prewarming operating rooms has been shown to limit hypothermia in pediatric surgical patients but may be associated with extreme discomfort for surgeons . We examined the effect of prewarming operating rooms on core temperatures during knee and hip arthroplasties . Sixty-six patients were r and omized to the prewarmed group at 24 ° C or control group at 17 ° C . The prewarmed group core temperature ( mean , 36.14 ° C ) before active warming was significantly higher ( P = .018 ) than that of the control group ( mean , 35.83 ° C ) . By the start of surgery , the difference was 36.01 ° C prewarmed vs 35.83 ° C control , P = .038 . There was no significant difference in the last recorded mean temperatures between groups : 36.35 ° C ( prewarmed ) vs 36.16 ° C ( control ) . A prewarmed operating room for adults undergoing knee or hip arthroplasty had minimal effect on preventing intraoperative hypothermia ",
"Postoperative infectious complications after breast surgery may result in significant morbidity , psychological trauma , and additional costs . We assessed the efficacy of preoperative antibiotic prophylaxis for surgery in a r and omized , double-blind trial of 1,766 patients undergoing breast surgery . From January 1 , 1996 to August 31 , 1997 , all eligible patients were assigned r and omly to receive a single dose of ceftriaxone ( 2 g ) or ceftazidime ( 2 g ) given intravenously at the induction of anesthesia , with no further doses . The groups were similar with respect to age , operative procedure , operative time and time to discharge after operation . The patients who received ceftriaxone prophylaxis had 54.4 % fewer overall infections than those who received ceftazidime prophylaxis . Wound infection occurred in 0.45 % of the ceftriaxone recipients ( 2 of 883 ) and 0.91 % of the ceftazidime recipients ( 8 of 883 ) . This prospect i ve r and omized double-blind study showed that the long-acting regimen containing ceftriaxone is more cost-effective than the short-acting ceftazidime in preventing postoperative infections in patients subjected to breast surgery",
"Background : R and omized controlled studies provide ample evidence that heparin is effective in reducing the risk of thromboembolic complications . Nevertheless , plastic surgeons are often reluctant to use heparin chemoprophylaxis for fear of postoperative bleeding . The authors investigated whether heparin chemoprophylaxis was associated with postoperative hematoma that required evacuation in patients who underwent transverse rectus abdominis myocutaneous ( TRAM ) flap breast reconstruction . Methods : A multicenter retrospective review of consecutive TRAM flap cases identified 679 patients , 392 in the heparin-treated group and 287 in the control group . The post hoc sample sizes were adequate to detect a 5 percent difference in hematoma rate with 89 percent power at an alpha level of 5 percent ( p reoperative hematoma , deep vein thrombosis , and pulmonary embolism were recorded . Results : Reoperative hematoma occurred in 0.5 percent of patients in the heparin-treated group and 1.0 percent of patients in the control group ; this difference was not statistically significant ( p = 0.66 ) . Thromboembolic events were detected at a low rate ( 0.8 percent in the heparin-treated group versus 1.4 percent in the untreated group ; p = 0.46 ) . Conclusions : The use of heparin for venous thrombotic prophylaxis did not increase the risk of reoperative hematoma after breast reconstruction with abdominal tissue . The authors propose a risk assessment that balances a statistical hematoma rate of 0.5 to 5 percent ( clinical ly observed rate , 0.5 percent ) with use of heparin prophylaxis against a rare ( clinical ly observed rate , 1.4 percent ) but morbid occurrence of thromboembolic complications when chemoprophylaxis is omitted",
"Background : Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in post‐operative pain . The aim of this r and omized , double‐blinded , placebo‐controlled trial ( Clinical Trials.gov ID NCT00938548 ) was to investigate the efficacy and safety of pregabalin for reducing post‐operative pain in patients after mastectomy",
"Background and objective A r and omized and prospect i ve study was performed to compare anaesthetic characteristics and stress hormone responses of two anaesthetic techniques . Methods Forty‐two patients undergoing day case excisional biopsy of breast mass were r and omly assigned to receive propofol – remifentanil or sevoflurane – N2O . Anaesthesia was induced and maintained either with sevoflurane and 50 % N2O in oxygen or with target‐controlled remifentanil and propofol in 50 % oxygen and air . Anaesthetic depth was monitored by the bispectral index . Results The times for induction ( 2.9 vs. 1.7 min ) and for laryngeal mask insertion ( 5.7 vs. 3.3 min ) were longer in the sevoflurane – N2O group than in the propofol – remifentanil group . However , apnoea ( 57.1 % vs. 9.5 % ) and bradycardia ( 23.8 % vs. 0 % ) were more prevalent with propofol – remifentanil . In the sevoflurane – N2O group , the emergence times to a verbal response ( 10.6 vs. 3.7 min ) , to extubation ( 11.8 vs. 4.0 min ) and to orientation ( 14.7 vs. 4.8 min ) were longer than in the propofol – remifentanil group . There were significantly more nausea ( 38.1 % vs. 4.8 % ) and vomiting ( 19.2 % vs. 0 % ) in the sevoflurane – N2O group than in the propofol – remifentanil group . The time to discharge was similar although there was less postoperative pain in the sevoflurane – N2O group . There were no differences in the perioperative cortisol responses in the two groups . Conclusions Smoother induction of anaesthesia was seen with sevoflurane – N2O . Propofol – remifentanil showed a quicker emergence with less nausea/vomiting . There were similar perioperative cortisol responses in the two anaesthetic techniques",
"Background : Immediate breast reconstruction using the transverse rectus abdominis musculocutaneous ( TRAM ) flap is associated with multiple risk factors for pulmonary thromboembolism , the incidence of which has been reported to be as high as 6.3 percent . The authors conducted a prospect i ve study of the efficacy of prophylactic use of low-molecular-weight heparin to prevent pulmonary thromboembolism . Methods : Six hundred fifty consecutive patients who underwent immediate breast reconstruction with TRAM flaps between August of 2001 and April of 2007 were included in this study . No medical prophylaxis was administered for the former 450 consecutive patients ( group 1 ) . Since February of 2006 , enoxaparin was routinely given to the latter 200 consecutive patients ( group 2 ) for 7 days , from the day of surgery . Fifty-four patients in group 1 ( group 1c ) and 68 patients in group 2 ( group 2c ) were routinely examined for asymptomatic pulmonary thromboembolism . Incidences of symptomatic and asymptomatic pulmonary thromboembolism , decreases in hemoglobin , and bleeding-related complications were compared . Results : Although the incidence of symptomatic pulmonary thromboembolism did not differ significantly between groups 1 and 2 ( 1.8 percent versus 0 percent ; p = 0.107 ) , that of asymptomatic pulmonary thromboembolism was significantly higher in group 1c than in group 2c ( 16.7 percent versus 0 percent ; p = 0.009 ) . The hemoglobin decrease was significantly different ( 2.5 g/dl in group 1 versus 2.8 g/dl in group 2 ; p = 0.001 ) , but the incidences of transfusion , hematoma , and seroma showed no statistically significant difference . Conclusion : Prophylactic use of low-molecular-weight heparin was effective in preventing pulmonary thromboembolism without increasing problematic bleeding-related complications in TRAM flap immediate breast reconstruction patients",
"BACKGROUND Breast cancer ( BC ) is currently the most frequent tumor in women . Through the years , BC management has evolved towards conservative surgery . However , even minimally invasive surgery can cause neuromotor and /or articular impairments which can lead to permanent damage , if not adequately treated . AIM To clinical ly evaluate upper ipsilateral limb function and the impact of certain post-surgical consequences arising after invasive or breast-conserving surgery for early BC , by intervening , or not intervening , with an early rehabilitation program . To investigate physical morbidity after sentinel ( SLND ) or axillary lymph node dissection ( ALND ) and after reconstructive surgery in the treatment of early BC . DESIGN Observational prospect i ve trial . SETTING Inpatient and outpatient treatment . POPULATION Eighty-three females participated in the study : 25 patients did not begin physiotherapy during hospitalization ( Group A ) , 58 patients received early rehabilitation treatment ( Group B ) . METHODS The patients of Groups A and B were compared with respect to the following criteria : shoulder-arm mobility , upper limb function , and presence of lymphedema . All patients were assessed at 15 - 30 , 60 and 180 days after surgery . RESULTS Statistically significant differences , in favor of Group B , were encountered at the 180-day follow-up visit , especially with respect to articular and functional limitation of the upper limb . CONCLUSION AND CLINICAL REHABILITATION IMPACT The results of the present study show that early assisted mobilization ( beginning on the first postoperative day ) and home rehabilitation , in conjunction with written information on pre caution ary hygienic measures to observe , play a crucial role in reducing the occurrence of postoperative side-effects of the upper limb",
"A 10-year prospect i ve study undertaken at Foothills Hospital in Canada used the infection of wounds to measure the rate of infection on the surgical services . The authors consider the effects of the following factors on the rate of infection : length of preoperative stay , preparation of the patient for surgery , identification of patients at risk , surgical technique and choice of procedure , and acquainting staff with statistics of wound infection rates ",
"Background Postoperative nausea and vomiting is a major cause of patient dissatisfaction towards surgery . For bariatric surgery , increased vomiting/retching is detrimental to surgical anastomosis . The present study evaluated the efficacy of aprepitant ( neurokinin-1 inhibitor ) as a prophylactic antiemetic in morbidly obese patients for laparoscopic bariatric surgery . Methods After institutional review board approval , 125 morbidly obese patients were recruited into this double-blind placebo-controlled trial . On r and om division , the patients received a tablet of aprepitant ( 80 mg ) in group A , or a similar-appearing placebo in group P , an hour prior to surgery . All patients received intravenous ondansetron ( 4 mg ) intraoperatively . Postoperatively , the patients were evaluated for nausea and vomiting by a blinded evaluator at 30 min , 1 , 2 , 6 , 24 , 48 , and 72 h. Results Both groups were evenly distributed for age , body mass index , type , and length of surgery . Cumulative incidence of vomiting at 72 h was significantly lower in group A ( 3 % ) compared to group P ( 15 % ; p = 0.021 ) . Odds ratio for vomiting in group P compared to group A was 5.47 times . On Kaplan – Meier plot , time to first vomiting was also significantly delayed in group A ( p = 0.019 ) . A higher number of patients showed complete absence of nausea or vomiting in group A compared to group P ( 42.18 vs. 36.67 % ) . On the other h and , nausea scores were unaffected by aprepitant , and no significant difference between groups was found at any of the measured time points . Conclusions In morbidly obese patients undergoing laparoscopic bariatric surgery , addition of aprepitant to ondansetron can significantly delay vomiting episodes simultaneously lowering the incidence of postoperative vomiting",
"Methods : In a prospect i ve r and omised placebo controlled double-blind study 210 ASA I-II women scheduled for elective termination of pregnancy received 1 g paracetamol , 8 mg lornoxicam or placebo orally 60 min before anaesthesia which was st and ardised with propofol , fentanyl and oxygen in nitrous oxide 1:2 . Postoperative pain was assessed by VAS-score at 30 and 60 min after end of surgery and at discharge as primary endpoints . Need for rescue medication and time to discharge were secondary endpoints . Results : All patients had an uncomplicated course . Overall pain intensity was low , however , the patients pretreated with lornoxicam had significantly less pain after surgery , no difference could however , be seen in need for rescue medication or time to discharge between the three groups . Conclusion : General pain prophylaxis may be argued in minor gynaecological surgical procedures where postoperative pain is of low intensity . If general prophylaxis is to be given in minor gynaecological surgery , a non steroidal anti-inflammatory ( NSAID ) such as lornoxicam , seems more efficacious as compared to a st and ard dose of 1 g paracetamol ",
"Background : The debate over the correct perioperative fluid management is unresolved . Methods : The impact of two intraoperative fluid regimes on postoperative outcome was prospect ively evaluated in 152 patients with an American Society of Anesthesiologists physical status of I – III who were undergoing elective intraabdominal surgery . Patients were r and omly assigned to receive intraoperatively either liberal ( liberal protocol group [ LPG ] , n = 75 ; bolus of 10 ml/kg followed by 12 ml · kg−1 · h−1 ) or restrictive ( restrictive protocol group [ RPG ] , n = 77 ; 4 ml · kg−1 · h−1 ) amounts of lactated Ringer 's solution . The primary endpoint was the number of patients who died or experienced complications . The secondary endpoints included time to initial passage of flatus and feces , duration of hospital stay , and changes in body weight , hematocrit , and albumin serum concentration in the first 3 postoperative days . Results : The number of patients with complications was lower in the RPG ( P = 0.046 ) . Patients in the LPG passed flatus and feces significantly later ( flatus , median [ range ] : 4 [ 3–7 ] days in the LPG vs. 3 [ 2–7 ] days in the RPG ; P their postoperative hospital stay was significantly longer ( 9 [ 7–24 ] days in the LPG vs. 8 [ 6–21 ] days in the RPG ; P = 0.01 ) . Significantly larger increases in body weight were observed in the LPG compared with the RPG ( P postoperative days , hematocrit and albumin concentrations were significantly higher in the RPG compared with the LPG . Conclusions : In patients undergoing elective intraabdominal surgery , intraoperative use of restrictive fluid management may be advantageous because it reduces postoperative morbidity and shortens hospital stay ",
"OBJECTIVE A postoperative regimen using a multimodal approach with enforced mobilization and early oral nutrition has been reported to improve convalescence but has not been compared with other postoperative regimens . METHODS Forty patients undergoing elective colorectal surgery were r and omly allocated to an intervention group receiving comprehensive information on the importance of mobilization , balanced anesthesia , and postoperative analgesia including epidural local anesthetics and enforced postoperative mobilization or a control group receiving anesthesia without epidural local anesthetics , postoperative analgesia with epidural morphine , and mobilization without fixed goals . All patients were offered early oral nutrition . The regimens were compared by means of ambulation time and physical activity , voluntary muscle strength , pulmonary function , and body composition . RESULTS The ambulation time improved substantially within 22 h in the intervention group versus 3 h in the control group on day 1 ( P = 0.0004 ) and within 8 h versus 2 h on day 4 ( P = 0.0003 ) . The voluntary strength of the quadriceps muscle decreased by 3 % in the intervention group versus 15 % in the control group on day 7 ( P = 0.04 ) . Two months postoperatively , the difference between groups was the same ( P = 0.02 ) . CONCLUSION This active per- and postoperative regimen based on a multimodal approach improved ambulation time and muscle function during admission and late convalescence",
"INTRODUCTION Active inspired gas humidification ( AH ) preserves body heat and maintains normothermia intraoperatively . However , it is unclear whether AH shows comparable influences during liver transplantation ( OLT ) , which may be affected by both large internal heat loss and external heat supply . Thus , the aim of this study was to evaluate the effect of AH compared with passive humidification ( PH ) on body temperature in OLT . MATERIAL S AND METHODS Thirty-four adult patients undergoing living donor OLT were r and omly enrolled into two groups : those given AH using a heated humidifier ( HH group , n = 17 ) and those using a heat- and -moisture exchanger ( HME group , n = 17 ) . Both core and skin temperatures ( Tc and Ts ) , as well as respiratory parameters , including static/dynamic lung compliances and PaO(2 ) , were recorded at predetermined times . RESULTS Both Tc and Ts were consistently higher among the HH versus the HME group after 2 hours of anesthesia . Differences in Tc and Ts between the two groups increased gradually over time . The overall Tc during surgery was higher among the HH than the HME group ( P = .023 ) . The incidences of hypothermia were lower in the HH group at 3 hours of anesthesia , 1 and 3 hours of reperfusion , and at the end of surgery ( P = .037 , 0.024 , 0.005 , and 0.010 respectively ) . The duration of hypothermia was lower in the HH than the HME group ( 3.9 ± 3.5 hours versus 6.7 ± 3.3 hours , P = .025 ) . Both groups showed no significant intraoperative changes in respiratory parameters ; there were no postoperative respiratory complications . CONCLUSION Active humidification warms the patient 's body effectively , lessening the incidence and duration of hypothermia during OLT with no respiratory risks",
"Purpose The use of opioids following surgery is associated with a high incidence of postoperative nausea and vomiting ( PONV ) . We conducted a prospect i ve , r and omized , double-blind , placebo-controlled study to investigate the effect of orally administered aprepitant , a neurokinin-1 receptor antagonist , for reducing PONV in patients with fentanyl-based , patient-controlled analgesia ( PCA ) given intravenously after gynecological laparoscopy . Methods One hundred and twenty female patients ( ages 21–60 ) undergoing laparoscopic hysterectomy were r and omly allocated to receive 80 mg ( A80 group , n = 40 ) or 125 mg aprepitant ( A125 group , n = 40 ) or placebo ( control group , n = 40 ) orally 2 h before anesthesia induction . Anesthesia was maintained with isoflurane and remifentanil , and PCA IV using fentanyl and ketorolac were provided for 48 h after surgery . Incidences of nausea , vomiting/retching , and use of rescue antiemetics were recorded at 2 , 24 , and 48 h after surgery . Complete response was defined as no PONV and no need for rescue treatment . Results The incidence of complete response was significantly lower in the A80 and A125 groups than in controls , 56 % and 63 % , vs. 28 % , respectively , P = 0.007 and P = 0.003 , respectively , during the first 48 h , and 65 % and 65 % vs. 38 % , respectively , both P = 0.025 , during the first 2 h. However , there were no statistically significant differences between A80 and A125 groups in the incidences of complete response and PONV during the study period . Conclusions Aprepitant 80 mg orally was effective in lowering the incidence of PONV in the first 48 h after anesthesia in patients receiving fentanyl-based PCA after gynecological laparoscopy",
" Background : Surgery is succeeded by long‐lasting state of relative peripheral insulin resistance , which is reduced by giving glucose infusion or oral carbohydrate‐rich drinks immediate before operating instead of fasting . The aim of the present study was to investigate whether oral carbohydrate or carbohydrate with peptide drinks preoperatively instead of fasting would improve postoperative voluntary muscle strength , nutritional intake and ambulation , decrease postoperative fatigue , anxiety and discomfort , and reduce the endocrine response to surgery",
"STUDY OBJECTIVE To determine whether magnesium sulfate ( MgSO(4 ) ) infusion during surgery reduces shivering during spinal anesthesia . DESIGN Double-blinded placebo-controlled , r and omized trial . SETTING Operation room of a university hospital . PATIENTS 60 patients , aged 40 to 70 years , scheduled for elective transurethral resection of the prostate ( TURP ) during spinal anesthesia . INTERVENTIONS Subarachnoid anesthesia consisting of hyperbaric bupivacaine three mL 0.5 % was injected using a 25-G Quincke spinal needle . Patients received either saline ( Group C , n = 30 ) or MgSO(4 ) ( Group Mg , n = 30 ) . Group Mg received an intravenous ( IV ) bolus of MgSO(4 ) 80 mg/kg via syringe pump over a 30-minute period , followed by a two g/hr infusion during the intraoperative period . Group C received an equal volume of saline . MEASUREMENTS Motor blockade was evaluated by Bromage motor scale . Sensory block level was assessed by pinprick test . Shivering was assessed after the completion of subarachnoid drug injection . Side effects were recorded . MAIN RESULTS Hypothermia was observed in all patients ( 100 % ) in Group Mg and in 24 patients ( 80 % ) in Group C ( P = 0.024 ) . The decrease in core temperature in Group Mg was significantly greater ( P Shivering was observed in two patients ( 6.7 % ) in Group Mg and 20 patients ( 66.7 % ) in Group C ( P = 0.0001 ) . CONCLUSIONS MgSO(4 ) infusion in the perioperative period significantly reduced shivering during TURP with spinal anesthesia . MgSO(4 ) infusion prevents shivering in patients receiving spinal anesthesia but increases the risk of hypothermia",
"BACKGROUND It remains to be determined if perioperative systemic magnesium can improve postoperative quality of recovery of patients undergoing ambulatory procedures . The main objective of the current investigation was to evaluate the effect of systemic magnesium on postoperative quality of recovery in patients undergoing outpatient segmental mastectomies . METHODS The study was a prospect i ve r and omized , double-blind , placebo-controlled , clinical trial . Female subjects were r and omized to receive intravenous magnesium ( MgSO4 50mg/kg in 100 mL of normal saline over 15 min before anesthesia induction , followed by an infusion of 15 mg/kg/hour ) or the same volume of saline . The primary outcome was the Quality of Recovery 40 ( QOR-40 ) question naire at 24 hours after surgery . RESULTS 50 subjects were recruited and 46 completed the study . Patients in the magnesium group had better global Quality of Recovery scores compared with the saline group , with a median difference of 24 ( 99 % CI , 3 to 33 ) , P oral opioids , median ( IQR ) of 10 ( 0 to 20 ) ( oral milligrams of morphine equivalents ) than the saline group , 30 ( 20 to 40 ) ( P The postoperative systemic magnesium concentrations were substantially higher in the magnesium group , 1.25 ± 0.28 mmol/L compared to control , 0.71 ± 0.11 mmol/L , P the postoperative systemic magnesium concentrations and 24 hour postoperative quality of recovery scores ( P = 0.004 ) , and also an inverse relationship with pain burden in the postoperative care unit ( P = 0.01 ) . CONCLUSIONS Systemic magnesium improves postoperative quality of recovery in patients undergoing outpatient segmental mastectomy . Systemic magnesium is a safe , inexpensive , efficacious strategy to improve quality of recovery after ambulatory surgery",
"Background : 2-Octyl-cyanoacrylate skin adhesive may be used for surgical wound closure . However , its use in plastic surgery has not been properly assessed . Methods : The authors conducted a prospect i ve , r and omized , controlled clinical intervention study in which the scar characteristics after use of skin adhesive were compared with those after suture closure . Bilateral reduction mammaplasty was performed in 50 patients . The method of closure ( sutures versus skin adhesive ) applied to each breast was determined r and omly , using each patient as her own control . Scars were assessed by the patient and by a blinded panel , at 1 week , 6 weeks , and 6 months after surgery , using a visual analogue scale , the modified Holl and er Wound Evaluation Scale , and the Patient and Observer Scar Assessment Scale . Results : Both patients and panelists expressed an overall preference for the adhesive side as of 1 week after surgery . Patients ’ visual analogue scale scores for scar comfort and scar appearance and panelists ’ visual analogue scale scores for aesthetic outcome were significantly better for the adhesive side after 6 weeks and 6 months ( p total Holl and er Wound Evaluation Scale score of the panelists after 6 weeks ( p total Patient and Observer Scar Assessment Scale score after 6 months was significantly better for the adhesive side according to the patients ( p 2-octyl-cyanoacrylate is a sound alternative for wound closure",
"Background : The exact risk that poor glucose control introduces to patients undergoing surgical closure has yet to be fully defined . Methods : The authors retrospectively analyzed a prospect ively collected data base of patients seen at their wound care center to evaluate the effects of chronic and perioperative glucose control in high-risk patients undergoing surgical wound closure . Hemoglobin A1c and blood glucose levels for the 5 days before and after surgical closure were recorded and compared with the primary endpoints of dehiscence , infection , and reoperation . Univariate and multivariate analyses were performed . Results : Seventy-nine patients had perioperative glucose levels and 64 had hemoglobin A1C levels available for analysis . Preoperative and postoperative hyperglycemia ( defined as any blood glucose measurement above 200 mg/dl ) as well as elevated A1C levels ( above 6.5 percent or 48 mmol/ml ) were significantly associated with increased rates of dehiscence ( odds ratio , 3.2 , p = 0.048 ; odds ratio , 3.46 , p = 0.028 ; and odds ratio , 3.54 , p = 0.040 , respectively ) . Variability in preoperative glucose ( defined as a range of glucose levels exceeding 200 points ) was significantly associated with increased rates of reoperation ( odds ratio , 4.14 , p = 0.025 ) and trended toward significance with increased rates of dehiscence ( p = 0.15 ) . In multivariate regression , only perioperative hyperglycemia and elevated A1c were significantly associated with increased rates of dehiscence . Conclusions : In primary closure of surgical wounds in high-risk patients , poor glycemic control is significantly associated with worse outcomes . Every effort should be made to ensure tight control in both the chronic and subacute perioperative periods . CLINICAL QUESTION /LEVEL OF EVIDENCE : Risk , II",
"Background : Breast cancer treatment with mastectomy and immediate breast reconstruction ( IBR ) is associated with intense pain in the primary post‐operative period . The present prospect i ve , placebo‐controlled and double‐blind study aim ed to evaluate the analgesic efficacy of diclofenac , a non‐steroid anti‐inflammatory drug ( NSAID ) , in combination with paracetamol and opioids . This was done by 64‐h assessment of post‐operative pain intensity , opioid consumption , blood loss , nausea and tiredness",
"BACKGROUND Perioperative hypothermia is a common complication of general anesthesia and occurs in up to 50 % of patients during ear , nose and throat ( ENT ) surgery . In this prospect i ve , r and omized controlled study the hypothesis that a new conductive warming blanket ( Barrier ® EasyWarm ® , Mölnlycke Health Care Erkrath , Germany ) is better in reducing the incidence of perioperative hypothermia in ENT surgery than insulation with a conventional hospital duvet alone was tested . MATERIAL S AND METHODS After approval of the local ethics committee and written informed consent 80 patients with a planned procedure time between 1 and 3 h were recruited . Anesthesia was induced and maintained using propofol , remifentanil and rocuronium and the core temperature was measured using an esophageal temperature probe . Patients in the study group were warmed at least 30 min prior to induction of anesthesia using the novel warming blanket ( Barrier ® EasyWarm ® ) and patients in the control group were insulated with a st and ard hospital duvet . Data were tested using Fisher 's exact test , Student 's t-test or the Mann-Whitney U-test as appropriate . Time-dependent changes in core temperature were evaluated using repeated measures analysis of variance ( ANOVA ) and post hoc Scheffé 's test . Results are expressed as mean ± SD or as median and interquartile range ( IQR ) as appropriate . A p higher core temperature in the study group at any time point . Furthermore , Fisher 's exact test showed no differences in the incidence of intraoperative ( 12 out of 29 versus 10 out of 32 patients , p = 0.44 ) or postoperative hypothermia ( 12 out of 29 versus 9 out of 32 patients , p = 0.30 ) between the groups . No adverse effects were observed . CONCLUSIONS In the studied patient group the new conductive warming blanket ( Barrier ® EasyWarm ® ) showed no superiority compared to conventional thermal insulation alone",
"BACKGROUND Intraoperative hypothermia is a common event during laparoscopic abdominal surgery . On one h and , intraoperative hypothermia can delay the metabolism and prevent tissue damage . One the other h and , long-term and severe intraoperative hypothermia may also lead to perioperative complications , such as increasing of peripheral resistance , coagulation dysfunction , intraoperative hemorrhage and postoperative shivering . Maintenance of normothermia during surgical procedures may improve the quality of patient care . OBJECTIVES This study investigated the feasibility and efficacy of intraoperative cutaneous warming with an underbody warming system during laparoscopic gastrointestinal surgery . METHODS 110 patients undergoing laparoscopic surgery for gastrointestinal cancer between January and December 2011 were r and omized into the laparoscopic control ( Control ) group and laparoscopic intervention ( Intervention ) group . Nasopharyngeal temperature , prothrombin time , activated partial thromboplastin time , and thrombin time were measured before and during surgery , intraoperative and postoperative complications , as well as shivering after anesthesia and visual analog scale score for pain evaluation after surgery were also recorded . Clinical risk factors that may cause intraoperative hypothermia during laparoscopic surgery were also analyzed by correlation analysis . RESULTS The two groups were comparable at the baseline . Intraoperative hypothermia was observed in 29 patients ( 52.7 % ) in Control group and 3 ( 5.5 % ) in Intervention group . Nasopharyngeal temperature in Control group was significantly decreased since 30min after the start of operation until the end of surgery comparing to that at the start of anesthesia , but there was no difference in the Intervention group . In Intervention group , the nasopharyngeal temperature was remaining at ∼36.5 ° C , indicating the feasibility and efficiency of the underbody warming system in preventing intraoperative hypothermia during laparoscopic gastrointestinal surgery . Moreover , with anesthesia and operation time increased , there was no significant change of coagulation function , hemoglobin level as well as less intraoperative hemorrhage , less postoperative shivering and lower visual analog scale score in Intervention group comparing to Control group . Multivariate logistic regression analysis revealed that anesthesia time and volume of CO2 were independent risk factors for perioperative hypothermia . CONCLUSIONS Cutaneous warming with an underbody warming system is a feasible and effective method to prevent intraoperative hypothermia during laparoscopic gastrointestinal surgery",
"AIMS AND OBJECTIVES This ABC to recovery study evaluated the combined and separate components of preoperative education and the effectiveness of wearing the Papilla Gown . BACKGROUND Surgical removal of the breast may lead to activity limitation , self-image issues , discomfort and later complication of lymphoedema . Design . This study used experimental and longitudinal design . METHODS One hundred and forty-five women undergoing mastectomies for stages two and three breast cancer were r and omised into four groups : education and Papilla Gown , education only , gown only and control . The outcomes of activity ( A ) , body image ( B ) , comfort ( C ) , knowledge and lymphoedema were assessed at baseline and /or 1 week and 6 months using three measures . All 145 participants completed the study question naires at first two measures , and forty-six of these participants completed the question naires at 6 months postoperatively . The setting for the study included two clinics and hospitals . To examine statistical significance at each time point after surgery , 2-way anovas were performed on ABC , knowledge and tape measurement to see whether there were any statistically significant differences between the four groups . All reported p-values are two sided . All statistical analyses were performed using sas 9.2 for Windows . RESULTS The mean age of the sample was 55 years . The study revealed that women who received the combined intervention demonstrated greater activity . Women who wore the gown only had a greater comfort level and decreased lymphoedema . Women that received preoperative education experienced increased knowledge . CONCLUSIONS Outcomes suggest that the combined intervention ( ABCs to recovery ) can improve recovery following mastectomy . Relevance to clinical practice . The results will be used to further modify the intervention and to increase awareness of nurse practitioners and other healthcare professionals of the specific needs of postmastectomy patients",
"Background : An interactive digital education aid for breast reconstruction patients was developed because of a perceived need to provide patients with more education regarding the treatment so that they can make better informed treatment decisions . A prospect i ve r and omized study was conducted to assess its effectiveness . Methods : Breast cancer patients who were c and i date s for breast reconstruction were recruited and r and omized into a control group and a study group . Both groups received routine assessment and education in the plastic surgery clinic , but the study group also watched the interactive digital education aid . Question naires assessing knowledge , anxiety , and satisfaction were administered ( 1 ) before the initial plastic surgery consultation , ( 2 ) immediately before surgery , and ( 3 ) 1 month after surgery . Results : A total of 133 women participated , 66 in the control group and 67 in the study group . Women in both groups showed decreased anxiety , increased knowledge , and enhanced satisfaction with their decision-making ability associated with preoperative instructions about reconstructive surgery . However , the study group was significantly more satisfied than the control group with the method of receiving information and showed a less steep learning curve regarding the different techniques of breast reconstruction . They also tended to have a reduced mean level of anxiety and increased satisfaction with the treatment choice compared with the control group . Conclusions : An interactive digital education aid is a beneficial educational adjunct for patients contemplating breast reconstruction . Patients who use an interactive digital education aid demonstrate greater factual knowledge , reduced anxiety , and increased postoperative satisfaction compared with patients given preoperative instructions using st and ard methods alone . The benefit of an interactive digital education aid is expected to be higher in a broad-based practice setting outside of a comprehensive cancer center",
"Background : This study assessed the efficacy of a continuous infusion pump system for postoperative pain control at muscle-sparing transverse rectus abdominis musculocutaneous ( TRAM ) flap donor sites . Methods : In this prospect i ve , r and omized , double-blind trial , a dual-catheter continuous infusion pump system was placed in the muscle-sparing TRAM flap donor-site area in all patients . Bupivacaine ( 0.375 % ; continuous infusion pump group ) or isotonic saline ( control group ) was infused at 4 ml/hour . All patients also had a patient-controlled anesthesia system delivering intravenous narcotics on dem and . Pain scores , patient satisfaction , narcotic use , milestones of surgical recovery , and side effects of narcotics were compared between the two groups . Results : Forty-eight patients were included in the study ( 23 continuous infusion pump patients and 25 control patients ) . The continuous infusion patients used less mean patient-controlled anesthesia narcotic during the first 2 postoperative days ( 78.0 mg versus 42.7 mg ; p = 0.019 ) and transitioned earlier to oral narcotics than did control patients . Patients ’ overall pain satisfaction scores were significantly better in the continuous infusion group than in the control group . There were no significant differences between groups with regard to overall abdominal pain intensity scores , total narcotic use , length of hospitalization , incidence of narcotic side effects , or milestones of surgical recovery . Conclusions : The continuous infusion pump system appears to be a safe and effective method for postoperative donor-site pain management in TRAM flap breast reconstruction patients and should be considered for postoperative donor-site pain management . However , continuous infusion pump local anesthetic delivery to the muscle-sparing TRAM flap donor site did not eliminate narcotic use for pain control",
"Background : Postoperative nausea and vomiting is a major challenge in the perioperative setting . The incidence can be as high as 80 percent , and the majority of the symptoms among out patients occur after discharge . This study evaluated the efficacy of a neurokinin-1 receptor antagonist ( aprepitant ) in reducing postoperative symptoms for up to 48 hours in patients undergoing outpatient plastic surgery . Methods : A prospect i ve , double-blinded , r and omized , two-arm evaluation of 150 ambulatory plastic surgery patients receiving a st and ardized general anesthetic , including postoperative nausea and vomiting prophylaxis with ondansetron and either aprepitant or placebo , was performed . The main outcome measures were the occurrence of vomiting and the severity of nausea for up to 48 hours postoperatively . Results : Overall , 9.3 percent of patients who received aprepitant versus 29.7 percent in group B had vomiting , with the majority of vomiting episodes occurring after hospital discharge . The Kaplan-Meier plot of the hazards of vomiting revealed an increased incidence of emesis in patients receiving ondansetron alone compared with the combination of ondansetron and aprepitant ( p = 0.006 ) . The incidence of nausea was not significantly different in the two groups . Severity of nausea , however , was significantly higher in those receiving ondansetron alone compared with those receiving ondansetron and aprepitant , as measured by a peak nausea score ( p = 0.014 ) and by multivariate analysis of variance results comparing repeated verbal rating scale scores over 48 hours after surgery ( p = 0.024 ) . Conclusion : In patients undergoing plastic surgery , the addition of aprepitant to ondansetron significantly decreases postoperative vomiting rates and nausea severity for up to 48 hours postoperatively . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , II",
"BACKGROUND Animal models and retrospective clinical data suggest that certain anaesthetic techniques can attenuate immunosuppression and minimize metastasis after cancer surgery . Natural killer ( NK ) T cells are a critical component of the anti-tumour immune response . We investigated the effect of serum from women undergoing primary breast cancer surgery , r and omized to propofol-paravertebral block ( PPA ) or sevoflurane-opioid ( GA ) anaesthetic techniques , on healthy human donor NK cell function and cytotoxicity against oestrogen and progesterone receptor-positive breast cancer cells ( HCC1500 ) . METHODS Ten subjects who donated serum before operation and 24 h after operation in an ongoing r and omized prospect i ve trial ( NCT 00418457 ) were r and omly selected . Serum from PPA ( n=5 ) and GA ( n=5 ) subjects was co-cultured with HCC1500 and healthy primary NK cells . NK cell activating receptors ( NKp30 , NKp44 , NKp46 , 2b4 , CD16 , NKG2D ) , cytokine production , NK CD107a expression , and cytotoxicity towards HCC1500 were examined . RESULTS Serum from PPA subjects did not alter normal NK marker expression or secretion of cytokines . Serum from GA subjects reduced NK cell activating receptor CD16 [ from mean ( sem ) , 82 (2)% to 50 (4)% , P=0.001 ] , IL-10 [ from 1700 ( 80 ) to 1200 ( 92 ) pg ml(-1 ) , P=0.001 ] , and IL-1β [ from 68 ( 12 ) to 19 ( 4 ) pg ml(-1 ) , P=0.01 ] . An increase in NK cell CD107a [ 23 (2)% to 37(3)% , P=0.007 ] and apoptosis of HCC1500 [ 11 (1)% to 21 (2)% , P=0.0001 ] was observed with PPA serum , but not GA serum , treated NK cells . CONCLUSION Serum from women with breast cancer undergoing surgical excision who were r and omized to receive a PPA anaesthetic technique led to greater human donor NK cell cytotoxicity in vitro compared with serum from women who received GA . CLINICAL TRIAL REGISTRATION NCT 041857",
"Background : Post-operative nausea and vomiting ( PONV ) is commonly seen after modified radical mastectomy ( MRM ) . In this r and omized double-blind prospect i ve study we compared the efficacy of ondansetron , granisetron and granisetron and dexamethasone combination for prevention of PONV following MRM in female patients . Material s and Methods : A total of 75 patients ( 20 - 60 years of age ) undergoing elective MRM were r and omly allocated to one of the three groups of 25 patients each . Group O received ondansetron 4 mg , Group G received granisetron 40 mcg/kg and group granisetron and dexamethasone ( G + D ) received granisetron 40 mcg/kg + dexamethasone 8 mg prior to induction . All episodes of PONV within 24 h after induction of anesthesia were recorded . Statistical Analysis : Statistical analysis was done using Kruskal-Wallis test ( nonparametric ANOVA ) . Results : The incidence of complete response ( no PONV , no rescue medication ) was 96 % with G+D , as compared with 86 % with granisetron and 4 % with ondansetron during 0 - 3h after surgery which was clinical ly significant ( P Granisetron and dexamethasone combination is more effective for prevention of PONV in comparison to individual ondansetron and granisetron in MRM"
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Ghrelin is a hormone with multiple physiologic functions , including promotion of growth hormone release , stimulation of appetite and regulation of energy homeostasis . Treatment with ghrelin/ghrelin-receptor agonists is a prospect i ve therapy for disease-related cachexia and malnutrition . In vitro studies have shown high expression of ghrelin in cancer tissue , although its role including its impact in cancer risk and progression has not been established . We performed a systematic literature review to identify peer- review ed human or animal in vivo original research studies of ghrelin , ghrelin-receptor agonists , or ghrelin genetic variants and the risk , presence , or growth of cancer using structured search es in PubMed data base as well as secondary search es of article reference lists , additional review s and meta-analyses . Overall , 45 ( 73.8 % ) of the 61 studies review ed , including all 11 involving exogenous ghrelin/ghrelin-receptor agonist treatment , reported either a None ( no statistically significant difference ) or inverse association of ghrelin/ghrelin-receptor agonists or ghrelin genetic variants with cancer risk , presence or growth ; 10 ( 16.7 % ) studies reported positive associations ; and 6 ( 10.0 % ) reported both negative or None and positive associations . Differences in serum ghrelin levels in cancer cases vs controls ( typically lower ) were reported for some but not all cancers . The majority of in vivo studies showed a None or inverse association of ghrelin with risk and progression of most cancers , suggesting that ghrelin/ghrelin-receptor agonist treatment may have a favorable safety profile to use for cancer cachexia . Additional large-scale prospect i ve clinical trials as well as basic bioscientific research are warranted to further evaluate the safety and benefits of ghrelin treatment in patients with cancer
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"Background —Ghrelin is a novel growth hormone – releasing peptide that also induces vasodilation , inhibits sympathetic nerve activity , and stimulates feeding through growth hormone – independent mechanisms . We investigated the effects of ghrelin on left ventricular ( LV ) function , exercise capacity , and muscle wasting in patients with chronic heart failure ( CHF ) . Methods and Results —Human synthetic ghrelin ( 2 & mgr;g/kg twice a day ) was intravenously administered to 10 patients with CHF for 3 weeks . Echocardiography , cardiopulmonary exercise testing , dual x-ray absorptiometry , and blood sampling were performed before and after ghrelin therapy . A single administration of ghrelin elicited a marked increase in serum GH ( 25-fold ) . Three-week administration of ghrelin result ed in a significant decrease in plasma norepinephrine ( 1132±188 to 655±134 pg/mL ; P ) . Ghrelin increased LV ejection fraction ( 27±2 % to 31±2 % ; P an increase in LV mass and a decrease in LV end-systolic volume . Treatment with ghrelin increased peak workload and peak oxygen consumption during exercise . Ghrelin improved muscle wasting , as indicated by increases in muscle strength and lean body mass . These parameters remained unchanged in 8 patients with CHF who did not receive ghrelin therapy . Conclusions —These preliminary results suggest that repeated administration of ghrelin improves LV function , exercise capacity , and muscle wasting in patients with CHF",
"BACKGROUND Patients with advanced cancer frequently experience anorexia and cachexia , which are associated with reduced food intake , altered body composition , and decreased functionality . We assessed anamorelin , a novel ghrelin-receptor agonist , on cachexia in patients with advanced non-small-cell lung cancer and cachexia . METHODS ROMANA 1 and ROMANA 2 were r and omised , double-blind , placebo-controlled phase 3 trials done at 93 sites in 19 countries . Patients with inoperable stage III or IV non-small-cell lung cancer and cachexia ( defined as ≥5 % weight loss within 6 months or body-mass index were r and omly assigned 2:1 to anamorelin 100 mg orally once daily or placebo , with a computer-generated r and omisation algorithm stratified by geographical region , cancer treatment status , and weight loss over the previous 6 months . Co- primary efficacy endpoints were the median change in lean body mass and h and grip strength over 12 weeks and were measured in all study participants ( intention-to-treat population ) . Both trials are now completed and are registered with Clinical Trials.gov , numbers NCT01387269 and NCT01387282 . FINDINGS From July 8 , 2011 , to Jan 28 , 2014 , 484 patients were enrolled in ROMANA 1 ( 323 to anamorelin , 161 to placebo ) , and from July 14 , 2011 , to Oct 31 , 2013 , 495 patients were enrolled in ROMANA 2 ( 330 to anamorelin , 165 to placebo ) . Over 12 weeks , lean body mass increased in patients assigned to anamorelin compared with those assigned to placebo in ROMANA 1 ( median increase 0·99 kg [ 95 % CI 0·61 to 1·36 ] vs -0·47 kg [ -1·00 to 0·21 ] , p no difference in h and grip strength in ROMANA 1 ( -1·10 kg [ -1·69 to -0·40 ] vs -1·58 kg [ -2·99 to -1·14 ] , p=0·15 ) or ROMANA 2 ( -1·49 kg [ -2·06 to -0·58 ] vs -0·95 kg [ -1·56 to 0·04 ] , p=0·65 ) . There were no differences in grade 3 - 4 treatment-related adverse events between study groups ; the most common grade 3 - 4 adverse event was hyperglycaemia , occurring in one ( given anamorelin in ROMANA 1 and in four ( 1 % ) of 330 patients given anamorelin in ROMANA 2 . INTERPRETATION Anamorelin significantly increased lean body mass , but not h and grip , strength in patients with advanced non-small-cell lung cancer . Considering the unmet medical need for safe and effective treatments for cachexia , anamorelin might be a treatment option for patients with cancer anorexia and cachexia . FUNDING Helsinn Therapeutics",
"Ghrelin , an endogenous lig and for the growth hormone secretagogue receptor , has two major functions : the stimulation of the growth hormone production and the stimulation of food intake . Accumulating evidence also suggests a role of ghrelin in cancer development . We conducted a case-control study on 1359 breast cancer cases and 2389 matched controls , nested within the European Prospect i ve Investigation into Cancer and Nutrition , to examine the association of common genetic variants in the genes coding for ghrelin ( GHRL ) and its receptor ( GHSR ) with anthropometric measures , circulating insulin growth factor I ( IGF-I ) and insulin-like growth factor-binding protein 3 and breast cancer risk . Pair-wise tagging was used to select the 15 polymorphisms that represent the majority of common genetic variants across the GHRL and GHSR genes . A significant increase in breast cancer risk was observed in carriers of the GHRL rs171407-G allele ( odds ratio : 1.2 ; 95 % confidence interval : 1.0 - 1.4 ; P = 0.02 ) . The GHRL single-nucleotide polymorphism rs375577 was associated with a 5 % increase in IGF-I levels ( P = 0.01 ) . A number of GHRL and GHSR polymorphisms were associated with body mass index ( BMI ) and height ( P between false-positive report probability ( FPRP ) approach suggests that these results are noteworthy ( FPRP GHRL variations are associated with BMI . Furthermore , we have observed evidence for association of GHRL polymorphisms with circulating IGF-I levels and with breast cancer risk . These associations , however , might also be due to chance findings and further large studies are needed to confirm our results",
"BACKGROUND Cancer anorexia-cachexia syndrome is associated with increased morbidity and mortality . Anamorelin is an oral ghrelin-receptor agonist with appetite-enhancing and anabolic activity . We assessed the effects of anamorelin on body composition , strength , quality of life , biochemical markers , and safety in patients with cancer anorexia-cachexia . METHODS Data were pooled , a priori , from two completed phase 2 , multicentre , placebo-controlled , double-blind trials in patients with advanced or incurable cancer and weight loss of 5 % or more . Patients were stratified by weight loss severity ( 5 - 15 % , > 15 % ) and r and omly allocated ( 1:1 ) with a computer-generated r and omisation schedule to anamorelin hydrochloride 50 mg or placebo once-daily for 12 weeks . Primary outcome was lean body mass by dual-energy x-ray absorptiometry over the 12 week treatment period in eligible patients who had at least one dose of study drug and post-treatment efficacy assessment . We assessed safety in all patients who received at least one dose of study drug . The trials are registered with Clinical Trials.gov , numbers NCT00219817 and NCT00267358 . FINDINGS Between June 29 , 2005 , and Oct 26 , 2006 , we enrolled 44 patients in the anamorelin group and 38 patients in the placebo group . 74 patients were eligible for the efficacy analyses . Over 12 weeks , lean body mass increased in 38 patients in the anamorelin group by a least-squares mean of 1.89 kg ( 95 % CI 0.84 to 2.95 ) compared with a decrease of a least-squares mean of -0.20 kg ( -1.23 to 0.83 ) for 36 patients in the placebo group ( difference 2.09 kg [ 0.94 - 3.25 ] ; p=0.0006 ) . 42 ( 95 % ) of 44 patients treated with anamorelin and 33 ( 87 % ) of 38 patients treated with placebo had adverse events . The most common grade 3 - 4 adverse events ( treatment-related or not ) in the anamorelin group were fatigue , asthenia , atrial fibrillation , and dyspnoea ( two [ 5 % ] each ) ; in the placebo group , such events were pneumonia ( three [ 8 % ] ) and anaemia , thrombocytopenia , abdominal pain , anxiety , and dyspnoea ( two [ 5 % ] each ) . INTERPRETATION Anamorelin treatment for 12 weeks had a favourable clinical response profile in patients with cancer anorexia-cachexia syndrome . These findings support further investigation in this setting . FUNDING Helsinn Therapeutics ( US ) , Helsinn Healthcare SA",
"Context : In clinical practice , the safety profile of GH replacement therapy for GH-deficient adults compared with no replacement therapy is unknown . Objective : The objective of this study was to compare adverse events ( AEs ) in GH-deficient adults who were GH-treated with those in GH-deficient adults who did not receive GH replacement . Design and Setting : This was a prospect i ve observational study in the setting of US clinical practice s. Patients and Outcome Measures : AEs were compared between GH-treated ( n = 1988 ) and untreated ( n = 442 ) GH-deficient adults after adjusting for baseline group differences and controlling the false discovery rate . The st and ardized mortality ratio was calculated using US mortality rates . Results : After a mean follow-up of 2.3 years , there was no significant difference in rates of death , cancer , intracranial tumor growth or recurrence , diabetes , or cardiovascular events in GH-treated compared with untreated patients . The st and ardized mortality ratio was not increased in either group . Unexpected AEs ( GH-treated vs untreated , P ≤ .05 ) included insomnia ( 6.4 % vs 2.7 % ) , dyspnea ( 4.2 % vs 2.0 % ) , anxiety ( 3.4 % vs 0.9 % ) , sleep apnea ( 3.3 % vs 0.9 % ) , and decreased libido ( 2.1 % vs 0.2 % ) . Some of these AEs were related to baseline risk factors ( including obesity and cardiopulmonary disease ) , higher GH dose , or concomitant GH side effects . Conclusions : In GH-deficient adults , there was no evidence for a GH treatment effect on death , cancer , intracranial tumor recurrence , diabetes , or cardiovascular events , although the follow-up period was of insufficient duration to be conclusive for these long-term events . The identification of unexpected GH-related AEs reinforces the fact that patient selection and GH dose titration are important to ensure safety of adult GH replacement",
"BACKGROUND Infusion of ghrelin to supraphysiologic levels inhibits glucose-stimulated insulin secretion , reduces insulin sensitivity , and worsens glucose tolerance in humans . OBJECTIVE The purpose of this study was to determine the effects of lower doses of ghrelin on insulin secretion and insulin sensitivity in healthy men and women . METHODS Acyl ghrelin ( 0.2 and 0.6 nmol kg(-1 ) h(-1 ) ) or saline was infused for 225 minutes in 16 healthy subjects on 3 separate occasions in r and omized order . An i.v . glucose tolerance test was performed , and the insulin sensitivity index ( SI ) was derived from the minimal model . Insulin secretion was measured as the acute insulin response to glucose ( AIRg ) and the disposition index was computed as AIRg × SI . RESULTS Ghrelin infusions at 0.2 and 0.6 nmol kg(-1 ) h(-1 ) raised steady-state plasma total ghrelin levels 2.2- and 6.1-fold above fasting concentrations . Neither dose of ghrelin altered fasting plasma insulin , glucose , or SI , but both doses reduced insulin secretion compared with the saline control , computed either as AIRg ( 384 ± 75 and 354 ± 65 vs 520 ± 110 pM · min [ mean ± SEM ] , respectively ; P decreased glucose tolerance . CONCLUSIONS Ghrelin infused to levels occurring in physiologic states such as starvation decreases insulin secretion without affecting insulin sensitivity . These findings are consistent with a role for endogenous ghrelin in the regulation of insulin secretion and suggest that ghrelin antagonism could improve β-cell function",
"Some recent epidemiologic studies have failed to confirm positive associations between insulin-like growth factor-I ( IGF-I ) and the risk of prostate cancer observed in earlier studies but have reported suggestive evidence for a positive association between IGF-binding protein-3 ( IGFBP-3 ) and prostate cancer risk , a result contradicting the earlier assumption that high levels of IGFBP-3 would be protective against prostate cancer . We tested the association between IGF-I and IGFBP-3 and prostate cancer risk by measuring the two peptides in plasma sample s collected at baseline in a prospect i ve cohort study of 17,049 men . We used a case-cohort design , including 524 cases diagnosed during a mean of 8.7 years follow-up and a r and omly sample d subcohort of 1,826 men . The association between each peptide level and prostate cancer risk was tested using Cox models adjusted for country of birth and alcohol consumption . The risk of prostate cancer was not associated with baseline levels of IGF-I or the molar ratio IGF-I/IGFBP-3 ( all odds ratios are between 0.82 and 1.08 ; Ptrend ≥ 0.2 ) , whereas the risk increased with baseline levels of IGFBP-3 ( Ptrend = 0.008 ) , the hazard ratio ( HR ) associated with a doubling of the concentration of IGFBP-3 being 1.70 ( 95 % confidence interval , 1.15 - 2.52 ) . The HR for quartile 4 relative to quartile 1 of IGFBP-3 was 1.49 ( 95 % confidence interval , 1.11 - 2.00 ) . The HRs did not differ by tumor aggressiveness or age at onset ( all Ps ≥ 0.4 ) . In our study , high levels of IGFBP-3 but not IGF-I were associated with an increased risk of prostate cancer . ( Cancer Epidemiol Biomarkers Prev 2006;15(6):1137–41",
"OBJECTIVE : Several large studies have shown a negative association between Helicobacter pylori ( H. pylori ) infection and esophageal adenocarcinoma . Diminution of gastric ghrelin secretion by H. pylori could protect against esophageal malignancy by decreasing appetite , food intake , and acid production , thereby decreasing weight and gastroesophageal reflux . METHODS : We evaluated the association of ghrelin with esophageal adenocarcinoma using a population from a previous nested case-control study . Among 128,992 enrolled in a multiphasic health checkup ( MHC ) between 1964 and 1969 , 52 patients developed esophageal adenocarcinoma by the year 2000 . Three r and om controls from the MHC cohort were matched to each case by age , sex , race , and the date and site of their MHC . Serum sample s collected at the MHC had been previously tested for IgG antibodies against H. pylori and the CagA protein . Serum ghrelin concentrations were determined by a commercial EIA on 52 % of the initial subjects ( 31 cases and 79 controls ) . RESULTS : A concentration of ghrelin greater than 3,200 pg/mL at MHC ( fourth quartile ) was associated with a lower risk of esophageal cancer ( H. pylori and body mass index [ BMI ] adjusted OR = 0.18 [ CI 0.04–0.78 ] ) . This inverse association was seen only in overweight subjects ( BMI ≥ 25 , P value for interaction = 0.09 ) . The effects of H. pylori and ghrelin were independent . CONCLUSION : Contrary to the original hypothesis , high rather than low serum ghrelin was associated with protection against esophageal adenocarcinoma but only among overweight subjects",
"Twenty-one adult patients were r and omised to receive ghrelin on days 1 and 8 and placebo on days 4 and 11 or vice versa , given intravenously over a 60-min period before lunch : 10 received 2 μg kg−1 ( lower-dose ) ghrelin ; 11 received 8 μg kg−1 ( upper-dose ) ghrelin . Active and total ghrelin , growth hormone ( GH ) , and insulin-like growth factor 1 levels were monitored at baseline ( 4–5 days before day 1 ) , during treatment days , and at end of study ( day 17/18 ) . Drug-related adverse events ( assessed by NCI-CTC-toxicity criteria and cardiac examination ) did not differ between ghrelin and placebo . No grade 3/4 toxicity or stimulation of tumour growth was observed . The peak increase of GH , a biological marker of ghrelin action , was 25 ng ml−1 with lower-dose and 42 ng ml−1 with upper-dose ghrelin . Morning fasting total ghrelin levels were higher ( P ml−1 ) . Insulin-like growth factor 1 levels did not change . At day 8 , 81 % of patients preferred ghrelin to placebo as against 63 % at the end of study . Nutritional intake and eating-related symptoms , measured to explore preliminary efficacy , did not differ between ghrelin and placebo . Ghrelin is well tolerated and safe in patients with advanced cancer . For safety , tolerance , and patients ' preference for treatment , no difference was observed between the lower- and upper-dose group",
"Although the majority of circulating ghrelin originates from the stomach , no prospect i ve study of the proportion of ghrelin derived from the stomach has been reported . Patients with early gastric cancer who underwent gastric resection were divided into three groups according to the extent and site of gastric resection : subtotal gastrectomy group ( n = 24 ) , proximal gastrectomy group ( n = 4 ) , and total gastrectomy group ( n = 12 ) . Patients with advanced gastric cancer who underwent gastrojejunostomy without gastrectomy served as the bypass group ( n = 5 ) . Blood sample s were collected from all patients preoperatively , at 1 h after gastric resection or gastrojejunostomy , and on postoperative d 1 , 3 , and 7 . The plasma ghrelin level was determined in all sample s and expressed as a percentage of the preoperative level . In the bypass group , no significant drop in the ghrelin level was observed at 1 h after gastrojejunostomy , and the ghrelin level remained stable through postoperative d 7 . In the subtotal gastrectomy group , the ghrelin concentration reached a nadir of 38.8 + /- 12.9 % of preoperative levels at 1 h after gastric resection and then gradually increased to 88.1 + /- 13.2 % by postoperative d 7 . In the proximal gastrectomy group , the nadir ghrelin level was 24.5 + /- 15.4 % at 1 h after gastric resection and was followed by a gradual recovery . However , the recovery rate was slower than that in the subtotal gastrectomy group , with the ghrelin level reaching only 47.6 + /- 18.8 % by postoperative d 7 ( P nadir ghrelin level was 28.6 + /- 11.1 % at 1 h after gastric resection and remained at 30.0 + /- 13.2 % until postoperative d 7 . These results suggest that compensatory ghrelin production can occur in the remnant stomach after the surgical removal of part of the stomach and that the proximal fundus is more important than the distal antrum and body in terms of the capacity for ghrelin production . The principal site of ghrelin production is clearly the stomach , which contributes 70 % of the circulating ghrelin concentration",
"Ghrelin is a recently identified endogenous lig and for the GH secretagogue receptor and is involved in a novel system for regulating GH release . However , little is known about its GH-releasing activity and other endocrine effects in humans . To address this issue , we studied the GH , ACTH , cortisol , PRL , LH , FSH , and TSH responses to synthetic human ghrelin . In four normal male adults ( 28 - 37 yr ) , iv ghrelin administration released GH in a dose-dependent manner and 0.2 , 1.0 , and 5.0 microg/kg ghrelin produced 43.3 + /- 6.0 , 81.5 + /- 12.7 , and 107.0 + /- 10.7 ng/mL of the GH peak values at 30 min , respectively . ACTH , cortisol , and PRL levels were also elevated after ghrelin injection , while the lowest dose ( 0.2 microg/kg ) result ed in only minimum peak values of these hormones ( 22.8 + /- 3.0 pg/mL , 9.4 + /- 1.9 microg/dL , and 4.6 + /- 0.6 ng/mL , respectively ) . There were no significant changes in LH , FSH , or TSH levels . This is the first study showing evidence that ghrelin strongly stimulates GH release in humans",
"Ghrelin is a growth hormone-releasing peptide , discovered in 1999 by Kojima et al. Its potential role in inflammation and stress response is not yet clear . The purpose of this study was to characterize perioperative levels of circulating ghrelin in relation to different surgical procedures . The authors compared plasma ghrelin changes with cortisol , cytokines , and acute-phase proteins . The prospect i ve study was performed on 22 patients with resection for colon cancer ( group 1 ) . Group 2 , functioning as a comparative group , consisted of 22 patients with elective laparotomic cholecystectomy . Plasma concentrations of ghrelin , cortisol , tumor necrosis factor-alpha ( TNF-alpha ) , interleukin-1beta , IL-6 , IL-8 , soluble IL-2 receptor , C reactive protein , and alpha1-antitrypsin were estimated repeatedly during a 72-hour postoperative period . Data revealed significant elevation of plasma ghrelin 24 hours after resection of coli ( median 508.0 ng/l , interquartile range 398.2 - 633.7 ng/l ) in relation to both preoperative levels ( 317.6 ng/l , 253.4 - 355.1 ng/l , p Ghrelin levels returned to initial status 36 - 48 hours after surgery with subsequent decline to subnormal levels . The regression coefficient was the highest for ghrelin and TNF-alpha 24 hours after laparotomy ( r=0.64 , p ghrelin and IL-6 24 hours after surgery ( r=0.56 , p Maximal postoperative levels of all tested parameters except for cortisol and IL-1beta differed significantly between both patient groups at p ghrelin shows itself as an acute-phase reactant . The significant correlation between ghrelin and inflammatory cytokines supposes their regulatory role in this period . Our comparison of more- and less-invasive surgical procedures with similar nutritional restrictions argues for a dominant role of inflammatory factors in postoperative ghrelin elevation",
"Many studies have pointed out a possible role of gut peptides , including gastrin and ghrelin , in the pathogenesis and natural history of gastrointestinal malignancies , one of the most common death cause in the Western world . The objective of this work is to check gastrin and ghrelin serum levels in patients with colorectal cancer according to tumour 's location , stage , Helicobacter pylori infection and BMI , in order to underst and the two peptides ' behaviour through the tumour 's natural history and evaluate their assay 's use in research and clinical practice . Twenty-nine subjects affected by colorectal cancer and 50 healthy controls were studied . Circulating gastrin and ghrelin levels and H. pylori serum antibodies were assessed by radioimmunologic assay and ELISA method . Gastrin and ghrelin serum levels were respectively slightly higher and significantly lower in colon cancer patients than in controls . Gastrin levels were higher in patients carrying left colon cancer and H. pylori infection while ghrelin levels were lower in both these groups . Both hormones ' serum levels decreased from tumour earlier to later stages . Significant differences persisted in the correlation between BMI and ghrelin levels in controls but not in patients . Additional studies are necessary to ascertain the significance of gastrin and ghrelin opposite behaviour in colon cancer probably linked with interferences in endocrine pathways involving other gut peptides in this compromised condition",
"Patients with craniopharyngioma ( CP ) , an embryological tumor located in the hypothalamic and /or pituitary region , often suffer from uncontrolled eating and severe obesity . We aim ed to compare peripherally secreted hormones involved in controlling food intake in normal weight and obese children and adolescents with CP vs. controls . Plasma insulin , glucose , total ghrelin , and peptide-YY ( PYY ) levels were assessed under fasting conditions as well as 60 min after liquid mixed meal in four groups : Normal weight ( n = 12 ) and obese ( n = 15 ) CP patients , and 12 normal weight and 15 obese otherwise healthy BMI - , gender- and age-matched controls . Homeostasis model assessment of insulin resistance ( HOMA(IR ) ) , as well as quantitative insulin sensitivity check index ( QUICKI ) were calculated . Obese CP subjects had significantly higher HOMA(IR ) , higher baseline and postmeal insulin but lower ghrelin levels , weaker postmeal changes for PYY , and lower QUICKI compared to obese controls . QUICKI data from all CP patients correlated positively with ghrelin and PYY % postmeal changes ( ghrelin : r = 0.38 , P = 0.023 ; PYY r = 0.40 , P = 0.017 ) and negatively with st and ard deviation score- BMI ( SDS- BMI : r = -0.49 , P = 0.002 ) . Tumor growth of 87 % obese and 58 % of normal weight CP patients affected the hypothalamic area which was associated with higher SDS- BMI and weaker % postmeal ghrelin changes ( P = 0.014 ) compared to CP patients without hypothalamic tumor involvement . Blunted postmeal ghrelin and PYY responses in obese CP subjects are likely due to their higher degree of insulin resistance and lower insulin sensitivity compared to matched obese controls . Thus , insulin resistance in CP patients seems to affect eating behavior by affecting meal responses of gut peptides",
"Cisplatin reduces plasma ghrelin levels through the 5‐hydroxytryptamine ( 5‐HT ) receptor . This may cause cisplatin‐induced gastrointestinal disorders and hinders the continuation of chemotherapy . The authors of this report conducted a prospect i ve , r and omized phase 2 trial to evaluate the effects of exogenous ghrelin during cisplatin‐based chemotherapy",
"Ghrelin is a novel endogenous natural lig and for the growth hormone ( GH ) secretagogue receptor that has recently been isolated from the rat stomach . Ghrelin administration stimulates GH secretion but also causes weight gain by increasing food intake and reducing fat utilization in rodents . To investigate the possible involvement of ghrelin in the pathogenesis of human obesity , we measured body composition ( by dual X-ray absorption ) as well as fasting plasma ghrelin concentrations ( radioimmunoassay ) in 15 Caucasians ( 8 men and 7 women , 31+/-9 years of age , 92+/-24 kg body wt , and 29+/-10 % body fat , mean + /- SD ) and 15 Pima Indians ( 8 men and 7 women , 33+/-5 years of age , 97+/-29 kg body wt , and 30+/-8 % body fat ) . Fasting plasma ghrelin was negatively correlated with percent body fat ( r = -0.45 ; P = 0.01 ) , fasting insulin ( r = -0.45 ; P = 0.01 ) and leptin ( r = -0.38 ; P = 0.03 ) concentrations . Plasma ghrelin concentration was decreased in obese Caucasians as compared with lean Caucasians ( P fasting plasma ghrelin was lower in Pima Indians , a population with a very high prevalence of obesity , compared with Caucasians ( 87+/-28 vs. 129+/-34 fmol/ml ; P fasting plasma insulin concentration . There was no correlation between fasting plasma ghrelin and height . Prospect i ve clinical studies are now needed to establish the role of ghrelin in the pathogenesis of human obesity",
"OBJECTIVE Activation of ghrelin receptors stimulates GH secretion and appetite , increasing lean body mass and body weight . However , clinical use of ghrelin is limited because it has a short half-life and must be administered parenterally . Anamorelin is a novel , orally active , non-peptidic ghrelin mimetic and growth hormone secretagogue . Our objective was to evaluate its hormonal effects in healthy subjects . DESIGN A double-blind , r and omized , placebo-controlled study evaluated the short-term effects of anamorelin on GH , insulin-like growth factor-1 ( IGF-1 ) , insulin-like growth factor binding protein 3 ( IGFBP-3 ) , prolactin , ACTH , LH , FSH , TSH , cortisol , insulin and glucose . Normal healthy volunteers ( n=32 ) recruited from the general population were administered escalating doses of anamorelin ( 25 , 50 , and 75 mg daily ) vs. placebo . RESULTS Anamorelin significantly increased GH levels at all doses ( p IGF-1 and IGFBP-3 compared to placebo following 5 - 6 days of treatment . Negligible effects on other anterior pituitary hormone profiles and on fasting glucose were noted and all mean hormone levels remained within normal range . Some degree of insulin resistance as assessed by HOMA-IR was evident after treatment with 75 mg dose but not with the 25 or the 50 mg doses . Significant dose-related increases in body weight were recorded . Changes in body weight directly correlated with changes in IGF-1 levels . Anamorelin was well tolerated . CONCLUSIONS Anamorelin increases GH , IGF-1 , IGFBP-3 and body weight with good tolerability and selectivity , without affecting other anterior pituitary axes or fasting glucose levels"
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4116d080-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Absorption factors are required to convert physiologic requirements for iron into Dietary Reference Values , but the absorption from single meals can not be used to estimate dietary iron absorption . OBJECTIVE The objective was to conduct a systematic review of iron absorption from whole diets . DESIGN A structured search was completed by using the Medline , EMBASE , and Cochrane CENTRAL data bases from inception to November 2011 . Formal inclusion and exclusion criteria were applied , and data extraction , validity assessment , and meta-analyses were undertaken . RESULTS Nineteen studies from the United States , Europe , and Mexico were included . Absorption from diets was higher with an enhancer ( st and ard mean difference : 0.53 ; 95 % CI : 0.21 , 0.85 ; P = 0.001 ) and was also higher when compared with low-bioavailability diets ( st and ard mean difference : 0.96 ; 95 % CI : 0.51 , 1.41 ; P single inhibitors did not reduce absorption ( possibly because of the limited number of studies and participants and their heterogeneity ) . A regression equation to calculate iron absorption was derived by pooling data for iron status ( serum and plasma ferritin ) and dietary enhancers and inhibitors from 58 individuals ( all from US studies ): log[nonheme-iron absorption , % ] = -0.73 log[ferritin , μg/L ] + 0.11 [ modifier ] + 1.82 . In individuals with serum ferritin concentrations from 6 to 80 μg/L , predicted absorption ranged from 2.1 % to 23.0 % . CONCLUSIONS Large variations were observed in mean nonheme-iron absorption ( 0.7 - 22.9 % ) between studies , which depended on iron status ( diet had a greater effect at low serum and plasma ferritin concentrations ) and dietary enhancers and inhibitors . Iron absorption was predicted from serum ferritin concentrations and dietary modifiers by using a regression equation . Extrapolation of these findings to developing countries and to men and women of different ages will require additional high- quality controlled trials
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"BACKGROUND Research conducted before genotyping was possible suggested that subjects heterozygous for the genetic mutation associated with hemochromatosis absorbed nonheme iron more efficiently than did control subjects when tested with a fortified meal . Heme-iron absorption in these subjects has not been reported . OBJECTIVE We compared the absorption of heme and nonheme iron from minimally or highly fortified test meals between HFE C282Y-heterozygous and wild-type control subjects . DESIGN After prospect i ve genotyping of 256 healthy volunteers , 11 C282Y-heterozygous and 12 wild-type control subjects were recruited , and their iron absorption was compared by using a hamburger test meal with or without added iron and ascorbic acid . After retrospective genotyping of 103 participants in previous iron-absorption studies , 5 C282Y-heterozygous subjects were compared with 72 wild-type control subjects . RESULTS HFE C282Y-heterozygous subjects did not differ significantly from wild-type control subjects in their absorption of either heme or nonheme iron from minimally or highly fortified test meals . No differences were detected in blood indexes of iron status ( including serum ferritin , transferrin saturation , and non-transferrin-bound iron ) or in blood lipids or transaminases , but heterozygotes had significantly greater , although normal , fasting glucose concentrations than did wild-type control subjects . Compound heterozygotes ( those who had both HFE C282Y and H63D mutations ) absorbed more nonheme ( but not heme ) iron from meals with high ( but not low ) iron bioavailability . CONCLUSIONS HFE C282Y-heterozygous subjects did not absorb dietary iron more efficiently , even when foods were highly fortified with iron from ferrous sulfate and ascorbic acid , than did control subjects . Iron fortification of foods should not pose an additional health risk to HFE C282Y heterozygotes",
"The effect of inulin , fructooligosaccharides , and galactooligosaccharides on true intestinal absorption of iron and calcium was measured in men by using double stable-isotope techniques ( oral 57Fe and 44Ca and intravenous 58Fe and 48Ca ) . The incorporation of iron isotopes into erythrocytes and the urinary excretion of calcium isotopes was measured with an inductively coupled plasma mass spectrometer . Twelve healthy , nonanemic , male subjects aged 20 - 30 y received four treatments consisting of a constant basal diet supplemented with 15 g/d inulin , fructooligosaccharide , or galactooligosaccharide , or not supplemented ( control treatment ) . These four treatments were given for 21 d each according to a r and omized , crossover design . Iron absorption was measured over the last 7 d of treatment ( days 15 - 21 ) and calcium absorption was measured on day 21 of each treatment period . Mean ( + /- SEM ) iron absorption was 5.5 + /- 1.6 % , 6.1 + /- 1.9 % , 5.3 + /- 1.9 % , and 5.1 + /- 1.5 % , respectively , during treatment with inulin , fructooligosaccharide , galactooligosaccharide , or the control ; mean ( SEM ) calcium absorption was 25.8 + /- 2.3 % , 26.3 + /- 1.9 % , 26.3 + /- 2.6 % , and 28.1 + /- 4.3 % , respectively . None of the differences between treatments was significant . It is concluded that 15 g/d inulin , fructooligosaccharide , or galactooligosaccharide did not have a negative effect on iron and calcium absorption in young healthy men",
"BACKGROUND Short-term measurements of iron absorption are substantially influenced by dietary bioavailability of iron , yet bioavailability negligibly affects serum ferritin in longer , controlled trials . OBJECTIVE Our objective was to test the hypothesis that in men fed diets with high or low iron bioavailability , iron absorption adapts to homeostatically maintain body iron stores . DESIGN Heme- and nonheme-iron absorption from whole diets were measured in 31 healthy men at 0 and 10 wk while the men consumed weighed , 2-d repeating diets with either high or low iron bioavailability for 12 wk . The diets with high and low iron bioavailability contained , respectively , 14.4 and 15.3 mg nonheme Fe/d and 1.8 and 0.1 mg heme Fe/d and had different contents of meat , ascorbic acid , whole grains , legumes , and tea . RESULTS Adaptation occurred with nonheme- but not with heme-iron absorption . Total iron absorption decreased from 0.96 to 0.69 mg/d ( P iron bioavailability between the diets from 8- to 4-fold . Serum ferritin was insensitive to diet but fecal ferritin was substantially lower with the low- than the high-bioavailability diet . Erythrocyte incorporation of absorbed iron was inversely associated with serum ferritin . CONCLUSIONS Iron-replete men partially adapted to dietary iron bioavailability and iron absorption from a high-bioavailability diet was reduced to approximately 0.7 mg Fe/d . Short-term measurements of absorption overestimate differences in iron bioavailability between diets",
"BACKGROUND Single-meal studies have indicated that calcium inhibits iron absorption in humans . However , numerous dietary factors influence iron absorption , and the effect of calcium may not be as pronounced when calcium is served as part of a whole diet . OBJECTIVE We investigated the effect of 3 sources of calcium served with the 3 main meals on nonheme-iron absorption from a 4-d diet . DESIGN (59)Fe absorption was estimated from whole-body retention measurements in 14 women aged 21 - 34 y , each of whom consumed four 4-d diets in a r and omized crossover design . The diets differed in the source of calcium as follows : a basic diet ( BD ) with a low content of calcium ( 224 mg Ca/d ) , a BD with a glass of milk served at each meal ( 826 mg Ca/d ) , a BD with calcium lactate ( 802 mg Ca/d ) , and a BD with a milk mineral isolate containing calcium ( 801 mg Ca/d ) . The 2 latter calcium sources were added to selected foods of the BD ( rye bread , white bread , chocolate cake , and orange juice ) , and these foods were consumed with the 3 meals . All diets provided 13.2 mg Fe/d . RESULTS No significant differences in nonheme-iron absorption were found between the BD and the BD supplemented with milk , calcium lactate , or the milk mineral isolate [ 7.4 % ( 95 % CI : 5.3 % , 10.5 % ) , 5.2 % ( 3.5 % , 7.9 % ) , 6.7 % ( 5.0 % , 8.9 % ) , and 5.1 % ( 3.2 % , 7.9 % ) , respectively ; P = 0.34 ] . CONCLUSION Consumption of a glass of milk with the 3 main meals or of an equivalent amount of calcium from fortified foods does not decrease nonheme-iron absorption from a 4-d diet",
"The effect of ascorbic acid supplementation on apparent iron absorption was tested in women with low iron stores . For 10 wk , 25 healthy nonpregnant women , aged 20 - 45 y with low serum ferritin ( 3.5 - 17.7 micrograms/L ) , consumed either a diet with predicted poorly bioavailable iron or a typical Western diet , classified according to dietary meat and ascorbic acid contents . Meals were supplemented with ascorbic acid ( 500 mg , three times a day ) for 5 of the 10 wk , in a double-blind , crossover design . Ascorbic acid did not affect most biochemical indexes of iron status , the biological half-life of 59Fe , or apparent iron absorption ( diet-feces ) from either diet , but slightly increased serum ferritin ( 11.9 vs 10.7 micrograms/L , P ascorbic acid has less effect on iron bioavailability than has been predicted from tests with single meals",
"BACKGROUND Adaptation of iron absorption in response to dietary iron bioavailability is less likely in premenopausal women , who generally have lower iron stores , than in men . OBJECTIVE The objective of the study was to ascertain whether iron absorption in women adapts to dietary iron bioavailability and whether adaptation reflects altered absorptive efficiency or adjustment to specific inhibitors or enhancers of absorption . DESIGN Heme- and nonheme-iron absorption from either high- or low-bioavailability diets was measured at 0 and 10 wk in premenopausal women as they consumed one of the diets for 12 wk ( r and omized 2 x 2 factorial design ) . The high- and low-bioavailability diets contained similar amounts of total iron , as 13.1 and 14.8 mg/d nonheme and 2.0 and 0.3 mg/d heme iron , respectively , and they differed in contents of meat , ascorbate , whole grains , legumes , and tea . RESULTS In premenopausal women , the efficiency of nonheme-iron absorption ( P = 0.06 , two-tailed test ) , but not of heme-iron absorption , tended to adapt in response to a 12-wk difference in dietary iron bioavailability , whether absorption was tested with high- or low-bioavailability menus . Bioavailability , but not adaptation , substantially influenced total iron absorption ( approximately 6-fold ) . In contrast with iron absorption from the low-bioavailability diet , that from the high-bioavailability diet consistently was inversely associated with serum ferritin . CONCLUSION Only the high-bioavailability diet enabled women to absorb more iron in relation to their low iron stores . Women consuming the high-bioavailability diet absorbed up to 4.5 mg ( 30 - 35 % ) dietary iron with minimal influence of the diet consumed during the previous 10 wk",
"A study was conducted in healthy young women to measure and compare the availability of iron from cereal-based diets with and without milk by use of in vivo and in vitro methods . In vitro iron-bioavailability tests demonstrated that the amounts of soluble and ionizable iron in cereal-based diets were increased two- and three-fold , respectively , when milk was added . 54Fe , a stable isotope of iron , and fecal monitoring were used to determine iron absorption in eight young women . Iron absorption was higher with milk than without milk in seven of the eight subjects but did not differ significantly between the two treatments . The results suggest that in vivo and in vitro effects differ and that the absorption of iron from cereal-based diets is neither enhanced nor inhibited by the addition of milk",
"Recent studies based on radioiron measurements from single meals have suggested that calcium has a strongly inhibitory influence on nonheme-iron absorption . In view of evidence that the importance of various dietary enhancers and inhibitors of absorption is greatly diminished when assessed by labeling a complete diet , the present study evaluated the effect of variations in calcium intake on total dietary nonheme-iron absorption . Nonheme-iron absorption was measured in 14 healthy volunteers during three periods in which the diet was freely chosen or modified to decrease or increase dietary calcium intake maximally . The diet was labeled during each 5-d period by including with each of the two main meals of the day a small bread roll tagged extrinsically with radioiron . Carefully maintained dietary records indicated that 69 - 78 % of the daily iron intake was labeled by this method . The basal calcium intake of 684 mg/d varied from 280 to 1281 mg/d when calcium intake was reduced or increased , respectively . Geometric mean iron-absorption values of 5.01 % , 4.71 % , and 5.83 % for the three dietary periods were not significantly different from one another . No significant relation was observed between nonheme-iron absorption and dietary factors known to influence iron absorption . We conclude that calcium intake had no significant influence on nonheme-iron absorption from a varied diet",
"BACKGROUND The suggestion that carriers of the HFE C282Y mutation absorb nonheme iron more efficiently than do carriers of the wild type has public health implication s for countries where the C282Y mutation is common and foods are fortified with iron . OBJECTIVE We investigated the effect of C282Y heterozygosity on nonheme-iron absorption from a diet high in bioavailable iron and from iron-fortified cereals . DESIGN The subjects were recruited from a parallel study investigating the relation between HFE mutations , habitual diet , and iron status . Iron absorption was measured in 15 wild-type carriers and 15 C282Y heterozygotes aged > /=40 y. Each subject consumed 3 meals of high iron bioavailability ( labeled with Fe-57 ) for 2 d and 2 meals with fortified cereal products ( labeled with Fe-54 ) for the next 3 d. Iron absorption was measured from isotope incorporation into red blood cells 14 d after the last labeled meal and was corrected for utilization of absorbed iron by means of an intravenous infusion of Fe-58 . RESULTS Absorption of Fe-57 with the high-iron-bioavailability diet was 6.8 + /- 6.8 % ( 0.6 + /- 0.6 mg/d ) in the wild-type carriers and 7.6 + /- 3.2 % ( 0.7 + /- 0.3 mg/d ) in the C282Y heterozygotes . Absorption of Fe-54 with cereal products was 4.9 + /- 2.0 % ( 0.7 + /- 0.3 mg/d ) in the wild-type carriers and 5.3 + /- 1.3 % ( 0.8 + /- 0.2 mg/d ) in the C282Y heterozygotes . CONCLUSIONS There was no overall significant difference between C282Y heterozygotes and wild-type men in iron absorption from either dietary nonheme iron or fortified cereal products",
"Meat increases absorption of non-haem iron in single-meal studies . The aim of the present study was to investigate , over a 5 d period , the potential increasing effect of consumption of pork meat in a whole diet on the fractional absorption of non-haem iron and the total absorption of iron , when compared to a vegetarian diet . A r and omised cross-over design with 3 x 5 d whole-diet periods with diets containing Danish-produced meat , Polish-produced meat or a vegetarian diet was conducted . Nineteen healthy female subjects completed the study . All main meals in the meat diets contained 60 g of pork meat and all diets had high phytic acid content ( 1250 mumol/d ) . All main meals were extrinsically labelled with the radioactive isotope (59)Fe and absorption of iron was measured in a whole body counter . The non-haem iron absorption from the Danish meat diet was significantly higher compared to the vegetarian diet ( P=0.031 ) . The mean fractional absorption of non-haem iron was 7.9 ( se1.1 ) , 6.8 ( se 1.0 ) and 5.3 ( se 0.6 ) % for the Danish and Polish meat diets and vegetarian diet , respectively . Total absorption of iron was higher for both meat diets compared to the vegetarian diet ( Danish meat diet : P=0.006 , Polish meat diet : P=0.003 ) . The absorption ratios of the present study were well in accordance with absorption ratios estimated using algorithms on iron bioavailability . Neither the meat diets nor the vegetarian diets fulfilled the estimated daily requirements of absorbed iron in spite of a meat intake of 180 g/d in the meat diets",
"Fe absorption is affected by many dietary factors . The objective of the present study was to measure the effects of high v. low content of vitamin C , meat and phytic acid in whole diets with Fe-fortified bread on the efficacy of Fe absorption . Thirty-two healthy women with low Fe stores were r and omised to three groups , each of which was given two of six test diets containing either low/high amounts of vitamin C , meat or phytic acid , respectively , in a cross-over design . Each diet was served throughout a 5 d period . Fe-fortified rye bread , extrinsically labelled with (59)Fe , was given with all main meals . Fe absorption was determined from whole-body counter measurements of (59)Fe retention . The fractional non-haem Fe absorption ( corrected to a 40 % st and ard absorption by measurements from the reference dose ) was 1.9 % v. 3.4 % ( P=0.04 ) for the low/high vitamin C diets , 3.0 % v. 3.5 % ( P=0.58 ) on the low/high meat diets and 4.9 % v. 3.8 % ( P=0.24 ) on the low/high phytic acid diet , respectively . The total Fe absorbed ( geometric mean with st and ard error ) varied from 0.43 ( se 0.11 ) mg from the diet with lowest bioavailability to 1.09 ( se 0.18 ) mg from the diet with highest bioavailability ( P Fe absorption . In the diet with a low content of enhancers and a high content of inhibitors , vitamin C improved non-haem Fe absorption . The total Fe absorption varied 2.5-fold after small alterations of the content of enhancers and inhibitors in the diet",
"OBJECTIVE To vali date a new method of measuring iron absorption from the whole diet over several days , to compare iron absorption from two types of diets and to relate iron absorption to iron requirements and iron stores . DESIGN Iron absorption from two diets was studied in 21 healthy young women . All non-haem iron in all meals was labelled to the same specific activity with an extrinsic radio-labelled iron tracer . Haem iron absorption was calculated from the amount of haem iron and absorption from a reference dose of iron . RESULTS Iron absorption was concordant with individual iron requirements measured from menstrual blood losses and body weights . Total iron absorption from one diet design ed to be highly bioavailable , would cover iron requirements in about 94 % of menstruating women . Iron absorption was reduced by half from a diet with less meat , more phytate and more calcium with main meals . This type of diet would cover iron requirements in only 65 % of adult menstruating women . For both diets there was a marked reduction in iron absorption with increasing serum ferritin . Iron balance was not positive above a serum ferritin of about 60 micrograms/l . CONCLUSIONS Bioavailability of dietary iron is a key factor in iron nutrition . A diet with much lean meat , ascorbic acid and a low phytate content can cover iron requirements in most non-pregnant women . The powerful control of iron absorption implies that dietary iron overload can not develop in normal subjects , even with diets having high iron content or high bioavailability"
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4116d0bc-06ff-11f0-808a-c43d1ab1c353
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Background Prolonged sitting has been associated with musculoskeletal dysfunction . For desk workers , workstation modifications frequently address the work surface and chair . Chairs which can prevent abnormal strain of the neuromuscular system may aid in preventing musculo-skeletal pain and discomfort . Anecdotally , adjustability of the seat height and the seat pan depth to match the anthropometrics of the user is the most commonly recommended intervention . Within the constraints of the current economic climate , employers dem and evidence for the benefits attributed to an investment in altering workstations , however this evidence -base is currently unclear both in terms of the strength of the evidence and the nature of the chair features . The purpose of this study was to evaluate the evidence for the effectiveness of chair interventions in reducing workplace musculoskeletal symptoms . Methods Pubmed , Cinahl , Pedro , ProQuest , SCOPUS and PhysioFocus were search ed . ‘ Ergonomic intervention ’ , ‘ chair ’ , ‘ musculoskeletal symptoms ’ , ‘ ergonomics ’ , ‘ seated work ’ were used in all the data bases . Articles were included if they investigated the influence of chair modifications as an intervention ; participants were in predominantly seated occupations ; employed a pre/post design ( with or without control or r and omising ) and if the outcome measure included neuro-musculoskeletal comfort and /or postural alignment . The risk of bias was assessed using a tool based on The Cochrane H and book . Results Five studies were included in the review . The number of participants varied from 4 to 293 participants . Three of the five studies were R and omised Controlled Trials , one pre and post-test study was conducted and one single case , multiple baselines ( ABAB ) study was done . Three studies were conducted in a garment factory , one in an office environment and one with university students . All five studies found a reduction in self-reported musculoskeletal pain immediately after the intervention . Bias was introduced due to poor r and omization procedures and lack of concealed allocation . Meta- analysis was not possible due to the heterogeneity of the data ( differing population , intervention and outcomes across studies ) . Conclusion The findings of this review indicate a consistent trend that supports the role of a chair intervention to reduce musculoskeletal symptoms among workers who are required to sit for prolonged periods . However the amount , level and quality of the evidence are only moderate therefore we can not make strong recommendations until further trials are conducted . The review also highlights gaps : for example in showing whether the effectiveness of a chair intervention has long-term impact , particularly with respect to musculoskeletal symptoms , as well as the recurrence of symptoms and the consequent cost of care
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"A previous study defined sitting comfort and discomfort as independent entities associated with different factors : discomfort is related to biomechanics and fatigue factors , and comfort to a sense of well-being and aesthetics . In this study a checklist for evaluation of chair comfort and discomfort was analysed in two field studies . In the first study two groups of subjects , ten secretaries and ten managers , evaluated two groups of ten chairs . Subjects assessed each chair three times during a workday using three different types of scales . The results of a factor analysis reconfirmed the factor structure of comfort and discomfort . Analysis of variance demonstrated that discomfort was related to fatigue accumulated during the workday , but it was not related to chair design . There was no significant Chair x Time period interaction , which implies that the rank order of preference among a set of chairs was established during the first assessment and did not change during the day . In a second field study 37 secretaries used three different formats of a Chair Evaluation Checklist with 14 items . The results of a factor analysis again confirmed the factor structure of comfort and discomfort . Analyses of variance demonstrated that subjects can evaluate comfort and discomfort simultaneously without any halo-effect . The results have method ological implication s for measurement of comfort and discomfort . The findings for comfort , as defined , carry an important message that aesthetic design matters . This could provide a unifying focus for ergonomists and design ers",
"A prospect i ve epidemiological field study covering a 2 years period has earlier been published . The study has a parallel group design with two intervention groups ( T and S ) and one control group ( C ) of Visual Display Unit ( VDU ) operators . The present paper covers the period from 2 to 6 years of the study . After 3.5 years , the C group got the same intervention in terms of new lighting system , new workplaces and at last an optometric examination and corrections if needed . The C group reported a significant reduction in visual discomfort after interventions while the two groups ( T and S ) continued to report significant reduction of visual discomfort after 6 years . By supporting the forearm on the table top , the C group reported significant reduction of shoulder and neck pain while the T group reported significant reduction in shoulder and back pain after 6 years . Organizational and psychosocial factors at work and outside work did not show any significant changes during the study period",
"STUDY DESIGN A cross-sectional nonexperimental study . OBJECTIVES To determine the prevalence of musculoskeletal symptoms during a 6-month period and explore the contributing factors associated with these symptoms in Chinese senior class high school students . We also explored the relationship between psychological distress and musculoskeletal symptoms in this population . BACKGROUND Musculoskeletal symptoms with no underlying identifiable pathology are a management puzzle to medical professionals . Finding the prevalence of musculoskeletal symptoms is the first step in the prevention of further chronic pain syndromes in young adults . No study , however , has directly measured the prevalence of musculoskeletal symptoms in this population . Investigations of the contributing factors to these symptoms , though rare , can provide information to assist in the prevention of further injuries . METHODS The Musculoskeletal Symptom Question naire ( MSQ ) and the 12- question version of the Chinese Health Question naire ( CHQ-12 ) were r and omly distributed to students ( n = 550 ) in 4 different high schools in the Tainan area of Taiwan . Of these , 471 students returned the question naires for analysis . Descriptive statistics were computed for means , st and ard deviations , and frequencies . Chi-square statistics were used for analysis of the association between psychological distress and musculoskeletal symptoms . RESULTS The most frequent complaints of musculoskeletal symptoms among the adolescent Chinese student population were reported as being located in the following anatomical areas : neck ( 56 % ) , shoulder ( 45 % ) , and back ( 37 % ) . Based on the results from the CHQ-12 , all of the participants were divided into 2 groups : a high psychological ( CHQ-12 score > or = 5 ) and a low psychological ( CHQ-12 score prevalence of musculoskeletal symptoms between these 2 groups ( P musculoskeletal symptoms was high in this adolescent population and demonstrated a certain association with psychological distress . We suggest that surveys of this type may serve as pre clinical detectors of future musculoskeletal disorders and may permit early interventions . Developing an intervention that addresses both physical and psychological problems may be beneficial for this population",
"Eighty computer users with musculoskeletal disorders participated in a six-month , r and omized , placebo-controlled trial evaluating the effects of four computer keyboards on clinical findings , pain severity , functional h and status , and comfort . The alternative geometry keyboards tested were : the Apple Adjustable Keyboard ™ [ kb1 ] , Comfort Keyboard System ™ [ kb2 ] , Microsoft Natural Keyboard ™ [ kb3 ] and placebo . Compared to placebo , kb3 and to a lesser extent kb1 groups demonstrated an improving trend in pain severity and h and function following six months of keyboard use . However , there was no corresponding consistent improvement in clinical findings in the alternative geometry keyboard groups compared to the placebo group . Overall , there was a significant correlation between improvement of pain severity and greater satisfaction with the keyboards . These results provide evidence that keyboard users may experience a reduction in h and pain after several months of use of some alternative geometry keyboards",
"Study Design . This is a 4-month r and omized controlled trial to evaluate the effect of chair design on neck/shoulder pain among sewing machine operators . Objective . Determine whether a chair with a curved seat pan leads to improved changes in monthly neck/shoulder pain scores compared with a control intervention . Summary of Background Data . Sewing machine operators experience a high prevalence and severity of neck and shoulder pain in comparison to other working population s probably due to the sustained shoulder abduction and neck and upper back flexion required of the task . An adjustable height task chair that supports a forward sitting posture may reduce these posture-related risk factors and reduce neck/shoulder pain . Material s and Methods . A total of 277 sewing machine operators with neck/shoulder pain were assigned to receive 1 ) miscellaneous items ( control group ) , 2 ) a chair with a flat seat pan plus miscellaneous items , or 3 ) a chair with a curved seat pan plus miscellaneous items . Participants completed a monthly question naire assessing neck/shoulder pain severity . Results . Based on estimates of pain score changes from a repeat- measures linear regression , participants who received the flat seat chair experienced a decline in pain of 0.14 ( 95 % confidence interval , 0.07–0.22 ) points per month compared with those in the control group , while those who received the curved seat experienced a decline of 0.34 ( 95 % confidence interval , 0.28–0.41 ) points per month compared with those in the control group . These estimates did not change after adjustment for potential covariates . Conclusions . These findings demonstrate that an adjustable height task chair with a curved seat pan can reduce neck and shoulder pain severity among sewing machine operators",
"Objective : Determine whether an adjustable chair with a curved or a flat seat pan improved monthly back and hip pain scores in sewing machine operators . Methods : This 4-month intervention study r and omized 293 sewing machine operators with back and hip pain . The participants in the control group received a placebo intervention , and participants in the intervention groups received the placebo intervention and one of the two intervention chairs . Results : Compared with the control group , mean pain improvement for the flat chair intervention was 0.43 points ( 95 % CI = 0.34 , 0.51 ) per month , and mean pain improvement for the curved chair intervention was 0.25 points ( 95 % CI = 0.16 , 0.34 ) per month . Conclusions : A height-adjustable task chair with a swivel function can reduce back and hip pain in sewing machine operators . The findings may be relevant to workers who perform visual- and h and -intensive manufacturing jobs"
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4116d0f8-06ff-11f0-808a-c43d1ab1c353
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Background Our objectives were to critically appraise and summarise the current evidence for the effectiveness of using cardiovascular disease ( CVD ) risk scoring ( total risk assessment - TRA ) in routine risk assessment in primary prevention of CVD compared with st and ard care with regards to patients outcomes , clinical risk factor levels , medication prescribing , and adverse effects . Methods We carried out an overview of existing systematic review s ( SRs ) . Presentation of the results aligned guidelines from the PRISMA statement . The data is presented as a narrative synthesis . We search ed MEDLINE ( Ovid ) , EMBASE , CENTRAL and SCOPUS data bases from January 1990 to March 2017 , review ed the reference lists of all included SRs and search ed for ongoing SRs in PROSPERO data base . We encompassed SRs and meta-analyses which took into account RCTs , quasi- RCTs , and observational studies investigating the effect of using CVD risk scoring . Only studies performed in a primary care setting , with adult participants free of clinical CVD were eligible . Intervention was CVD risk assessment with use of the total CVD risk scoring compared with st and ard care with no use of TRA . Results We identified 2157 records , we then recognised and analysed 10 relevant SRs . One SR reported statistically insignificant reduction of CVD death , when using TRA , the second SR presented meta- analysis which reported no effect on fatal and non-fatal CV events compared with conventional care ( 5.4 % vs 5.3 % ; RR 1.01 , 95 % CI 0.95 to 1.08 ; I2 = 25 % ) . Three SRs have shown that using TRA causes no adverse events . The impact of TRA on global CVD risk as well as individual risk factors is ambiguous , but a tendency towards slight reduction of blood pressure , total cholesterol and smoking levels , especially in high risk patient groups was observed . TRA had no influence on lifestyle behaviour . Conclusions There is limited evidence , of low overall quality , suggesting a possible lack of effectiveness of TRA in reducing CVD events and mortality , as well as a clinical ly insignificant influence on individual risk factor levels . Using TRA does not cause harm to patients .Trial registration Systematic review protocol was registered with the International PROSPERO data base - registration number CRD42016046898
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[
"BACKGROUND Worldwide implementation of risk-based cardiovascular disease ( CVD ) prevention requires risk prediction tools that are contemporarily recalibrated for the target country and can be used where laboratory measurements are unavailable . We present two cardiovascular risk scores , with and without laboratory-based measurements , and the corresponding risk charts for 182 countries to predict 10-year risk of fatal and non-fatal CVD in adults aged 40 - 74 years . METHODS Based on our previous laboratory-based prediction model ( Globorisk ) , we used data from eight prospect i ve studies to estimate coefficients of the risk equations using proportional hazard regressions . The laboratory-based risk score included age , sex , smoking , blood pressure , diabetes , and total cholesterol ; in the non-laboratory ( office-based ) risk score , we replaced diabetes and total cholesterol with BMI . We recalibrated risk scores for each sex and age group in each country using country-specific mean risk factor levels and CVD rates . We used recalibrated risk scores and data from national surveys ( using data from adults aged 40 - 64 years ) to estimate the proportion of the population at different levels of CVD risk for ten countries from different world regions as examples of the information the risk scores provide ; we applied a risk threshold for high risk of at least 10 % for high-income countries ( HICs ) and at least 20 % for low-income and middle-income countries ( LMICs ) on the basis of national and international guidelines for CVD prevention . We estimated the proportion of men and women who were similarly categorised as high risk or low risk by the two risk scores . FINDINGS Predicted risks for the same risk factor profile were generally lower in HICs than in LMICs , with the highest risks in countries in central and southeast Asia and eastern Europe , including China and Russia . In HICs , the proportion of people aged 40 - 64 years at high risk of CVD ranged from 1 % for South Korean women to 42 % for Czech men ( using a ≥10 % risk threshold ) , and in low-income countries ranged from 2 % in Ug and a ( men and women ) to 13 % in Iranian men ( using a ≥20 % risk threshold ) . More than 80 % of adults were similarly classified as low or high risk by the laboratory-based and office-based risk scores . However , the office-based model substantially underestimated the risk among patients with diabetes . INTERPRETATION Our risk charts provide risk assessment tools that are recalibrated for each country and make the estimation of CVD risk possible without using laboratory-based measurements . FUNDING National Institutes of Health",
"Objective To develop and vali date version two of the QRISK cardiovascular disease risk algorithm ( QRISK2 ) to provide accurate estimates of cardiovascular risk in patients from different ethnic groups in Engl and and Wales and to compare its performance with the modified version of Framingham score recommended by the National Institute for Health and Clinical Excellence ( NICE ) . Design Prospect i ve open cohort study with routinely collected data from general practice , 1 January 1993 to 31 March 2008 . Setting 531 practice s in Engl and and Wales contributing to the national Q RESEARCH data base . Participants 2.3 million patients aged 35 - 74 ( over 16 million person years ) with 140 000 cardiovascular events . Overall population ( derivation and validation cohorts ) comprised 2.22 million people who were white or whose ethnic group was not recorded , 22 013 south Asian , 11 595 black African , 10 402 black Caribbean , and 19 792 from Chinese or other Asian or other ethnic groups . Main outcome measures First ( incident ) diagnosis of cardiovascular disease ( coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records or linked Office for National Statistics death certificates . Risk factors included self assigned ethnicity , age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol : high density lipoprotein cholesterol , body mass index , family history of coronary heart disease in first degree relative under 60 years , Townsend deprivation score , treated hypertension , type 2 diabetes , renal disease , atrial fibrillation , and rheumatoid arthritis . Results The validation statistics indicated that QRISK2 had improved discrimination and calibration compared with the modified Framingham score . The QRISK2 algorithm explained 43 % of the variation in women and 38 % in men compared with 39 % and 35 % , respectively , by the modified Framingham score . Of the 112 156 patients classified as high risk ( that is , ≥20 % risk over 10 years ) by the modified Framingham score , 46 094 ( 41.1 % ) would be reclassified at low risk with QRISK2 . The 10 year observed risk among these reclassified patients was 16.6 % ( 95 % confidence interval 16.1 % to 17.0%)—that is , below the 20 % treatment threshold . Of the 78 024 patients classified at high risk on QRISK2 , 11 962 ( 15.3 % ) would be reclassified at low risk by the modified Framingham score . The 10 year observed risk among these patients was 23.3 % ( 22.2 % to 24.4%)—that is , above the 20 % threshold . In the validation cohort , the annual incidence rate of cardiovascular events among those with a QRISK2 score of ≥20 % was 30.6 per 1000 person years ( 29.8 to 31.5 ) for women and 32.5 per 1000 person years ( 31.9 to 33.1 ) for men . The corresponding figures for the modified Framingham equation were 25.7 per 1000 person years ( 25.0 to 26.3 ) for women and 26.4 ( 26.0 to 26.8 ) for men ) . At the 20 % threshold , the population identified by QRISK2 was at higher risk of a CV event than the population identified by the Framingham score . Conclusions Incorporating ethnicity , deprivation , and other clinical conditions into the QRISK2 algorithm for risk of cardiovascular disease improves the accuracy of identification of those at high risk in a nationally representative population . At the 20 % threshold , QRISK2 is likely to be a more efficient and equitable tool for treatment decisions for the primary prevention of cardiovascular disease . As the validation was performed in a similar population to the population from which the algorithm was derived , it potentially has a “ home advantage . ” Further validation in other population s is therefore advised",
"Results are reported from a trial of multifactorial prevention of coronary heart disease ( CHD ) in occupational groups , involving r and omization of 66 factories to intervention and control ( 49,781 men ages 40 to 59 ) in the United Kingdom , Belgium , Italy , and Pol and . Net average reductions in the intervention factors were 1.2 % ( plasma cholesterol ) , 8.9 % ( daily cigarettes ) , 0.4 % ( weight ) , 2 % ( systolic blood pressure ) , and 11 % for a combined risk estimate . Reductions were larger in high-risk men ( 19 % for the combined estimate ) . Red blood cell fatty acid profiles were substantially changed . There was a net overall reduction of 7.4 % in fatal CHD and 2.7 % in total deaths . Benefits were larger in centers achieving larger risk factor reductions , and in one country -- Belgium -- the net decreases in CHD incidence and total deaths were significant at the 5 % level . Benefit was at least as great in men with established ECG abnormality . It is concluded that CHD risk in middle-aged men seems to be reducible by simple and cost-effective means",
"The Cochrane Data base of Systematic Review s ( CDSR ) evolved in response to Archie Cochrane 's challenge to the medical profession to assemble \" a critical summary , adapted periodically , of all ... relevant r and omized controlled trials \" . CDSR has been an electronic publication from its inception and this has meant that Cochrane review s ( i ) need not be constrained by lack of space ; ( ii ) can be up date d as new information becomes available and when mistakes or other ways of improving them are identified ; and ( iii ) can be cross-linked to other , related sources of relevant information . Although CDSR has become widely cited , it must continue to evolve in the light of technological and method ological developments , and in response to the needs of people making decisions about health care",
"Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level . Design R and omised controlled community based trial . Setting Suburbs of Copenhagen , Denmark Participants 59 616 people aged 30 - 60 years r and omised with different age and sex r and omisation ratios to an intervention group ( n=11 629 ) and a control group ( n=47 987 ) . Intervention The intervention group was invited for screening , risk assessment , and lifestyle counselling up to four times over a five year period . All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits ( at baseline and after one and three years ) ; those at high risk of ischaemic heart disease , according to predefined criteria , were furthermore offered six sessions of group based lifestyle counselling on smoking cessation , diet , and physical activity . After five years all were invited for a final counselling session . Participants were referred to their general practitioner for medical treatment , if relevant . The control group was not invited for screening . Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group . Secondary outcome measures were stroke , combined events ( ischaemic heart disease , stroke , or both ) , and mortality . Results 6091 ( 52.4 % ) people in the intervention group participated at baseline . Among 5978 people eligible at five year follow-up ( 59 died and 54 emigrated ) , 4028 ( 67.4 % ) attended . A total of 3163 people died in the 10 year follow-up period . Among 58 308 without a history of ischaemic heart disease at baseline , 2782 developed ischaemic heart disease . Among 58 940 without a history of stroke at baseline , 1726 developed stroke . No significant difference was seen between the intervention and control groups in the primary end point ( hazard ratio for ischaemic heart disease 1.03 , 95 % confidence interval 0.94 to 1.13 ) or in the secondary endpoints ( stroke 0.98 , 0.87 to 1.11 ; combined endpoint 1.01 , 0.93 to 1.09 ; total mortality 1.00 , 0.91 to 1.09 ) . Conclusion A community based , individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease , stroke , or mortality at the population level after 10 years . Trial registration Clinical trials NCT00289237",
"The Multiple Risk Factor Intervention Trial was a r and omized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease ( CHD ) in 12,866 high-risk men aged 35 to 57 years . Men were r and omly assigned either to a special intervention ( SI ) program consisting of stepped-care treatment for hypertension , counseling for cigarette smoking , and dietary advice for lowering blood cholesterol levels , or to their usual sources of health care in the community ( UC ) . Over an average follow-up period of seven years , risk factor levels declined in both groups , but to a greater degree for the SI men . Mortality from CHD was 17.9 deaths per 1,000 in the SI group and 19.3 per 1,000 in the UC group , a statistically nonsignificant difference of 7.1 % ( 90 % confidence interval , -15 % to 25 ) . Total mortality rates were 41.2 per 1,000 ( SI ) and 40.4 per 1,000 ( UC ) . Three possible explanations for these findings are considered : ( 1 ) the overall intervention program , under these circumstances , does not affect CHD mortality ; ( 2 ) the intervention used does affect CHD mortality , but the benefit was not observed in this trial of seven years ' average duration , with lower-than-expected mortality and with considerable risk factor change in the UC group ; and ( 3 ) measures to reduce cigarette smoking and to lower blood cholesterol levels may have reduced CHD mortality within subgroups of the SI cohort , with a possibly unfavorable response to antihypertensive drug therapy in certain but not all hypertensive subjects . This last possibility was considered most likely , needs further investigation , and lends support to some preventive measures while requiring re assessment of others",
"Objectives : The SCORE model predicts the ten-year risk of cardiovascular mortality but it is still unknown whether applying the SCORE in clinical practice subsequently improves cardiovascular disease ( CVD ) outcomes . The objective of this study is to assess the effect of total cardiovascular risk estimation using the SCORE in preventing serious cardiovascular events in European adults without prior CVD . Methods and results : Data sources : eight bibliographical data bases ( 2003 – August 2015 ) , other internet sources and reference lists of articles were checked . This was supplemented by contact with the board members of the European Society of Cardiology ( ESC ) and the authors of the SCORE model . Study eligibility criteria : all prospect i ve studies in any language investigating the effect of using the SCORE on the clinical outcome ( CVD death , major events and adverse outcomes ) in an adult population were examined . Two review ers assessed the studies independently ( titles , abstract s , full texts ) . After removal of duplicates , 5,256 records were screened and 14 full text papers considered . No eligible studies were identified . An extensive literature search revealed no r and omized control trial or other prospect i ve study comparing significant clinical outcomes between groups that used the SCORE and those who did not . Conclusions : The effect of using the SCORE ( with or without subsequent intervention ) on CVD death , all-cause mortality , major CVD events like myocardial infa rct ion and stroke , as well as adverse outcomes , is still unknown . A cluster r and omised controlled trial is warranted to evaluate the use of the SCORE on important outcomes",
"To assess the combined influence of blood pressure ( BP ) , serum cholesterol level , and cigarette smoking on death from coronary heart disease ( CHD ) and to describe how these associations vary with age , data on those factors and on mortality for 316,099 men screened for the Multiple Risk Factor Intervention Trial ( MRFIT ) were examined . Vital status of participants has been determined after an average follow-up of 12 years ; 6327 deaths from CHD have been identified . Strong grade d relationships between serum cholesterol levels above 4.65 mmol/L ( 180 mg/dL ) , systolic BP above 110 mm Hg , and diastolic BP above 70 mm Hg and mortality due to CHD were evident . Smokers with serum cholesterol and systolic BP levels in the highest quintiles had CHD death rates that were approximately 20 times greater than nonsmoking men with systolic BP and cholesterol levels in the lowest quintile . Systolic and diastolic BP , serum cholesterol level , and cigarettes per day were significant predictors of death due to CHD in all age groups . Systolic BP was a stronger predictor than diastolic BP . These results , together with the findings of clinical trials , offer strong support for intensified preventive efforts in all age groups"
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4116d134-06ff-11f0-808a-c43d1ab1c353
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INTRODUCTION This systematic review aims to illustrate the outcome of vital pulp therapy , namely direct pulp capping , partial pulpotomy , and full pulpotomy , in vital permanent teeth with cariously exposed pulp . METHODS Electronic data base MEDLINE via Ovid , PubMed , and Cochrane data bases were search ed . H and search ing was performed through reference lists of endodontic textbooks , endodontic-related journals , and relevant articles from electronic search ing . The r and om effect method of weighted pooled success rate of each treatment and the 95 % confidence interval were calculated by the DerSimonian-Laird method . The weighted pooled success rate of each treatment was estimated in 4 groups : > 6 months-1 year , > 1 - 2 years , > 2 - 3 years , and > 3 years . All statistics were performed by STATA version 10 . The indirect comparison of success rates for 4 follow-up periods and the indirect comparison of clinical factors influencing the success rate of each treatment were performed by z test for proportion ( P success rate was in the range of 72.9%-99.4 % . The fluctuation of the success rate of direct pulp capping was observed ( > 6 months-1 year , 87.5 % ; > 1 - 2 years , 95.4 % ; > 2 - 3 years , 87.7 % ; and > 3 years , 72.9 % ) . Partial pulpotomy and full pulpotomy sustained a high success rate up to more than 3 years ( partial pulpotomy : > 6 months-1 year , 97.6 % ; > 1 - 2 years , 97.5 % ; > 2 - 3 years , 97.6 % ; and > 3 years , 99.4 % ; full pulpotomy : > 6 months-1 year , 94 % ; > 1 - 2 years , 94.9 % ; > 2 - 3 years , 96.9 % ; and > 3 years , 99.3 % ) . CONCLUSIONS Vital permanent teeth with cariously exposed pulp can be treated successfully with vital pulp therapy . Current best evidence provides inconclusive information regarding factors influencing treatment outcome , and this emphasizes the need for further observational studies of high quality
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"PURPOSE The purpose of this study was to compare mineral trioxide aggregate ( MTA ) with calcium hydroxide ( Ca(OH)2 ) clinical ly and radiographically as a pulpotomy agent in immature permanent teeth ( apexogenesis ) . METHODS Fifteen children , each with at least 2 immature permanent teeth requiring pulpotomy ( apexogenesis ) , were selected for this study . All selected teeth were evenly divided into 2 test groups . In group 1 , the conventional Ca(OH)2pulpotomy ( control ) was performed , whereas in group 2 , the MTA pulpotomy ( experimental ) was done . The children were recalled for clinical and radiographic evaluations after 3 , 6 , and 12 months . RESULTS The follow-up evaluations revealed failure due to pain and swelling detected at 6 and 12 months postoperative evaluations in only 2 teeth treated with Ca(OH)2 . The remaining 28 teeth appeared to be clinical ly and radiographically successful 12 months postoperatively . Calcific metamorphosis was a radiographic finding in 2 teeth treated with Ca(OH)2 and 4 teeth treated with MTA . CONCLUSIONS Mineral trioxide aggregate showed clinical and radiographic success as a pulpotomy agent in immature permanent teeth ( apexogenesis ) and seems to be a suitable alternative to calcium hydroxide",
"Three intermediary base material s , a zinc oxide-eugenol ( Cavitec ) and two calcium hydroxide liners ( Life and Dycal ) , were selected at r and om for use as a base beneath amalgam or composite restorations on humans following complete caries removal . Life and Dycal , selected at r and om , were also used as direct and indirect pulp capping agents as clinical ly indicated . Clinical evaluations of signs and symptoms were made before treatment and at one-week , six-month , and one-year intervals following treatment . Histological evaluations were performed on three complete caries removal teeth and 18 direct pulp capping teeth six months following treatment . No significant differences in clinical symptomatology result ed between the material s in the complete caries removal group or the indirect and direct pulp capping groups",
"In a prospect i ve study , partial pulpotomy was performed on six permanent molars with deep carious lesions and pulpal involvement . The bleeding pulp was irrigated with normal tap water until bleeding had stopped and the exposed pulp was covered with calcium hydroxide followed by zinc oxide eugenol , and finally covered with a semipermanent restoration . All teeth showed hard tissue barrier formation , both clinical ly and radiographically , within three months and were free from subjective and objective symptoms through the observation period ( average observation period was 26 months ) . The patients also experienced the therapy positively . These findings and those of others have helped gain more recognition for partial pulpotomy as a strong possible alternative therapy when pulps are exposed by deep carious lesions and a bleeding pulp is exposed during the excavation process . The rationale for this therapy is to remove the infected and /or inflamed pulpal areas beneath the carious lesion and disintegrated tissue . A rapid and simplified procedure would allow the general practitioner to perform this procedure when necessary at dental clinics , without specialist facilities under conditions that avoid unnecessary contamination of the pulp",
"Diseases of the dental pulp often have an infectious origin , and treatments are aim ed to control infections of the root canal system . Endodontic treatment principles originally evolved on the basis of trial and error , and only in recent decades have scientific methods been adopted to support clinical strategies . Yet , relevant research on the disease processes , their diagnoses , and efficient treatment are rare in the endodontic literature . Hence , the advancement of biologically based knowledge significant to clinical endodontics has been slow . Therefore , many differences of opinion still prevail in this field of dentistry . This review highlights and analyzes the background of some of the more heavily debated issues in recent years . Specifically , it deals with disagreements regarding the clinical management of pulpal exposures by caries in the adult dentition , definitions of success and failure of endodontic therapy , and causes of and measures to control infections of the root canal system . Clearly , a most apparent gap in the published endodontic literature is the lack of r and omized clinical trials that address the more significant controversial matters relating to the management of pulpal wounds , medication , and the number of appointments required for the treatment of infected root canals . However , trials in endodontics require extremely long follow-up periods if valid conclusions are to be generated . Therefore , it is not to be expected that there will be rapid solutions to these issues in the foreseeable future",
"After 2 yrs ' follow-up , mineral trioxide aggregate ( MTA ) appeared suitable for this purpose",
"UNLABELLED Carious pulp exposure in permanent molars of children is a common incident . Mineral trioxide aggregate is a new material that possesses numerous exciting possibilities for pulp therapy . AIM The purpose of this study was to evaluate the efficiency of MTA as a direct pulp capping agent in young permanent teeth . METHODS Thirty asymptomatic permanent molars with pulp exposures were treated by pulp capping using MTA . At each recall ( 6 12 , 18 and 24 months ) , the teeth were assessed clinical ly , through pulpal sensitivity tests , as well as radiographically to evaluate periapical healing . RESULTS None of the cases reported spontaneous pain at the six months follow up and the pulp showed signs of vitality and absence of periapical radiolucency . At 24 months , the clinical and radiographic success rate was 93 % with evidence of continued root growth . CONCLUSION Pulp capping with MTA is recommended for teeth with carious pulp exposures specially immature teeth with high potential for healing",
"Aim : To prospect ively compare the clinical success rate of partial pulpotomy treatment in permanent molars using calcium hydroxide ( CH ) and mineral trioxide aggregates ( MTA ) as pulp dressing agents . Methods : Restorable permanent first molars ( 64 ) with carious pulp exposures were r and omly assigned to two groups ; CH and MTA . A st and ardized operative procedure was followed in both groups . Following isolation and caries removal , the exposed superficial pulp tissue layers were removed with a sterile flame shape diamond bur to a depth of 2–4 mm . Bleeding was controlled and pulp dressed with either a paste of non- setting Ca(OH)2 followed by a setting layer of Ca(OH)2 , or with grey MTA . The dressing material s in both groups were then covered with a layer of light cured glass ionomer cement . The teeth were either restored using amalgam , or where grossly carious with preformed metal crowns . Patients were scheduled for follow-up at 3 , 6 , 12 months and annually thereafter . Results : There were 34 patients ( 17 males and 17 females ) with 51 teeth available for evaluation . The age of patients at the time of restoration ranged between 6.8 to 13.3 years ( mean of 10.3 ±1.8 years ) . The follow-up period ranged from 25.4 to 45.6 months with an average of 34.8 ± 4.4 months . There was no statistically significant difference in the success rate of teeth treated with CH ( 91 % ) in comparison to teeth treated with MTA ( 93 % ) . Radiographically , a hard tissue barrier under CH was noticed in 12 ( 55 % ) teeth compared with 18 ( 64 % ) teeth under MTA ( p=0.4 ) . Conclusions : MTA has clinical success rate comparable to CH as a pulp dressing material for partial pulpotomy in permanent molars with carious",
"Direct pulp capping of carious-exposed pulp was performed on 44 teeth . We evaluated the success rates of these cases , and analyzed the relationships between the success rates and their clinical findings . Furthermore , we examined the length of time necessary for adequate postoperative follow-up . The success rate in this study was 81.8 % . Age of the patients , type of teeth , responses to thermal stimuli and percussion , and the diameter of pulpal exposure had no bearing on the success rate . However , the degree of bleeding on pulpal exposure was related to the success rate ( p = 0.042 ) . The success rates of cases in which postoperative follow-up periods were 3 to 18 months were similar ( 80 to 83 % ) , whereas those with follow-up for 21 months ( 91.7 % ) and 24 months ( 100 % ) showed higher success rates . These results showed that direct pulp capping was applicable to carious-exposed pulp , and the degree of bleeding is indicative of the prognosis of this treatment . The length of time necessary for adequate postoperative follow-up was suggested to be 21 months",
"AIM The purpose of this study was to evaluate clinical ly and radiographically pulpotomies carried out under intrapulpal injection of anaesthetic solution . METHODOLOGY Forty-one permanent m and ibular molar teeth presenting with deep carious lesions and /or exposed pulps , with or without periapical changes on radiographic examination , were treated with pulpotomy and dressed with calcium hydroxide . The teeth were divided into three groups . Group A consisted of 15 teeth , where intrapulpal anaesthesia was administered by a slow injection of lidocaine hydrochloride 2 % . Group B , with 14 teeth , where intrapulpal anaesthesia was obtained with lidocaine hydrochloride 2 % with adrenaline 1:100,000 . Group C consisted of 12 teeth in which anaesthesia was performed with a m and ibular block using prilocaine hydrochloride 3 % with felypressin 1 : 100,000 . Healing was evaluated using clinical and radiographic criteria : dentine barrier formation , absence of clinical symptoms and resolution of periapical involvement . RESULTS After an observation time of 6 - 8 weeks ( postoperative control ) and 24 - 32 weeks ( intermediate control ) , healing occurred in 13 teeth from group A ( 87 % ) , in 11 teeth from group B ( 79 % ) and in 10 teeth from group C ( 83 % ) . No statistical difference was demonstrated between the three groups ( Fisher 's exact test ) . CONCLUSIONS Based on the methodology adopted , intrapulpal injection of anaesthetic solution did not impair healing in pulpotomized teeth",
"OBJECTIVE The aim of this study was to investigate the clinical performance and survival of stainless steel crown ( SSC ) restoration and modified open-s and wich technique using resin-modified glass ionomer cement . DESIGN R and omized clinical trial . SETTING General dental practice . MATERIAL S AND METHODS A total of 87 children aged 4 - 7 years at baseline with one or more primary molars that have undergone pulp therapy were r and omly assigned to receive either SSC or modified open-s and wich restoration . One hundred and sixty restorations were placed and evaluated after 6 , 12 , 18 , and 24 months using the Ryge criteria . RESULTS Comparable survival rates were observed for both SSC and modified open-s and wich restoration . With only four SSCs and six modified open-s and wich restorations failing over 24 months , the survival rates were high for both material s ( 2-year survival rate : 95.0 % for SSCs and 92.5 % for modified open-s and wich restorations ) . Significantly better gingival health ( P restorations compared with SSCs , as only one modified open-s and wich restoration was rated Charlie compared to 13 SSCs . No significant differences were observed between the two material s for marginal integrity , proximal contact , occlusion , or recurrent caries . CONCLUSION The 2-year results indicated that the modified open-s and wich restoration is an appropriate alternative to SSC in extensive restorations , particularly where aesthetic considerations are important"
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BACKGROUND Surgery remains the best curative option for appropriately selected patients with lung cancer . Evidence suggests that improving cardiovascular fitness and functional capacity can accelerate post-surgery recovery and reduce mortality . However , the effect of exercise intervention for patients surgically treated for Non-Small Cell Lung Cancer [ NCSLC ] has not been fully examined . PURPOSE This review examines the literature regarding exercise intervention for patients who are surgically treated for NSCLC focussing on three key areas : method ological quality , intervention design ( e.g. duration , frequency , type ) and outcomes measured . METHODS A search of Medline , EMBASE , CINAHL and PsychINFO was undertaken . R and omised Controlled Trials [ RCTs ] and non- RCTs including exercise training pre or post lung cancer resection were included . Descriptive characteristics were extracted and method ological quality assessed using Downs and Black appraisal checklist . RESULTS Twenty studies ( eight RCT 's ) were included : nine pre-surgical , nine post-surgical and two pre to post-surgical . The quality of evidence is question able with many limitations ( e.g. small sample s , inadequate allocation concealment and a lack of clear reporting on timing , adverse events and follow-up ) . Regarding design of exercise intervention and outcomes measured , there was much variation between studies producing a disparate set of data . An optimal programme is still to be determined ; however , suggestions are made relating to type of exercise ( i.e. mixing aerobic , resistance and breathing exercises ) . Preliminary work from this review suggests that exercise intervention compared with usual care both pre and post-surgery is associated with improved cardiopulmonary exercise capacity , increased muscle strength and reduced fatigue , post-operative complications and hospital length of stay . Results concerning pulmonary function , quality of life , and blood gas analysis were variable and inconsistent . CONCLUSION In order to implement exercise intervention appropriate for patients surgically treated for NCSLC , more high quality r and omised controlled trials are required and more work concerning feasibility , acceptability and effectiveness of specific interventions on outcomes is warranted
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"STUDY OBJECTIVES Surgical resection remains the treatment of choice for anatomically resectable non-small cell lung cancer . However , the presence of associated comorbid conditions increases the risk of death and surgical complications . Several studies have evaluated the usefulness of preoperative exercise testing for predicting postoperative morbidity and mortality . The aim of this study was to establish whether exercise testing could predict poor surgical outcome in lung cancer surgery and whether the absolute value or percentage of predicted value is the better predictor of the surgical outcome . DESIGN The study was design ed as a prospect i ve study . PATIENTS AND SETTING One hundred thirty patients with potentially operable lung cancer at Papworth Hospital over 2 years were recruited ; of these , 101 underwent curative surgery . INTERVENTIONS Spirometry and cardiopulmonary exercise tests were performed for every patient ( n = 99 ) , except for two patients with back problems . We also recorded the outcome of surgery , in particular , complications and mortality . MEASUREMENTS AND RESULTS Mean maximum oxygen transport at peak exercise ( Vo(2)peak ) was 18.3 mL/kg/min ( SD , 4.7 mL/kg/min ) , and mean percentage of predicted Vo(2)peak value was 84.4 % ( SD , 30 % ) . Poor surgical outcome was significantly related to Vo(2)peak percentage of predicted ( p actual oxygen uptake value . CONCLUSIONS The use of the percentage of predicted Vo(2)peak value would be a better indicator of surgical outcome , since it predicts the surgical outcome better , and corrects for normal physiologic ranges . The threshold of Vo(2)peak for surgical intervention could be set between 50 % and 60 % of predicted without excess surgical mortality",
"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",
"Purpose It has not previously been shown whether there is any benefit to multi-morbid patients with lung cancer who participate in complex interdisciplinary rehabilitation programmes after primary therapy . The purpose of this prospect i ve study was to assess changes in exercise capacity and quality of life before and after an in-patient training programme . Patients and methods Forty-five patients with lung cancer ( WHO I-III after surgery and /or radiotherapy and /or chemotherapy ) were enrolled in a 28-day in-patient rehabilitation programme that included st and ardised aerobic training . Functional status and health-related quality of life ( QLQ-C30 , QLQ-LC13 , SF-36 , and MFI-20 ) were examined at the beginning of the study and at day 28 . Results A substantial increase in work performance ( bicycle ergometry from 68 ± 3 to 86 ± 4 W , p addition , heart rate at rest was reduced ( from 84 ± 2 to 80 ± 1 beats per minute , p ( indicator of the efficacy of endurance training ) was significantly increased ( from 9.7 ± 1 to 12.9 ± 1 root mean square of successive differences , p improvement in quality of life ( 48 ± 3 to 62 ± 2 , p fatigue was reduced from 66 ± 3 to 41 ± 4 , p patients with lung cancer results in improvements in both physiological and psychological parameters after therapy . A follow-on study in order to determine to what extent this benefit persists over the long-term , particularly , in comparison with patients who have not participated in a rehabilitation programme , is currently being conducted",
"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",
" The effects of endurance training on exercise capacity and health-related quality of life ( HRQL ) in chronic obstructive pulmonary disease ( COPD ) patients have been studied thoroughly , while resistance training has been rarely evaluated . This study investigated the effects of resistance training in comparison with endurance training in patients with moderate to severe COPD and peripheral muscle weakness ( isometric knee extension peak torque ) . Forty-eight patients ( age 64±8 yrs , forced expiratory volume in one second 38±17 % pred ) were r and omly assigned to resistance training ( RT , n=24 ) or endurance training ( ET , n=24 ) . The former consisted of dynamic strengthening exercises . The latter consisted of walking , cycling and arm cranking . Respiratory and peripheral muscle force , exercise capacity , and HRQL were re-evaluated in all patients who completed the 12-week rehabilitation ( RT n=14 , ET n=16 ) . Statistically significant increases in knee extension peak torque ( RT 20±21 % , ET 42±21 % ) , maximal knee flexion force ( RT 31±39 % , ET 28±37 % ) , elbow flexion force ( RT 24±19 % , ET 33±25 % ) , 6-min walking distance ( 6MWD ) ( RT 79±74 m , ET 95±57 m ) , maximum workload ( RT 15±16 Watt , ET 14±13 Watt ) and HRQL ( RT 16±25 points , ET 16±15 points ) were observed . No significant differences in changes in HRQL and 6MWD were seen between the two treatments . Resistance training and endurance training have similar effects on peripheral muscle force , exercise capacity and health-related quality of life in chronic obstructive pulmonary disease patients with peripheral muscle weakness",
"Our aim was to determine the minimal important difference ( MID ) for 6-min walk distance ( 6MWD ) and maximal cycle exercise capacity ( MCEC ) in patients with severe chronic obstructive pulmonary disease ( COPD ) . 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4–6 weeks of pre-trial rehabilitation , and 6 months after r and omisation to surgery or medical care . The St George 's Respiratory Question naire ( domain and total scores ) and University of California San Diego Shortness of Breath Question naire ( total score ) served as anchors for anchor-based MID estimates . In order to calculate distribution-based estimates , we used the st and ard error of measurement , Cohen 's effect size and the empirical rule effect size . Anchor-based estimates for the 6MWD were 18.9 m ( 95 % CI 18.1–20.1 m ) , 24.2 m ( 95 % CI 23.4–25.4 m ) , 24.6 m ( 95 % CI 23.4–25.7 m ) and 26.4 m ( 95 % CI 25.4–27.4 m ) , which were similar to distribution-based MID estimates of 25.7 , 26.8 and 30.6 m. For MCEC , anchor-based estimates for the MID were 2.2 W ( 95 % CI 2.0–2.4 W ) , 3.2 W ( 95 % CI 3.0–3.4 W ) , 3.2 W ( 95 % CI 3.0–3.4 W ) and 3.3 W ( 95 % CI 3.0–3.5 W ) , while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26±2 m for 6MWD and 4±1 W for MCEC for patients with severe COPD",
"STUDY OBJECTIVES Although the benefit of pulmonary rehabilitation ( PR ) has been demonstrated for patients with COPD , the benefit for patients with non- COPD lung disorders is still unclear . In the present study , we compared the effect of PR on patients with post-tuberculosis ( TBC ) lung disorders and patients with COPD . DESIGN We performed a prospect i ve nonr and omized open trial over a 9-week period . PATIENTS AND METHODS Thirty-two patients with post-TBC lung disorders ( thoracoplasty , 25 patients ; mean [ + /- SD ] age , 71 + /- 5 years ; FEV(1 ) , 0.84 + /- 0.29 L ) and 32 age-matched and FEV(1)-matched COPD patients were enrolled in the study . First , we compared the exercise tolerance between groups using a 6-min walking test . Next , we trained the patients using a 9-week outpatient PR program . We assessed improvement using clinical dyspnea ratings , a daily activity score , and the results of a 6-min walking test . RESULTS When age and FEV(1 ) were matched , the distance covered during the 6-min walking test did not differ between the groups . After rehabilitation , significant improvement was observed in both the post-TBC group and the COPD group in terms of Medical Research Council dyspnea grade , transition dyspnea index , activity score , and 6-min walking distance ( 42 m [ p PR is as beneficial in post-TBC lung disorder patients as in COPD patients if the severity of the disability is similar",
"Deterioration in exercise tolerance and impairment in quality of life ( QoL ) are common consequences of lobectomy . This study evaluates additional exercise and strength training after lung resection on QoL , exercise tolerance and muscle strength . Fifty-three ( 28 male ) patients attending thoracotomy for lung cancer , mean age , range 64 ( 32 - 82 ) years ; mean pack years ( SD ) 31.9 ( 26.8 ) ; BMI 25.6 ( 4.2 ) ; FEV1 2.0 ( 0.7 ) l were r and omised to control ( usual care ) or intervention ( twice daily training plus usual care ) . After discharge the intervention group received monthly home visits and weekly telephone calls , the control group received monthly telephone calls up to 12 weeks . Assessment pre-operatively , 5 day and 12 weeks post-operatively consisted of quadriceps strength using magnetic stimulation , 6 Minute Walking Distance ( 6MWD ) and QoL-EORTC-QLQ-LC13 . QoL was unchanged over 12 weeks ; 6MWD showed significant deterioration at 5 days post-operatively compared with pre-operatively , mean difference (SD)-131.6 ( 101.8 ) m and -128.0 ( 90.7 ) m in active and control groups respectively ( p=0.89 between groups ) which returned to pre-operative levels by 12 weeks in both groups . Quadriceps strength over the 5 day in-patient period showed a decrease of -8.3 ( 11.3 ) kg in the control group compared to increase of 4.0 ( 21.2 ) kg in the intervention group ( p=0.04 between groups ) . Strength training after thoracotomy successfully prevented the fall in quadriceps strength seen in controls , however , there was no effect on 6MWD or QoL. 6MWD returned to pre-operative levels by 12 weeks regardless of additional support offered",
"Introduction : A stepwise approach to the functional assessment of lung resection c and i date s is widely accepted , and this approach incorporates the measurement of exercise peak Vo2 when spirometry and radionuclear studies suggest medical inoperability . A new functional operability ( FO ) algorithm incorporates peak exercise Vo2 earlier in the preoperative assessment to determine which patients require preoperative radionuclear studies . This algorithm has not been studied in a multicenter study . Methods : The CALGB ( Cancer and Leukemia Group B ) performed a prospect i ve multi-institutional study to investigate the use of primary exercise Vo2 measurement for the prediction of surgical risk . Patients with known or suspected resectable non-small cell lung cancer ( NSCLC ) were eligible . Exercise testing including measurement of peak oxygen uptake ( Vo2 ) , spirometry , and single breath diffusion capacity ( DLCO ) was performed on each patient . Nuclear perfusion scans were obtained on selected high-risk patients . After surgery , morbidity and mortality data were collected and correlated with preoperative data . Mortality and morbidity were retrospectively compared by algorithm-based risk groups . Results : Three hundred forty-six patients with suspected lung cancer from nine institutions underwent thoracotomy with or without resection ; 57 study patients did not undergo thoracotomy . Patients who underwent surgery had a median survival time of 30.9 months , whereas patients who did not undergo surgery had a median survival time of 15.6 months . Among the 346 patients who underwent thoracotomy , 15 patients died postoperatively ( 4 % ) , and 138 patients ( 39 % ) exhibited at least one cardiorespiratory complication postoperatively . We found that patients who had a peak exercise Vo2 of complications ( p = 0.0001 ) and were also more likely to have a poor outcome ( respiratory failure or death ) if the peak Vo2 was 58 patients who did not meet FO algorithm criteria for operability , but who still tolerated lung resection with a 2 % mortality rate . Conclusions : Our data provide multicenter validation for the use of exercise Vo2 for preoperative assessment of lung cancer patients , and we encourage an aggressive approach when evaluating these patients for surgery",
"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",
"Purpose . Following surgical lung resection , patients frequently suffer functional decline and reduced activity levels . Despite this exercise interventions are not routinely provided . This study aim ed to establish the safety and feasibility of exercise administered following lung resection in an Australian setting . Method . Pilot r and omized controlled trial . Fifteen individuals ( 53 % male ) , mean ± st and ard deviation age 65.5 ± 16.1 years , undergoing surgery for suspected lung cancer . R and omization occurred postoperatively . Control arm received protocol ized inpatient respiratory physiotherapy . Intervention arm additionally received twice daily exercise until discharge home and twice weekly as outpatient for 8 weeks . Outcome measures ( safety , feasibility , functional capacity , functional mobility , and health-related quality of life [ HRQoL ] ) were assessed preoperatively and 2 and 12 weeks postoperatively . Results . Fifteen participants ( lung cancer n = 10 ) were assigned to control ( n = 8) and intervention ( n = 7 ) groups . Inpatient exercise was delivered on 71 % of occasions ( 35 out of 49 planned sessions ) . Four participants attended outpatient exercise sessions and these participants attended sessions on 81 % of occasions ( 52 out of 64 planned sessions ) . No adverse events occurred . There was a significant between group difference in 6-Minute Walk Test ( 6MWT ; P = .024 ) . In both groups the 6MWT declined from baseline to 2 weeks postoperative and then improved up to 12 weeks ; improvements were greater in the intervention group . Intervention was associated with positive trends of improvement in some HRQoL domains . Conclusions . Exercise intervention performed in the inpatient and outpatient setting s for individuals following lung resection was safe and feasible . The uptake rate for outpatient exercise was 57 % , similar to previous trials ; however , adherence was excellent within the subgroup of participants who attended . Further research is required to investigate the best setting of exercise delivery and explore ways to improve the uptake rate",
"PURPOSE / OBJECTIVES To examine the demographic , medical , and social-cognitive correlates of adherence to a presurgical exercise training intervention in patients awaiting surgery for suspected malignant lung lesions . DESIGN Pilot study , single-group , prospect i ve design with convenience sampling . SETTING Exercise training was performed at a university research fitness center in western Canada . SAMPLE 19 patients awaiting surgical resection of suspected malignant lung lesions . METHODS At baseline , participants completed a question naire including the Theory of Planned Behavior variables of perceived behavioral control , attitude , and subjective norm , as well as medical and demographic information . Participants were asked to attend five supervised exercise sessions per week during surgical wait time ( X = 8 + /- 2.4 weeks ) . MAIN RESEARCH VARIABLES Theory of Planned Behavior variables and exercise adherence . FINDINGS Adherence to the exercise intervention was 73 % ( range = 0%-100 % ) . Correlates of adherence were perceived behavioral control ( r = 0.63 ; p = 0.004 ) and subjective norm ( r = 0.51 ; p = 0.014 ) . Participants with greater than 80 % adherence reported significantly higher behavioral control than participants with less than 80 % adherence ( X difference = 1.1 ; 95 % confidence interval = 0.1 - 2.2 ; p = 0.035 ) . Men had better adherence than women ( X difference = 24.9 % ; 95 % confidence interval = 0.4 - 49.4 ; p = 0.047 ) . CONCLUSIONS Perceived behavioral control and subjective norm were the strongest correlates of exercise adherence . Women could be at risk for poor exercise adherence prior to lung surgery . IMPLICATION S FOR NURSING This information could be useful for clinicians in their attempts to improve adherence to exercise interventions in patients awaiting surgery for malignant lung lesions",
"OBJECTIVE To evaluate the effect of 4 weeks of pulmonary rehabilitation ( PR ) versus chest physical therapy ( CPT ) on the preoperative functional capacity and postoperative respiratory morbidity of patients undergoing lung cancer resection . DESIGN R and omized single-blinded study . SETTING A teaching hospital . PARTICIPANTS Patients undergoing lung cancer resection ( N=24 ) . INTERVENTIONS Patients were r and omly assigned to receive PR ( strength and endurance training ) versus CPT ( breathing exercises for lung expansion ) . Both groups received educational classes . MAIN OUTCOME MEASURES Functional parameters assessed before and after 4 weeks of PR or CPT ( phase 1 ) , and pulmonary complications assessed after lung cancer resection ( phase 2 ) . RESULTS Twelve patients were r and omly assigned to the PR arm and 12 to the CPT arm . Three patients in the CPT arm were not su bmi tted to lung resection because of inoperable cancer . During phase 1 evaluation , most functional parameters in the PR group improved from baseline to 1 month : forced vital capacity ( FVC ) ( 1.47L [ 1.27 - 2.33L ] vs 1.71L [ 1.65 - 2.80L ] , respectively ; P=.02 ) ; percentage of predicted FVC ( FVC% ; 62.5 % [ 49%-71 % ] vs 76 % [ 65%-79.7 % ] , respectively ; P 6-minute walk test ( 425.5±85.3 m vs 475±86.5 m , respectively ; P maximal inspiratory pressure ( 90±45.9cmH(2)O vs 117.5±36.5cmH(2)O , respectively ; P and maximal expiratory pressure ( 79.7±17.1cmH(2)O vs 92.9±21.4cmH(2)O , respectively ; P lower incidence of postoperative respiratory morbidity ( P=.01 ) , a shorter length of postoperative stay ( 12.2±3.6d vs 7.8±4.8d , respectively ; P=.04 ) , and required a chest tube for fewer days ( 7.4±2.6d vs 4.5±2.9d , respectively ; P=.03 ) compared with the CPT arm . CONCLUSIONS These findings suggest that 4 weeks of PR before lung cancer resection improves preoperative functional capacity and decreases the postoperative respiratory morbidity ",
"BACKGROUND We planned to investigate the effect of preoperative short period intensive physical therapy on lung functions , gas-exchange , and capacity of diffusion , and ventilation-perfusion distribution of patients with non-small cell lung cancer . METHODS Sixty patients with lung cancer , who were deemed operable , were r and omly allocated into two groups . Intensive physical therapy was performed in patients in the study group before operation . Both groups received routine physical therapy after operation . RESULTS There was no difference in pulmonary function tests between the two groups . Intensive physical therapy statistically significantly increased peripheral blood oxygen saturation . At least one complication was noted in 5 patients ( 16.7 % ) in the control group , and 2 ( 6.7 % ) , in the study group . However , there was no statistically significant difference ( p = 0,4 ) . The hospital stay has been found to be statistically significantly shortened by intensive physical therapy ( p Ventilation-perfusion distribution was found to be significantly effected by intensive physical therapy . The change was prominent in the the contralateral lung ( p Intensive physical therapy appeared to increase oxygen saturation , reduce hospital stay , and change the ventilation/perfusion distribution . It had a significant , positive effect on the exercise capacity of patients",
"The aim of this study was to explore the effects of presurgical exercise training on quality of life ( QOL ) in patients with malignant lung lesions . Using a single-group prospect i ve design , patients were enrolled in supervised aerobic exercise training for the duration of surgical wait time ( mean 59.7 days ) . Participants completed assessment s of cardiorespiratory fitness ( peak oxygen consumption ) and QOL using the Functional Assessment of Cancer Therapy-Lung scales , including the trial outcome index ( TOI ) and the lung cancer subscale ( LCS ) at baseline , immediately presurgery , and postsurgery ( mean , 57 days ) . 9 participants provided complete data . Repeated- measures analysis indicated a significant effect for time on TOI ( P = .006 ) and LCS ( P = .009 ) . Paired analysis revealed that QOL was unchanged after exercise training ( ie , baseline to presurgery ) , but there were significant and clinical ly meaningful declines from presurgery to postsurgery in the LCS ( −3.6 , P = .021 ) and TOI ( −8.3 , P = .018 ) . Change in peak oxygen consumption from presurgery to postsurgery was significantly associated with change in the LCS ( r = 0.70 , P = .036 ) and TOI ( r = 0.70 , P = .035 ) . Exercise training did not improve QOL from baseline to presurgery . Significant declines in QOL after surgery seem to be related to declines in cardiorespiratory fitness . A r and omized controlled trial is needed to further investigate these relationships",
"Using Rogers ’ science of unitary human beings , changes in hope and power among 104 lung cancer patients were examined in relation to participation in a preoperative exercise program . Participants were r and omly assigned to exercise or no-exercise and a repeated measures ANOVA was employed . The exercise group ’s power increased while the no-exercise group ’s power decreased . No differences in hope emerged . Positive correlations between hope and power were observed . Findings suggest that exercise is a form of knowing participation in change and illustrate a relation between one ’s ability to envision a better future and one ’s potential to actualize options through choice",
"BACKGROUND Survival characteristics of patients who have recurrent nonsmall-cell lung cancer after surgical resection are not well understood . Little objective evidence exists to justify treatment for these patients . METHODS We prospect ively followed 1,361 consecutive patients with nonsmall-cell lung cancer who underwent complete surgical resection at our institution from January 1997 to December 2001 . Only patients having recurrent cancer were included in the analysis . Multivariable Cox proportional hazards models were used to evaluate the effect of prognostic factors on postrecurrence survival . RESULTS Follow-up was achieved in 1,073 patients , and recurrent cancer developed in 445 . Complete information was available on 390 patients for analysis . There were 262 men and 128 women . Median age at time of recurrence was 69 years . Median time from surgical resection to recurrence was 11.5 months , and median postrecurrence survival was 8.1 months . Recurrence was intrathoracic in 171 patients , extrathoracic in 172 , and a combination of both in 47 . Treatments after recurrence included surgery in 43 patients , chemotherapy in 59 , radiation in 73 , and a combination in 96 . All patients who received treatment survived longer than those who received no treatment . Preoperative chemotherapy and postoperative radiotherapy for the primary lung cancer , poor Eastern Cooperative Oncology Group Performance Status , decreased disease-free interval from initial resection to recurrence , symptoms at recurrence , and certain location of recurrence significantly decreased postrecurrence survival . CONCLUSIONS In our experience , treatment for recurrent nonsmall-cell lung cancer significantly prolongs survival . Various treatment modalities including surgery should be considered in patients with postoperative recurrent nonsmall-cell lung cancer",
"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",
"Introduction : Little is known about the effects of rehabilitation for patients with lung cancer after thoracotomy . The primary objective of this study was to evaluate the effect of a multidisciplinary rehabilitation program on quality of life ( QOL ) and secondary objectives were to determine its effects on pain and exercise capacity and the feasibility of combining rehabilitation with adjuvant chemotherapy . Methods : Patients who had undergone a thoracotomy for lung cancer were r and omized between rehabilitation and usual care . Rehabilitation consisted of twice-weekly training for 12 weeks starting 1 month after hospital discharge , scheduled visits to pain specialists , and medical social work . QOL and pain were measured with vali date d question naires at baseline and after 1 , 3 , 6 , and 12 months . Exercise tolerance was assessed at baseline and after 3 months with a 6-minute walking distance test . Results : The study closed prematurely because of the introduction of video-assisted thoracoscopic surgery . Of 57 r and omized patients , 49 patients ( 23 active and 26 control ) were analyzed . QOL was not significantly different between groups , although , the active group reported more pain after 3 and 6 months and more limitations because of physical problems after 3 months . In the active group , 6-minute walking distance improved by 35 m from preoperative baseline , as opposed to the control group that showed a decline by 59 m ( p = 0.024 for difference ) . Patients treated with adjuvant chemotherapy showed decreased attendance at training sessions . Conclusion : Rehabilitation did not result in a better QOL . Exercise tolerance improved at the cost of more pain and more limitations because of physical problems . We suggest that rehabilitation is better postponed for 3 to 4 months after hospital discharge",
"Although lung cancer is a highly prevalent type of cancer , the effects of an inpatient multidisciplinary rehabilitation program on pulmonary function and exercise capacity have never been studied in these patients . Pulmonary function , 6-min walking distance and peak exercise capacity of 10 patients with a severely impaired pulmonary function following treatment of lung cancer were assessed in this pilot study before and after an 8-week inpatient multidisciplinary rehabilitation program . At baseline , patients had a restrictive pulmonary function and an apparent exercise intolerance ( median 6-min walking distance : 63.6 % predicted ; median peak cycling load : 58.5 % predicted ) . Despite the lack of change in median pulmonary function [ FEV1 : -0.01L , p = 0.5469 ] , functional exercise capacity [ 145 m ; 43.2 % of the initial values , p=0.0020 ] and peak exercise capacity [ 26 W ; 34.4 % of the initial values , p = 0.0078 ] improved significantly compared to baseline . Future trials have to corroborate the present findings . Nevertheless , patients with lung cancer have a clear indication to start a comprehensive rehabilitation program following intensive treatment of their disease . In fact , based on the results of the present pilot study it appears that these patients are good c and i date s for pulmonary rehabilitation programs",
"Background : Two prevalent unmet supportive care needs reported by the non – small cell lung cancer ( NSCLC ) population include the need to manage fatigue and attain adequate exercise to meet the physical dem and s of daily living . Yet , there are no guidelines for routine rehabilitative support to address fatigue and exercise for persons with NSCLC during the critical transition from hospital to home after thoracotomy . Objective : The objective of this study was to evaluate the feasibility , acceptability , safety , and changes in study end points of a home-based exercise intervention to enhance perceived self-efficacy for cancer-related fatigue ( CRF ) self-management for persons after thoracotomy for NSCLC transitioning from hospital to home . Interventions / Methods : Guided by the principles of the Transitional Care Model and the Theory of Symptom Self-management , a single-arm design composed of 7 participants with early-stage NSCLC performed light-intensity walking and balance exercises in a virtual reality environment with the Nintendo Wii Fit Plus . Exercise started the first week after hospitalization for thoracotomy and continued for 6 weeks . Results : The intervention positively impacted end points such as CRF severity ; perceived self-efficacy for fatigue self-management , walking , and balance ; CRF self-management behaviors ( walking and balance exercises ) ; and functional performance ( number of steps taken per day ) . Conclusions : A home-based , light-intensity exercise intervention for patients after thoracotomy for NSCLC is feasible , safe , well tolerated , and highly acceptable showing positive changes in CRF self-management . Implication s for Practice : Beginning evidence suggests that a light-intensity in-home walking and balance intervention after hospitalization for thoracotomy for NSCLC is a potentially effective rehabilitative CRF self-management intervention . Next steps include testing of this health-promoting self-management intervention in a larger-scale r and omized controlled trial",
"Background : Little is known about rehabilitation for postthoracotomy non – small cell lung cancer ( NSCLC ) patients . This research uses a perceived self-efficacy-enhancing light-intensity exercise intervention targeting a priority symptom , cancer-related fatigue ( CRF ) , for postthoracotomy NSCLC patients . This article reports on phase II of a 2-phase study . Phase I focused on initiation and tolerance of exercise during the 6 weeks immediately after thoracotomy , whereas phase II addressed maintenance of exercise for an additional 10 weeks including participants initiating and completing chemotherapy and /or radiation therapy . Objective : The objective of this study was to investigate the feasibility , acceptability , and preliminary efficacy of an exercise intervention for postthoracotomy NSCLC patients to include those initiating and completing adjuvant therapy . Interventions / Methods : A single-arm design composed of 7 participants postthoracotomy for NSCLC performed light-intensity exercises using an efficacy-enhancing virtual-reality approach using the Nintendo Wii Fit Plus . Results : Despite most participants undergoing chemotherapy and /or radiation therapy , participants adhered to the intervention at a rate of 88 % with no adverse events while giving the intervention high acceptability scores on conclusion . Likewise , participants ’ CRF scores improved from initiation through the conclusion of the intervention with perceived self-efficacy for walking at a light intensity continuously for 60 minutes , improving significantly upon conclusion over presurgery values . Conclusions : Postthoracotomy NSCLC patients maintained exercise for an additional 10 weeks while undergoing adjuvant therapy showing rehabilitation potential because the exercise intervention was feasible , safe , well tolerated , and highly acceptable showing positive changes in CRF self-management . Implication s for Practice : A r and omized controlled trial is needed to further investigate these relationships",
"Systemic inflammation plays an important role in the initiation , promotion , and progression of lung carcinogenesis . The effects of interventions to lower inflammation have not been explored . Accordingly , we conducted a pilot study to explore the effects of exercise training on changes in biomarkers of systemic inflammation among patients with malignant lung lesions . Using a single-group design , 12 patients with suspected operable lung cancer were provided with structured exercise training until surgical resection . Participants underwent cardiopulmonary exercise testing , 6 min walk testing , pulmonary function testing , and blood collection at baseline and immediately prior to surgical resection . Systemic inflammatory markers included intracellular adhesion molecule (ICAM)-1 , macrophage inflammatory protein-1alpha , interleukin (IL)-6 , IL-8 , monocyte chemotactic protein-1 , C-reactive protein , and tumor necrosis factor-alpha . The overall exercise adherence rate was 78 % , with patients completing a mean of 30 + /- 25 sessions . Mean peak oxygen consumption increased 2.9 mL.kg-1.min-1 from baseline to presurgery ( p = 0.016 ) . Results indicate that exercise training result ed in a significant reduction in ICAM-1 ( p = 0.041 ) . Changes in other inflammatory markers did not reach statistical significance . Change in cardiorespiratory fitness was not associated with change in systemic inflammatory markers . This exploratory study provides an initial step for future studies to eluci date the potential role of exercise , as well as identify the underlying mechanisms of action , as a means of modulating the relationship between inflammation and cancer pathogenesis"
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& NA ; Orlistat , an inhibitor of intestinal lipase , promotes body weight reduction . The lipid‐lowering efficacy of orlistat is controversial and the effect of orlistat‐induced body weight reduction on lipid changes has not been explored in meta‐regression analyses . A systematic literature search was conducted to identify r and omized controlled trials investigating the efficacy of orlistat on plasma total , low‐density lipoprotein and high‐density lipoprotein cholesterol , triglycerides and lipoprotein(a ) levels . Thirty‐three studies were included in the meta‐ analysis ( 5522 and 4210 participants in the orlistat therapy and control groups , respectively ) . Orlistat reduced body weight ( weighted mean difference : −2.12 , p , total‐cholesterol ( weighted mean difference : −0.30 mmol/L , p 0.001 ) , low‐density lipoprotein cholesterol ( weighted mean difference : −0.27 mmol/L , p 0.001 ) , high‐density lipoprotein cholesterol ( weighted mean difference : −0.034 mmol/L , p and triglyceride ( weighted mean difference : −0.09 mmol/L , p . Total‐ and low‐density lipoprotein cholesterol‐lowering were associated negatively with duration of orlistat treatment and positively with body weight changes . In conclusion , Orlistat treatment slightly reduces cholesterol and triglyceride levels , but not lipoprotein(a ) levels . Total‐ and low‐density lipoprotein cholesterol levels reductions are more consistent in patients with greater body weight reduction and shorter duration of orlistat treatment . Graphical abstract Figure . No caption available . HighlightsOrlistat is an inhibitor of intestinal lipase promoting body weight reduction , but whose lipid‐lowering efficacy is controversial . We investigated the efficacy of orlistat on plasma lipids and body weight in a meta‐ analysis of 33 studies including 9732 participants .Orlistat was associated with a slight but significant decrease in body weight , plasma cholesterol and triglyceride concentrations , whereas plasma Lp(a ) levels were not affected by orlistat treatment . Greater body weight reduction and lower duration of orlistat treatment promoted more consistent plasma total‐ and LDL‐cholesterol lowering
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"Objective To assess the effect of orlistat plus diet compared with diet alone in promoting weight loss and blood pressure reduction in hypertensive , overweight/obese patients . Design A pragmatic r and omized , controlled trial . Setting Hypertension clinic of a university hospital . Patients Hypertensive patients aged 18–75 years with a body mass index greater than 25 kg/m2 . Interventions Orlistat 360 mg/day combined with a hypocaloric diet ( treatment group ) , or a calorie-restricted diet alone ( control group ) . Main outcome measures Primary outcomes were reductions in weight and blood pressure . Secondary outcomes were decreases in lipid and glucose concentrations . A subgroup analysis of the main outcomes among diabetic and non-diabetic patients was also performed . Results A total of 204 patients were included in the intention-to-treat analysis . After 12 weeks the orlistat group lost , on average , 3.7 kg and the control group lost 2.0 kg in weight ( P decreased by 15.3 and 11.4 mmHg , respectively , in the group given orlistat plus a hypocaloric diet and by 11.6 and 5.2 mmHg , respectively , in the control group given the calorie-restricted diet alone ( P = 0.25 and P = 0.0004 , respectively ) . Fasting glucose ( 0.82 and 0.17 mmol/l , P = 0.01 ) and total cholesterol ( 0.85 and 0.56 mmol/l , P = 0.05 ) were reduced to a greater extent with orlistat than with diet alone . The mean reduction in triglycerides with orlistat plus the hypocaloric diet was 0.75 mmol/l and that in the control group was 0.30 mmol/l ( P = 0.28 ) ; the increases in high-density lipoprotein cholesterol were 0.05 and 0.00 mmol/l , respectively , in the two groups ( P = 0.17 ) . Treatment improved blood pressure and glucose control in the individuals with diabetes , but not in those without diabetes . Conclusion In both groups there was a reduction in weight , blood pressure and metabolic parameters . The orlistat group performed better in reducing weight , DBP , glucose and cholesterol . Results show that even a small reduction in weight helps to control blood pressure and glucose . The cost – benefit of the use of orlistat should be evaluated for hypertensive obese patients",
"CONTEXT The prevalence of overweight and obesity in children and adolescents is increasing rapidly . In this population , behavioral therapy alone has had limited success in providing meaningful , sustained weight reduction , and pharmacological treatment has not been extensively studied . OBJECTIVE To determine the efficacy and safety of orlistat in weight management of adolescents . DESIGN , SETTING , AND PATIENTS Multicenter , 54-week ( August 2000-October 2002 ) , r and omized , double-blind study of 539 obese adolescents ( aged 12 - 16 years ; body mass index [ BMI ] > or=2 units above the 95th percentile ) at 32 centers in the United States and Canada . INTERVENTIONS A 120-mg dose of orlistat ( n = 357 ) or placebo ( n = 182 ) 3 times daily for 1 year , plus a mildly hypocaloric diet ( 30 % fat calories ) , exercise , and behavioral therapy . MAIN OUTCOME MEASURES Change in BMI ; secondary measures included changes in waist and hip circumference , weight loss , lipid measurements , and glucose and insulin responses to oral glucose challenge . RESULTS There was a decrease in BMI in both treatment groups up to week 12 , thereafter stabilizing with orlistat but increasing beyond baseline with placebo . At the end of the study , BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo ( P = .001 ) . Compared with 15.7 % of the placebo group , 26.5 % of participants taking orlistat had a 5 % or higher decrease in BMI ( P = .005 ) ; 4.5 % and 13.3 % , respectively , had a 10 % or higher decrease in BMI ( P = .002 ) . At study end , weight had increased 0.53 kg with orlistat and 3.14 kg with placebo ( P fat mass . Waist circumference decreased in the orlistat group but increased in the placebo group ( -1.33 cm vs + 0.12 cm ; P gastrointestinal tract adverse events occurred in 9 % to 50 % of the orlistat group and in 1 % to 13 % of the placebo group . CONCLUSIONS In combination with diet , exercise , and behavioral modification , orlistat statistically significantly improved weight management in obese adolescents compared with placebo . The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group",
"OBJECTIVE : To evaluate the effectiveness of a culturally appropriate lifestyle intervention combined with orlistat in producing weight loss with obese Mexican-American women . SUBJECTS : Mexican-American women ( N=108 ) , aged 21–65 y , with a body mass index ( BMI ) ≥27 kg/m2 were r and omized to 1 y of treatment with orlistat and a culturally tailored lifestyle modification intervention ( OLM ; n=56 ) or a wait-list control group ( WLC ; n=52 ) . DESIGN : A r and omized , controlled , open-label 12-month study . Orlistat was dosed at 120 mg , three times per day . The OLM intervention included behavior modification , a low-fat ( ≤30 % of total daily calories ) diet , and moderate physical activity ( ≥150 min/week).MEASUREMENT : Primary outcomes included changes in body weight ( kg ) , BMI , waist circumference , blood pressure , glucose , and lipids . RESULTS : A total of 72 ( 37 OLM , 35 WLC ) and 66 participants ( 32 OLM , 34 WLC ) completed the 6- and 12-month follow-ups , respectively . Repeated- measures ANOVA demonstrated a significant time × treatment interaction ( Wilks ' λ=12.61 ; P achieved significant weight loss relative to the WLC group during the study ( mean percentage weight loss±s.e.m . ; −8.1%±1.2 vs −1.6%±0.7 at 6 months and −8.8%±1.5 vs −0.2%±1.0 at 12 months , respectively ) . OLM-treated patients also experienced significant reductions in waist circumference , low-density-lipoprotein , and total cholesterol . CONCLUSIONS : This study demonstrates the effectiveness of an intervention combining orlistat and lifestyle modification with Mexican-American women , a population with substantial risk for obesity",
"BACKGROUND Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment . OBJECTIVE This multicenter , double-blind , placebo-controlled study was design ed to test the hypothesis that orlistat , a gastrointestinal lipase inhibitor , is significantly more effective than a placebo in preventing weight regain . DESIGN Obese subjects who lost > or = 8 % of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet ( 4180-kJ/d deficit ) with no adjunctive pharmacotherapy were r and omly assigned to receive placebo , 30 mg orlistat , 60 mg orlistat , or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain . Of 1313 recruited subjects [ body mass index ( in kg/m2 ) : 28 - 43 ] , 729 subjects lost > or = 8 % of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase . RESULTS After 1 y , subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects ( 32.8 + /- 4.5 % compared with 58.7 + /- 5.8 % regain of lost weight ; P orlistat group than in the placebo group regained lost weight ( 47.5 % of subjects compared with 29.9 % ) . In addition , orlistat treatment ( 120 mg 3 times daily ) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo ( P orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors",
"The objective of this study was to quantify the effectiveness of orlistat plus a reduced calorie diet on decreasing cardiovascular disease risk in obese individuals with elevated low-density lipoprotein ( LDL ) cholesterol concentrations , and to compare the beneficial effects in patients with hypercholesterolemia only ( type IIA ) with those in subjects with combined dyslipidemia ( type IIB ) . Hypercholesterolemic patients treated with orlistat lost more weight ( mean + /- SEM 9.9 + /- 0.4 vs 6.1 + /- 0.5 kg , p = 0.0001 ) and had greater decreases in plasma cholesterol ( p = 0.0001 ) , LDL cholesterol ( p = 0.0001 ) , triglycerides ( p = 0.06 ) , glucose ( p = 0.07 ) , and insulin ( p = 0.02 ) concentrations compared with the diet-only treated patients . The greater degree of weight loss in orlistat-treated subjects was similar irrespective of the form of dyslipidemia , and plasma total and LDL cholesterol and insulin levels decreased to a significantly greater degree ( p orlistat and who had either type IIA and IIB dyslipidemia . However , triglyceride and insulin concentrations decreased and high-density lipoprotein ( HDL ) cholesterol increased to a significantly greater degree following orlistat-assisted weight loss in patients with type IIB compared with type IIA subjects , which was associated with a significantly greater decrease in the ratio of LDL/HDL cholesterol . Thus , weight loss in response to a reduced calorie diet in obese hypercholesterolemic patients was associated with a significant decrease in plasma LDL cholesterol levels . The beneficial metabolic effects of weight loss were accentuated in response to orlistat administration , and the improvement was greatest in patients with combined dyslipidemia ( type IIB )",
"Aim : The aim of our study was to comparatively evaluate the efficacy and safety of orlistat and sibutramine treatment in obese hypertensive patients , with a specific attention to cardiovascular effects and to side effects because of this treatment",
"Background : Orlistat reduces energy uptake by the impairment of fat digestion and some evidence indicates it also lowers plasma cholesterol",
"OBJECTIVE The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a st and ardized diet , comparing the action of orlistat , fluvastatin , orlistat with fluvastatin , and placebo on anthropometric measurements , blood pressure ( BP ) , and lipid profile . METHODS This was a 1-year , r and omized , double-blind , placebo-controlled trial . The patients were prescribed a controlled-energy diet and were r and omly allocated to receive placebo , orlistat 120 mg TID ( O group ) , fluvastatin 80 mg/d ( F group ) , or olistat 120 mg TID with fluvastatin 80 mg/d ( OF group ) . Clinical measurements ( body weight , body mass index [ BMI ] , waist circumference , and BP ) and lipid profile assessment ( total cholesterol [ TC ] , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , and triglycerides [ TGs ] ) were performed at baseline and after 6 months and 1 year of treatment . RESULTS The study included 99 obese patients with hypercholesterolemia ( 48 men and 51 women ; mean [ SD ] age , 51 [ 9 ] years ) . There were no significant differences between groups in baseline demographic , BP , or plasma lipid values . Three patients dropped out ( 2 women in the O group and 1 man in the OF group ) due to adverse events related to orlistat treatment , including gastrointestinal events ( oily spotting and fecal urgency ) . Ninety-six patients completed the study . There were significant differences from baseline ( mean [ SD ] ) in BMI , waist circumference reduction ( WCR ) , and body weight loss ( BWL ) at 6 months in the OF group ( 29.9 [ 1.1 ] kg/m(2 ) , 2.7 [ 0.8 ] cm , and 7.4 [ 0.9 ] kg , respectively ; all P BMI , WCR , and BWL at 1 year in the O group ( 29.0 [ 1.0 ] kg/m(2 ) , 3.0 [ 1.0 ] cm , and 8.6 [ 1.0 ] kg , respectively ; all P systolic and diastolic BP were observed at 1 year in the O and F groups ( all P TC and LDL-C in the F group ( both P TC , LDL-C , and TGs in the OF group ( P HDL-C in the OF group ( P TC in the O , F , and OF groups ( P LDL-C ( P TGs ( P HDL-C was significantly higher than baseline in the F and OF groups ( P < 0.02 and P < 0.01 , respectively ) . CONCLUSION Improvements in clinical and lipid-profile parameters were found at 1 year with all 3 treatments",
"Aims The aims of the study were , first , to critically evaluate lipoprotein(a ) [ Lp(a ) ] as a cardiovascular risk factor and , second , to advise on screening for elevated plasma Lp(a ) , on desirable levels , and on therapeutic strategies . Methods and results The robust and specific association between elevated Lp(a ) levels and increased cardiovascular disease (CVD)/coronary heart disease ( CHD ) risk , together with recent genetic findings , indicates that elevated Lp(a ) , like elevated LDL-cholesterol , is causally related to premature CVD/CHD . The association is continuous without a threshold or dependence on LDL- or non-HDL-cholesterol levels . Mechanistically , elevated Lp(a ) levels may either induce a prothrombotic/anti-fibrinolytic effect as apolipoprotein(a ) resembles both plasminogen and plasmin but has no fibrinolytic activity , or may accelerate atherosclerosis because , like LDL , the Lp(a ) particle is cholesterol-rich , or both . We advise that Lp(a ) be measured once , using an isoform-insensitive assay , in subjects at intermediate or high CVD/CHD risk with premature CVD , familial hypercholesterolaemia , a family history of premature CVD and /or elevated Lp(a ) , recurrent CVD despite statin treatment , ≥3 % 10-year risk of fatal CVD according to European guidelines , and /or ≥10 % 10-year risk of fatal + non-fatal CHD according to US guidelines . As a secondary priority after LDL-cholesterol reduction , we recommend a desirable level for Lp(a ) be niacin 1–3 g/day , as a meta- analysis of r and omized , controlled intervention trials demonstrates reduced CVD by niacin treatment . In extreme cases , LDL-apheresis is efficacious in removing Lp(a ) . Conclusion We recommend screening for elevated Lp(a ) in those at intermediate or high CVD/CHD risk , a desirable level use of niacin for Lp(a ) and CVD/CHD risk reduction",
"Orlistat , an inhibitor of gastrointestinal lipases , limits the absorption of ingested fat and could become a potential treatment for obesity . This analysis was performed to eluci date the relationship between orlistat dose and intensity of inhibition of dietary fat absorption ( assessed by measuring fecal fat excretion ) . In 11 phase I double‐blind , placebo‐controlled , parallel‐group r and omized studies , a total of 171 subjects received oral daily doses that ranged from 30 to 1200 mg orlistat or matching placebo three times a day for 9 to 10 days . The results of the daily mean fecal fat excretion percentage ( relative to ingested fat ) were correlated to the orlistat daily dose . A simple maximum‐effect model that included a basal value was used to fit the dose‐response relationship for all evaluable subjects . The mean maximum percentage of ingested fat excreted in the feces was approximately 32 % during orlistat administration compared with 5 % during placebo administration . The orlistat daily dose that produced 50 % of the maximum effect was 98 mg/day . The model‐fitting suggests the existence of a steep portion of the dose‐response curve up to approximately 400 mg/day , with a subsequent tendency to plateau at higher doses . Such an analysis was instrumental in identifying appropriate doses to be used in therapeutic trials for weight loss in obese patients",
"OBJECTIVE —To investigate the efficacy of orlistat on the maintenance of weight loss over 3 years following a major weight loss induced by very-low-energy diet ( VLED ) in obese patients with metabolic risk factors such as dyslipidemia , impaired fasting glucose , and diet-treated type 2 diabetes . RESEARCH DESIGN AND METHODS —Initially , weight loss was induced by an 8-week VLED ( 600–800 kcal/day ) in 383 patients with a mean BMI of 37.5 kg/m2 ( range 30.0–45.2 ) . Those who lost ≥5 % of their body weight ( 309 of 383 patients ) were then r and omized to receive lifestyle counseling for 3 years together with either orlistat 120 mg t.i.d . or matching placebo capsules . Primary end points were the maintenance of ≥5 % weight loss after 3 years . Additionally , differences in the development of type 2 diabetes between orlistat and placebo were analyzed . RESULTS —The VLED induced a mean weight loss of 14.4 ± 2 .. 0 kg among the subsequently r and omized patients . The mean weight gain after 3 years was lower with orlistat than with placebo ( 4.6 ± 8.6 vs. 7.0 ± 7.1 kg ; P achieved ≥5 % weight loss also favored orlistat ( 67 vs. 56 % ; P = 0.037 ) . Waist circumference was significantly more reduced in the orlistat group ( P . The incidences of new cases of type 2 diabetes were significantly reduced in the orlistat group ( 8 cases out of 153 subjects ) versus placebo ( 17 cases out of 156 subjects ) ( P = 0.041 ) . CONCLUSIONS —The addition of orlistat to lifestyle intervention was associated with maintenance of an extra 2.4 kg weight loss after VLED for up to 3 years in obese subjects . The combination of orlistat and lifestyle intervention was associated with a reduced occurrence of type 2 diabetes ",
"OBJECTIVE The purpose of this study was to assess the effect of orlistat , a gastrointestinal lipase inhibitor , on body weight , glycemic control , and cardiovascular risk factors in metformin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS A 1-year multicenter , r and omized , double-blind , placebo-controlled trial of 120 mg orlistat t.i.d . ( n = 249 ) or placebo ( n = 254 ) combined with a reduced-calorie diet was conducted in overweight and obese patients with suboptimal control of type 2 diabetes . RESULTS After 1 year of treatment , mean ( + /-SE ) weight loss was greater in the orlistat than in the placebo group ( -4.6 + /- 0.3 % vs. -1.7 + /- 0.3 % of baseline wt , P Orlistat treatment caused a greater improvement in glycemic control than placebo , as evidence d by a greater reduction in serum HbA(1c ) , adjusted for changes in metformin and sulfonylurea therapy ( -0.90 + /- 0.08 vs. -0.61 + /- 0.08 , P = 0.014 ) ; a greater proportion of patients achieving decreases in HbA(1c ) of > or = 0.5 and > or = 1.0 % ( both P fasting serum glucose ( -2.0 + /- 0.2 vs. -0.7 + /- 0.2 mmol/l , P = 0.001 ) . Compared with the placebo group , patients treated with orlistat also had greater decreases in total cholesterol , LDL cholesterol , and systolic blood pressure ( all P orlistat experienced gastrointestinal side effects than placebo ( 83 vs. 62 % , P orlistat group ( 44 vs. 35 % , P Orlistat is a useful adjunctive treatment for producing weight loss and improving glycemic control , serum lipid levels , and blood pressure in obese patients with type 2 diabetes who are being treated with metformin",
"OBJECTIVE Effects of weight loss on vascular function are unknown . We compared , in the face of similar weight loss over 3 - 6 months , effects of orlistat ( 120 mg t.i.d . , n = 23 ) and placebo ( n = 24 ) on in vivo endothelial function in a high-risk group of obese ( BMI 32.1 + /- 0.4 kg/m(2 ) ) premenopausal nondiabetic women with a history of gestational diabetes . RESEARCH DESIGN AND METHODS Forearm blood flow responses to intra-arterial infusions of acetylcholine ( ACh ) and sodium nitroprusside ( SNP ) , body composition , and serum lipids were determined before and after weight loss . RESULTS Weight loss averaged 7.3 + /- 0.2 kg ( 8.3 + /- 0.1 % ) and 7.4 + /- 0.2 kg ( 8.2 + /- 0.1 % ) of initial body weight in the orlistat and placebo groups , respectively . Forearm and body compositions changed similarly in both groups . Responses to ACh increased by 41 % to the low dose ( 5.9 + /- 0.6 vs. 8.3 + /- 0.3 for flow in the experimental/control arm , P orlistat group , but they remained unchanged in the placebo group . The blood flow responses to SNP did not differ significantly between the groups . LDL cholesterol decreased significantly in the orlistat group from 3.5 + /- 0.2 to 3.0 + /- 0.1 mmol/l ( P placebo group . Within the orlistat group , the decrease in LDL cholesterol correlated significantly with the improvement in the blood flow response to ACh ( r = -0.44 , P Orlistat but not moderate ( 8 % ) weight loss per se improves endothelial function in women with previous gestational diabetes . This improvement is associated with a lowering of LDL cholesterol by orlistat",
"BACKGROUND We assessed and directly compared weight loss effects of sibutramine and orlistat treatment in a group of obese , poorly-controlled type 2 diabetic patients . METHODS This study recruited 34 diabetic subjects [ glycohemoglobin ( HbA1c ) > 8 % ] with a body mass index of at least 27 kg/m2 . A 36-week , three-phase , prospect i ve , r and omized , cross-over comparative study was conducted . In phase 1 , 34 patients were r and omly divided into two groups . One group received sibutramine for 3 months , then completed a 3 month wash-out period and , finally , shifted to orlistat for another 3 months . The second group followed the same procedure but received orlistat first and then sibutramine . The efficacy measures were rate of weight reduction , glycemic control , insulin sensitivity and cardiovascular risk factors , including waist circumference , lipid profiles and blood pressure . RESULTS The sibutramine-treated group achieved 2.0 kg ( 2.5 % ) weight loss with observable but not statistically significant changes in insulin sensitivity , glycemic control , and cardiovascular risk factors . There were no significant changes in systolic or diastolic blood pressure . The weight reduction in the orlistat-treated group was only 0.8 kg ( 0.9 % ) , which was significantly less than that of the sibutramine group . There were significant differences in total cholesterol , low density lipoprotein cholesterol and HbA1C . Direct comparative analysis revealed no significant differences between these two groups . CONCLUSION This study indicates that sibutramine treatment produced greater reduction in weight than orlistat in obese , poorly-controlled type 2 diabetic patients . However , no significant differences in waist circumference , and lipid or glucose levels were found between the two groups",
"BACKGROUND Two potent weight loss therapies , a low-carbohydrate , ketogenic diet ( LCKD ) and orlistat therapy combined with a low-fat diet ( O + LFD ) , are available to the public but , to our knowledge , have never been compared . METHODS Overweight or obese out patients ( n = 146 ) from the Department of Veterans Affairs primary care clinics in Durham , North Carolina , were r and omized to either LCKD instruction ( initially , , 120 mg orally 3 times daily , plus low-fat diet instruction ( 30 % energy from fat , 500 - 1000 kcal/d deficit ) delivered at group meetings over 48 weeks . Main outcome measures were body weight , blood pressure , fasting serum lipid , and glycemic parameters . RESULTS The mean age was 52 years and mean body mass index was 39.3 ( calculated as weight in kilograms divided by height in meters squared ) ; 72 % were men , 55 % were black , and 32 % had type 2 diabetes mellitus . Of the study participants , 57 of the LCKD group ( 79 % ) and 65 of the O + LFD group ( 88 % ) completed measurements at 48 weeks . Weight loss was similar for the LCKD ( expected mean change , -9.5 % ) and the O + LFD ( -8.5 % ) ( P = .60 for comparison ) groups . The LCKD had a more beneficial impact than O + LFD on systolic ( -5.9 vs 1.5 mm Hg ) and diastolic ( -4.5 vs 0.4 mm Hg ) blood pressures ( P High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups . Low-density lipoprotein cholesterol levels improved within the O + LFD group only , whereas glucose , insulin , and hemoglobin A(1c ) levels improved within the LCKD group only ; comparisons between groups , however , were not statistically significant . CONCLUSION In a sample of medical out patients , an LCKD led to similar improvements as O + LFD for weight , serum lipid , and glycemic parameters and was more effective for lowering blood pressure . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00108524",
"The effect of orlistat , a nonabsorbed inhibitor of gastric and pancreatic lipases , was examined in patients with primary hyperlipidaemia ( serum cholesterol ≥6.2 mmol·l−1 and triglycerides ≤5.0 mmol·l−1 ) not responsive to dietary change alone . In a multicentre , r and omised , double-blind study , 103 men and 70 women received 30 , 90 , 180 , or 360 mg of orlistat or placebo for 8 weeks . Total and low-density lipoprotein cholesterol levels were reduced by 4 % and 5 % with 30 mg orlistat , by 7 % and 8 % with 90 mg orlistat , by 7 % and 7 % with 180 mg orlistat and by 11 % and 10 % with 360 mg orlistat compared to placebo . High density lipoprotein cholesterol levels significantly decreased in the 360 mg orlistat group . Triglyceride levels significantly increased in the placebo group but not in the drug groups . Body weight decreased by 1.2 kg with 360 mg orlistat , despite a weight maintenance diet . Decreases in vitamin E and D levels occurred , although both vitamins remained within the normal range . Adverse effects from the gastrointestinal tract were frequent , but led to discontinuation of therapy in only seven patients . Orlistat is a new therapeutic drug for the treatment of hyperlipidaemia that may be particularly useful among overweight patients . Its potential place in therapy will await long-term studies . Vitamin supplementation should be considered during treatment",
"This study describes the changes in risk factors for coronary heart disease in obese persons with syndrome X after orlistat-assisted weight loss . Data were available for 1,700 patients who completed 52 weeks of weight loss ; 128 were defined as having syndrome X by being in the quintile with the highest plasma triglyceride levels ( > 2.2 mM/L ) and the lowest high-density lipoprotein cholesterol ( HDL , 1.5 mM/L ) . Subjects were placed on a calorie-restricted diet , and r and omized to receive orlistat or placebo . Initial values were higher in those with syndrome X for diastolic blood pressure ( p = 0.03 ) , plasma insulin ( p = 0.0001 ) , triglyceride ( p = 0.0001 ) concentrations , and ratio of low-density lipoprotein cholesterol to HDL cholesterol ( p = 0.0001 ) , and were lower for HDL cholesterol ( p = 0.001 ) concentrations . Weight loss was greater in both groups of orlistat-treated patients ( p = 0.026 ) ; in those with syndrome X , it was associated with a significant reduction in plasma insulin ( p = 0.019 ) and triglyceride ( p = 0.0001 ) concentrations , an increase in HDL cholesterol concentration , and a decrease in low-density lipoprotein/HDL cholesterol ratio ( p = 0.0001 ) . There were no significant changes in plasma insulin , triglycerides , or HDL cholesterol concentration in the non-syndrome X group . In conclusion , weight loss attenuates coronary heart disease risk factors in obese persons with syndrome X , and the risk factor reduction is enhanced with administration of orlistat",
"OBJECTIVE It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity . A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated . We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight , and thus the incidence of type 2 diabetes , in obese patients . RESEARCH DESIGN AND METHODS In a 4-year , double-blind , prospect i ve study , we r and omized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo , three times daily . Participants had a BMI > /=30 kg/m2 and normal ( 79 % ) or impaired ( 21 % ) glucose tolerance ( IGT ) . Primary endpoints were time to onset of type 2 diabetes and change in body weight . Analyses were by intention to treat . RESULTS Of orlistat-treated patients , 52 % completed treatment compared with 34 % of placebo recipients ( P cumulative incidence of diabetes was 9.0 % with placebo and 6.2 % with orlistat , corresponding to a risk reduction of 37.3 % ( P = 0.0032 ) . Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT . Mean weight loss after 4 years was significantly greater with orlistat ( 5.8 vs. 3.0 kg with placebo ; P orlistat recipients with impaired ( 5.7 kg ) or normal glucose tolerance ( NGT ) ( 5.8 kg ) at baseline . A second analysis in which the baseline weights of subjects who dropped out of the study was carried forward also demonstrated greater weight loss in the orlistat group ( 3.6 vs. 1.4 kg ; P orlistat plus lifestyle changes result ed in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinical ly representative obese population . Difference in diabetes incidence was detectable only in the IGT subgroup ; weight loss was similar in subjects with IGT or NGT [ correction ]",
"OBJECTIVE To assess the effect of orlistat on body weight and cardiovascular risk amongst obese patients at high coronary risk . DESIGN After screening , patients entered a two-week single-blind placebo lead-in period , during which they followed a mildly hypocaloric diet , before being r and omized to double-blind treatment with either orlistat 120 mg or placebo three times daily , in conjunction with dietary intervention for 1 years . SETTING The study was conducted at 33 primary care centres in Sweden . SUBJECTS A total of 382 obese adults ( body mass index 28 - 38 kg m-2 ) with type 2 diabetes , hypercholesterolaemia and /or hypertension were recruited , of whom 376 were r and omized to orlistat ( n = 190 ) or placebo ( n = 186 ) . MAIN OUTCOME MEASURES Change in body weight , waist and hip circumferences , blood pressure , serum lipid profile , fasting glucose and HbA1c . RESULTS After 1 years , mean weight loss was significantly greater with orlistat compared with placebo ( 5.9 % vs. 4.6 % ; P orlistat-treated patients than placebo recipients maintained weight loss of > or = 5 % ( 54.2 % vs. 40.9 % ; P Orlistat was also associated with significantly greater improvements than placebo in total serum cholesterol ( - 3.3 % vs. -0.5 % ; P LDL-cholesterol ( - 7.0 % vs. -1.1 % ; P fasting glucose ( 5.1 % vs. -0.1 % ; P HbA1c ( - 2.7 % vs. -0.5 % ; P patients with type 2 diabetes . Orlistat was well tolerated . CONCLUSIONS Treatment with orlistat in conjunction with diet promotes significantly greater weight loss and cardiovascular risk factor reduction than diet alone amongst obese patients at high risk of future coronary events",
"OBJECTIVE To determine the effect of orlistat , a new lipase inhibitor , on long-term weight loss , to determine the extent to which orlistat treatment minimizes weight regain in a second year of treatment , and to assess the effects of orlistat on obesity-related risk factors . RESEARCH METHODS AND PROCEDURES This was a 2-year , multicenter , r and omized , double-blind , placebo-controlled study . Obese patients ( body mass index 28 to 43 kg/m2 ) were r and omized to placebo or orlistat ( 60 or 120 mg ) three times a day , combined with a hypocaloric diet during the first year and a weight maintenance diet in the second year of treatment to prevent weight regain . Changes in body weight , lipid profile , glycemic control , blood pressure , quality of life , safety , and tolerability were measured . RESULTS Orlistat-treated patients lost significantly more weight ( p placebo-treated patients after Year 1 ( 6.6 % , 8.6 % , and 9.7 % for the placebo , and orlistat 60 mg and 120 mg groups , respectively ) . During the second year , orlistat therapy produced less weight regain than placebo ( p = 0.005 for orlistat 60 mg ; p orlistat 120 mg ) . Several obesity-related risk factors improved significantly more with orlistat treatment than with placebo . Orlistat was generally well tolerated and only 6 % of orlistat-treated patients withdrew because of adverse events . Orlistat leads to predictable gastrointestinal effects related to its mode of action , which were generally mild , transient , and self-limiting and usually occurred early during treatment . DISCUSSION Orlistat administered for 2 years promotes weight loss and minimizes weight regain . Additionally , orlistat therapy improves lipid profile , blood pressure , and quality of life",
"UNLABELLED OBJECTIVE ; Weight loss improves glycemic control , lipid profiles , and blood pressure in patients with type 2 diabetes . However , successful long-term weight loss is difficult for these patients , particularly those treated with insulin . The aim of this study was to assess the effect of orlistat , a gastrointestinal lipase inhibitor , on weight loss , glycemic control , and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS This study was a 1-year multicenter , r and omized , double-blind , placebo-controlled trial of orlistat ( 120 mg three times a day ) or placebo combined with a reduced-calorie diet in overweight or obese adults ( BMI 28 - 40 kg/m(2 ) ) with type 2 diabetes treated with insulin alone or combined with oral agents , but with suboptimal metabolic control ( HbA(1c ) 7.5 - 12.0 % ) . Outcome measurements included changes in body weight , glycemic control , blood pressure , and serum lipids . RESULTS ; After 1 year , the orlistat group lost significantly more weight ( -3.89 + /- 0.3 % of baseline body weight , means + /- SE ) than the placebo group ( -1.27 + /- 0.3 % , P Orlistat treatment , compared with placebo , produced greater decreases in HbA(1c ) ( -0.62 + /- 0.08 vs. -0.27 + /- 0.08 % , P = 0.002 ) , fasting serum glucose ( -1.63 + /- 0.3 vs. -1.08 + /- 0.3 mmol/l , P = 0.02 ) , and the required doses of insulin and other diabetic medications . Orlistat also produced greater improvements than placebo in serum total cholesterol ( P = 0.0002 ) and LDL cholesterol concentrations ( P = 0.001 ) and LDL/HDL ratio ( P = 0.01 ) . CONCLUSIONS ; Orlistat therapy produces clinical ly significant weight loss , with improvements in glycemic control and cardiovascular disease risk factors , in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy",
"Heart failure is the leading cause of hospitalization . Obesity is increasingly common and is a major public health problem . The aim of this study is to assess whether obese patients with heart failure can benefit from losing weight via an orlistat-assisted diet . This r and omized clinical trial included obese patients with ejection fractions Orlistat and diet counseling were compared with diet counseling alone . Twenty-one consecutive obese patients with heart failure were recruited . Significant improvement in 6-minute walk test ( 45.8 m ; 95 % confidence interval , 5.2 - 86.4 m ; p=0.031 ) , functional class ( -0.6+/-0.5 , p=0.014 ) , weight loss ( -8.55 kg ; 95 % confidence interval , -13.0 to -4.1 kg ; p total cholesterol ( p=0.017 ) , low-density lipoprotein cholesterol ( p=0.03 ) , and triglycerides ( p=0.036 ) were observed in the orlistat group . Orlistat can promote significant weight loss and symptoms of relief in obese patients with heart failure , as measured by 6-minute walk test and functional capacity . The lipid profile improved . Orlistat was safe and well tolerated",
"BACKGROUND AND AIM Previous studies have demonstrated that oxidative stress is increased in obese patients . The high-density lipoprotein ( HDL ) associated human paraoxonase 1 ( PON1 ) can inhibit low-density lipoprotein oxidation and has an antiatherogenic effect . Our objective was to assess the effects of orlistat therapy combined with diet on body mass index ( BMI ) , waist circumference , lipid parameters , blood pressure , serum glucose level and PON1 activity . METHODS AND RESULTS A longitudinal , multicenter , r and omized study with and without orlistat treatment was performed . One hundred thirty nine otherwise healthy , obese subjects were divided in to two groups : 78 persons received orlistat ( 120 mg three times a day ) combined with diet while 61 persons were kept on diet only . Anthropometrical parameters , serum lipid levels and PON1 activity were measured at baseline and after 6 months of treatment . BMI and waist circumference were reduced more pronouncedly in the orlistat group than in the control group . Patients receiving orlistat also had significantly greater improvements in fasting blood glucose levels and blood pressure . The orlistat-treated group showed a greater reduction in total cholesterol and triglyceride levels . In addition , the serum PON1 activity in these patients was significantly increased compared to the diet-only group . CONCLUSIONS The 6-month treatment with orlistat had a beneficial effect on the lipid profile and improved the antioxidant status by increasing serum PON1 activity . However , because of the limited therapeutic effectiveness , obese patients with hypercholesterolemia should receive additional lipid lowering medications",
"CONTEXT Orlistat , a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30 % , may promote weight loss and reduce cardiovascular risk factors . OBJECTIVE To test the hypothesis that orlistat combined with dietary intervention is more effective than placebo plus diet for weight loss and maintenance over 2 years . DESIGN R and omized , double-blind , placebo-controlled study conducted from October 1992 to October 1995 . SETTING AND PARTICIPANTS Obese adults ( body mass index [ weight in kilograms divided by the square of height in meters ] , 30 - 43 kg/m2 ) evaluated at 18 US research centers . INTERVENTION Subjects received placebo plus a controlled-energy diet during a 4-week lead-in . On study day 1 , the diet was continued and subjects were r and omized to receive placebo 3 times a day or orlistat , 120 mg 3 times a day , for 52 weeks . After 52 weeks , subjects began a weight-maintenance diet , and the placebo group ( n = 133 ) continued to receive placebo and orlistat-treated subjects were rer and omized to receive placebo 3 times a day ( n = 138 ) , orlistat , 60 mg ( n = 152 ) or 120 mg ( n = 153 ) 3 times a day , for an additional 52 weeks . MAIN OUTCOME MEASURES Body weight change and changes in blood pressure and serum lipid , glucose , and insulin levels . RESULTS A total of 1187 subjects entered the protocol , and 892 were r and omly assigned on day 1 to double-blind treatment . For intent-to-treat analysis , 223 placebo-treated subjects and 657 orlistat-treated subjects were evaluated . During the first year orlistat-treated subjects lost more weight ( mean + /- SEM , 8.76+/-0.37 kg ) than placebo-treated subjects ( 5.81+/-0.67 kg ) ( P orlistat , 120 mg 3 times a day , during year 1 and year 2 regained less weight during year 2 ( 3.2+/-0.45 kg ; 35.2 % regain ) than those who received orlistat , 60 mg ( 4.26+/-0.57 kg ; 51.3 % regain ) , or placebo ( 5.63+/-0.42 kg ; 63.4 % regain ) in year 2 ( P orlistat , 120 mg 3 times a day , was associated with improvements in fasting low-density lipoprotein cholesterol and insulin levels . CONCLUSIONS Two-year treatment with orlistat plus diet significantly promotes weight loss , lessens weight regain , and improves some obesity-related disease risk factors",
"Objective : Orlistat and sibutramine are widely prescribed antiobesity agents that are approved for 2 years of continuous use . Previous 1–4-year r and omized , placebo-controlled trials of these drugs have reported average weight losses of attrition rates of up to 60 % . The objective of this study was to determine the long-term persistence with orlistat and sibutramine therapy outside a clinical trial setting . Design , setting and patients : Population -based administrative data from British Columbia , Canada , were used to create an inception cohort of orlistat and sibutramine users and determine the 2-year persistence with therapy . Main outcome measure : Persistence with therapy at 2 years . Drug discontinuation was defined as the failure to refill a prescription within 120 days . Patients discontinuing therapy were censored at the 60-day mark . Results : Nearly 17 000 users of orlistat and 3500 users of sibutramine were identified . For both orlistat and sibutramine , 1-year persistence rates were 2-year persistence rates were 2 % . Conclusion : This population -based , retrospective cohort analysis demonstrated very poor long-term persistence rates with orlistat and sibutramine and discontinuation rates that were much higher than those reported in clinical trials",
"Aim : The aim of this study is to compare the effect of orlistat vs. placebo on the predicted 10‐year cardiovascular disease ( CVD ) risk in obese people with one or more cardiovascular risk factors treated for 12 months , in conjunction with a fat‐reduced , but otherwise ad libitum , diet",
"Few well-controlled diet studies have investigated the effects of reducing dietary saturated fatty acid ( SFA ) intake in premenopausal and postmenopausal women or in blacks . We conducted a multicenter , r and omized , crossover- design trial of the effects of reducing dietary SFA on plasma lipids and lipoproteins in 103 healthy adults 22 to 67 years old . There were 46 men and 57 women , of whom 26 were black , 18 were postmenopausal women , and 16 were men > or = 40 years old . All meals and snacks , except Saturday dinner , were prepared and served by the research centers . The study was design ed to compare three diets : an average American diet ( AAD ) , a Step 1 diet , and a low-SFA ( Low-Sat ) diet . Dietary cholesterol was constant . Diet composition was vali date d and monitored by a central laboratory . Each diet was consumed for 8 weeks , and blood sample s were obtained during weeks 5 through 8 . The compositions of the three diets were as follows : AAD , 34.3 % kcal fat and 15.0 % kcal SFA ; Step 1 , 28.6 % kcal fat and 9.0 % kcal SFA ; and Low-Sat , 25.3 % kcal fat and 6.1 % kcal SFA . Each diet provided approximately 275 mg cholesterol/d . Compared with AAD , plasma total cholesterol in the whole group fell 5 % on Step 1 and 9 % on Low-Sat . LDL cholesterol was 7 % lower on Step 1 and 11 % lower on Low-Sat than on the AAD ( both P HDL cholesterol fell 7 % on Step 1 and 11 % on Low-Sat ( both P HDL cholesterol were seen in all subgroups except blacks and older men . Plasma triglyceride levels increased approximately 9 % between AAD and Step 1 but did not increase further from Step 1 to Low-Sat . Changes in triglyceride levels were not significant in most subgroups . Surprisingly , plasma Lp(a ) concentrations increased in a stepwise fashion as SFA was reduced . In a well-controlled feeding study , stepwise reductions in SFA result ed in parallel reductions in plasma total and LDL cholesterol levels . Diet effects were remarkably similar in several subgroups of men and women and in blacks . The reductions in total and LDL cholesterol achieved in these different subgroups indicate that diet can have a significant impact on risk for atherosclerotic cardiovascular disease in the total population",
"AIM To assess the effect of orlistat on body weight and concomitant diseases in patients with body mass index ( BMI ) of > 28 kg/m2 and poorly controlled type 2 diabetes , hypertension or hypercholesterolaemia . METHODS This trial was a six-month , r and omized , double-blind , placebo-controlled study of orlistat 120 mg three times daily plus a mildly reduced-calorie diet . 1004 obese patients ( BMI 28 - 40 kg/m2 ) were included by 253 private endocrinologists and received orlistat ( n = 499 ) or placebo ( n = 505 ) . Patients were stratified by concomitant disorder ( type 2 diabetes , n = 193 ; hypertension , n = 614 ; hypercholesterolaemia , n = 197 ) . Body weight , anthropometry , lipid and glycaemic control parameters and blood pressure . RESULTS After six months , orlistat produced a significantly greater weight loss than placebo in type 2 diabetes ( -4.2 % vs. -1.4 % ) , hypertension ( -6.2 % vs. -1.9 % ) and hypercholesterolaemia ( -5.5 % vs. -2.3 % ) groups ( p HbA(1c ) in the type 2 diabetes group ( -0.54 vs. -0.18 % ; p = 0.002 ) and low-density lipoprotein (LDL)-cholesterol in the hypercholesterolaemia group ( -11.7 % vs. -4.5 % ; p = 0.004 ) with orlistat vs. placebo . Early weight loss ( > or = 5 % at 12 weeks ) was associated with the highest weight loss in each group , and the highest decreases in HbA1c , LDL-cholesterol and diastolic blood pressure in patients with type 2 diabetes , hypercholesterolaemia and hypertension , respectively , at six months . The incidence of adverse events was similar for orlistat and placebo , except for certain generally well-tolerated gastrointestinal events that were more common with orlistat . CONCLUSION Orlistat plus a mildly reduced-calorie diet produced clinical ly meaningful weight loss and improvements in risk factors in overweight and obese patients with poorly controlled type 2 diabetes , hypertension or hypercholesterolaemia",
"Orlistat lowers lipids and improves insulin sensitivity , but its effect on other metabolic syndrome related parameters is not known . To assess its influence on adiponectin , high sensitive C-reactive protein ( hs-CRP ) and other metabolic syndrome related parameters , this study enrolled 106 participants in a weight-reduction program and categorized them into a group of 51 who had been treated with orlistat 360 mg/day for one year and a group of 55 age and sex and body mass index ( BMI ) matched controls . The orlistat group had greater changes in BMI , % body fat ( % BF ) , waist circumference , and insulin resistance , hs-CRP , leptin and adiponectin levels after one year on the program than the controls . After adjusting for % BF and waist circumference , change of serum leptin and adiponectin levels remained significantly different . It was found that orlistat could effectively manage obesity related co-morbidities , especially insulin resistance and atherosclerosis risk . It decreases leptin and increases adiponectin independent of % BF and waist circumference . Therefore , orlistat appears to have anti-diabetic and anti-atherogenic properties and may help prevent metabolic syndrome in the overweight people",
"OBJECTIVE : Assessment of the effects of orlistat 120 mg three times daily vs placebo on weight loss and serum lipids in obese hypercholesterolemic patients . DESIGN : A 24 week multicentre , double-blind , r and omized , placebo-controlled trial . After a 2-week single-blind run-in period ( placebo+diet ( −600 kcal/day ; ≤30 % of calories as fat ) ) , 294 patients were su bmi tted to the hypocaloric diet and r and omly assigned to either orlistat 120 mg or placebo three times daily . Patients who completed the double-blind study ( n=255 ) were eligible for participation in a subsequent 24 week open-label orlistat extension phase . SUBJECTS : Patients with body mass index ( BMI ) 27–40 kg/m2 and hypercholesterolemia ( low-density-lipoprotein cholesterol , LDL-C , 4.1–6.7 mmol/l ) . MEASUREMENTS : Efficacy assessment s included weight loss , lipid levels , other cardiovascular risk factors and anthropometric parameters . Safety assessment s. RESULTS : Weight loss during run-in was similar in both groups . After r and omization , orlistat-treated patients lost significantly more weight than placebo recipients : mean percentage weight loss from start of run-in to week 24 was−6.8 % in the orlistat group and −3.8 % in the placebo group ( P the orlistat group than in the placebo group achieved clinical ly meaningful weight loss of ≥5 % ( 64 vs 39 % ) or ≥10 % ( 23 vs 13 % ) at week 24 . Treatment with orlistat was associated with significantly greater changes in total cholesterol ( −11.9 % vs −4.0 % ; P ) and LDL-C ( −17.6 vs −7.6 % ; P category of weight loss during the double-blind treatment period , change in LDL-C was more pronounced in orlistat-treated patients than in placebo recipients , indicating that orlistat had a direct cholesterol-lowering effect that was independent of weight reduction ( P Adjunction of orlistat during the extension phase in patients who initially received placebo induced a further decrease in weight , total cholesterol and LDL-C. Orlistat was generally well tolerated with a safety profile comparable to placebo , with the exception of a higher incidence of gastrointestinal events ( ≥1 event in 64 vs 38 % of patients ) . CONCLUSION : Orlistat as an adjunct to dietary intervention promotes weight loss and reduces LDL-C beyond the effect of weight loss in overweight or obese patients with concomitant hypercholesterolemia ",
"BACKGROUND We undertook a r and omised controlled trial to assess the efficacy and tolerance of orlistat , a gastrointestinal lipase inhibitor , in promoting weight loss and preventing weight regain in obese patients over a 2-year period . METHODS 743 patients ( body-mass index 28 - 47 kg/m2 ) , recruited at 15 European centres , entered a 4-week , single-blind , placebo lead-in period on a slightly hypocaloric diet ( 600 kcal/day deficit ) . 688 patients who completed the lead-in were assigned double-blind treatment with orlistat 120 mg ( three times a day ) or placebo for 1 year in conjunction with the hypocaloric diet . In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance ( eucaloric ) diet . FINDINGS From the start of lead-in to the end of year 1 , the orlistat group lost , on average , more bodyweight than the placebo group ( 10.2 % [ 10.3 kg ] vs 6.1 % [ 6.1 kg ] ; LSM difference 3.9 kg [ p orlistat regained , on average , half as much weight as those patients switched to placebo ( p placebo to orlistat lost an additional 0.9 kg during year 2 , compared with a mean regain of 2.5 kg in patients who continued on placebo ( p Total cholesterol , low-density lipoprotein ( LDL ) cholesterol , LDL/high-density lipoprotein ratio , and concentrations of glucose and insulin decreased more in the orlistat group than in the placebo group . Gastrointestinal adverse events were more common in the orlistat group . Other adverse symptoms occurred at a similar frequency during both treatments . INTERPRETATION Orlistat taken with an appropriate diet promotes clinical ly significant weight loss and reduces weight regain in obese patients over a 2-year period . The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy and adverse events",
"OBJECTIVE : To assess the efficacy and tolerability of orlistat ( Xenical ® ) in producing and maintaining weight loss over a 12-month period . DESIGN : Patients were r and omized to double-blind treatment with either orlistat 120 mg or placebo three times daily , in conjunction with a low-energy diet , for 12 months . SETTING : Five centres in the UK.SUBJECTS : 228 obese adult patients with body mass index between 30 and 43 kg/m2 and mean weight 97 kg ( range 74–144 kg ) . INTERVENTIONS : All patients were prescribed a low-energy diet , providing 30 % of energy from fat , design ed to produce an individually tailored energy deficit of approximately 600 kcal/day , for a run-in period of 4 weeks and then 12 months , plus orlistat 120 mg or placebo three times daily . MAIN OUTCOME MEASURES : Change in body weight ( the primary efficacy parameter ) , waist circumference and adverse events were review ed regularly , together with serum lipids , insulin , glucose and plasma levels of fat-soluble vitamins and β carotene . RESULTS : Based on an intent-to-treat analysis , after 1 y of treatment patients receiving orlistat had lost an average of 8.5 % of their initial body weight compared with 5.4 % for placebo-treated patients ; 35 % of the orlistat group lost at least 5 % of body weight compared with 21 % of the placebo group ( P 10 % of body weight . Orlistat-treated patients showed significant decreases ( P ) in serum levels of total cholesterol , low density lipoprotein cholesterol , and in the low density lipoprotein : high density lipoprotein ratio in comparison with placebo . Both groups had similar adverse-event profiles , except for gastrointestinal events , which were 26 % more frequent in the orlistat group but were mostly mild and transient . To maintain normal plasma levels of fat-soluble vitamins , supplements of vitamins A , D and E were given to 1.8 % , 8.0 % and 3.6 % , respectively , of orlistat-treated patients , compared with 0.9 % of placebo-treated patients for each vitamin type . After 1 y , the decrease in vitamin E and β carotene was significantly greater in orlistat-treated patients compared with those receiving placebo ( P was found in the mean vitamin E : total cholesterol ratio in either group after 52 weeks . Conclusions : Orlistat , in conjunction with a low-energy diet , produced greater and more frequent significant weight loss than placebo during 1 y of treatment . One-third of orlistat-treated patients achieved clinical ly relevant weight loss ( ≥5 % initial body weight ) . There was also an improvement in relevant serum lipid parameters . Fat-soluble vitamin supplements may be required during chronic therapy . Orlistat was well tolerated and offers a promising new approach to the long-term management of obesity",
"Co-existence of obesity and type 2 DM exacerbates metabolic and other remediable health consequences further . Various pharmacological therapies have been adopted when changing of lifestyle fail to achieve target glycaemic control . Our objective is to find out whether Orlistat can reduce both weight and need for oral hypoglycaemic agent ( OHA ) and improves glycaemic status , lipid disorders , blood pressure in Bangladesh type 2 DM with obesity . In this center , open-label , r and omized , controlled pilot trial 36 type 2 patients with obesity were enrolled . All patients aged 40 - 65 years had BMI > 25 kg/m2 taking sulfonylureas and hypocalorie diet . Twenty one r and omly cases were treated with orlistat 120 mg three times daily for 6 months and 15 without orlistat as control . Body weight , waist circumferances , fasting blood sugar , HbAlc , serum lipids , blood pressure and dose of drugs were monitored at 0,12 , 24 weeks . After 6 months , orlistat group showed non-significant weight loss than control group ( 3.95 % vs 1.42 % from base lines ) , but showed significant reduction of waist circumference ( 6 % vs 0.63 % , p0.05 from base line ) . Orlistat group had significant improvement in glycaemic status ( HbA1c changes : 22.37 % vs 13.38 % , p0.05 and FBS changes : 21.76 % vs 22.95 % , p p ) . Lipid profile had reduced significantly from base lines ( Chol : 19.31 % vs 9.12%,p 0.05 ; LDL Chol : 24.99 % vs 19.09 % , p p>0.05 ) . Diastolic pressure had improved significantly in orlistat group ( 6.73 % vs 3.70 % , p 0.05 ) . Reduction of OHA doses were found in both groups . Thus orlistat can be used as an adjuvant therapy with other OHA in managing glycaemic control , lipid profiles and blood pressure",
"BACKGROUND High-density lipoprotein ( HDL ) includes discrete subfractions . HDL exhibits anti-atherogenic properties , which have been partly linked to the activity of HDL-associated enzymes , such as the lipoprotein associated phospholipase A(2 ) ( HDL-LpPLA(2 ) ) and paraoxonase-1 ( PON1 ) . OBJECTIVE We assessed in an open-label r and omised study the effect of orlistat and ezetimibe , alone or in combination , on plasma HDL subclasses and HDL-associated enzyme activities in overweight and obese subjects ( body mass index > 28 kg/m(2 ) ) with hypercholesterolemia [ total cholesterol > 200 mg/100 ml ( 5.2 mmol/l ) ] . METHODS Eighty-six people were prescribed a low-fat low-calorie diet and were r and omly allocated to receive orlistat 120 mg , three times daily ( O group ) , ezetimibe 10 mg/day ( E group ) or both ( OE group ) for 6 months . HDL subfractions were determined using a polyacrylamide gel-tube electrophoresis method . RESULTS Levels of HDL cholesterol ( HDL-C ) and apolipoprotein AI did not change significantly in any group . In group O the cholesterol concentration of HDL-2 subclass increased significantly , while the cholesterol of HDL-3 subclass decreased significantly . In groups E and OE HDL-2 subclass did not significantly change , while the cholesterol concentration of HDL-3 subclass decreased significantly . We observed a non-significant decrease in the HDL-LpPLA(2 ) and PON1 activity in all groups . However , the ratios of both enzyme activities to low-density lipoprotein cholesterol ( LDL-C ) levels ( an index of atherogenicity ) significantly increased in all groups . CONCLUSION Although HDL-C levels did not change after treatment with orlistat and ezetimibe , alone or in combination , there were alterations of the HDL-2 and HDL-3 subclasses . The activity of HDL-LpPLA(2 ) and PON1 per mg LDL-C increased significantly in all groups",
"OBJECTIVE Orlistat decreases the absorption of dietary triglycerides by inhibiting intestinal lipases . Orlistat therapy is associated with a greater decline in plasma low-density lipoprotein-cholesterol concentrations than that expected from weight loss alone . Therefore , we evaluated the effect of orlistat treatment on dietary cholesterol absorption as a possible mechanism for the independent effect of orlistat on plasma cholesterol concentration . RESEARCH METHODS AND PROCEDURES Cholesterol absorption from a st and ardized meal , containing 72 mg of cholesterol , was determined in 18 subjects with class II abdominal obesity ( BMI , 35.0 to 39.9 kg/m(2 ) ) by simultaneous administration of intravenous ( [ (2)H(6 ) ] cholesterol ) and oral ( [ (2)H(5 ) ] cholesterol ) cholesterol tracers . In protocol 1 ( n = 9 ) , cholesterol absorption was determined on two different occasions , 10 to 20 days apart , to assess the reproducibility of the tracer method . In protocol 2 ( n = 9 ) , cholesterol absorption was determined with and without orlistat therapy in a prospect i ve , r and omized , crossover design to assess the effect of orlistat on cholesterol absorption . RESULTS In protocol 1 , cholesterol absorption from the test meal was the same on both occasions ( 53 + /- 5 % and 51 + /- 5 % ) . In protocol 2 , orlistat treatment caused a 25 % reduction in cholesterol absorption , from 59 + /- 6 % to 44 + /- 5 % ( p orlistat inhibits dietary cholesterol absorption , which may have beneficial effects on lipoprotein metabolism in obese subjects that are independent of weight loss itself",
"Objective To investigate the hypothesis that weight reduction with orlistat plus mild caloric restriction leads to better blood pressure control than diet alone in obese individuals with inadequately controlled hypertension . Design This was a 1-year , prospect i ve , r and omized , double-blind , placebo-controlled , multicenter trial of orlistat plus diet versus placebo plus diet in obese hypertensives . Interventions Participants were r and omized to receive either orlistat or placebo ; all received a 600 kcal deficient diet with no more than 30 % of calories from fat . Weight and blood pressure , lipid levels and fasting glucose and insulin levels were followed . Main outcome measures Patients on orlistat experienced greater weight loss ( −5.4 ± 6.4 versus −2.7 ± 6.4 kg , P greater reduction in body mass index ( −1.9 ± 2.3 versus −0.9 ± 2.2 kg/m2 , P 0.001 ) . Target weight loss , defined as ⩾ 5 % body weight ( BW ) , was obtained in more orlistat-treated patients than in the placebo group ( 46 versus 23 % , P decreased more in orlistat-treated patients than in the placebo group ( −11.4 ± 8.3 versus −9.2 ± 8.4 mmHg , P = 0.002 ) . A greater percentage of orlistat-treated patients reached goal diastolic blood pressure ( BP ) , defined as final diastolic BP The orlistat-treated group had significantly greater reductions in total cholesterol ( P cholesterol ( P = 0.001 ) and non-high-density lipoprotein cholesterol ( P obtained in more orlistat-treated patients ( 36.1 versus 24.0 % , P program with orlistat is more effective than diet alone to lower blood pressure and results in greater cardiovascular risk reduction ",
"AIM To determine if obese non-insulin-dependent diabetic patients lose more weight when treated for 24 weeks ( 6 months ) with orlistat ( 120 mg t.i.d . ) , in conjunction with a hypocaloric diet plus behavioural counselling , than when treated by placebo ( t.i.d . ) plus similar instructions . The secondary objectives were to evaluate the effects on glucose profile and to determine the tolerability and safety of orlistat . DESIGN Double-blind , parallel , r and omized , placebo-controlled , multicentre study . SUBJECTS Obese , non-insulin-dependent diabetic patients , aged 18 - 70 years old , with BMI > 27 kg/m2 , evaluated at 10 Latin-American centres , in five countries . EFFICACY AND TOLERABILITY MEASUREMENTS : After screened , eligible patients passed by a 2-week placebo run-in period receiving a hypocaloric diet . On day 0 , patients were r and omized to orlistat or placebo for 24 weeks . At each visit , body weight , blood pressure and waist circumference were measured . At the screening visit , baseline visit ( week 0 ) , and at weeks 8 , 16 and 24 , a central laboratory was in charge of measuring fasting glucose and insulin , HbA1c , postpr and ial glucose and insulin , fasting total cholesterol , HDL-cholesterol , LDL-cholesterol , triglycerides , and postpr and ial triglycerides . Other safety laboratory assessment s were measured locally at the screening visit , baseline visit and at the end of the study . Adverse events were assessed at each visit from baseline . RESULTS After 24 weeks of treatment , the orlistat group lost an average of 4.7 % of initial body weight vs. 3.0 % in the placebo group ( p = 0.0003 ) . A greater weight loss was achieved in the orlistat compared with the placebo group ( 4.24 + /- 0.23 vs. 2.58 + /- 1.46 kg , p = 0.0003 ) . Almost twice as many patients receiving orlistat ( 30 % vs. 17 % ) lost > or = 5 % of initial body weight ( p = 0.003 ) . Orlistat treatment plus diet compared to placebo plus diet was associated with significant improvement in glycaemic control , as reflected in decreases in HbA1c ( p = 0.04 ) , fasting plasma glucose ( p = 0.036 ) and postpr and ial glucose ( p = 0.05 ) . Orlistat-treated patients had a mean decrease in glucose levels of 1.00 + /- 0.34 mmol/l [ 3.7 % ] vs. 0.01 + /- 0.30 mmol/l for placebo group , at week 24 and an absolute decrease of HbA1c of 0.61 + /- 0.15 vs. a decrease of 0.22 + /- 0.14 % in the placebo group . Orlistat therapy also result ed in significantly greater improvements than placebo in lipid profile , with reductions in total cholesterol ( p = 0.0001 ) and LDL-cholesterol ( p = 0.002 ) . Mild to moderate transient gastrointestinal events were reported , mainly with orlistat treatment , but their association with withdrawal from the study was low . CONCLUSION Orlistat is a useful and an effective therapy in obese diabetic patients , promoting clinical ly significant weight loss and improved glycaemic control and lipid profile",
"INTRODUCTION Obesity is a chronic disease and a serious health problem that leads to increased prevalence of diabetes , hypertension , dyslipidemia and gallbladder disease . OBJECTIVE To evaluate the efficacy of orlistat for weight loss and improved lipid profile compared to placebo in obese patients with hypercholesterolemia , treated over a period of 6 months . METHODOLOGY In a 6-month , multicenter ( 10 centers in Portugal ) , double-blind , parallel , placebo-controlled study , 166 patients , aged 18 - 65 years , body mass index ( BMI ) > or = 27 kg/m2 , LDL cholesterol > 155 mg/dl , were r and omized to a reduced calorie diet ( 600 kcal/day deficit ) plus orlistat three times a day or placebo . Exclusion criteria included triglycerides > 400 mg/dl , severe cardiovascular disease , uncontrolled hypertension , type 1 or 2 diabetes under pharmacological treatment , and gastrointestinal or pancreatic disease . RESULTS The mean difference in weight from baseline was 5.9 % ( 5.6 kg ) in the orlistat group vs. 2.3 % ( 2.2 kg ) in the placebo group . In the orlistat group 49 % of patients achieved 5 - 10 % weight loss and 8.8 % achieved > 10 % . The orlistat group showed a significant reduction in total and LDL cholesterol , with similar changes for HDL in both treatment groups . The frequency of gastrointestinal adverse events was slightly higher in the orlistat group than in the placebo group , leading to discontinuation in 7 patients . CONCLUSION Treatment with orlistat plus a reduced calorie diet for 6 months achieved significant reductions in weight , BMI and lipid parameters",
"The objective of this study was to evaluate and compare the effect of treatment with orlistat vs. metformin on the hormonal and biochemical features of patients with polycystic ovarian syndrome ( PCOS ) . Twenty-one Caucasian women with PCOS [ mean ( + /-SEM ) age 27 + /- 0.9 yr and body mass index 36.7 + /- 3.3 kg/m(2 ) ] participated in this prospect i ve , r and omized , open-labeled study . All subjects had an 8-wk run-in period of dietary modification and then r and omized to receive either metformin ( 500 mg three times daily ) or orlistat ( 120 mg three times daily ) for 3 months . Weight , blood pressure , and fasting blood sample s were taken at screening , r and omization , and on completion . Insulin resistance ( IR ) was calculated using the homeostasis model of assessment (HOMA)-IR method [ HOMA-IR = ( insulin x glucose)/22.5 ] . The results are expressed as mean + /- SEM . When compared with baseline , treatment with both orlistat [ 93.5 + /- 11.5 ng/dl ( 3.24 + /- 0.4 nmol/liter ) vs. 114.5 + /- 11.5 ng/dl ( 3.97 + /- 0.4 nmol/liter ) , P = 0.039 ] and metformin [ 97.2 + /- 11.5 ng/dl ( 3.37 + /- 0.4 nmol/liter ) vs. 120.0 + /- 8.7 ng/dl ( 4.16 + /- 0.3 nmol/liter ) , P = 0.048 ] produced a significant reduction in total testosterone . Treatment with orlistat produced a 4.69 % reduction in weight ( 99.0 + /- 6.0 vs. 94.6 + /- 6.1 kg , P = 0.002 ) , and this reduction was more significant than the reduction produced by metformin ( 4.69 vs. 1.02 % , P = 0.006 ) . There was no significant reduction seen after either treatment group for fasting insulin , HOMA-IR , SHBG , or any of the lipid parameters studied . In this study , orlistat produced a significant reduction in weight and total testosterone . The reduction in total testosterone was similar to that seen after treatment with metformin . Therefore , orlistat may prove to be a useful adjunct in the treatment of PCOS"
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4116d1e8-06ff-11f0-808a-c43d1ab1c353
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Background : Muscle weakness is the main cause of motor impairment among stroke survivors and is associated with reduced peak muscle torque . Objective : To systematic ally investigate and organize the evidence of the reliability of muscle strength evaluation measures in post-stroke survivors with chronic hemiparesis . Data Sources : Two assessors independently search ed four electronic data bases in January 2014 ( Medline , Scielo , CINAHL , Embase ) . Study Selection : Inclusion criteria comprised studies on reliability on muscle strength assessment in adult post-stroke patients with chronic hemiparesis . Data Extraction : We extracted outcomes from included studies about reliability data , measured by intraclass correlation coefficient ( ICC ) and /or similar . The meta-analyses were conducted only with isokinetic data . Results : Of 450 articles , eight articles were included for this review . After quality analysis , two studies were considered of high quality . Five different joints were analyzed within the included studies ( knee , hip , ankle , shoulder , and elbow ) . Their reliability results varying from low to very high reliability ( ICCs from 0.48 to 0.99 ) . Results of meta- analysis for knee extension varying from high to very high reliability ( pooled ICCs from 0.89 to 0.97 ) , for knee flexion varying from high to very high reliability ( pooled ICCs from 0.84 to 0.91 ) and for ankle plantar flexion showed high reliability ( pooled ICC = 0.85 ) . Conclusion : Objective muscle strength assessment can be reliably used in lower and upper extremities in post-stroke patients with chronic hemiparesis
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"This study was undertaken to determine muscle strength of trunk flexion-extension in hemiplegic patients after stroke compared with that of normal controls . The design consisted of a nonr and omized control trial in a secondary care setting ( a rehabilitation unit at a hospital facility ) . The subjects included 25 post-stroke male hemiplegic patients and 25 male healthy controls . The maximal peak torques of trunk flexion-extension at angular velocities of 0 degrees ( isometric contraction ) , 60 degrees , 120 degrees , and 150 degrees/s were measured by using an isokinetic dynamometer ( Cybex Trunk Extension-Flexion Unit , Cybex , Ronkonkoma , NY ) . Peak torque of trunk flexion and extension in hemiplegic patients was significantly smaller than that of healthy controls ( P 0.05 ) . The weakness of trunk flexion-extension muscles in hemiplegic patients might be accounted for by the bilateral innervation from the motor cortex , the insufficient use of high threshold motor units , and disuse atrophy",
"The purpose of this study was to establish test-retest reliability of measurement procedures for quantifying isokinetic concentric peak torque ( PT ) at the knee using normalization methods post-stroke . A second aim was to estimate the change required to show clinical ly significant improvements in knee muscles strength . The isokinetic normalized PT ( NPT ) values for the knee extensors and flexors were measured in each participant at two different angular velocities during two sessions 1 day apart . Thirty participants with mild to moderate hemiparesis after stroke who were able to walk were tested . The normalized PT measures for the knee muscles of the affected lower extremity were highly reliable ( intraclass correlation coefficients ranged from 0.85 to 0.98 ; p relative changes ( the percent smallest real difference , SRD% ) for extensors NPT ( ranged from 22.35 % to 25.68 % ) were lower than flexors NPT ( ranged from 74.01 % to 76.31 % ) , indicating that the affected isokinetic knee flexors had more r and om variation than the knee extensors . This study supports the use of isokinetic dynamometers for the assessment of knee muscle strength in participants with chronic mild to moderate post-stroke hemiparesis and to measure clinical improvements . Established measurement error and smallest real differences in normalized PT will aid interpretation of real changes in muscle strength in this clinical population",
"This study was undertaken to determine whether the direction of trunk rotation would have any effect on trunk muscle performance of post-stroke hemiplegic patients . The design consisted of a nonr and omized control trial in a setting of secondary care ( rehabilitation unit at hospital facility ) . The subjects included 65 hemiplegic patients ( 50 males ) and age-matched 80 healthy controls ( 38 females ) . Isokinetic trunk rotatory muscle performance at angular velocities of 60 , 120 , and 150 degrees per second was measured by using an isokinetic dynamometer ( Cybex Torso Rotation Unit ) . There were no significant differences in the peak torque and best work between the right and left directions of the trunk rotation in the hemiplegic patients or in healthy controls , regardless of the gender of the subjects ( paired t test , P > 0.05 ) . The muscle performance of the hemiplegic patients was significantly lower than that of the controls for both genders ( t test , P trunk rotatory muscle performance , although the performance itself was slightly decreased",
"We established reliability of upper-limb muscle performance in adults with post-stroke hemiparesis . Ten adults with post-stroke hemiparesis ( 51.5 ± 34 . 5 months ) performed isokinetic concentric shoulder flexion , elbow flexion , and extension at 3 criterion speeds ( 30 ° /s , 75 ° /s , and 120 ° /s ) on 3 separate occasions ( Days 1,7 , and 49 ) . As several participants were unable to reach criterion speeds , actual speed and power were also analyzed . Relative reliability ( intr-aclass correlation coefficient-ICC ) was excellent for torque and power ( 0.82 to 0.98 ) but less consistent for speed ( 0.63 to 0.99 ) . Absolute reliability ( st and ard error of measurement-%SEM ) ranged between 0 % to 34 % . No systematic errors were observed across sessions . Smallest real differences ( SRD ) ranged between 4–11Nm for torque and 3–24W for power . Shoulder flexion , elbow flexion , and elbow extension torque , speed , and power can be measured reliably following stroke . Given that many of these individuals demonstrate inability to generate torque at preselected speeds , power may be a more valid indicator of muscle performance",
"BACKGROUND Emerging evidence on the velocity-dependent nature of force impairment in post-stroke hemiparesis has emphasized the complexity of strength and motor performance assessment s in this clinical population . The need to establish reliability and responsiveness of muscle performance measures across a broad range of concentric and eccentric movement speeds is therefore clear , as these metrics will provide benchmarks both for making clinical inference and evaluating meaningful clinical change following interventions . METHODS Isokinetic knee extensor strength was tested at 14 angular velocities in 17 adults with chronic post-stroke hemiparesis ( > 18 months ) , and 13 non-disabled controls . Identical tests were conducted on two occasions separated by two days . Test-retest reliability of maximal isokinetic torque was evaluated using intraclass correlation . Absolute reliability was assessed using st and ard error of measurement from which smallest real differences were derived . FINDINGS Overall , intraclass correlation coefficients were excellent for both hemiparetic ( 0.891 ) and control ( 0.937 ) groups . Intraclass correlation coefficients for each criterion speed were also high for both groups ( > 0.86 ) . Measurement error relative to the mean torque varied between 14.1 % and 26.3 % for hemiparetic subjects and 6.0 - 18.1 % for controls . The smallest real difference relative to mean torque was 39.0 - 72.7 % and 16.6 - 50.2 % for hemiparetic and control subjects , respectively . INTERPRETATION Isokinetic knee extension torque can be measured reliably in persons with chronic post-stroke hemiparesis and in non-disabled controls across a full functional range of concentric and eccentric speeds . Established measurement error and smallest real differences will aid interpretation of longitudinal observations of muscle performance in this clinical population"
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BACKGROUND Evidence from controlled trials encourages the intake of dietary pulses ( beans , chickpeas , lentils and peas ) as a method of improving dyslipidemia , but heart health guidelines have stopped short of ascribing specific benefits to this type of intervention or have grade d the beneficial evidence as low . We conducted a systematic review and meta- analysis of r and omized controlled trials ( RCTs ) to assess the effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction . METHODS We search ed electronic data bases and bibliographies of selected trials for relevant articles published through Feb. 5 , 2014 . We included RCTs of at least 3 weeks ' duration that compared a diet emphasizing dietary pulse intake with an isocaloric diet that did not include dietary pulses . The lipid targets investigated were low-density lipoprotein ( LDL ) cholesterol , apolipoprotein B and non-high-density lipoprotein ( non-HDL ) cholesterol . We pooled data using a r and om-effects model . RESULTS We identified 26 RCTs ( n = 1037 ) that satisfied the inclusion criteria . Diets emphasizing dietary pulse intake at a median dose of 130 g/d ( about 1 serving daily ) significantly lowered LDL cholesterol levels compared with the control diets ( mean difference -0.17 mmol/L , 95 % confidence interval -0.25 to -0.09 mmol/L ) . Treatment effects on apolipoprotein B and non-HDL cholesterol were not observed . INTERPRETATION Our findings suggest that dietary pulse intake significantly reduces LDL cholesterol levels . Trials of longer duration and higher quality are needed to verify these results . TRIAL REGISTRATION Clinical Trials.gov , no. NCT01594567
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"Clinical studies have shown that fiber consumption facilitates weight loss and improves lipid profiles ; however , the beneficial effects of high fermentable fiber low glycemic index ( GI ) diets under conditions of weight maintenance are unclear . In the Legume Inflammation Feeding Experiment , a r and omized controlled cross-over feeding study , 64 middle-aged men who had undergone colonoscopies within the previous 2 years received both a healthy American ( HA ) diet ( no legume consumption , fiber consumption = 9 g/1,000 kcal , and GI = 69 ) and a legume enriched ( 1.5 servings/1,000 kcal ) , high fiber ( 21 g/1,000 kcal ) , low GI ( GI = 38 ) diet ( LG ) in r and om order . Diets were isocaloric and controlled for macronutrients including saturated fat ; they were consumed each for 4 weeks with a 2–4 week break separating dietary treatments . Compared to the HA diet , the LG diet led to greater declines in both fasting serum total cholesterol ( TC ) and low density lipoprotein cholesterol ( LDL-C ) ( P in high density lipoprotein cholesterol ( HDL-C ; P ( P = 0.02 ) after the LG diet , compared to the HA diet . Insulin-sensitive ( IS ) subjects had greater reductions in TC ( P ( P ( P ( P = 0.02 ) after the LG diet , compared to the HA diet . In conclusion , a high legume , high fiber , low GI diet improves serum lipid profiles in men , compared to a healthy American diet . However , IR individuals do not achieve the full benefits of the same diet on cardiovascular disease ( CVD ) lipid risk factors",
"Dried beans lower serum lipid concentrations in healthy and hyperlipidemic subjects . To determine the effects of canned beans on serum lipid concentrations , 24 hyperlipidemic men ate one of three bean diets for 21 d in a metabolic ward . Diets A and B included 227 g canned beans ( 120 g beans with 107 g tomato sauce ) daily , in a single dose for diet A and in a divided dose for diet B. Diet C included 182 g canned beans ( 162 g beans with 20 g tomato sauce ) daily in a divided dose . All bean diets combined lowered serum cholesterol and triglyceride concentrations 10.4 % ( p less than 0.001 ) and 10.8 % ( p less than 0.025 ) , respectively . Diet B was as effective as diet C , and the groups on those diets had greater cholesterol reductions than did the group on diet A. Serum cholesterol reduction was positively correlated ( p less than 0.01 ) with intake of total dietary fiber and soluble fiber . The ratios of low- to high-density-lipoprotein cholesterol remained constant for all groups . Body weight decreased 1.0 - 1.5 kg for all groups despite constant energy intakes . Canned beans may make an important contribution to hyperlipidemia management",
"Beans improve serum lipids and may reduce the risk of colon cancer by increasing colonic SCFA formation . We assessed whether pinto bean consumption affects in vitro fecal bacterial fermentation and production of SCFA , colonic bacterial population s , and serum lipids . Adults grouped as premetabolic syndrome ( pre-MetSyn ) ( n = 40 ) or controls ( n = 40 ) were r and omly assigned to consume either a bean entrée [ 1/2 cup ( 130 g ) of dried , cooked pinto beans ] or an isocaloric chicken soup entrée daily for 12 wk . Measurements included in vitro fecal fermentation of various resistant starch substrates , fecal bacterial speciation , and blood lipids . When expressed as a difference between baseline and treatment , propionate production from fecal material fermented in vitro with bean flour was higher ( P volunteers consuming beans than in those consuming soup . During the treatment period alone , bean consumption did not affect propionic acid production with any substrate but lowered ( P butyric acid production when cornstarch was the substrate . In all volunteers , bean consumption decreased fecal production of isovaleric ( P isobutyric ( P acids from cornstarch by as much as 50 % . Of the bacterial population s tested , only Eubacterium limosum was affected by bean consumption and was approximately 50 % lower than in those consuming soup . Beans lowered serum total cholesterol ( P . Bean consumption lowered serum HDL-cholesterol ( P LDL-cholesterol ( P serum triglycerides , VLDL cholesterol , or glucose . This study provides evidence that bean consumption can improve lipid profiles associated with cardiovascular disease , but does not clearly confer health benefits related to colon cancer risk",
"Background : Regular consumption of diets with increased protein or fibre intakes may benefit body weight and composition and cardiovascular disease risk factors . Lupin flour is a novel food ingredient high in protein and fibre . Objective : To investigate the effects of a lupin-enriched diet , during and following energy restriction , on body weight and composition and cardiovascular disease risk factors in overweight individuals . Design : Participants ( n=131 ) were recruited to a 12-month parallel- design trial . They were r and omly assigned to consume lupin-enriched foods or matching high-carbohydrate control foods . All participants underwent 3 months of weight loss , 1 month of weight stabilization and 8 months of weight maintenance . Body weight and composition and cardiovascular disease risk factors were assessed at baseline , 4 and 12 months . Results : Lupin , relative to control , did not significantly influence ( mean difference ( 95 % CI ) ) weight loss at 4 months ( 0.1 kg ( −1.2 , 1.4 ) ) and 12 months ( −0.6 kg ( −2.0 , 0.8 ) ) , maintenance of weight loss from 4 to 12 months ( −0.7 kg ( −1.83 , 0.48 ) ) or measures of body fat and fat-free mass . Relative to control , 24-h ambulatory systolic ( −1.3 mm Hg ( −2.4 , −0.3 ) , P=0.016 ) and diastolic ( −1.0 mm Hg ( −1.9 , −0.2 ) , P=0.021 ) blood pressures were lower at 12 months but not at 4 months ; fasting insulin concentrations and homeostasis model assessment ( HOMA ) scores were significantly lower at 4 months ( −1.2 mU l–1 ( −1.3 , −1.1 ) , P=0.004 and −0.6 units ( −1.0 , −0.19 ) , P=0.004 ) and 12 months ( −1.3 mU l–1 ( −1.4 , −1.1 ) , P from lupin-enriched foods does not enhance weight loss or improve the maintenance of weight loss . However , such a diet may provide cardiovascular health benefits in terms of insulin sensitivity and blood pressure",
"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 Legumes , including beans , chickpeas , and lentils , are among the lowest glycemic index ( GI ) foods and have been recommended in national diabetes mellitus ( DM ) guidelines . Yet , to our knowledge , they have never been used specifically to lower the GI of the diet . We have therefore undertaken a study of low-GI foods in type 2 DM with a focus on legumes in the intervention . METHODS A total of 121 participants with type 2 DM were r and omized to either a low-GI legume diet that encouraged participants to increase legume intake by at least 1 cup per day , or to increase insoluble fiber by consumption of whole wheat products , for 3 months . The primary outcome was change in hemoglobin A1c ( HbA1c ) values with calculated coronary heart disease ( CHD ) risk score as a secondary outcome . RESULTS The low-GI legume diet reduced HbA1c values by -0.5 % ( 95 % CI , -0.6 % to -0.4 % ) and the high wheat fiber diet reduced HbA1c values by -0.3 % ( 95 % CI , -0.4 % to -0.2 % ) . The relative reduction in HbA1c values after the low-GI legume diet was greater than after the high wheat fiber diet by -0.2 % ( 95 % CI , -0.3 % to -0.1 % ; P CHD risk reduction on the low-GI legume diet was -0.8 % ( 95 % CI , -1.4 % to -0.3 % ; P = .003 ) , largely owing to a greater relative reduction in systolic blood pressure on the low-GI legume diet compared with the high wheat fiber diet ( -4.5 mm Hg ; 95 % CI , -7.0 to -2.1 mm Hg ; P glycemic control and reduced calculated CHD risk score in type 2 DM",
"Background : Lupin kernel flour ( LKF ) is a novel food ingredient that is high in protein and fibre . We have previously shown that partial substitution of refined wheat-derived carbohydrate in bread with protein and fibre from LKF can reduce appetite and energy intake acutely . In addition , several studies have suggested that lupin may reduce cholesterol concentrations and benefit glucose and insulin metabolism . Aim : The aim of this study was to investigate the effects on body weight and composition and blood lipids , glucose and insulin of an ad libitum LKF-enriched diet higher in dietary protein and fibre . Subjects and methods : A total of 88 overweight and obese men and women were recruited for a 16-week parallel- design r and omized controlled trial . Participants replaced 15–20 % of their usual daily energy intake with white bread ( control ) or LKF-enriched bread ( lupin ) in an ad libitum diet . Measurements of body weight and composition , and fasting blood biochemical measurements were performed at baseline and 16 weeks . The primary analysis included 74 participants ( 37 per group ) who completed the intervention . Results : At baseline , mean ( ±s.d . ) body mass index and total cholesterol were 30.6±3.5 kg m−2 and 5.37±0.94 mmol l−1 , respectively . Estimated ( mean between-group difference ( 95 % confidence interval ) ) protein ( 13.7 ( 2.28 , 25.0 ) g per day ) and fibre ( 12.5 ( 8.79 , 16.2 ) g per day ) intakes were higher during the intervention with lupin than with control . For lupin relative to control , the net effects on body weight ( −0.4 ( −1.3 , 0.6 ) kg ) , fat mass ( −0.5 ( −1.1 , 0.2 ) kg ) and percentage ( −0.5 ( −1.1 , 0.1)% ) , plasma leptin ( −1.66 ( −4.91 , 1.59 ) ng ml−1 ) and adiponectin ( 0.20 ( −0.73 , 1.13 ) mg l−1 , as well as serum total cholesterol ( −0.08 ( −0.38 , 0.22 ) mmol l−1 ) , triglycerides ( 0.09 ( −0.10 , 0.21 ) mmol l−1 ) , glucose ( 0.10 ( −0.11 , 0.30 ) mmol l−1 ) and insulin ( 0.40 ( −1.20 , 2.00 ) mU l−1 ) were not significant . Conclusions : This study does not support the proposal that an ad libitum diet enriched in LKF result ing in moderate changes in both protein and fibre intakes can benefit body weight and composition or fasting blood lipids , glucose and insulin concentrations in overweight men and women with mildly elevated total cholesterol concentrations",
"Objective : To investigate the effect of bread formulated with 6 g of β-glucan ( oat soluble fiber ) on serum lipids in overweight normotensive subjects with mild to moderate hypercholesterolemia . Design : Thirty-eight male subjects [ mean age 59.8 ± 0.6 yr , mean body mass index ( BMI ) 28.3 ± 0.6 kg/m2 ] who were eligible for the study ate an isocaloric diet for a 1-week period . They were then divided into 2 groups : group A ( n = 19 ) , who were maintained on American Heart Association ( AHA ) Step II diet , including whole wheat bread , and group B ( n = 19 ) , who were maintained on AHA Step II diet containing high levels of monounsaturated fatty acids plus bread containing 6 g of β-glucan ( Nutrim-OB ) for 8 weeks . Plasma lipids and glucose were measured at baseline and after weeks 8 in all subjects . All subjects were advised to walk for 60 minutes every day . Results : There was a significant increase ( ↑27.8 % ) in plasma high density lipoprotein ( HDL ) cholesterol in the β-glucan group ( group A ) from 39.4 ± 2.0 to 49.5 ± 2.1 mg/dL ( P reduction in total cholesterol in the 2 groups to approximately the same extent : group A , from 232.8 ± 2.7 mg/dL to 202.7 ± 6.7 mg/dL ; P ; P also decreased significantly in the two groups : group A , from 160.3 ± 2.8 mg/dL to 133.2 ± 5.4 mg/dL ; P 0.04 ) . There was a small and insignificant reduction in plasma very LDL ( VLDL ) cholesterol and triglycerides in the two groups . Similarly , non-HDL cholesterol levels were also decreased , with β-glucan diet producing significantly higher effect ( ↓24.5 % vs. ↓16.1 % ; P The β-glucan diet also produced higher reduction in total cholesterol/HDL cholesterol ratio ( ↓33.3 % vs. ↓8.4 % ; P 0.003 ) and LDL cholesterol/HDL cholesterol ratio ( ↓42.1 % vs. ↓13.3 % ; P without β-glucan . The β-glucan diet also decreased fasting plasma glucose ( P reduced body weight and BMI significantly , with β-glucan diet having a greater effect . Conclusions : Six grams of β-glucan from oats added to the AHA Step II diet and moderate physical activity improved lipid profile and caused a decrease in weight and , thus , reduced the risk of cardiovascular events in overweight male individuals with mild to moderate hypercholesterolemia . The diet with added β-glucan was well accepted and tolerated",
"Oat or bean products , rich in water-soluble fiber , have distinct hypocholesterolemic effects in humans . After a control diet , 20 hypercholesterolemic men were r and omly allocated to oat-bran or bean supplemented diets for 21 days on a metabolic ward . Control and test diets provided equivalent energy , fat , and cholesterol but test diets had twice more total and 3-fold more soluble fiber . Oat-bran diets decreased serum cholesterol concentrations by 19 % ( p less than 0.0005 ) and calculated low-density lipoprotein cholesterol by 23 % ( p less than 0.0025 ) . Bean diets decreased serum cholesterol concentrations by 19 % ( p less than 0.0005 ) and low-density lipoprotein cholesterol by 24 % ( p less than 0.0005 ) . Oat-bran increased fecal weight by 43 % but beans did not . While oat-bran increased fecal bile acid excretion , beans had the opposite effect . Oat-bran or bean supplements may have an important role in nutritional management of selected hypercholesterolemic patients",
"CONTEXT Combining foods with recognized cholesterol-lowering properties ( dietary portfolio ) has proven highly effective in lowering serum cholesterol under metabolically controlled conditions . OBJECTIVE To assess the effect of a dietary portfolio administered at 2 levels of intensity on percentage change in low-density lipoprotein cholesterol ( LDL-C ) among participants following self-selected diets . DESIGN , SETTING , AND PARTICIPANTS A parallel- design study of 351 participants with hyperlipidemia from 4 participating academic centers across Canada ( Quebec City , Toronto , Winnipeg , and Vancouver ) r and omized between June 25 , 2007 , and February 19 , 2009 , to 1 of 3 treatments lasting 6 months . INTERVENTION Participants received dietary advice for 6 months on either a low-saturated fat therapeutic diet ( control ) or a dietary portfolio , for which counseling was delivered at different frequencies , that emphasized dietary incorporation of plant sterols , soy protein , viscous fibers , and nuts . Routine dietary portfolio involved 2 clinic visits over 6 months and intensive dietary portfolio involved 7 clinic visits over 6 months . MAIN OUTCOME MEASURES Percentage change in serum LDL-C. RESULTS In the modified intention-to-treat analysis of 345 participants , the overall attrition rate was not significantly different between treatments ( 18 % for intensive dietary portfolio , 23 % for routine dietary portfolio , and 26 % for control ; Fisher exact test , P = .33 ) . The LDL-C reductions from an overall mean of 171 mg/dL ( 95 % confidence interval [ CI ] , 168 - 174 mg/dL ) were -13.8 % ( 95 % CI , -17.2 % to -10.3 % ; P dietary portfolio ; -13.1 % ( 95 % CI , -16.7 % to -9.5 % ; P Percentage LDL-C reductions for each dietary portfolio were significantly more than the control diet ( P 2 dietary portfolio interventions did not differ significantly ( P = .66 ) . Among participants r and omized to one of the dietary portfolio interventions , percentage reduction in LDL-C on the dietary portfolio was associated with dietary adherence ( r = -0.34 , n = 157 , P dietary portfolio compared with the low-saturated fat dietary advice result ed in greater LDL-C lowering during 6 months of follow-up . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00438425",
"Objective : To compare the effect of a diet supplemented with chickpeas to a wheat-based diet of similar fibre content on serum lipids , glucose tolerance , satiety and bowel function . A third , lower-fibre wheat diet provided further information on dietary fibre quantity and bowel function and satiety . Method : Twenty-seven free-living adults followed two r and omized , crossover dietary interventions each of five weeks duration . The chickpea diet included canned drained chickpeas , bread and shortbread biscuits containing 30 % chickpea flour . The wheat diet included high-fibre wheat breakfast cereals and wholemeal bread . The diets were isoenergetic to the participants ’ usual diet , matched for macronutrient content and controlled for dietary fibre . Following on from the second r and omised intervention , a sub-group of 18 participants underwent a third , isoenergetic lower-fibre wheat diet that included low-fibre breakfast cereals and bread . Results : Repeated measures ANOVA revealed reductions in serum TC of 0.25 mmol/L ( p LDL-C of 0.20 mmol/L ( p = 0.02 ) following the chickpea diet compared to the wheat . An unintended significant increase in PUFA and corresponding decrease in MUFA consumption occurred during the chickpea diet and statistical adjustment for this reduced but did not eliminate the effect on serum lipids . There was no significant difference in glucose tolerance . Perceived general bowel health improved significantly during the chickpea diet although there was considerable individual variation . Some participants reported greater satiety during the chickpea diet . Conclusions : The small but significant decrease in serum TC and LDL-C during the chickpea diet compared to the equivalent fibre wheat diet was partly due to unintentional changes in macronutrient intake occurring because of chickpea ingestion . If dietary energy and macronutrients were not controlled , chickpea consumption might result in greater benefits via influence on these factors",
"Objective : To determine effects of daily intake of 1/2 cup pinto beans , black-eyed peas or carrots ( placebo ) on risk factors for coronary heart disease ( CHD ) and diabetes mellitus ( DM ) in free-living , mildly insulin resistant adults over an 8 week period . Methods : R and omized , crossover 3 × 3 block design . Sixteen participants ( 7 men , 9 women ) received each treatment for eight-weeks with two-week washouts . Fasting blood sample s collected at beginning and end of periods were analyzed for total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol , triacylglycerols , high-sensitivity C-reactive protein , insulin , glucose , and hemoglobin A1c . Results : A significant treatment-by-time effect impacted serum TC ( p = 0.026 ) and LDL ( p = 0.033 ) after eight weeks . Paired t-tests indicated that pinto beans were responsible for this effect ( p = 0.003 ; p = 0.008 ) . Mean change of serum TC for pinto bean , black-eyed pea and placebo were −19 ± 5 , 2.5 ± 6 , and 1 ± 5 mg/dL , respectively ( p = 0.011 ) . Mean change of serum LDL-C for pinto bean , black-eyed pea and placebo were −14 ± 4 , 4 ± 5 , and 1 ± 4 mg/dL , in that order ( p = 0.013 ) . Pinto beans differed significantly from placebo ( p = 0.021 ) . No significant differences were seen with other blood concentrations across the 3 treatment periods . Conclusions : Pinto bean intake should be encouraged to lower serum TC and LDL-C , thereby reducing risk for CHD",
"The nutritional composition of dietary intake could produce specific effects on metabolic variables such as mitochondrial oxidation , whose underst and ing could contribute to apply more individualized weight-lowering strategies . This study assessed the effects of four hypocaloric diets with high protein content or different food distribution on metabolic changes and mitochondrial oxidation accompanying weight loss . Thirty-five obese men ( body mass index of 31.8 + /- 3.0 kg/m(2 ) and 38 + /- 7 years old ) were r and omly assigned to one of the four treatments ( 8 weeks ) : control diet ( C-diet ) ; legume diet ( L-diet ) ; fatty fish diet ( FF-diet ) ; or high-protein diet ( HP-diet ) . Body composition , blood pressure , resting energy expenditure , mitochondrial oxidation , blood biomarkers , and dietary intake were assessed . The HP-diet and L-diet achieved the greater body weight reduction ( -8.4 + /- 1.2 % and -8.3 + /- 2.9 % , respectively ) , as compared to the C-diet ( -5.5 + /- 2.5 % ; P = .042 ) . The high-density lipoprotein cholesterol concentrations were reduced in all dietary groups except for the FF-diet . Total and low-density lipoprotein cholesterol levels were significantly improved by the L-diet ( P homeostatic model assessment index of insulin resistance value was significantly reduced in those men following the HP-diet . Mitochondrial oxidation was specifically activated by the HP-diet and L-diet at the end of the study . Interestingly , a lineal regression model explained about 25 % ( P = .029 ) of the mitochondrial oxidation variability as influenced by the diet changes once adjusted by resting energy expenditure . The specific consumption of legumes or high protein content within a hypocaloric diet could activate mitochondrial oxidation , which could involve additional benefits to those associated with the weight reduction",
"The plasma cholesterol lowering potential of canned baked beans was examined in a cross-over comparison with canned spaghetti . The difference in total dietary non-starch polysaccharide ( NSP ) of 12 g daily ( 6.6 g difference in soluble NSP ) , was insufficient to alter the plasma cholesterol , HDL cholesterol , triglyceride and glucose concentrations in 20 mildly hyper-cholesterolaemic men . Thus , eating an average of six 440 g cans of this source of baked beans per week , large servings , does not lower the plasma cholesterol when dietary fat is not displaced",
"The effects of consuming an increased amount of soluble fibre as oat bran or beans were examined in 40 free-living hypercholesterolaemic men and women . The subjects were initially established on a low-fat background diet ( 29 % of energy from fat ) and then 55 g low-fibre oat bran , 55 g high-fibre oat bran or 80 g mixed cooked beans were added to their diet in r and om order for 6 week periods . Body weight and overall composition of the diet did not change . Plasma cholesterol and low-density lipoprotein cholesterol ( LDL-C ) were unchanged . High-density lipoprotein cholesterol ( HDL-C ) was significantly higher on all three intervention diets than on the lower fibre run-in diet . Supplementation of a moderately low-fat diet with palatable quantities of oat bran or beans without changing the overall fat intake does not appear to significantly lower cholesterol but may have a benefit by increasing HDL-C and reducing the ratio of LDL-C to",
"Aim : To compare the effects of a chickpea-supplemented diet and those of a wheat-supplemented diet on human serum lipids and lipoproteins . Methods : Forty-seven free-living adults participated in a r and omized crossover weight maintenance dietary intervention involving two dietary periods , chickpea-supplemented and wheat-supplemented diets , each of at least 5 weeks duration . Results : The serum total cholesterol and low-density lipoprotein cholesterol levels were significantly lower ( both p chickpea-supplemented diet as compared with the wheat-supplemented diet . Protein ( 0.9 % of energy , p = 0.01 ) and monounsaturated fat ( 3.3 % of total fat , p carbohydrate intake significantly higher ( 1.7 % of energy , p chickpea-supplemented diet as compared with the wheat-supplemented diet . Multivariate analyses suggested that the differences in serum lipids were mainly due to small differences in polyunsaturated fatty acid and dietary fibre contents between the two intervention diets . Conclusions : Inclusion of chickpeas in an intervention diet results in lower serum total and low-density lipoprotein cholesterol levels as compared with a wheat-supplemented diet",
"Our purpose was to determine the effects of a pulse-based diet in individuals 50 years or older for reducing CVD risk factors . A total of 108 participants were r and omised to receive pulse-based foods ( two servings daily of beans , chickpeas , peas or lentils ; about 150 g/d dry weight ) or their regular diet for 2 months , followed by a washout of 1 month and a cross-over to the other diet for 2 months . Anthropometric measures , body composition and biochemical markers ( i.e. serum LDL-cholesterol ( LDL-C ) , as the primary outcome , and other lipids , glucose , insulin and C-reactive protein ) were assessed before and after each diet phase . A total of eighty-seven participants ( thirty males and fifty-seven females ; 59·7 ( sd 6·3 ) years , body mass 76 ( sd 16 ) kg ) completed the study . Compared with the regular diet , the pulse-based diet decreased total cholesterol by 8·3 % ( pulse , 4·57 ( sd 0·93 ) to 4·11 ( sd 0·91 ) mmol/l ; regular , 4·47 ( sd 0·94 ) to 4·39 ( sd 0·97 ) mmol/l ; P 0·001 ) and LDL-C by 7·9 % ( pulse , 2·93 ( sd 0·84 ) to 2·55 ( sd 0·75 ) mmol/l ; regular , 2·96 ( sd 0·86 ) to 2·81 ( sd 0·83 ) mmol/l ; P = 0·01 ) . In a sub- analysis of individuals with high lipid levels at baseline ( twenty individuals with high cholesterol ) , the pulse-based diet reduced cholesterol by 6 % compared with the regular diet ( pulse , 5·62 ( sd 0·78 ) to 5·26 ( sd 0·68 ) mmol/l ; regular , 5·60 ( sd 0·91 ) to 5·57 ( sd 0·85 ) mmol/l ; P = 0·05 ) . A pulse-based diet is effective for reducing total cholesterol and LDL-C in older adults and therefore reduces the risk of CVD"
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Background Synbiotics , probiotics or prebiotics are being added to infant formula to promote growth and development in infants . Previous review s ( 2007 to 2011 ) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity . This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics , probiotics or prebiotics . Methods Cochrane methodology was followed using r and omized controlled trials ( RCTs ) which compared term infant formula containing probiotics , prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants . The mean difference ( MD ) and corresponding 95 % confidence intervals ( CI ) were reported for continuous outcomes , risk ratio ( RR ) and corresponding 95 % CI for dichotomous outcomes . Where appropriate , meta- analysis was performed ; heterogeneity was explored using subgroup and sensitivity analyses . If studies were too diverse a narrative synthesis was provided . Results Three synbiotic studies ( N = 475 ) , 10 probiotics studies ( N = 933 ) and 12 prebiotics studies ( N = 1563 ) were included . Synbiotics failed to significantly increase growth in boys and girls . Use of synbiotics increased stool frequency , had no impact on stool consistency , colic , spitting up / regurgitation , crying , restlessness or vomiting . Probiotics in formula also failed to have any significant effect on growth , stool frequency or consistency . Probiotics did not lower the incidence of diarrhoea , colic , spitting up / regurgitation , crying , restlessness or vomiting . Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain . Prebiotics increased stool frequency but had no impact on stool consistency , the incidence of colic , spitting up / regurgitation , crying , restlessness or vomiting . There was no impact of prebiotics on the volume of formula tolerated , infections and gastrointestinal microflora . The quality of evidence was compromised by imprecision , inconsistency of results , use of different study preparations and publication bias . Authors ’ conclusions There is not enough evidence to state that supplementation of term infant formula with synbiotics , probiotics or prebiotics does result in improved growth or clinical outcomes in term infants . There is no data available to establish if synbiotics are superior to probiotics or prebiotics
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"Objective . To investigate the effect of 2 different species of probiotics in preventing infections in infants attending child care centers . Methods . A double-blind , placebo-controlled , r and omized trial was conducted from December 1 , 2000 , to September 30 , 2002 , at 14 child care centers in the Beer-Sheva area of Israel in healthy term infants 4 to 10 months old . Infants were assigned r and omly to formula supplemented with Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( American Type Culture Collection 55730 ) , or no probiotics . Duration of feeding , including follow-up , for each participant was 12 weeks . All infants were fed only the assigned formula and were not breastfed due to parental decision before recruitment to the study . Probiotic or prebiotic food products or supplements were not allowed . Main outcome measures were number of days and number of episodes with fever ( > 38 ° C ) and number of days and number of episodes with diarrhea or respiratory illness . Results . Participants ( n = 201 ) were similar regarding gestational age , birth weight , gender , and previous breastfeeding . The controls ( n = 60 ) , compared with those fed B lactis ( n = 73 ) or L reuteri ( n = 68 ) , had significantly more febrile episodes ( mean [ 95 % confidence interval ] : 0.41 [ 0.28–0.54 ] vs 0.27 [ 0.17–0.37 ] vs 0.11 [ 0.04–0.18 ] , respectively ) . The controls also had more diarrhea episodes ( 0.31 [ 0.22–0.40 ] vs 0.13 [ 0.05–0.21 ] vs 0.02 [ 0.01–0.05 ] , respectively ) and episodes of longer duration ( 0.59 [ 0.34–0.84 ] vs 0.37 [ 0.08–0.66 ] vs 0.15 [ 0.12–0.18 ] days , respectively ) . The L reuteri group , compared with BB-12 or controls , had a significant decrease of number of days with fever , clinic visits , child care absences , and antibiotic prescriptions . Rate and duration of respiratory illnesses did not differ significantly between groups . Conclusions . Child care infants fed a formula supplemented with L reuteri or B lactis had fewer and shorter episodes of diarrhea , with no effect on respiratory illnesses . These effects were more prominent with L reuteri , which was also the only supplement to improve additional morbidity parameters ",
"The addition of probiotics to infant formula has been shown to be an efficient way to increase the number of beneficial bacteria in the intestine in order to promote a gut flora resembling that of breast-fed infants . The objective of the present study was to evaluate the safety and tolerance of a combination of two probiotic strains in early infancy . A group of 126 newborns were r and omised to receive a prebiotic-containing starter formula supplemented with Lactobacillus paracasei ssp . paracasei and Bifidobacterium animalis ssp . lactis or the same formula without probiotics for the first 3 months of life . A total of eighty infants continued the study until they were aged 6 months . Growth measurements were taken monthly at healthy baby clinics . Diaries were used to monitor behaviour , infections , use of antibiotics , as well as stool characteristics . Normal growth occurred in all infants and no statistically significant differences were detected between the probiotics group and the control group for gain in weight , length and head circumference . Infants in the probiotics group produced softer and more frequent stools during the first 3 months of life . No differences were found in crying and sleeping hours , number of parent-diagnosed infections , antibiotic use , visits to the general practitioner and number of adverse events . The use of a prebiotic-containing starter formula supplemented with L. paracasei ssp . paracasei and B. animalis ssp . lactis in early infancy is safe , well tolerated and has no adverse effects on growth and infant behaviour",
"A mixture of neutral short chain galactooligosaccharides and long chain fructo-oligosaccharides ( scGOS/lcFOS ) has been shown to have prebiotic and immunomodulatory effects comparable to human milk oligosaccharides . This can be translated into clinical practice as a potential to prevent infections and allergy . The hypothesis of this study was that this specific prebiotic mixture could have a preventive effect against infections during the first 6 mo of life . In a prospect i ve , r and omized , double-blind , placebo-controlled trial , healthy term infants with a parental history of atopy were fed either prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . The primary outcome measures were infectious episodes , number of infections requiring antibiotics , and incidence of infections . During the study period , infants in the scGOS/lcFOS group had fewer episodes of all types of infections combined ( P = 0.01 ) . They also tended to have fewer upper respiratory tract infection episodes ( P = 0.07 ) and fewer infections requiring antibiotic treatment ( P = 0.10 ) . Similarly , the cumulative incidence of recurring infections was significantly lower in the scGOS/lcFOS group . The cumulative incidence of any recurring infection and recurring respiratory infections was 3.9 and 2.9 % in the scGOS/lcFOS group and 13.5 and 9.6 % in the placebo group , respectively ( P Oligosaccharide prebiotics reduced the number of infectious episodes and the incidence of recurring , particularly respiratory , infections during the first 6 mo of life . Although the exact mechanism of action is under investigation , it is very likely that the immune modulating effect of this prebiotic mixture through intestinal flora modification is the principal mechanism for the observed infection prevention early in life",
"BACKGROUND Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants . OBJECTIVE The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance . DESIGN In a prospect i ve , controlled , double-blind , r and omized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from . Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age . RESULTS Two hundred eighty-four infants were enrolled . During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d , indicating equivalent weight gain . Secondary outcomes did not show significant differences between groups during the treatment period . CONCLUSION Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well",
"A mixture of neutral short-chain galactooligosaccharides ( scGOS ) and long-chain fructooligosaccharides ( lcFOS ) has been shown to reduce the incidence of atopic dermatitis ( AD ) and infectious episodes during the first 6 mo of life . This dual protection occurred through the intervention period . The present study evaluated if these protective effects were lasting beyond the intervention period . In a prospect i ve , r and omized , double-blind , placebo-controlled design , healthy term infants with a parental history of atopy were fed either a prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . Following this intervention period , blind follow-up continued until 2 y of life . Primary endpoints were cumulative incidence of allergic manifestations . Secondary endpoints were number of infectious episodes and growth . Of 152 participants , 134 infants ( 68 in placebo , 66 in intervention group ) completed the follow-up . During this period , infants in the scGOS/lcFOS group had significantly lower incidence of allergic manifestations . Cumulative incidences for AD , recurrent wheezing , and allergic urticaria were higher in the placebo group , ( 27.9 , 20.6 , and 10.3 % , respectively ) than in the intervention group ( 13.6 , 7.6 , and 1.5 % ) ( P episodes of physician-diagnosed overall and upper respiratory tract infections ( P fever episodes ( P fewer antibiotic prescriptions ( P Growth was normal and similar in both groups . Early dietary intervention with oligosaccharide prebiotics has a protective effect against both allergic manifestations and infections . The observed dual protection lasting beyond the intervention period suggests that an immune modulating effect through the intestinal flora modification may be the principal mechanism of action",
"BACKGROUND Nonpathogenic live bacteria are consumed as food by many children , particularly in the form of yogurt . The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented . OBJECTIVE The goal was to evaluate tolerance to formulas containing 2 levels of probiotic supplementation and effects on growth , general clinical status , and intestinal health in free-living healthy infants . DESIGN This was a prospect i ve , double-blind , r and omized , placebo-controlled study of healthy infants aged 3 - 24 mo . Infants were assigned to receive a st and ard milk-based formula containing 1 x 10(7 ) colony-forming units (CFU)/g each of Bifidobacterium lactis and Streptococcus thermophilus , formula containing 1 x 10(6 ) CFU/g each of B. lactis and S. thermophilus , or unsupplemented formula . Clinical outcomes included formula intake , gastrointestinal tolerance , anthropometric measures , daycare attendance , and history of illness . RESULTS One hundred eighteen infants aged ( + /- SD ) 7.0 + /- 2.9 mo at enrollment consumed formula for 210 + /- 127 d. There were no significant differences in age , sex , formula consumption , or length of study between groups . The supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability ( P frequency of antibiotic use ( P . There were no significant differences between groups in growth , health care attention seeking , daycare absenteeism , or other health variables . CONCLUSION Long-term consumption of formulas supplemented with B. lactis and S. thermophilus was well tolerated and safe and result ed in adequate growth , reduced reporting of colic or irritability , and a lower frequency of antibiotic use",
"Adding prebiotics or probiotics to infant formula to improve the intestinal flora of formula-fed infants is considered to be a major innovation . Several companies have brought relevant formulations onto the market . However , comparative data on the effects of pre- and probiotics on the intestinal microflora of infants are not available . The present study aim ed to compare the effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the composition and metabolic activity of the intestinal microflora . Before birth , infants were r and omised and double blindly allocated to one of three formulas . The prebiotic ( GOS/FOS ) group ( n 19 ) received regular infant formula supplemented with a mixture of galacto-oligosaccharides and fructo-oligosaccharides ( 6 g/l ) . The probiotic ( Bb-12 ) group ( n 19 ) received the same formula supplemented with 6.0x10(10 ) viable cells of B. animalis per litre . The st and ard group ( n 19 ) received non-supplemented regular formula . A group of sixty-three breast-fed infants was included as a reference group . Faecal sample s were taken at postnatal day 5 and 10 , and week 4 , 8 , 12 and 16 . Compared with the groups fed Bb-12 and st and ard formula , the GOS/FOS formula group showed higher faecal acetate ratio ( 69.7 % ( sem 2.7 ) , 69.9 % ( sem 3.9 ) and 82.2 % ( sem 5.3 ) ; P lactate concentration ( 11.3 ( sem 7.9 ) , 3.1 ( sem 2.3 ) and 34.7 ( sem 10.7 ) mmol/kg faeces ) and lower pH ( 6.6 ( sem 0.2 ) , 7.1 ( sem 0.2 ) and 5.6 ( sem 0.2 ) ; P percentage of bifidobacteria between the GOS/FOS ( 59.2 % ( sem 7.7 ) ) , Bb-12 ( 52.7 % ( sem 8.0 ) ) and the st and ard ( 51.8 % ( sem 6.4 ) ) groups were not statistically significant at 16 weeks . Feeding infants GOS/FOS formula result ed in a similar effect on metabolic activity of the flora as in breast-fed infants . In the Bb-12 group , composition and metabolic activity of the flora were more similar to those of the st and ard group",
"Background : Colic , regurgitation and constipation are common feeding problems in formula‐fed infants that might benefit from dietary treatment . A formula containing fructo‐ and galacto‐oligosaccharides , partially hydrolysed proteins , low levels of lactose and palmitic acid in the β position and higher density has been tested to reduce the occurrence of these symptoms . The aim of this prospect i ve study was to describe the effects of such a formula in infants with minor gastrointestinal disorders . Methods : An observational prospect i ve trial involving practising Italian paediatricians was performed . Formula fed‐infants up to 90 d of age with minor gastrointestinal problems such as infantile colics and /or regurgitation and /or constipation were enrolled in the study from January 2001 to May 2001 . The study was completed within 14 d of treatment . On days 1 , 7 and 14 the infants were visited by the paediatricians . Parents were given a structured diary to record daily episodes of colic , regurgitation and type and number of stools . Results : Of the 932 infants enrolled , 604 completed the study . Of the 214 infants with colic , 169 ( 79 % ) demonstrated a reduction in frequency of colic from 4.1 ± 2.0 per day at the beginning of the study to 2.0 ± 1.8 at the end of the study ( I.C. 95 % : 1.72–2.39 ; p reduction in the number of episodes of colic of 1.8 per day at the beginning of the study ( I.C. 95 % : 1.49–2.11 ; p 201 infants with regurgitation problems , 141 ( 70 % ) demonstrated a reduction of frequency of the symptoms from 4.2 ± 2.0 per day at the beginningof the study to 2.1 ± 2.2 at the end of the study ( I.C. 95 % : 1.75–2.35 ; p 1.87 in the number of regurgitation episodes was reported between day 1 and day 7 ( I.C. 95 % : 1.57–2.16 ; p 232 infants with constipation , 147 ( 63 % ) demonstrated an increase in the daily number of stools of 0.42 ( I.C. 95 % : 0.5–0.3 ; p increase in stool frequency of 0.41 ( I.C. 95 % : 0.51–0.23 ; p 14 . Parents’evaluation of the formula was 7.9 ± 1.8 ( score 0–10 ) ; 550 parents ( 91 % ) gave a positive judgement ( score > 6 ) . The evaluation by the paediatricians of the improvement in symptoms after the treatment was 8.2 ± 1.5 ; 574 ( 95 % ) a positive effect ( score > 6 )",
"Background Nutrilon Omneo ( new formula ; NF ) contains high concentration of sn-2 palmitic acid , a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein . It is hypothesized that NF positively affects stool characteristics in constipated infants . Methods Thirty-eight constipated infants , aged 3–20 weeks , were included and r and omized to NF ( n = 20 ) or a st and ard formula ( SF ; n = 18 ) in period 1 and crossed-over after 3 weeks to treatment period 2 . Constipation was defined by at least one of the following symptoms : 1 ) defecation frequency 2 ) painful defecation ; 3 ) abdominal or rectal palpable mass . Results Period 1 was completed by 35 infants . A significant increase in defecation frequency ( NF : 3.5 pre versus 5.6/week post treatment ; SF 3.6 pre versus 4.9/week post treatment ) was found in both groups , but was not significantly different between the two formulas ( p = 0.36 ) . Improvement of hard stool consistency to soft stool consistency was found more often with NF than SF , but did not reach statistical significance ( 90 % versus 50 % ; RR , 1.8 ; 95 % CI , 0.9–3.5 ; p = 0.14 ) . No difference was found in painful defecation or the presence of an abdominal or rectal mass between the two groups . Twenty-four infants completed period 2 . Only stool consistency was significantly different between the two formulas ( 17 % had soft stools on NF and hard stools on SF ; no infants had soft stools on SF and hard stools on NF , McNemar test p = 0.046 ) . Conclusion The addition of a high concentration sn-2 palmitic acid , prebiotic oligosaccharides and partially hydrolyzed whey protein result ed in a strong tendency of softer stools in constipated infants , but not in a difference in defecation frequency . Formula transition to NF may be considered as treatment in constipated infants with hard stools",
"Background : Oligosaccharides may alter postnatal immune development by influencing the constitution of gastrointestinal bacterial flora . Aims : To investigate the effect of a prebiotic mixture of galacto- and long chain fructo-oligosaccharides on the incidence of atopic dermatitis ( AD ) during the first six months of life in formula fed infants at high risk of atopy . Methods : Prospect i ve , double-blind , r and omised , placebo controlled trial ; 259 infants at risk for atopy were enrolled . A total of 102 infants in the prebiotic group and 104 infants in the placebo group completed the study . If bottle feeding was started , the infant was r and omly assigned to one of two hydrolysed protein formula groups ( 0.8 g/100 ml prebiotics or maltodextrine as placebo ) . All infants were examined for clinical evidence of atopic dermatitis . In a subgroup of 98 infants , faecal flora was analysed . Results : Ten infants ( 9.8 % ; 95 CI 5.4–17.1 % ) in the intervention group and 24 infants ( 23.1 % ; 95 CI 16.0–32.1 % ) in the control group developed AD . The severity of the dermatitis was not affected by diet . Prebiotic supplements were associated with a significantly higher number of faecal bifidobacteria compared with controls but there was no significant difference in lactobacilli counts . Conclusion : Results show for the first time a beneficial effect of prebiotics on the development of atopic dermatitis in a high risk population of infants . Although the mechanism of this effect requires further investigation , it appears likely that oligosaccharides modulate postnatal immune development by altering bowel flora and have a potential role in primary allergy prevention during infancy",
"Background Human milk oligosaccharides have been shown to stimulate selectively the growth of Bifidobacteria and Lactobacilli in the intestine . In this study , the bifidogenic effect of an experimental prebiotic oligosaccharide mixture consisting of low-molecular-weight galactooligosaccharides and high-molecular-weight fructooligosaccharides was analyzed in 90 term infants . Methods Two test formulas were supplemented with either 0.4 g/dL or with 0.8 g/dL oligosaccharides . In the control formula , maltodextrin was used as placebo . At study day 1 and study day 28 , the fecal species , colony forming units ( cfu ) and pH were measured and stool characteristics , growth , and side effects were recorded . Results At study day 1 , the median number of Bifidobacteria did not differ among the groups ( 0.4 g/dL group , mean [ interquartile range ] 8.5 [ 1.9 ] cfu/g ; 0.8 g/dL group , 7.7 [ 6.1 ] cfu/g ; and the placebo group , 8.8 [ 6.1 ] cfu/g ) ( figures in square brackets are interquartile range ) . At the end of the 28-day feeding period , the number of Bifidobacteria was significantly increased for both groups receiving supplemented formulas ( the 0.4 g/dL group , 9.3 [ 4.9 ] cfu/g ; the 0.8 g/dL group , 9.7 [ 0.8 ] cfu/g ) versus the placebo group ( 7.2 [ 4.9 ] cfu/g , P The number of Lactobacilli also increased significantly in both groups fed the supplemented formulas ( versus placebo , P change in fecal pH ( P the stool frequency result ed in a significant difference between the placebo group and the group fed the 0.8 g/dL formula at day 28 ( P stool consistency ( 0.8 g/dL versus placebo , P incidence of side effects ( crying , regurgitation , vomiting ) or growth . Conclusions These data indicate that supplementation of a term infant 's formula with a mixture of galacto- and fructooligosaccharides has a dose-dependent stimulating effect on the growth of Bifidobacteria and Lactobacilli in the intestine and results in softer stool with increasing dosage of supplementation",
"Objectives : To determine whether probiotics administered for 6 months postnatally affect gastrointestinal symptoms , crying and the compositional development of the gut microbiota through infancy . Methods : The study comprised of 132 newborns whose mothers were r and omized to receive placebo or Lactobacillus rhamnosus GG ( ATCC 53103 ) before delivery . The treatments of mothers/infants continued for 6 months postnatally . A specific symptom chart was used to monitor gastrointestinal symptoms and infant 's crying during the 7th and the 12th weeks of life . Fluorescent in situ hybridization was used to establish the Bifidobacterium , Lactobacillus/Enterococcus , Bacteroides and Clostridium counts in fecal sample s at 6 , 12 , 18 and 24 months of age . Results : Numbers of different types of stools , vomits and crying time were comparable between the groups during the 7th and the 12th weeks of life . Dominant microbiota consisted of bifidobacteria throughout the study . At 6 months , there were less clostridia in faeces in the placebo compared with the probiotic group ( P = 0.026 ) , whereas after long-term follow-up at 2 years , there were less lactobacilli/enterococci and clostridia in faeces in the probiotic group than in the placebo group ( P = 0.011 and P = 0.032 , respectively ) , reflecting the impact of clostridia as a marker of microbiota succession in healthy infants . Conclusions : Probiotic administration in the first months of life was well tolerated and did not significantly interfere with long-term composition or quantity of gut microbiota",
"Probiotics and long-chain PUFA ( LC-PUFA ) may be beneficial supplements for infants who are not breast-fed . The aim of the present study is to evaluate the safety of an infant formula containing the LC-PUFA DHA and arachidonic acid ( AA ) and the probiotic Bifidobacterium lactis by comparing the growth rate of infants fed the supplemented and unsupplemented formulas . One hundred and forty-two healthy , term infants were enrolled in a single-centre , r and omised , double-blind , controlled , parallel-group trial , and allocated to receive either st and ard or probiotic and LC-PUFA-containing experimental formulas . The infants were fed with their assigned formulas for 7 months . The primary outcome ( weight gain ) and the secondary outcomes ( length , head circumference and formula tolerance ) were measured throughout the study . LC-PUFA status was assessed at 4 months of age and immune response to childhood vaccines was measured at 7 months of age . There was no significant difference in growth between the two groups . The 90 % CI for the difference in mean weight gain was - 0.08 , 3.1 g in the intention-to-treat population and 0.1 - 3.8 g in the per protocol population , which lay within the predefined boundaries of equivalence , - 3.9 - 3.9 . There were no significant differences in mean length and head circumference . DHA and AA concentrations were higher in infants in the experimental formula group compared with the control formula group . No influence of the supplements on the response to vaccines was observed . Growth characteristics of term infants fed the starter formula containing a probiotic and LC-PUFA were similar to st and ard formula-fed infants",
"Over the last two decades the incidence of allergic diseases has increased in industrialized countries , and consequently new approaches have to be explored",
"Objectives : To come even closer to the functional composition of human milk , acidic oligosaccharides ( AOS ) from pectin were added to well known neutral prebiotics ( galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( FOS ) ) . The effect of AOS and GOS/FOS/AOS on intestinal flora , stool characteristics as well as acceptance and tolerance was investigated . Methods : Human milk contains 75 % to 85 % neutral and 15 % to 25 % acidic oligosaccharides . In this prospect i ve , r and omized , double blind study , a mixture of 80 % neutral oligosaccharides ( from long-chain galacto- and long-chain fructo-oligosaccharides ) with 20 % acidic oligosaccharides derived from pectin hydrolysis was investigated . Forty-six term infants were fed a st and ard formula supplemented with either maltodextrin as control ( n = 15 ) , or with 0.2 g acidic oligosaccharides ( n = 16 ) , or with the latter plus 0.6 g neutral oligosaccharides ( mixture of galacto- and fructo-oligosaccharides ; n = 15 ) . Fecal flora using plating technique and pH were measured . Stool characteristics and possible side effects ( crying , vomiting , and regurgitation ) were recorded . Results : There was no difference in the bifidobacteria counts between the control and the group supplemented with acidic oligosaccharides alone ( 8.75 ± 0.50 vs. 8.58 ± 0.94 log colony forming units [CFU]/g stool ) . In infants fed the combination of acidic and neutral oligosaccharides , bifidobacteria were increased ( 9.61 ± 0.70 log CFU/g stool ; P . Stool consistency was softest in infants fed the complete oligosaccharide mixture , but also in those fed formula supplemented with acidic oligosaccharides alone , the stool consistency was significantly softer compared with the control group . Fecal pH increased in the controls , remained constant in acidic oligosaccharides alone , and decreased in the complete mixture of oligosaccharides group . Conclusion : There was no difference in growth , crying , vomiting , and regurgitation patterns between the groups . In summary , acidic oligosaccharides from pectin hydrolysate are well tolerated as ingredient in infant formulae but do not affect intestinal microecology",
"AIM To investigate the effect of a new infant formula supplemented with a low level ( 0.24 g/100 mL ) of galacto-oligosaccharide ( GOS ) on intestinal micro-flora ( Bifidobacteria , Lactobacilli and E. coli ) and fermentation characteristics in term infants , compared with human milk and a st and ard infant formula without GOS . METHODS Term infants ( n = 371 ) were approached in this study in three hospitals of China . All infants started breast-feeding . Those who changed to formula-feeding within 4 wk after birth were r and omly assigned to one of the two formula groups . Growth and stool characteristics , and side effects that occurred in recruited infants were recorded in a 3-mo follow-up period . Fecal sample s were collected from a sub population of recruited infants for analysis of intestinal bacteria ( culture technique ) , acetic acid ( gas chromatography ) and pH ( indicator strip ) . RESULTS After 3 mo , the intestinal Bifidobacteria , Lactobacilli , acetic acid and stool frequency were significantly increased , and fecal pH was decreased in infants fed with the GOS-formula or human milk , compared with those fed with the formula without GOS . No significant differences were observed between the GOS formula and human milk groups . Supplementation with GOS did not influence the incidence of crying , regurgitation and vomiting . CONCLUSION A low level of GOS ( 0.24 g/100 mL ) in infant formula can improve stool frequency , decrease fecal pH , and stimulate intestinal Bifidobacteria and Lactobacilli as in those fed with human milk",
"Objectives : The intestinal flora of breast-fed infants is generally dominated by Bifidobacteria . We aim ed to investigate whether an infant formula supplemented with galacto-oligosaccharides and fructo-oligosaccharides ( GOS/FOS ) is able to establish a bifido-dominant microflora , not only in numbers but also with respect to the metabolic activity in the colon . Methods : Two groups of infants fed infant formula with 0.8 g/100 ml GOS/FOS in a ratio of 9:1 ( OSF group ) , or control formula ( SF group ) were evaluated in a r and omised , double blind , placebo controlled intervention study . A breast-fed group was studied in parallel . At study onset and after 4 and 6 weeks , faecal sample s were examined for the number of bifidobacteria , pH , short chain fatty acids and lactate . Results : After 6 weeks , the mean proportion of bifidobacteria was significantly higher in the OSF group ( 59.6 % versus 49.5 % in the SF group ; P stool mean pH and an increased proportion of acetate and a decreased proportion of propionate . The mean pH in the OSF and SF groups were 5.7 and 6.3 , respectively ( P GOS/FOS mixture to an infant formula has a stimulating effect on the growth of bifidobacteria and on the metabolic activity of the total intestinal flora . The changes in short chain fatty acids , lactate and pH in the prebiotic group represent a fermentation profile that is closer to that observed in breast-fed infants compared to infants fed control formula",
"Objectives Probiotics may be useful in preventing acute infectious diarrhea . Bifidobacteria are particularly attractive as probiotics agent because they constitute the predominant colonic flora of breastfed infants and are thought to play a role in the decreased incidence of diarrhea in breastfed infants . Methods This was a multicenter , double-blind , controlled study to evaluate the efficacy of a milk formula supplemented with viable Bifidobacterium lactis strain Bb 12 ( BbF ) in the prevention of acute diarrhea in infants younger than 8 months living in residential nurseries or foster care centers . Results Ninety healthy children received either the BbF or a conventional formula ( CF ) daily . The mean duration of the stay in the residential center was similar ( 137 v 148 days ) . At enrollment , there were no differences between the two groups with respect to age ( 3.7 ± 2.1 months ) , gender , anthropometric data , history of allergy or gastrointestinal disease , frequency of breast-feeding in the neonatal period or timing of introduction of solid food . Altogether , 28.3 % of the BbF infants had diarrhea during the study compared with 38.7 % of controls ( NS ) . There was a statistically insignificant trend for shorter episodes of diarrhea in the BbF group ( 5.1 ± 3.3 days v 7 ± 5.5 days , NS ) . The number of days with diarrhea was 1.15 ± 2.5 in the BbF group with a daily probability of diarrhea of 0.84 versus 2.3 ± 4.5 days and 1.55 , respectively , in the CF group ( P = 0.0002 and 0.0014 ) . Feeding infants with the BbF reduced their risk of getting diarrhea by a factor of 1.9 ( range , 1.33–2.6 ) . Analysis of the cumulative incidence of diarrheal episodes showed a trend that the first onset of diarrhea occurred later in the BbF group . Conclusion These results provide some evidence that viable Bifidobacterium lactis strain Bb 12 , added to an acidified infant formula , has some protective effect against acute diarrhea in healthy children",
"Objective : To compare the safety and tolerance of two formulas , supplemented with different probiotic agents , in early infancy . Design : Prospect i ve r and omized placebo-controlled trial . Setting : Clinics of a University Medical Center . Subjects : Full-term healthy infants aged less than 4 months . Intervention : Infants were r and omly assigned for 4 weeks to a st and ard milk-based formula supplemented with either Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( ATCC 55730 ) or a probiotics-free formula . Measures of Outcome : Growth parameters , daily characteristics of feeding , stooling and behavior , and side effects . Results : Fifty-nine infants , aged 3–65 days , were included . Subjects in all three groups were similar at entry in terms of gestational age , birth weight , sex , growth parameters and breast feeding rate prior to the study . The supplemented formulas were well accepted and did not reveal any adverse effects . A comparison of growth parameters , and variables of feeding , stooling and crying and irritability did not reveal any significant differences between groups . Conclusions : The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy , was safe , well tolerated and did not adversely affect growth , stooling habits or infant behavior",
"A r and omized double blind clinical trial was conducted to assess the efficacy of a special infant formula containing Lactobacillus rhamnosus LMG P-22799 ( probiotic : 5 x 10(8 ) CFU/100mL ) , inulin ( prebiotic : 0.15 g/100mL ) , dietary fiber ( soy polysaccharides : 0.2 g/100mL ) and increased amounts of zinc+iron ( + 0.4 and + 0.6 mg/100mL , respectively ) as active ingredients for the early dietary management of 58 Indonesian well-nourished male infants aged 3 - 12 months suffering from acute diarrhea with moderate dehydration . After adequate oral rehydration , the patients were r and omly assigned to receive either a low lactose infant formula supplemented with added precooked rice ( 1.5 g/100mL ) with the above active ingredients ( study group ) or a low lactose infant formula with added precooked rice without the above active ingredient supplement ( control group ) . No antibiotic , anti-secretory drug or antiemetic was given at all . Both study and control groups showed similar outcomes for weight gain and stool weight . The duration of diarrhea was significantly shorter in the study group than in the control group ( 1.63 versus 2.45 days ; p No treatment failure or other side effects were observed during the course of the study . The present study supports the evidence for the efficacy of a special anti-diarrhea infant formula containing probiotic , prebiotic , fiber and iron+zinc after oral rehydration by shortening the duration of infantile diarrhea in developing countries . However , from the results of our study we can not discern the individual contribution of the active ingredients and also not whether they may act independent from each other or in a synergistic way",
"Objectives : Regarding safety , we investigated the effect of prenatal probiotic and 6 months of pro- and prebiotic supplementation of infants on their hematologic values at 6 months and 2 years and factors affecting these values . Patients and Methods : In a prospect i ve r and omized controlled probiotic intervention trial in infants at high risk for allergy , we obtained blood sample s consecutively from 98 infants at 6 months and from 658 children at 2 years to measure hematologic values . We collected fecal sample s at 3 and 6 months to measure immunologic development by calprotectin , α-1-antitrypsin , tumor necrosis factor-α , and immunoglobulin A. Results : At 6 months , infants in the probiotic group had significantly lower hemoglobin ( Hb ) values than did the placebo group , mean ( SD ) : 119.8 g/L ( 6.3 ) versus 123.3 g/L ( 8.4 ) , P = 0.025 . Adjustment for factors that might affect Hb values ( breast-feeding duration , solid-food introduction , and sex ) , revealed no need for adjustment . A significant negative correlation emerged between Hb values at 6 months and fecal calprotectin at age 3 months r = −0.301 , P = 0.009 , which was affected neither by breast-feeding , sex , nor study group . At 2 years , hematologic values in both groups became similar . Conclusions : Probiotics cause a gut mucosal inflammation with decreased Hb values during intervention , corrected after halting the supplementation",
"Purpose of review This review summarizes the clinical efficacy of probiotics and prebiotics in gastrointestinal disorders and examines the mechanisms of action related to their therapeutic effect . Recent findings The demonstration that immune and epithelial cells can discriminate between different microbial species has extended the known mechanism(s ) of action of probiotics beyond simple barrier and antimicrobial effects . It has also confirmed that probiotic bacteria modulate mucosal and systemic immune activity and epithelial function . The progressive unraveling of these mechanisms of action has led to new credence for the use of probiotics and prebiotics in clinical medicine . Level I evidence now exists for the therapeutic use of probiotics in infectious diarrhea in children , recurrent Clostridium difficile – induced infections and postoperative pouchitis . Level II evidence is emerging for the use of probiotics in other gastrointestinal infections , prevention of postoperative bacterial translocation , irritable bowel syndrome , and in both ulcerative colitis and Crohn disease . Nevertheless , one consistent feature has emerged over the past year : Not all probiotic bacteria have similar therapeutic effects . Future clinical trials will need to incorporate this fact into trial planning and design . Summary The use of probiotics and prebiotics as therapeutic agents for gastrointestinal disorders is rapidly moving into the “ mainstream . ” Mechanisms of action explain the therapeutic effects and r and omized ; controlled trials provide the necessary evidence for their incorporation into the therapeutic armamentarium",
"We assessed the growth , tolerance , and acceptability as well as fecal flora composition and stool pH of 20 healthy full-term infants fed with a fermented whey-adapted infant formula containing viable bifidobacteria ( 10(6)/g of powder ) during the first 2 months of life . This fermented infant formula , first biologically acidified by Streptococcus thermophilus and Lactobacillus helveticus , was compared to a whey-adapted , nonacidified , low-phosphate infant formula in a double-blind , r and omized controlled study . The results were compared to a control group ( n = 14 ) of fully breast-fed infants . The fermented whey-adapted formula containing viable bifidobacteria induced a prevalence of colonization with bifidobacteria at 1 month of age similar to that of breast-fed infants ( 12/20 versus 8/14 ) but significantly higher than in the group fed the st and ard infant formula ( 4/20 ) . The mean bacterial count of bifidobacteria was similar in all colonized infants ; however , fecal pH was significantly lower in the breast-fed infants than in the nonacidified bottle-fed infants . This kind of infant formula was well tolerated and promoted a normal growth during the first 2 months",
"BACKGROUND & AIM The addition of prebiotics to infant formula modifies the composition of intestinal microflora . Aim of the study was to test the hypothesis that prebiotics reduce the incidence of intestinal and respiratory infections in healthy infants . METHODS A prospect i ve , r and omized , placebo-controlled , open trial was performed . Healthy infants were enrolled and r and omized to a formula additioned with a mixture of galacto- and fructo-oligosaccharides or to a control formula . The incidence of intestinal and respiratory tract infections and the anthropometric measures were monitored for 12 months . RESULTS Three hundred and forty two infants ( mean age 53.7+/-32.1 days ) were enrolled . The incidence of gastroenteritis was lower in the supplemented group than in the controls ( 0.12+/-0.04 vs. 0.29+/-0.05 episodes/child/12 months ; p=0.015 ) . The number of children with more than 3 episodes tended to be lower in prebiotic group ( 17/60 vs. 29/65 ; p=0.06 ) . The number of children with multiple antibiotic courses/year was lower in children receiving prebiotics ( 24/60 vs. 43/65 ; p=0.004 ) . A transient increase in body weight was observed in children on prebiotics compared to controls during the first 6 months of follow-up . CONCLUSIONS Prebiotic administration reduce intestinal and , possibly , respiratory infections in healthy infants during the first year of age",
"Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health . Although these organisms have a long record of safe use , it is important to identify any adverse effects in potentially vulnerable population s. In a r and omized , double-blinded , placebo-controlled trial , we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants . Two strains of lactobacilli ( Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08 ) and bifidobacteria ( Bifidobacterium animalis subsp . lactis CUL34 and Bifidobacterium bifidum CUL20 ) with a total of 1 x 10(10 ) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0 - 6 mo . Adverse events ( AE ) were classified according to WHO International Statistical Classification of Diseases criteria . Common symptoms were recorded by regular question naires . Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar . Compliance with the trial interventions , loss to follow-up , symptoms , drug usage , infant growth , method of feeding , visits to the doctor , and mothers ' assessment of infant health were similar in the 2 groups . Fifteen ( 6.8 % ) mothers and 73 ( 33.2 % ) infants in the treatment group and 21 ( 9.0 % ) mothers and 75 ( 32.1 % ) infants in the placebo group reported AE ( P = 0.49 and P = 0.84 , respectively ) . Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group . None of the AE were attributed to the intervention . Our findings support the safe use of this consortium of organisms during pregnancy and early infancy",
"Goals : This clinical trial was carried out to determine whether oral treatment with a commercial probiotic formula containing Bifidobacterium lactis and Streptococcus thermophilus would reduce the frequency of antibiotic-associated diarrhea ( AAD ) in infants . Study : In this double-bind formula controlled study , 80 infants , 6 to 36 months of age , were r and omly assigned to receive a commercial formula containing 107 viable cells of B. lactis and 106viable cells of S. thermophilus at the initiation of antibiotics for a duration of 15 days . The infants were assessed daily for formula intake , stool frequency , and stool consistency for a total duration of 30 days . Seventy-seven infants received nonsupplemented formula for the entire duration . Results : There was a significant difference in the incidence of AAD in the children receiving probiotic-supplemented formula ( 16 % ) than nonsupplemented formula ( 31 % ) . Conclusions : The present study shows that prevention against AAD in infants was obtained by oral treatment with daily dose of B. lactis and S. thermophilus",
"BACKGROUND Probiotic bacteria have beneficial effects on the immune system and gastrointestinal tract , but the impacts of their long-term consumption on health and growth in early infancy are not well documented . The aim of this study was to evaluate the influence of Lactobacillus rhamnosus GG (LGG)-enriched formula on growth and faecal microflora during the first 6 months of life in normal healthy infants . MATERIAL S AND METHODS One hundred and twenty healthy infants ( up to 2 months ) received LGG-supplemented formula or regular formula in a double-blind , r and omized manner until the age of 6 months . Weight , length and head circumference were measured monthly and transformed into st and ard deviation scores ( SDS ) . Faecal sample s were obtained from a r and om sample of infants ( n=25 ) at entry and at the end of the study . RESULTS One hundred and five infants ( 51 in the LGG group ) completed the study . Children receiving LGG-supplemented formula grew better : their changes in their length and weight SDS ( DeltaSDS ) at the end of the study were significantly higher than those receiving regular formula ( 0.44+/- 0.37 versus 0.07+/- 0.06 , P defecation frequency 9.1+/-2.06 versus 8.0+/- 2.8 ( P colonization with lactobacilli was found in the LGG group , 91 % versus 76 % ( P Infants fed with LGG-enriched formula grew better than those fed with regular formula . Further studies are necessary to clarify the mechanism of LGG in infant growth",
"OBJECTIVES The larger number of bifidobacteria in the intestine of breast-fed infants has been associated with their better health compared with formula-fed infants . We assessed the safety and tolerability of an experimental formula containing 2 x 10(7 ) colony-forming units of Bifidobacterium longum BL999 and 4 g/L of a prebiotic mixture containing 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides . METHODS A 7-mo prospect i ve , r and omized , reference-controlled , double-blinded trial was performed in infants who were not breast fed after the 14th day of birth . One hundred thirty-eight infants were enrolled and assigned to receive the control or experimental formula until they were 112 d old . Mean weight gain ( primary outcome ) and recumbent length , head circumference , tolerability ( gastrointestinal symptoms ) , and overall morbidity ( secondary outcomes ) were measured at 14 , 28 , 56 , 84 , and 112 d of age . RESULTS Equivalence in mean weight gain between the two groups was shown . The treatment difference in the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d . No statistically significant difference in recumbent length , head circumference , or incidence of adverse events was found between the two groups . Infants in the experimental group had fewer incidences of constipation and had stool characteristics that suggest that the experimental formula was tolerated well . Furthermore , these infants showed a trend toward fewer respiratory tract infections . CONCLUSIONS The starter formula containing BL999 and galacto-oligosaccharides/fructo-oligosaccharides is safe and well-tolerated",
"The aim of the study was to evaluate whether supplementation of milk-formulas with prebiotic fructo-oligosaccharides or a probiotic , Lactobacillus johnsonii La1 ( La1 ) , could modulate the composition of the fecal microbiota of formula-fed infants , compared to breastfed ( BF ) infants . Ninety infants close to 4 months of age were r and omized into one of three groups to be blindly assigned to receive for 13 weeks : a ) an infant formula ( Control ) , b ) the same formula with fructo-oligosaccharides ( Prebio ) , or c ) with La1 ( Probio ) . At the end of this period , all infants received the control formula for 2 additional weeks . Twenty-six infants , breastfed throughout the study , were recruited to form group BF . Fecal sample s were obtained upon enrolment and after 7 and 15 weeks . Bacterial population s were assessed with classical culture techniques and fluorescent in situ hybridisation ( FISH ) . Seventy-six infants completed the study . On enrolment , higher counts of Bifidobacterium and Lactobacillus and lower counts of enterobacteria were observed in BF compared to the formula-fed infants ; these differences tended to disappear at weeks 7 and 15 . No major differences for Clostridium , Bacteroides or Enterococcus were observed between the groups or along the follow up . Probio increased fecal Lactobacillus counts ( p excreted live La1 in their stools at week 7 but only 17 % at week 15 . Increased Bifidobacterium counts were observed at week 7 in the 3 formula groups , similar to BF infants . These results confirm the presence of higher counts of bifidobacteria and lactobacilli in the microbiota of BF infants compared to formula-fed infants before dietary diversification , and that La1 survives in the infant digestive tract",
"BACKGROUND Oligosaccharides in human milk may protect infants by improving the intestinal micro-flora and fermentation . This study was to investigate effects of infant formula milk consisting of galacto-oligosaccharide ( GOS ) on intestinal microbial population s and the fermentation characteristics in term infants in comparison with that of human milk . METHODS The test formula ( Frisolac H , Friesl and , Netherl and ) was supplemented with GOS at a concentration of 0.24 g/dl . Human milk and another formula without oligosaccharides ( Frisolac H , Friesl and , Netherl and ) were used as positive and negative control respectively . Growth , stool characteristics , and side effects of the recruited infants were recorded after 3 and 6 months ' follow-up , and the fecal species were collected for the analysis of intestinal micro-flora , short chain fatty acid ( SCFA ) and pH. RESULTS At the end of 3- and 6-month feeding period , intestinal Bifidobacteria and Lactobacilli were significantly increased in infants fed with GOS supplemented formula and human milk when compared with infants fed with negative control formula ; however , there was no statistically significant difference between GOS supplemented formula and human milk groups . Stool characteristics were influenced by the supplement and main fecal SCFA ( acetic ) , and stool frequency were significantly increased in infants fed with GOS supplemented formula and human milk , while the fecal pH was significantly decreased as compared with that of negative control ( P incidence of side effects ( including crying , regurgitation and vomiting ) . CONCLUSIONS Supplementing infant formula with GOS at a concentration of 0.24 g/dl stimulates the growth of Bifidobacteria and Lactobacilli in the intestine and stool characteristics are similar to in term infants fed with human milk ",
"BACKGROUND The intestinal flora of breast-fed infants is generally dominated by bifidobacteria which have beneficial properties . Their presence is due to various compounds of breast milk including prebiotic substances . AIM This prospect i ve , double blind , study compared the growth , acceptability and the proportion of bifidobacteria and clostridia in the stool flora of bottle-fed infants r and omized to receive a formula with a specific mixture of 0.4 g/100 ml prebiotic galacto- and long-chain fructooligosaccharides or the same formula without added prebiotics . METHODS Within 0 - 14 days after birth at term , healthy bottle-fed infants were enrolled to receive either a prebiotic formula or a st and ard formula . At recruitment anthropometric measurements were done . These were repeated at the age of 6 and 12 weeks . Stool sample s were taken at inclusion and at the age of 6 weeks . The number of bifidobacteria and clostridia was determined by fluorescent in situ hybridization . RESULTS There was good tolerance of the prebiotic formula . Somatic growth was similar in the two groups . Stool frequency was significantly higher in the prebiotic group ( P=0.031 ) . Infants in the prebiotic group had also softer stools as compared to the control group ( P=0.026 ) . Baseline values of microorganisms at study entry were similar . The percentage of faecal clostridia at the completion of the study was significantly lower in the prebiotic group ( P=0.042 ) , while the proportion of faecal bifidobacteria was higher in the prebiotic group as compared to the control group . However this difference did not reach statistical significance ( P=0.262 ) . The percentage of E. coli was lower in the prebiotic group but again this did not reach statistical significance ( P=0.312 ) . CONCLUSION An infant formula containing prebiotic oligosaccharides is well tolerated , leads to normal somatic growth and suppresses the numbers of clostridia in the faeces with a trend for higher percentage of stool bifidobacteria and lower percentage of E. coli",
"A double‐blind , r and omized , controlled study was performed in 90 full term infants to evaluate dose‐related bifidogenic effects of a new synergistic mixture of galacto‐oligosaccharides ( GOS ) and fructo‐oligosacharides ( FOS ) . The GOS/FOS mixture showed a dose‐dependent stimulatory effect on the intestinal growth of bifidobacteria . Also stool consistency and faecal pH were positively affected",
"Objectives : The present study was design ed to evaluate the effect of 2 different combinations of prebiotic ingredients , polydextrose ( PDX ) , galactooligosaccharides ( GOS ) , and lactulose ( LOS ) , at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age . Patients and Methods : Healthy , formula-fed , term infants ( n = 226 ) were r and omly assigned to 1 of 3 study formula groups : control group ( n = 76 ) , PG4 group ( control formula supplemented with 4 g/L of a prebiotic blend , n = 74 ) , or PGL8 group ( control formula supplemented with 8 g/L of a prebiotic blend , n = 76 ) . Anthropometric measurements were taken at 14 , 30 , 60 , 90 , and 120 days of age , and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30 , 60 , 90 , and 120 days of age . Adverse events were recorded throughout the study . Results : There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point . Significant differences in stool consistency were detected among the 3 formula groups at 30 , 60 , and 90 days of age ( P looser stools than the control group . The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age ( P = 0.021 and P = 0.017 , respectively ) , but all of the groups were similar at 60 , 90 , and 120 days of age . A statistical difference was detected among the formula groups in 3 categories of adverse events : diarrhea ( control vs PG4 , 4 % vs 18 % , P = 0.008 ) , eczema ( PG4 vs control , 18 % vs 7 % , P = 0.046 ; PG4 vs PGL8 , 18 % vs 4 % , P = 0.008 ) , and irritability ( control vs PGL8 , 4 % vs 16 % , P = 0.027 ) . Conclusions : Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula . A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics",
"Acute diarrhea is a common cause of infant morbidity and mortality . Probiotic supplemented infant formula is one of the effective methods for prevention of rotavirus diarrhea . Other benefits of the probiotics supplemented formula were evaluated by monitoring the growth of the children . A double-blind , placebo-controlled trial was done in 148 children aged 6 - 36 months . They were divided into 3 groups : the Bb12 group , 51 children received infant formula with Bifidobacteria Bb12 supplement ; the Bb12+ST group , 54 children received infant formula with Bb12 and Streptococcus thermophilus supplement ; and the control group , 43 children received infant formula without supplement . The mean weight Z-score according to WHO reference st and ard of the Bbl2 group was -1.8 + /- 0.12 , the Bb12+ST group was -1.4 + /- 0.11 and the control group was -1.8 + /- 0.13 at entry . The mean weight Z-score of children after 6 month showed that the children in the Bbl2+ST group had the highest increase in weight which was increased from -1.4 + /- 0.11 to -0.9 + /- 0.12 compared to the Z-score of the Bb12 group which had increased from -1.8 + /- 0.12 to -1.2 + /- 0.13 and in the control group from -1.8 + /- 0.13 to -1.7 + /- 0.25 . In terms of the mean height Z-score , the Bb12 group was -2.7 + /- 0.14 to -1.7 + /- 0.16 which was higher than the Bb12+ST group ( - 2.2 + /- 0.13 to -1.7 + /- 0.13 ) but was not different from the control group . However , the mean weight/height Z-score of the Bbl2+ST group had approached the reference st and ard ( Bb12 group -0.1 + /- 0.11 to -0.1 + /- 0.13 , Bb12+ST group -0.1 + /- 0.10 to 0.3 + /- 0.17 , control group -0.4 + /- 0.12 to -0.1 + /- 0.16 ) . Data showed that children who received the probiotics supplement formula had better growth during the 6 month period ",
"Background : Probiotic , prebiotic , and synbiotic ( a combination of pro- and prebiotic ) supplements increasingly are being used to prevent and treat a variety of health conditions . Although colonization is considered a key element in the success of such treatments , few clinical studies have addressed colonizing ability . Studies are even more limited in neonates and infants , who may benefit most from such treatment . The present study was conducted to determine the colonizing ability , tolerance , and impact on the stool flora of 7 days of administration of a synbiotic supplement to a neonatal cohort , in preparation for a larger hospital-based trial . Patients and Methods : In this r and omized , double-masked , controlled trial , healthy inborn newborns > 35 weeks of gestational age and > 1800 g birth weight were r and omized between 1 and 3 days after birth to receive an oral synbiotic preparation ( Lactobacillus plantarum and fructooligosaccharides ) or a dextrose saline placebo . Two babies were treated with the synbiotic preparation for every 1 baby treated with the placebo . Duration of therapy was 7 days . Comprehensive stool cultures were done at baseline and on days 3 , 7 , 14 , 21 , and 28 . Results : Nineteen infants received the active study supplement and 12 infants received the placebo for 7 days . L plantarum was cultured from the stools of 84 % of the treated infants after 3 days of treatment , and from 95 % of infants on day 28 after birth . Of the infants , 100 % , 94 % , 88 % , 56 % , and 32 % remained colonized at months 2 , 3 , 4 , 5 , and 6 , respectively . In both groups , the total mean number of species and the mean log colony counts increased over time . The number of bacterial species was significantly higher on days 21 and 28 in the synbiotic preparation group compared with placebo ( P = 0.002 and 0.03 , respectively ) . There was a linear increase in the mean log gram-negative colony counts in the placebo group during the 4-week period that was significantly higher than that in the Lactobacillus group on days 14 , 21 , and 28 ( P higher gram-positive colony counts on days 14 ( P = 0.002 ) and 28 ( P = 0.04 ) . Only 1 infant in the placebo group was colonized with L fermentum during the first 28 days of life . No difference was found in the percent increase in weight between baseline and day 7 , but on day 28 and months 2 , 3 , and 6 , the percent increase from baseline was higher in the probiotic-treated group ( P ≤ 0.05 ) . The supplement was tolerated well . Conclusions : The synbiotic preparation colonized quickly after 3 days of administration and the infants stayed colonized for several months after therapy was stopped . There was an increase in bacterial diversity and gram-positive organisms and a reduction of gram-negative bacterial load in the treatment group . Because a combination preparation was used , it is difficult to specifically attribute the colonization to either the probiotic or prebiotic component in this study . Larger efficacy trials are warranted to examine the mechanism of action and precise effects of these supplements",
"Secretory immunoglobulin A ( SIgA ) plays an important role in the defence of the gastrointestinal tract . The level of faecal SIgA antibody is associated with increased neutralization and clearance of viruses . Formula-fed infants who lack the transfer of protective maternal SIgA from breast milk may benefit from strategies to support maturation of humoral immunity and endogenous production of SIgA. We aim ed at study ing the effects of st and ard , prebiotic and probiotic infant formulas on the faecal SIgA levels . At birth , infants of whom the mother had decided not to breastfeed were allocated to one of three formula groups in a r and omized , double-blind fashion . Nineteen infants received st and ard infant formula ; 19 received prebiotic formula containing a specific mixture of 0.6 g galacto-oligosaccharides (GOS)/fructo-oligosaccharides (FOS)/100 ml formula and 19 received probiotic formula containing 6.0 x 10(9 ) cfu Bifidobacterium animalis/100 ml formula . Faecal sample s were taken on postnatal day 5 , day 10 , wk 4 and every 4 wk thereafter until wk 32 . SIgA in faeces was determined by an enzyme-linked immunosorbent assay . During the intervention , infants fed on prebiotic formula showed a trend towards higher faecal SIgA levels compared with the st and ard formula-fed infants reaching statistical significance at the age of 16 wk . In contrast , infants fed on the probiotic formula showed a highly variable faecal SIgA concentration with no statistically significant differences compared with the st and ard formula group . Formula-fed infants may benefit from infant formulas containing a prebiotic mixture of GOS and FOS because of the observed clear tendency to increase faecal SIgA secretion . Adding viable B. animalis strain Bb-12 to infant formula did not reveal any sign for such a trend",
"Objective : To test the safety and effect on faecal microbiota of a formula with prebiotic oligosaccharides alone or in combination with acidic oligosaccharides in infants at the age of partial formula feeding . Patients and Methods : The study was a double-blind , placebo-controlled , r and omised intervention trial in which 82 healthy , full-term , partially breast-fed children , from 1 week to 3 months old , were given 1 of the following formulae : whey-based formula ( control group ) , whey-based formula with galacto- and long-chain fructo-oligosaccharides ( scGOS/lcFOS group ) , or whey-based formula with galacto- and long-chain fructo-oligosaccharides added with pectin-derived acidic oligosaccharides ( scGOS/lcFOS/pAOS group ) . Children were studied for the duration of the partial formula feeding period and every 2 weeks for 2 months after breast-feeding cessation . The total bacteria count and the proportion of 7 bacterial families were determined using in situ hybridisation coupled to flow cytometry . Results : The total bacterial count did not alter with time or type of feeding ( 9.9 ± 0.1 log10 cells per gram wet weight ) . Compared with the control group , there was an increase of the Bifidobacterium genus ( P = 0.0001 ) , and a decrease of proportions for the Bacteroides group ( P = 0.02 ) and the Clostridium coccoides group ( P = 0.01 ) in both oligosaccharide groups . The proportion of bifidobacteria was significantly higher in the scGOS/lcFOS/pAOS compared with the scGOS/lcFOS group ( P < 0.01 ) . Conclusions : Infant formulae appear to be clinical ly safe and effective on infant microbiota . They minimize the alteration of faecal microbiota after cessation of breast-feeding and promote bifidobacteria proportions , with a stronger effect when acidic oligosaccharides are present",
"OBJECTIVE . Live probiotic bacteria and dietary prebiotic oligosaccharides ( together termed synbiotics ) increasingly are being used in infancy , but evidence of long-term safety is lacking . In a r and omized , placebo-controlled , double-blind trial , we studied the safety and long-term effects of feeding synbiotics to newborn infants . METHODS . Between November 2000 and March 2003 , pregnant mothers carrying infants at high risk for allergy were r and omly assigned to receive a mixture of 4 probiotic species ( Lactobacillus rhamnosus GG and LC705 , Bifidobacterium breve Bb99 , and Propionibacterium freudenreichii ssp shermanii ) or a placebo for 4 weeks before delivery . Their infants received the same probiotics with 0.8 g of galactooligosaccharides , or a placebo , daily for 6 months after birth . Safety data were obtained from clinical examinations and interviews at follow-up visits at ages 3 , 6 , and 24 months and from question naires at ages 3 , 6 , 12 , and 24 months . Growth data were collected at each time point . RESULTS . Of the 1018 eligible infants , 925 completed the 2-year follow-up assessment . Infants in both groups grew normally . We observed no difference in neonatal morbidity , feeding-related behaviors ( such as infantile colic ) , or serious adverse events between the study groups . During the 6-month intervention , antibiotics were prescribed less often in the synbiotic group than in the placebo group ( 23 % vs 28 % ) . Throughout the follow-up period , respiratory infections occurred less frequently in the synbiotic group ( geometric mean : 3.7 vs 4.2 infections ) . CONCLUSION . Feeding synbiotics to newborn infants was safe and seemed to increase resistance to respiratory infections during the first 2 years of life",
"Background / Aims : Supplementation with certain probiotics can improve gut microbial flora and immune function but should not have adverse effects . This study aim ed to assess the risk of D-lactate accumulation and subsequent metabolic acidosis in infants fed on formula containing Lactobacillus johnsonii ( La1 ® ) . Methods : In the framework of a double-blind , r and omized controlled trial enrolling 71 infants aged 4–5 months , morning urine sample s were collected before and 4 weeks after being fed formulas with or without La1 ( 1 × 108/g powder ) or being breastfed . Urinary D- and L-lactate concentrations were assayed by enzymatic , fluorimetric methods and excretion was normalized per mol creatinine . Results : At baseline , no significant differences in urinary D-/L-lactate excretion among the formula-fed and breastfed groups were found . After 4 weeks , D-lactate excretion did not differ between the two formula groups , but was higher in both formula groups than in breastfed infants . In all infants receiving La1 , urinary D-lactate concentrations remained within the concentration ranges of age-matched healthy infants which had been determined in an earlier study using the same analytical method . Urinary L-lactate also did not vary over time or among groups . Conclusions : Supplementation of La1 to formula did not affect urinary lactate excretion and there is no evidence of an increased risk of lactic acidosis",
"OBJECTIVE Cholesterol is a nutrient of essential importance in infant feeding because it is necessary in membrane development . In adults with high lipid levels , high doses of inulin ( oligofructose ) inconsistently decreased levels of serum cholesterol . The aim of the present study was to evaluate cholesterol and triacylglycerol levels in infants receiving a formula with a specific mixture of 0.6 g/100 mL of galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( lcFOS ) in a ratio of 9/1 , a control formula , or breast milk . Because the level of lcFOS in the infant milk is low , we hypothesized that there would be no differences between the formula groups . METHODS Two hundred fifteen infants were included in a prospect i ve , r and omized , double-blinded , placebo-controlled trial during the first 6 mo of life . Formula-fed infants were r and omized to receive a st and ard infant formula with a specific mixture of 0.6 g/100 mL of GOS/lcFOS , in a ratio of 9/1 , or a control formula . Breast-fed infants were r and omized to receive one of these two formulas after the mother had decided to discontinue breastfeeding . Serum levels of cholesterol , high-density lipoprotein , low-density lipoprotein ( LDL ) , and triacylglycerol were determined at 8 and 26 wk of age and were provided for infants who received the GOS/lcFOS formula or control formula from birth or after cessation of breastfeeding and for the subgroups that were fully fed with breast milk and formula . RESULTS One hundred eighty-seven infants completed the study . Total cholesterol and LDL levels at 8 and 26 wk were significantly lower in the formula-fed groups than in the breast-fed infants . There were no significant differences between the formula-fed groups . Levels of triacylglycerols and high-density lipoprotein did not differ between groups . CONCLUSION Our study demonstrated no differences in total cholesterol and LDL cholesterol in infants receiving an infant formula with GOS/lcFOS from infants receiving a control infant formula . Furthermore , total cholesterol and LDL cholesterol levels were higher in breast-fed infants than in formula-fed infants",
"BACKGROUND The increase in allergic diseases is attributed to a relative lack of microbial stimulation of the infantile gut immune system . Probiotics , live health-promoting microbes , might offer such stimulation . OBJECTIVE We studied the effect of a mixture of 4 probiotic bacterial strains along with prebiotic galacto-oligosaccharides in preventing allergic diseases . METHODS We r and omized 1223 pregnant women carrying high-risk children to use a probiotic preparation or a placebo for 2 to 4 weeks before delivery . Their infants received the same probiotics plus galacto-oligosaccharides ( n = 461 ) or a placebo ( n = 464 ) for 6 months . At 2 years , we evaluated the cumulative incidence of allergic diseases ( food allergy , eczema , asthma , and allergic rhinitis ) and IgE sensitization ( positive skin prick test response or serum antigen-specific IgE level > 0.7 kU/L ) . Fecal bacteria were analyzed during treatment and at age 2 years . RESULTS Probiotic treatment compared with placebo showed no effect on the cumulative incidence of allergic diseases but tended to reduce IgE-associated ( atopic ) diseases ( odds ratio [ OR ] , 0.71 ; 95 % CI , 0.50 - 1.00 ; P = .052 ) . Probiotic treatment reduced eczema ( OR , 0.74 ; 95 % CI , 0.55 - 0.98 ; P = .035 ) and atopic eczema ( OR , 0.66 ; 95 % CI , 0.46 - 0.95 ; P = .025 ) . Lactobacilli and bifidobacteria more frequently ( P treatment showed no effect on the incidence of all allergic diseases by age 2 years but significantly prevented eczema and especially atopic eczema . The results suggest an inverse association between atopic diseases and colonization of the gut by probiotics . CLINICAL IMPLICATION S The prevention of atopic eczema in high-risk infants is possible by modulating the infant 's gut microbiota with probiotics and prebiotics"
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BACKGROUND Pharmacological prophylaxis has been proven to reduce the risk of cardiovascular events in individuals with atherosclerotic occlusive arterial disease . However , the role of prophylaxis in individuals with abdominal aortic aneurysm ( AAA ) remains unclear . Several studies have shown that despite successful repair , those people with AAA have a poorer rate of survival than healthy controls . People with AAA have an increased prevalence of coronary heart disease and risk of cardiovascular events . Despite this association , little is known about the effectiveness of pharmacological prophylaxis in reducing cardiovascular risk in people with AAA . This is an up date of a Cochrane review first published in 2014 . OBJECTIVES To determine the long-term effectiveness of antiplatelet , antihypertensive or lipid-lowering medication in reducing mortality and cardiovascular events in people with abdominal aortic aneurysm ( AAA ) . SEARCH METHODS For this up date the Cochrane Vascular Information Specialist ( CIS ) search ed the Cochrane Vascular Specialised Register ( 14 April 2016 ) . In addition , the CIS search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) ( 2016 , Issue 3 ) and trials registries ( 14 April 2016 ) and We also search ed the reference lists of relevant articles . SELECTION CRITERIA R and omised controlled trials in which people with AAA were r and omly allocated to one prophylactic treatment versus another , a different regimen of the same treatment , a placebo , or no treatment were eligible for inclusion in this review . Primary outcomes included all-cause mortality and cardiovascular mortality . DATA COLLECTION AND ANALYSIS Two review authors independently selected studies for inclusion , and completed quality assessment and data extraction . We resolved any disagreements by discussion . Only one study met the inclusion criteria of the review , therefore we were unable to perform meta- analysis . MAIN RESULTS No new studies met the inclusion criteria for this up date . We included one r and omised controlled trial in the review . A subgroup of 227 participants with AAA received either metoprolol ( N = 111 ) or placebo ( N = 116 ) . There was no clear evidence that metoprolol reduced all-cause mortality ( odds ratio ( OR ) 0.17 , 95 % confidence interval ( CI ) 0.02 to 1.41 ) , cardiovascular death ( OR 0.20 , 95 % CI 0.02 to 1.76 ) , AAA-related death ( OR 1.05 , 95 % CI 0.06 to 16.92 ) or increased nonfatal cardiovascular events ( OR 1.44 , 95 % CI 0.58 to 3.57 ) 30 days postoperatively . Furthermore , at six months postoperatively , estimated effects were compatible with benefit and harm for all-cause mortality ( OR 0.71 , 95 % CI 0.26 to 1.95 ) , cardiovascular death ( OR 0.73 , 95 % CI 0.23 to 2.39 ) and nonfatal cardiovascular events ( OR 1.41 , 95 % CI 0.59 to 3.35 ) . Adverse drug effects were reported for the whole study population and were not available for the subgroup of participants with AAA . We considered the study to be at a generally low risk of bias . We down grade d the quality of the evidence for all outcomes to low . We down grade d the quality of evidence for imprecision as only one study with a small number of participants was available , the number of events was small and the result was consistent with benefit and harm . AUTHORS ' CONCLUSIONS Due to the limited number of included trials , there is insufficient evidence to draw any conclusions about the effectiveness of cardiovascular prophylaxis in reducing mortality and cardiovascular events in people with AAA . Further good- quality r and omised controlled trials that examine many types of prophylaxis with long-term follow-up are required before firm conclusions can be made
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"BACKGROUND Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results . This r and omised controlled trial , done in 190 hospitals in 23 countries , was design ed to investigate the effects of perioperative beta blockers . METHODS We r and omly assigned 8351 patients with , or at risk of , atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate ( n=4174 ) or placebo ( n=4177 ) , by a computerised r and omisation phone service . Study treatment was started 2 - 4 h before surgery and continued for 30 days . Patients , health-care providers , data collectors , and outcome adjudicators were masked to treatment allocation . The primary endpoint was a composite of cardiovascular death , non-fatal myocardial infa rct ion , and non-fatal cardiac arrest . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00182039 . FINDINGS All 8351 patients were included in analyses ; 8331 ( 99.8 % ) patients completed the 30-day follow-up . Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint ( 244 [ 5.8 % ] patients in the metoprolol group vs 290 [ 6.9 % ] in the placebo group ; hazard ratio 0.84 , 95 % CI 0.70 - 0.99 ; p=0.0399 ) . Fewer patients in the metoprolol group than in the placebo group had a myocardial infa rct ion ( 176 [ 4.2 % ] vs 239 [ 5.7 % ] patients ; 0.73 , 0.60 - 0.89 ; p=0.0017 ) . However , there were more deaths in the metoprolol group than in the placebo group ( 129 [ 3.1 % ] vs 97 [ 2.3 % ] patients ; 1.33 , 1.03 - 1.74 ; p=0.0317 ) . More patients in the metoprolol group than in the placebo group had a stroke ( 41 [ 1.0 % ] vs 19 [ 0.5 % ] patients ; 2.17 , 1.26 - 3.74 ; p=0.0053 ) . INTERPRETATION Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm , and the importance and need for large r and omised trials in the perioperative setting . Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol ",
"Objective —To get a better insight into the role of hemostasis in coronary artery disease ( CAD ) , we assessed the impact of von Willebr and factor ( vWF ) , fibrinogen , thrombin-antithrombin ( TAT ) complexes , D-dimers , and plasmin-antiplasmin ( PAP ) complexes on the risk of cardiovascular event in a prospect i ve cohort of CAD patients . Methods and Results —The prospect i ve Atherogene cohort includes 1057 individuals with an angiographically proven coronary artery disease at baseline . After a median follow-up of 6.6 years , 135 individuals died from a cardiovascular cause and 97 had a nonfatal cardiovascular event . Higher levels of all 5 hemostatic markers at baseline were associated with an increased risk of cardiovascular death , but not of nonfatal event . Except for vWF , these associations remained significant after adjustment for conventional cardiovascular risk factors and C-reactive protein ( CRP ) levels ( P for trend according to increasing tertiles=0.20 , 0.011 , 0.026 , 0.019 , and 0.01 for vWF , fibrinogen , TAT , D-Dimer , and PAP , respectively ) . When including the 5 hemostatic markers in a stepwise Cox regression analysis where conventional risk factors and CRP were forced into the model , fibrinogen and D-dimers remained independently associated with the risk of cardiovascular death . Adjusted hazard ratios ( 95 % CI ) associated with one SD increase of fibrinogen and D-dimers were 1.27 ( 1.04 to 1.55 ) and 1.29 ( 1.09 to 1.53 ) , respectively . Conclusions —In patients with coronary artery disease , fibrinogen and D-dimer levels are independent predictors of subsequent cardiovascular death . Our data support a role of impaired coagulation/fibrinolysis process in the complications of coronary artery disease",
"OBJECTIVES The purpose of this study was to assess the value of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate ( HR ) control scheduled for major vascular surgery . BACKGROUND Treatment guidelines of the American College of Cardiology/American Heart Association recommend cardiac testing in these patients to identify subjects at increased risk . This policy delays surgery , even though test results might be redundant and beta-blockers with tight HR control provide sufficient myocardial protection . Furthermore , the benefit of revascularization in high-risk patients is ill-defined . METHODS All 1,476 screened patients were stratified into low-risk ( 0 risk factors ) , intermediate-risk ( 1 to 2 risk factors ) , and high-risk ( > or =3 risk factors ) . All patients received beta-blockers . The 770 intermediate-risk patients were r and omly assigned to cardiac stress-testing ( n = 386 ) or no testing . Test results influenced management . In patients with ischemia , physicians aim ed to control HR below the ischemic threshold . Those with extensive stress-induced ischemia were considered for revascularization . The primary end point was cardiac death or myocardial infa rct ion at 30-days after surgery . RESULTS Testing showed no ischemia in 287 patients ( 74 % ) ; limited ischemia in 65 patients ( 17 % ) , and extensive ischemia in 34 patients ( 8.8 % ) . Of 34 patients with extensive ischemia , revascularization before surgery was feasible in 12 patients ( 35 % ) . Patients assigned to no testing had similar incidence of the primary end point as those assigned to testing ( 1.8 % vs. 2.3 % ; odds ratio [ OR ] 0.78 ; 95 % confidence interval [ CI ] 0.28 to 2.1 ; p = 0.62 ) . The strategy of no testing brought surgery almost 3 weeks forward . Regardless of allocated strategy , patients with a HR Cardiac testing can safely be omitted in intermediate-risk patients , provided that beta-blockers aim ing at tight HR control are prescribed",
"Background — Few studies have examined whether hemostatic markers contribute to risk of coronary disease and ischemic stroke independently of conventional risk factors . This study examines 11 hemostatic markers that reflect different aspects of the coagulation process to determine which have prognostic value after accounting for conventional risk factors . Methods and Results — A total of 2398 men aged 49 to 65 years were examined in 1984 to 1988 , and the majority gave a fasting blood sample for assay of lipids and hemostatic markers . Men were followed up for a median of 13 years , and cardiovascular disease ( CVD ) events were recorded . There were 486 CVD events in total , 353 with prospect i ve coronary disease and 133 with prospect i ve ischemic stroke . On univariable analysis , fibrinogen , low activated protein C ratio , D-dimer , tissue plasminogen activator ( tPA ) , and plasminogen activator inhibitor-1 ( PAI-1 ) were associated significantly with risk of CVD . On multivariable analyses with conventional risk factors forced into the proportional hazards model , fibrinogen , D-dimer , and PAI-1 were significantly associated with risk of CVD , whereas factor VIIc showed an inverse association ( P=0.001 ) . In a model that contained the conventional risk factors , the hazard ratio for subsequent CVD in the top third of the distribution of predicted risk relative to the bottom third was 2.7 for subjects without preexisting CVD . This ratio increased to 3.7 for the model that also contained the 4 hemostatic factors . Conclusions — Fibrinogen , D-dimer , PAI-1 activity , and factor VIIc each has potential to increase the prediction of coronary disease/ischemic stroke in middle-aged men , in addition to conventional risk factors",
"Background : Perioperative metoprolol increases postoperative stroke . Animal studies indicate that the mechanism may be related to attenuated & bgr;2-adrenoreceptor-mediated cerebral vasodilatation . The authors therefore conducted a cohort to study whether the highly & bgr;1-specific & bgr;-blocker ( bisoprolol ) was associated with a reduced risk of postoperative stroke compared with less selective & bgr;-blockers ( metoprolol or atenolol ) . Methods : The authors conducted a single-center study on 44,092 consecutive patients with age 50 yr or more having noncardiac , nonneurologic surgery . The primary outcome was stroke within 7 days of surgery . The secondary outcome was a composite of all-cause mortality , postoperative myocardial injury , and stroke . A propensity score-matched cohort was created to assess the independent association between bisoprolol and less & bgr;1-selective agents metoprolol or atenolol . A secondary analysis using logistic regression , based on previously identified confounders , also compared selective & bgr;1-antagonism . Results : Twenty-four percent ( 10,756 ) of patients were exposed to in-hospital & bgr;-blockers . A total of 88 patients ( 0.2 % ) suffered a stroke within 7 days of surgery . The matched cohort consisted of 2,462 patients , and the pairs were well matched for all variables . Bisoprolol was associated with fewer postoperative strokes than the less selective agents ( odds ratio = 0.20 ; 95 % CI , 0.04–0.91 ) . Multivariable risk-adjustment in the & bgr;-blockers-exposed patients comparing bisoprolol with the less selective agents was associated with a similarly reduced stroke rate . Conclusions : The use of metoprolol and atenolol is associated with increased risks of postoperative stroke , compared with bisoprolol . These findings warrant confirmation in a pragmatic r and omized trial",
"AIM To assess the long-term cardioprotective effect of bisoprolol in a r and omized high-risk population after successful major vascular surgery . High-risk patients were defined by the presence of one or more cardiac risk factor(s ) and a dobutamine echocardiography test positive for ischaemia . METHODS 1351 patients were screened prior to surgery , 846 patients had one or more risk factor(s ) , and 173 of these patients also had ischaemia during dobutamine echocardiography . One hundred and twelve patients could be r and omized for additional bisoprolol therapy or st and ard care . Eleven patients died in the peri-operative period ( up to 1 month after surgery ) . R and omized patients continued bisoprolol or st and ard care after surgery . During follow-up of 101 survivors ( median 22 months , range 11 - 30 ) cardiac death or myocardial infa rct ion was noted . No patient was lost during follow-up . Results The incidence of cardiac events during follow-up in the bisoprolol group was 12 % vs 32 % in the st and ard care group ( P=0.025 ) . Cardiac death occurred in 15 patients , nine patients in the st and ard care and in six in the bisoprolol group ; myocardial infa rct ion occurred in six patients , five in the st and ard care and one in the bisoprolol group . The odds ratio for cardiac death or myocardial infa rct ion after surgery in high-risk patients with additional bisoprolol therapy was 0.30 ( 0.11 - 0.83 ) . CONCLUSIONS Bisoprolol significantly reduced long-term cardiac death and myocardial infa rct ion in high-risk patients after successful major cardiac vascular surgery",
"Objective : This study was design ed to investigate whether patients with stable coronary artery disease ( CAD ) receiving chronic statin treatment who are undergoing noncardiac emergency surgery benefit from acute atorvastatin reload . Methods : A total of 500 patients with stable CAD and regular administration of statin before noncardiac emergency surgery were r and omized to atorvastatin reload ( n = 250 ) or placebo ( n = 250 ) . All patients received atorvastatin treatment thereafter . The primary end point was a 30-day incidence of major adverse cardiac events ( MACE ) . Secondary end points were the incidence of atrial fibrillation ( AF ) during hospitalization and length of hospital stay . Results : The primary end point occurred in 2.4 % of patients treated with atorvastatin reload and in 8 % in the placebo arm ( p = 0.0088 ) . The incidence of AF during hospitalization was 6.8 % in patients treated with atorvastatin reload and 17 % in the placebo arm ( p = 0.0003 ) . Compared with the placebo arm , the atorvastatin reload arm shortened the length of stay ( 9.8 ± 3.3 vs. 10.6 ± 3.5 days , p = 0.009 ) . Multivariable analysis suggested that atorvastatin reload conferred a 65 % risk reduction of 30-day MACE ( odds ratio 0.35 , 95 % confidence interval 0.18 - 0.86 ; p = 0.005 ) . Conclusion : The trial suggests that atorvastatin reload may improve the clinical outcome of patients with stable CAD receiving chronic statin treatment who are undergoing noncardiac emergency surgery",
"Screening for abdominal aortic aneurysm ( AAA ) is commonly restricted to men . Recent studies have indicated a possible increase in deaths due to ruptured AAA in women , and a higher rate of rupture in women than in men . The present report details results from a r and omized controlled trial that assessed the effects of screening women for AAA",
"The aim of this study was to assess cardiovascular predictors for all-cause long-term mortality in patients undergoing st and ard endovascular aneurysm repair ( EVAR ) for infrarenal abdominal aortic aneurysm ( AAA ) . Consecutive patients treated with EVAR ( Zenith ® stent grafts ; Cook ) between May 1998 and February 2006 were prospect ively enrolled in a computerized data base , together with retrospectively collected data on medication , and electrocardiographic and echocardiographic variables . Mortality was assessed on 1 December 2010 . The median follow-up time was 68 months and the median age was 74 years ( range 53–89 ) for the 304 patients . Mortality at the end of follow-up was 54.3 % ( 165/304 ) . The proportion of deaths caused by vascular diseases was 61 % ( 101/165 ) . In the univariate analysis , low preoperative ejection fraction ( EF ) ( p = 0.004 ) , absence of statin medication ( p = 0.007 ) , and medication with diuretics ( p = 0.028 ) or digitalis ( p = 0.016 ) were associated with an increased long-term mortality rate . Myocardial ischemia on electrocardiogram ( ECG ) ( hazard ratio ( HR ) 1.6 [ 95 % CI 1.1–2.4 ] ) and anemia ( HR 1.5 [ 95 % CI 1.0–2.1 ] ) were found to be independent predictors for long-term mortality after Cox regression analysis . There was a trend that chronic kidney disease , stage ≥ 3 ( HR 1.5 [ 95 % CI 1.0–2.2 ] ) , and age 80 years and above ( HR 1.5 [ 95 % CI 1.0–2.4 ] ) were independently associated with long-term mortality . In conclusion , ischemia on ECG and anemia were independently related to an increased long-term mortality rate after EVAR , and these predictive factors seem to be most important for critical assessment in the preoperative medical work-up",
"PURPOSE Whether small abdominal aortic aneurysms ( AAAs ) ( should be repaired early to enhance late survival remains controversial . Long-term population -based data on the surgical outcome for small AAAs may help to establish practice guidelines until r and omized clinical trials are completed . METHODS To examine an entire community experience with small AAAs , we conducted a population -based analysis of the recognition , reasons for operation , perioperative mortality rates , and late survival in Olmsted County , Minnesota . RESULTS The incidence of recognized small AAAs increased thirtyfold during a 30-year period . The propensity to repair small AAAs also increased during the same period . Eventually one third of small AAAs were repaired . The primary reasons for surgical consultation and operation were presence of the aneurysm ( 49 % ) , expansion on serial examination ( 28 % ) , nonspecific abdominal or back symptoms ( 18 % ) , and excessive patient anxiety about the aneurysm ( 5 % ) . Community operative mortality rates for small AAAs were low ( 2.6 % ) compared with those for large aneurysms ( 5.5 % ) ( p = 0.65 ) . However , the observed 5-year survival rate for the group undergoing repair of small aneurysms was 62 % , which was significantly less than the 83 % expected survival for the general population ( p Relative survival for the operated small and large aneurysms was similar . The primary cause of death for both groups was myocardial infa rct ion . CONCLUSIONS The results of our population -based analysis indicate that early operative results for elective repair of small AAAs are excellent , but late survival remains significantly impaired by coronary heart disease . Consequently , our data question whether early repair of small AAAs will enhance late survival . Until r and omized clinical trials on management of small AAAs are completed , most small AAAs should be monitored for expansion and operated on electively when they approach or enter the range of 5 to 6 cm in good-risk patients",
"OBJECTIVES This article describes the rationale and design of the DECREASE-XIII trial , which aims to evaluate the potential of esmolol infusion , an ultra-short-acting beta-blocker , during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery . DESIGN A double-blind , placebo-controlled , r and omised trial . MATERIAL S & METHODS A total of 260 vascular surgery patients will be r and omised to esmolol or placebo as an add-on to st and ard medical care , including chronic low-dose beta-blockers . Esmolol is titrated to maintain a heart rate within a target window of 60 - 80 beats per minute for 24 h from the induction of anaesthesia . Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h , starting 1 day prior to surgery . The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug . Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia , troponin T release , myocardial infa rct ion and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension . CONCLUSIONS This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters",
"BACKGROUND Although the initial results of endovascular repair of abdominal aortic aneurysms were promising , current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair . METHODS We conducted a multicenter , r and omized trial comparing open repair with endovascular repair in 345 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable c and i date s for both techniques . The outcome events analyzed were operative ( 30-day ) mortality and two composite end points of operative mortality and severe complications and operative mortality and moderate or severe complications . RESULTS The operative mortality rate was 4.6 percent in the open-repair group ( 8 of 174 patients ; 95 percent confidence interval , 2.0 to 8.9 percent ) and 1.2 percent in the endovascular-repair group ( 2 of 171 patients ; 95 percent confidence interval , 0.1 to 4.2 percent ) , result ing in a risk ratio of 3.9 ( 95 percent confidence interval , 0.9 to 32.9 ) . The combined rate of operative mortality and severe complications was 9.8 percent in the open-repair group ( 17 of 174 patients ; 95 percent confidence interval , 5.8 to 15.2 percent ) and 4.7 percent in the endovascular-repair group ( 8 of 171 patients ; 95 percent confidence interval , 2.0 to 9.0 percent ) , result ing in a risk ratio of 2.1 ( 95 percent confidence interval , 0.9 to 5.4 ) . CONCLUSIONS On the basis of the overall results of this trial , endovascular repair is preferable to open repair in patients who have an abdominal aortic aneurysm that is at least 5 cm in diameter . Long-term follow-up is needed to determine whether this advantage is sustained",
"BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors prevent the expansion and rupture of aortic aneurysms in animals . We investigated the association between ACE inhibitors and rupture in patients with abdominal aortic aneurysms . METHODS We did a population -based case-control study of linked administrative data bases in Ontario , Canada . The sample included consecutive patients older than 65 ( n=15,326 ) admitted to hospital with a primary diagnosis of ruptured or intact abdominal aortic aneurysm between April 1 , 1992 , and April 1 , 2002 . FINDINGS Patients who received ACE inhibitors before admission were significantly less likely to present with ruptured aneurysm ( odds ratio [ OR ] 0.82 , 95 % CI 0.74 - 0.90 ) than those who did not receive ACE inhibitors . Adjustment for demographic characteristics , risk factors for rupture , comorbidities , contraindications to ACE inhibitors , measures of health-care use , and aneurysm screening yielded similar results ( 0.83 , 0.73 - 0.95 ) . Consistent findings were noted in subgroups at high risk of rupture , including patients older than 75 years and those with a history of hypertension . Conversely , such protective associations were not observed for beta blockers ( 1.02 , 0.89 - 1.17 ) , calcium channel blockers ( 1.01 , 0.89 - 1.14 ) , alpha blockers ( 1.15 , 0.86 - 1.54 ) , angiotensin receptor blockers ( 1.24 , 0.71 - 2.18 ) , or thiazide diuretics ( 0.91 , 0.78 - 1.07 ) . INTERPRETATION ACE inhibitors are associated with a reduced risk of ruptured abdominal aortic aneurysm , unlike other antihypertensive agents . R and omised trials of ACE inhibitors for prevention of aortic rupture might be warranted",
"BACKGROUND Patients with abdominal aortic aneurysms ( AAA ) are predisposed to cardiovascular events and often experience continual expansion of their aneurysm . Cardiovascular events and expansion rates are positively correlated with aneurysm size . AAA is usually associated with intraluminal thrombus , which has previously been implicated in AAA pathogenesis . This study prospect ively assessed the association of infrarenal abdominal aortic thrombus volume with cardiovascular events and AAA growth . METHODS Ninety-eight patients with AAAs underwent computed tomography angiography ( CTA ) . The volume of infrarenal aorta thrombus was measured by a previously vali date d technique . Patients were monitored prospect ively for a median of 3 years ( interquartile range [ IQR ] , 2.0 - 3.6 years ) , and cardiovascular events ( nonfatal stroke , nonfatal myocardial infa rct ion , coronary revascularization , amputation , and cardiovascular death ) were recorded . Of the original patients , 39 underwent repeat CTA a median of 1.5 years ( IQR , 1.1 - 3.3 years ) after entry to the study . Kaplan-Meier and Cox proportional analysis were used to examine the association of aortic thrombus with cardiovascular events and average weighted AAA growth . RESULTS There were 28 cardiovascular events during follow-up . The incidence of cardiovascular events was 23.4 % and 49.2 % for patients with small ( smaller than the median ) and large ( median or larger ) volumes of aortic thrombus , respectively , at 4 years ( P = .040 ) . AAA thrombus volume of median or larger was associated with increased cardiovascular events ( relative risk [ RR ] 2.8 , 95 % confidence interval [ CI ] , 1.01 - 5.24 ) independent of other risk factors , including initial AAA diameter , but was only of borderline significance when patients were censored at the time of AAA repair ( RR , 2.35 ; 95 % CI , 0.98 - 5.63 ) . In the subset of patients with CTA follow-up , the median annual increase in AAA volume was 5.1 cm³ ( IQR , 0.8 - 10.3 cm³ ) . Annual AAA volume increase was positively correlated with initial AAA diameter ( r = 0.44 , P = .006 ) and thrombus volume ( r = 0.50 , P = .001 ) . Median or larger aortic thrombus volume was associated with rapid AAA volume increase ( ≥ 5 cm/y ) , independent of initial aortic diameter ( RR , 15.0 ; 95 % CI , 1.9 - 115.7 ; P = .009 ) . CONCLUSION In this small cohort , infrarenal aortic thrombus volume was associated with the incidence of cardiovascular events and AAA progression . These results need to be confirmed and mechanisms underlying the associations clarified in large further studies",
"OBJECTIVE To investigate risk factors associated with aneurysm rupture using patients r and omized into the U.K. Small Aneurysm Trial ( n = 1090 ) or monitored for aneurysm growth in the associated study ( n = 1167 ) . SUMMARY BACKGROUND DATA The U.K. Small Aneurysm Trial has shown that ultrasound surveillance is a safe management option for patients with small abdominal aortic aneurysms ( 4.0 to 5.5 cm in diameter ) , with an annual rupture rate of 1 % . METHODS In the cohort of 2257 patients ( 79 % male ) , aged 59 to 77 years , 103 instances of abdominal aortic aneurysm rupture were identified during the 7-year period of follow-up ( 1991 - 1998 ) . Almost all patients ( 98 % ) had initial aneurysm diameters in the range of 3 to 6 cm , and the majority of ruptures ( 76 % ) occurred in patients with aneurysms > or = 5 cm in diameter . Kaplan-Meier survival and Cox regression analysis were used to identify baseline risk factors associated with aneurysm rupture . RESULTS After 3 years , the annual rate of aneurysm rupture was 2.2 % ( 95 % confidence interval 1.7 to 2.8 ) . The risk of rupture was independently and significantly associated with female sex ( p initial aneurysm diameter ( p FEV1 ( p = 0.004 ) , current smoking ( p = 0.01 ) , and higher mean blood pressure ( p = 0.01 ) . Age , body mass index , serum cholesterol concentration , and ankle/brachial pressure index were not associated with an increased risk of aneurysm rupture . CONCLUSIONS Within this cohort of patients , women had a threefold higher risk of aneurysm rupture than men . Effective control of blood pressure and cessation of smoking are likely to diminish the risk of rupture",
"BACKGROUND Noncardiac surgery is associated with significant cardiovascular mortality , morbidity , and cost . Small trials of beta-blockers suggest that they may prevent cardiovascular events in patients undergoing noncardiac surgery , but trial results are inconclusive . We have initiated the POISE trial to definitively establish the effects of beta-blocker therapy in patients undergoing noncardiac surgery . METHODS The POISE trial is a blinded , r and omized , and controlled trial of controlled-release metoprolol versus placebo in 10000 patients at risk for a perioperative cardiovascular event who are undergoing noncardiac surgery . Patients will receive the study drug 2 to 4 hours before surgery and subsequently for 30 days . The primary outcome is a composite of cardiovascular death , nonfatal myocardial infa rct ion , and nonfatal cardiac arrest at 30 days . Patients will also be followed for events at 1 year . RESULTS To date , the POISE trial has recruited > 6300 patients in 182 centers in 21 countries . Currently , the patients ' mean age is 69 years ; 63 % are males , 43 % have a history of coronary artery disease , 43 % have a history of peripheral arterial disease , and 30 % have diabetes . Most participants have undergone vascular ( 42 % ) , intraabdominal ( 23 % ) , or orthopedic ( 19 % ) surgery . CONCLUSIONS The POISE trial is a large international trial that will provide a reliable assessment of the effects of beta-blocker therapy in patients undergoing noncardiac surgery",
"OBJECTIVES Increasing numbers of patients with small abdominal aortic aneurysms ( AAA ) are being diagnosed . The aim of this paper is to define the fate of those patients undergoing surveillance of small AAAs . SETTING U.K. district general hospital . METHODS A prospect i ve study has been carried out of all patients undergoing surveillance . At the time of the first consultation the patient was assessed , a Detsky score calculated and the referral source noted . End points of the study were elective repair of the aneurysm , aneurysm rupture or death of the patient . RESULTS Details of 267 patients were analysed . The referral source was general practitioner in 39 % , patients with peripheral vascular disease in 32 % and department of urology in 21 % . None were referred from population screening . The cumulative 5-year risks of rupture , elective repair or non-AAA related deaths were 15 % , 26 % and 46 % for all patients , 4 % , 13 % and 38 % for patients initially presenting with AAA less than 4 cm diameter and 21 % , 42 % and 54 % for patients presenting with an AAA 4 - 5.5 cm diameter . All but one of 11 patients whose aneurysm ruptured were unfit or had declined elective repair . There were 56 non-AAA related deaths , the majority due to cardiovascular causes . Those patients with low Detsky scores had a 5-year survival of 62 % , those with high scores 44 % . The age/sex matched survival or a normal population at 5 years in 80 % . CONCLUSION Overall the non-AAA related mortality was greater than the risks of rupture or elective repair . It is important to bear in mind the poor prognosis of this group of patients compared with a normal population when considering elective repair of small AAAs",
"BACKGROUND Perioperative myocardial ischemia is the single most important potentially reversible risk factor for mortality and cardiovascular complications after noncardiac surgery . Although more than 1 million patients have such complications annually , there is no effective preventive therapy . METHODS We performed a r and omized , double-blind , placebo-controlled trial to compare the effect of atenolol with that of a placebo on overall survival and cardiovascular morbidity in patients with or at risk for coronary artery disease who were undergoing noncardiac surgery . Atenolol was given intravenously before and immediately after surgery and orally thereafter for the duration of hospitalization . Patients were followed over the subsequent two years . RESULTS A total of 200 patients were enrolled . Ninety-nine were assigned to the atenolol group , and 101 to the placebo group . One hundred ninety-four patients survived to be discharged from the hospital , and 192 of these were followed for two years . Overall mortality after discharge from the hospital was significantly lower among the atenolol-treated patients than among those who were given placebo over the six months following hospital discharge ( 0 vs. 8 percent , P deaths from cardiac causes during the first six to eight months . Combined cardiovascular outcomes were similarly reduced among the atenolol-treated patients ; event-free survival throughout the two-year study period was 68 percent in the placebo group and 83 percent in the atenolol group ( P=0.008 ) . CONCLUSIONS In patients who have or are at risk for coronary artery disease who must undergo noncardiac surgery , treatment with atenolol during hospitalization can reduce mortality and the incidence of cardiovascular complications for as long as two years after surgery",
"Objective : Cardiovascular complications represent a major cause of morbidity and mortality in patients undergoing vascular surgery . This was a prospect i ve r and omized , open-label study to investigate the effect of lipid-lowering treatment by statin monotherapy or intensified by combining statin with ezetimibe on a 12-month prognosis after vascular surgery . Methods : Patients were r and omly assigned to receive rosuvastatin ( RSV ) 10 mg/d or rosuvastatin 10 mg/d plus ezetemibe ( RSV/EZT ) 10 mg/d , starting prior to scheduled surgical procedure . The primary end point was the first major cardiovascular event , including death from cardiac causes , nonfatal myocardial infa rct ion , ischemic stroke , and unstable angina . Results : A total of 136 patients assigned to RSV and 126 to RSV/EZT completed the study protocol . As many as 6.6 % of patients in the RSV group experience a major cardiovascular event within 30 days after surgery versus 5.6 % in the RSV/EZT group ( P = .72 ) . From month 1 to 12 of the follow-up period , primary end point was observed ( 9 taking RSV vs 2 in the RSV/EZT group [ P = .04 ] ) . Intensified lipid-lowering therapy with RSV/EZT was associated with a greater decrease in low-density lipoprotein cholesterol levels compared with RSV ( 75.87 ± 31.64 vs 87.19 ± 31.7 , P = .004 ) , while no differential effect on triglyceride , high-density lipoprotein cholesterol or high-sensitivity C-reactive protein levels was noted between groups . Conclusion : Our findings indicate that statin therapy intensified by ezetimibe may reduce the incidence of cardiovascular events within the first 12 months after vascular surgery . Nonetheless , whether the use of ezetimibe as an add-on therapy to reduce cardiovascular risk in these patients needs to be tested in larger future studies",
"BACKGROUND Endovascular aneurysm repair ( EVAR ) is a new technology to treat patients with abdominal aortic aneurysm ( AAA ) when the anatomy is suitable . Uncertainty exists about how endovascular repair compares with conventional open surgery . EVAR trial 1 was instigated to compare these treatments in patients judged fit for open AAA repair . METHODS Between 1999 and 2003 , 1082 elective ( non-emergency ) patients were r and omised to receive either EVAR ( n=543 ) or open AAA repair ( n=539 ) . Patients aged at least 60 years with aneurysms of diameter 5.5 cm or more , who were fit enough for open surgical repair ( anaesthetically and medically well enough for the procedure ) , were recruited for the study at 41 British hospitals proficient in the EVAR technique . The primary outcome measure is all-cause mortality and these results will be released in 2005 . The primary analysis presented here is operative mortality by intention to treat and a secondary analysis was done in per- protocol patients . FINDINGS Patients ( 983 men , 99 women ) had a mean age of 74 years ( SD 6 ) and mean AAA diameter of 6.5 cm ( SD 1 ) . 1047 ( 97 % ) patients underwent AAA repair and 1008 ( 93 % ) received their allocated treatment . 30-day mortality in the EVAR group was 1.7 % ( 9/531 ) versus 4.7 % ( 24/516 ) in the open repair group ( odds ratio 0.35 [ 95 % CI 0.16 - 0.77 ] , p=0.009 ) . By per- protocol analysis , 30-day mortality for EVAR was 1.6 % ( 8/512 ) versus 4.6 % ( 23/496 ) for open repair ( 0.33 [ 0.15 - 0.74 ] , p=0.007 ) . Secondary interventions were more common in patients allocated EVAR ( 9.8 % vs 5.8 % , p=0.02 ) . INTERPRETATION In patients with large AAAs , treatment by EVAR reduced the 30-day operative mortality by two-thirds compared with open repair . Any change in clinical practice should await durability and longer term results",
"Objectives : We explored whether preoperative rosuvastatin could protect the cardiac health of patients with coronary artery disease undergoing emergency , noncardiac surgery . Methods : We r and omized 550 noncardiac emergency surgery patients with stable coronary artery disease on long-term statin therapy to treatment with and without preoperative rosuvastatin . All patients received rosuvastatin after surgery . We evaluated the incidence of myocardial necrosis and major adverse cardiovascular and cerebrovascular events ( MACCE ) 30 days and 6 months after surgery . Results : Creatinine kinase-myocardial b and ( CK-MB ) isoform elevations occurred less frequently 12 and 24 h after noncardiac emergency surgery in the experimental group than in the control group ( p = 0.029 ) . After surgery , the incidence of MACCE was also lower in the experimental group than in the control group ( p = 0.019 ) . The difference was mainly due to the incidence of perioperative myocardial infa rct ion ( p = 0.029 ) . Multivariable analysis found that rosuvastatin reload reduced the incidence of MACCE 52 % 6 months after surgery ( p = 0.03 ) . Conclusions : Preoperative rosuvastatin reload therapy decreases the incidence of myocardial necrosis and MACCE after noncardiac emergency surgery in patients with stable coronary artery disease on long-term statin therapy",
"Objectives This study aim ed to ( a ) investigate whether atorvastatin reload protects against acute heart failure ( AHF ) in patients with stable coronary artery disease ( CAD ) undergoing noncardiac emergency surgery and decreases the incidence of major adverse cardiac events ( MACE ) during hospitalization and ( b ) eluci date its possible mechanism of action . Material s and methods In total , 500 patients with stable CAD before noncardiac emergency surgery were r and omized either to the atorvastatin reload or to the placebo group . All patients received atorvastatin treatment postoperatively . The primary end point was the incidence of AHF during hospitalization , and the secondary end point was the incidence of MACE during hospitalization . Preoperative and 72 h postoperative changes in high-sensitivity C-reactive protein and interleukin-6 levels were compared between the two groups . Results AHF during hospitalization occurred in 5.2 % of patients in the atorvastatin reload group and 11.2 % in the placebo group ( P=0.0225 ) . MACE during hospitalization occurred in 2.4 % of patients in the atorvastatin reload group and 8.0 % in the placebo group ( P=0.0088 ) . According to multivariable analysis , atorvastatin reload conferred a 50 % reduction in the risk of AHF during hospitalization ( odds ratio , 0.50 ; 95 % confidence interval , 0.2–0.8 ; P=0.005 ) . The median decrease in the high-sensitivity C-reactive protein and interleukin-6 levels was significantly greater in the atorvastatin reload group ( P Atorvastatin reload may improve the clinical outcome of patients with stable CAD undergoing noncardiac emergency surgery by decreasing the incidence of AHF and MACE during hospitalization . The mechanism of this protective effect may involve inhibition of inflammation",
"OBJECTIVE The purpose of this study was to assess prospect ively the incidence , health care re source utilization , and economic burden associated with perioperative myocardial ischemic injury ( PMII ) in high-risk patients undergoing noncardiac vascular surgery . METHODS Two hundred thirty-six patients consented to participate in a pharmacoeconomic sub study as part of a r and omized , multicenter clinical trial . Patients were assessed for myocardial ischemic injury by using clinical , biochemical , and electrocardiographic criteria . PMII was defined as fatal or nonfatal myocardial infa rct ion , new or worsened congestive heart failure , or new arrhythmias . Re source utilization parameters were compared for patients with and without PMII . Patients underwent the following index procedures : open abdominal aortic aneurysm repair ( n = 44 ) , bypass for aortoiliac disease ( n = 29 ) , bypass for femoropopliteal disease ( n = 62 ) , bypass for femorotibial disease ( n = 71 ) , extra-anatomic bypass ( n = 23 ) , and miscellaneous ( n = 7 ) . Patients undergoing carotid endarterectomy or only endovascular interventions were excluded . The incremental cost of PMII was estimated by applying the average costs ( adjusted to 2004 US dollars ) of the hospital ward ( dollar 700.00/d ) or intensive care unit ( dollar 2500.00/d ) to the length of stay differences for patients with and without PMII . RESULTS The overall mortality was 3.4 % ( 8/236 ) , and 7 of 8 deaths were related to PMII . PMII occurred in 42 ( 17.8 % ) of 236 patients : 22 myocardial infa rct ions , 11 congestive heart failures , and 12 new arrhythmias ( 3 patients had 2 PMII events ) . There was no evidence of differences in the incidence of PMII among the various index procedures . PMII was associated with a dramatic increase in re source utilization . The mean length of stay was 16.8 and 10.0 days for patients with and without PMII , respectively ( P Intensive care unit care was required by 35 ( 83.3 % ) of 42 patients with and 121 ( 62.4 % ) of 194 patients without PMII ( P mean intensive care unit length of stay was 6.6 and 3.7 days for patients with and without PMII , respectively ( P re source utilization and cost . The increase in re source utilization associated with PMII result ed in an estimated incremental cost per patient of dollar 9980.00 . If 250,000 high-risk open vascular operations are performed annually in the United States , the economic burden of PMII in these procedures alone approximates dollar 444 million . Strategies to decrease PMII incidence and severity should be evaluated in large-scale prospect i ve trials",
"BACKGROUND Cardiovascular complications are the most important causes of perioperative morbidity and mortality among patients undergoing major vascular surgery . METHODS We performed a r and omized , multicenter trial to assess the effect of perioperative blockade of beta-adrenergic receptors on the incidence of death from cardiac causes and nonfatal myocardial infa rct ion within 30 days after major vascular surgery in patients at high risk for these events . High-risk patients were identified by the presence of both clinical risk factors and positive results on dobutamine echocardiography . Eligible patients were r and omly assigned to receive st and ard perioperative care or st and ard care plus perioperative beta-blockade with bisoprolol . RESULTS A total of 1351 patients were screened , and 846 were found to have one or more cardiac risk factors . Of these 846 patients , 173 had positive results on dobutamine echocardiography . Fifty-nine patients were r and omly assigned to receive bisoprolol , and 53 to receive st and ard care . Fifty-three patients were excluded from r and omization because they were already taking a beta-blocker , and eight were excluded because they had extensive wall-motion abnormalities either at rest or during stress testing . Two patients in the bisoprolol group died of cardiac causes ( 3.4 percent ) , as compared with nine patients in the st and ard-care group ( 17 percent , P=0.02 ) . Nonfatal myocardial infa rct ion occurred in nine patients given st and ard care only ( 17 percent ) and in none of those given st and ard care plus bisoprolol ( P death from cardiac causes or nonfatal myocardial infa rct ion occurred in 2 patients in the bisoprolol group ( 3.4 percent ) and 18 patients in the st and ard-care group ( 34 percent , P Bisoprolol reduces the perioperative incidence of death from cardiac causes and nonfatal myocardial infa rct ion in high-risk patients who are undergoing major vascular surgery",
"The optimal dosing strategy for perioperative beta-blockers to safely achieve recommended target heart rates ( HRs ) by current guidelines is not well defined . An HR-titrated perioperative beta-blocker dosing regimen versus a fixed-dose regimen was assessed by clinical outcomes , postoperative heart rate , and beta-blocker-related complications . Patients ( n = 64 ) scheduled to undergo moderate- to high-risk vascular surgery and without contraindications to beta-blockade were r and omized to either a fixed-dose or HR-titrated beta-blocker dosing schedule . Clinical outcomes and HRs were followed immediately preoperatively to 24 hr postoperatively . A difference in mean HR between the two dosing arms was significant immediately postoperatively ( 70.1 vs. 58.2 bpm for fixed dose and HR-titrated arms , respectively ; p = 0.012 ) but at no other time points . However , the HR-titrated strategy led to a significant reduction in the percentage of HR measurements > 80 bpm ( 34.5 % vs. 16.1 % , p absolute HR change ( 17.5 vs. 22.5 bpm , p = 0.034 ) . There were no significant differences in the occurrence of asymptomatic hypotension between the two study arms , and no beta-blocker-related adverse events occurred in either study arm . An aggressive , HR-titrated perioperative beta-blocker dosing strategy was associated with more consistent maintenance of postoperative HRs within the range recommended by current guidelines and did not result in increased drug-related adverse events . The question of what is the best perioperative beta-blocker dosing regimen warrants further evaluation in a large-scale clinical trial",
"Purpose Evidence suggests that statins reduce cardiovascular complications in patients undergoing noncardiac surgery , although questions remain regarding the mechanism of benefit and the preferred dosing strategy . In this trial , we evaluated the perioperative effects on C-reactive protein ( CRP ) that result ed from starting atorvastatin within seven days of noncardiac surgery . The objective was to identify anti-inflammatory effects of atorvastatin prior to conducting a large r and omized trial with clinical end points . Methods In a single centre , parallel group , placebo-controlled trial , sixty high cardiac risk participants over age 45 yr undergoing noncardiac surgery were assigned r and omly to one of three groups to receive atorvastatin 80 mg ( A ) and /or placebo ( P ) . Group AA ( n = 26 ) received atorvastatin seven days before surgery , the day of surgery , and for seven days post surgery . Group PA ( n = 17 ) received placebo seven days before surgery , atorvastatin on the day of surgery , and atorvastatin for seven days post surgery . Group PP ( n = 17 ) received placebo at all times . All participants , health care professionals , research assistants , and outcome adjudicators were masked to treatment allocation . Analyses were by intention to treat . The primary outcome was the C-reactive protein level at 48 hr . Results Fifty-six participants completed the 30-day follow-up . The mean ( st and ard deviation ) changes in CRP levels from baseline at 48 hr in Groups AA , PA , and PP were 141.0 ( 72.4 ) , 153.5 ( 42.2 ) , and 111.2 ( 84.6 ) , respectively . The mean differences ( 95 % confidence interval ) at 48 hr for AA vs PA , AA vs PP , and PA vs PP were : −20.1 ( −81.2 to 41.1 ) , 22.7 ( −31.7 to 77.2 ) , and 42.8 ( −20.0 to 105.7 ) , respectively , adjusting for baseline CRP , type of procedure , presence of coronary artery disease , use of medications , and for multiple comparisons using Tukey ’s method . Conclusions Administration of atorvastatin , initiated within seven days preoperatively , was not associated with clinical ly significant reductions in CRP levels . ( Clinical Trials.gov number , NCT00967434).RésuméObjectifDes données probantes suggèrent que les statines réduisent les complications cardiovasculaires chez des patients subissant une chirurgie non cardiaque bien que des questions demeurent concernant le mécanisme de ce bénéfice et la meilleure stratégie posologique à adopter . Au cours de cette étude , nous avons évalué les effets périopératoires sur la protéine C-réactive ( CRP ) résultant d’une prise d’atorvastatine commençant dans les sept jours précédant une chirurgie non cardiaque . L’objectif était d’identifier les effets anti-inflammatoires de l’atorvastatine avant de mener une gr and e étude r and omisée comportant des critères cliniques d’évaluation . MéthodesSoixante participants d’un seul centre , à risque cardiaque élevé , âgés de plus de 45 ans et devant subir une chirurgie non cardiaque , ont participé à une étude r and omisée contre placebo et à groupes parallèles ; ils ont été r and omisés dans l’un des trois groupes pour y recevoir de l’atorvastatine 80 mg ( A ) et/ou un placebo ( P ) . Les patients du groupe AA ( n = 26 ) ont reçu de l’atorvastatine pendant sept jours avant la chirurgie , le jour de la chirurgie , et pendant sept jours après l’intervention chirurgicale . Les patients du groupe PA ( n = 17 ) ont reçu un placebo pendant sept jours avant la chirurgie , de l’atorvastatine le jour de la chirurgie et pendant sept jours après l’intervention chirurgicale . Les patients du groupe PP ( n = 17 ) ont reçu un placebo pendant toute la durée de l’étude . Tous les participants ( professionnels de soins de santé , assistants de recherche et évaluateurs des résultats ) ignoraient l’assignation au groupe de traitement . Les analyses ont été réalisées sur l’intention de traiter . Le principal critère d’évaluation était le taux de protéine C-réactive à 48 heures . RésultatsCinquante-six participants ont terminé le suivi de 30 jours . Les variations moyennes ( écart-type ) des concentrations de CRP à 48 heures par rapport à la ligne de base dans les groupes AA , PA et PP ont été , respectivement , de 141,0 ( 72,4 ) , 153,5 ( 42,2 ) et de 111,2 ( 84,6 ) . Les différences moyennes ( intervalle de confiance à 95 % ) à 48 heures pour les groupes AA contre PA , AA contre PP et PA contre PP ont été , respectivement : −20,1 ( −81,2 à 41,1 ) , 22,7 ( −31,7 à77,2 ) , et 42,8 ( −20,0 à 105,7 ) , après ajustement pour la CRP à la ligne de base , le type d’intervention , la présence d’une coronaropathie , l’utilisation de médicaments et pour les comparaisons multiples selon la méthode de Tukey . Conclusions L’administration d’atorvastatine , débutée dans les sept jours précédant une intervention chirurgicale n’a pas été associée à des baisses cliniquement significatives des concentrations de CRP . ( Numéro Clinical Trials.gov : NCT00967434 )",
"We compared the effects of lipid lowering with rosuvastatin ( RSV ) monotherapy versus intensified treatment by combining RSV with ezetimibe ( EZT ) on kidney function in patients undergoing vascular surgery . Patients were r and omly assigned to either 10 mg/d RSV ( n = 136 ) or RSV 10 mg/d plus EZT 10 mg/d ( RSV/EZT , n = 126 ) . At 12 months , a similar decrease in estimated glomerular filtration rate ( eGFR ) was noted . Patients who achieved a low-density lipoprotein cholesterol ( LDL-C ) of eGFR decrease than those patients having an LDL-C limit of more than 100 mg/dL. There were no significant changes in the urinary total protein to creatinine ratio in either group . Significant microalbuminuria was evident in both the groups . Patients undergoing vascular surgery show deterioration in their renal function during the first year , despite statin therapy . Intensified lipid-lowering therapy by adding EZT does not appear to have any renoprotective effect",
"Abdominal aortic aneurysm is common . The aim of this study was to assess the effect of smoking on prevalence and management . Patients attending the vascular unit and appropriate controls were prospect ively recruited . A smoking history revealed tobacco exposure in pack years . Serum cotinine was assessed biochemically . Independent risk factors were statistically determined . In all , 202 ( 186 men ) patients were recruited , with 202 ( 197 men ) controls . A total of 69 patients tested positive for cotinine , whereas 39 controls were positive ( P = .001 ) . Smoking and ischemic heart disease were significant predictors for aneurysm prevalence . Cardiac disease emerged as a more important predictor than smoking in symptomatic patients . In noncardiac patients , smoking and hypercholesterolemia were significant risk factors . Smoking is a significant predictor for aneurysm development . In high-risk patients , the cardiac disease process is the most important factor , with control of this imperative . However , in noncardiac patients , smoking cessation and lipid-lowering therapy are crucial",
"BACKGROUND Adverse cardiac events are common after vascular surgery . We hypothesized that perioperative statin therapy would improve postoperative outcomes . METHODS In this double-blind , placebo-controlled trial , we r and omly assigned patients who had not previously been treated with a statin to receive , in addition to a beta-blocker , either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery . Lipid , interleukin-6 , and C-reactive protein levels were measured at the time of r and omization and before surgery . The primary end point was the occurrence of myocardial ischemia , defined as transient electrocardiographic abnormalities , release of troponin T , or both , within 30 days after surgery . The secondary end point was the composite of death from cardiovascular causes and myocardial infa rct ion . RESULTS A total of 250 patients were assigned to fluvastatin , and 247 to placebo , a median of 37 days before vascular surgery . Levels of total cholesterol , low-density lipoprotein cholesterol , interleukin-6 , and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group . Postoperative myocardial ischemia occurred in 27 patients ( 10.8 % ) in the fluvastatin group and in 47 ( 19.0 % ) in the placebo group ( hazard ratio , 0.55 ; 95 % confidence interval [ CI ] , 0.34 to 0.88 ; P=0.01 ) . Death from cardiovascular causes or myocardial infa rct ion occurred in 12 patients ( 4.8 % ) in the fluvastatin group and 25 patients ( 10.1 % ) in the placebo group ( hazard ratio , 0.47 ; 95 % CI , 0.24 to 0.94 ; P=0.03 ) . Fluvastatin therapy was not associated with a significant increase in the rate of adverse events . CONCLUSIONS In patients undergoing vascular surgery , perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome . ( Current Controlled Trials number , IS RCT N83738615 .",
"BACKGROUND The relationship between numerous risk factors and perioperative mortality after cardiovascular surgery has been studied extensively . While improved perioperative survival and fewer cardiovascular events have been related to statin therapy , its effect on long-term survival after aneurysm repair remains to be eluci date d. The aim of this study is to determine the effect of statin therapy on long-term survival after open and endovascular aneurysm repair and to identify other cardiovascular and patient-related risk factors in this respect . METHODS A post-hoc analysis of a r and omized trial comparing open and endovascular abdominal aortic aneurysm repair was performed . In this multicenter trial , 351 patients were r and omly assigned to undergo either open abdominal aortic aneurysm repair or endovascular repair . Patients who were on lipid-lowering medication at their inclusion in the trial ( n = 135 ) were compared with those who were not ( n = 216 ) . RESULTS During 6 years of follow-up , 118 ( 33.6 % ) patients died after r and omization . Statin therapy , baseline characteristics , Society for Vascular Surgery/International Society for Cardiovascular Surgery risk factors , aneurysm size , re interventions , antiplatelet or anticoagulant agents , and β-blockers were used to identify prognostic factors influencing survival . After identification of significant factors in a Kaplan-Meier analysis , a multivariable Cox regression analysis was applied . Statin therapy at inclusion in the trial was independently associated with better overall survival after open or endovascular aneurysm repair ( hazard ratio [ HR ] , 0.5 ; 95 % confidence interval [ CI ] , 0.3 - 0.8 ; P = .004 ) . Statins were especially associated with fewer cardiovascular deaths ( HR , 0.4 ; 95 % CI , 0.2 - 0.9 ; P = .025 ) . Several risk factors were associated with poor survival after open and endovascular aneurysm repair : age > 70 ( HR , 3.4 ; 95 % CI , 2.2 - 5.0 ; P of cardiac disease at baseline ( HR , 1.9 ; 95 % CI , 1.3 - 2.8 ; P = .001 ) , and moderate/severe tobacco use ( HR , 1.7 ; 95 % CI , 1.2 - 2.5 ; P = .004 ) . Gender , aneurysm size , the need for reintervention , pulmonary disease , renal disease , carotid disease , hypertension , diabetes mellitus , antiplatelet or anticoagulant agents , and β-blockers were not significantly associated with impaired long-term survival ( P > .05 ) . CONCLUSIONS Despite the limitations of a post-hoc analysis of a prospect ively maintained trial , we conclude that statin therapy at the beginning of the trial is independently associated with improved long-term survival after open or endovascular aneurysm repair , while age above 70 years , a history of cardiovascular disease , and tobacco use are associated with decreased long-term survival"
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Purpose Cerebrospinal fluid shunt infection is associated with patient morbidity and high cost . We conducted a systematic review of the current evidence of comprehensive surgical protocol s or individual interventions design ed to reduce shunt infection incidence . Methods A systematic review using PubMed and SCOPUS identified studies evaluating the effect of a particular intervention on shunt infection risk . Systemic prophylactic antibiotic or antibiotic-impregnated shunt efficacy studies were excluded . A total of 7429 articles were screened and 23 articles were included . Results Eight studies evaluated the effect of comprehensive surgical protocol s. Shunt infection was reduced in all studies ( absolute risk reduction 2.2–12.3 % ) . Level of evidence was low ( level 4 in seven studies ) due to the use of historical controls . Compliance ranged from 24.6 to 74.5 % . Surgical scrub with antiseptic foam and omission of a 5 % chlorhexidine gluconate preoperative hair wash were both associated with increased shunt infection . Twelve studies evaluated the effect of a single intervention . Only antibiotic-impregnated suture , a no-shave policy , and double gloving with glove change prior to shunt h and ling , were associated with a significant reduction in shunt infection . In a hospital with high methicillin-resistant staphylococcus aureus ( MRSA ) prevalence , a r and omized controlled trial found that perioperative vancomycin rather than cefazolin significantly reduced shunt infection rates . Conclusion Despite wide variation in compliance rates , the implementation of comprehensive surgical protocol s reduced shunt infection in all published studies . Antibiotic-impregnated suture , a no-shave policy , double gloving with glove change prior to device manipulation , and 5 % chlorhexidine hair wash were associated with significant reductions in shunt infection
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"OBJECT Implantation of cerebrospinal fluid ( CSF ) shunting devices is associated with a 5 - 15 % risk of infection as cited in contemporary pediatric neurosurgical literature . Shunt infections typically require complete removal of the device and prolonged antibiotic treatment followed by shunt replacement . Moreover , shunt infections are commonly associated with prolonged hospital stays , potential comorbidity , and the increased risk of neurological compromise due to ventriculitis or surgical complications . The authors prospect ively evaluated the incidence of CSF shunt infection following shunt procedures performed using either antimicrobial suture ( AMS ) or conventional suture . METHODS In a single-center , prospect i ve , double-blinded , r and omized controlled trial , the authors enrolled 61 patients , among whom 84 CSF shunt procedures were performed over 21 months . R and omization to the study ( AMS ) or control ( placebo ) group was stratified to minimize the effect of known shunt infection risk factors on the findings . Antibacterial shunt components were not used . The primary outcome measure was the incidence of shunt infection within 6 months of surgery . RESULTS The shunt infection rate in the study group was 2 ( 4.3 % ) of 46 procedures and 8 ( 21 % ) of 38 procedures in the control group ( p = 0.038 ) . There were no statistically significant differences in shunt infection risk factors between the groups ( procedure type and time , age suture-related adverse events were reported in either group . CONCLUSIONS These results support the suggestion that the use of AMS for CSF shunt surgery wound closure is safe , effective , and may be associated with a reduced risk of postoperative shunt infection . A larger r and omized controlled trial is needed to confirm this association",
"BACKGROUND Cerebrospinal fluid ( CSF ) shunts become infected primarily by bacterial organisms indigenous to the patient 's skin flora , but bacteria from the operating room environment , hospital , or no obvious source may also infect a shunt . To decrease the incidence of shunt infection , a no-touch technique protocol was developed and utilized in a prospect i ve manner . METHODS A before-after trial analysis was performed to compare the infection rates between patients who had CSF shunts placed using the no-touch technique protocol versus patients who had surgery without the protocol . Patients were stratified by age , etiology of hydrocephalus , type of shunt surgery , and presence of a contaminated skin wound , namely , tracheostomy , gastrostomy-jejunostomy , colostomy , or halo . The differences in infection rates were analyzed with the Fisher exact test with midpoint value correction , and st and ard statistical methods were used to calculate the 90 % confidence interval odds ratio and number to treat . RESULTS The no-touch technique protocol result ed in a clinical ly significant threefold decrease in shunt infection rate from 9.1 % to 2.9 % ( p = 0.058 at 0.10 level , odds ratio 0.305 , confidence interval 0.084 - 1.11 ) , and a near threefold decrease in the infection rate per patient from 11.3 % to 3.9 % ( p = 0.032 at 0.10 level , odds ratio 0.243 , confidence interval 0.065 - 0.906 ) . CONCLUSIONS The no-touch technique protocol as described herein is a useful method to decrease shunt infection . A larger prospect i ve , r and omized , multicenter clinical trial is encouraged to stringently assess the efficacy of the protocol",
"OBJECT The rate of infection following shunt procedures is unacceptably high . The authors have hypothesized that the key to reducing the shunt infection rate is in reducing bacteria in the operating field and wound . This hypothesis has been tested in a prospect i ve nonr and omized controlled manner . METHODS Data obtained in all patients undergoing shunt insertions or revisions for hydrocephalus performed between October 1 , 2003 , and June 12 , 2009 , were review ed . Starting in August 2006 , we began routinely irrigating the operating field and wound with saline solution from a syringe . Prior to this , we had not used any irrigation techniques , providing an adequate control group ( Group A ) for the effect of the irrigation technique . Prior to November 2007 , we used saline containing amikacin for irrigation ( Group B ) . After that date , we used saline only for irrigation ( Group C ) . RESULTS A total of 150 shunt procedures were performed in 79 girls and 71 boys during the study period . The mean age of all patients was 44.0 + /- 59.1 months . Groups A , B , and C comprised 61 , 40 , and 49 shunt procedures , respectively . There was no statistical difference in age among the 3 groups . Nine infections occurred within 90 days in the postoperative period . The overall infection rate was 6.0 % . Eight infections occurred before introducing the irrigation procedure ( infection rate 13.1 % ) . One infection was noted after introducing irrigation ( Group B [ 0.0 % ] + Group C [ 2.0 % ] ; combined B and C infection rate = 1.1 % ) . There was a statistical difference in the infection rate between Group A and Groups B and C combined ( p = 0.003 ) , Groups A and B ( p = 0.021 ) , and Groups A and C ( p = 0.035 ) . In contrast , no statistical difference was observed between Groups B and C ( p > 0.99 ) . Six of the 9 infections were due to staphylococcal species . CONCLUSIONS An irrigation technique used to reduce bacteria in the operating field and wound is effective for preventing shunt infection . Irrigation alone , and not antibiotics , contributed to the prophylaxis of shunt infection",
"BACKGROUND AND PURPOSE Shunt infection represents a particularly morbid condition , which can also result in mortality . In order to decrease the high morbidity and mortality rates , prevention is an essential step . The purpose of this study was to compare the prophylactic use of ceftriaxone and trimethoprim-sulfamethoxazole ( SXT ) for the prevention of ventriculoperitoneal ( VP ) shunt infection . METHODS In this prospect i ve , single-institution , r and omized clinical trial , 107 children with hydrocephalus and an indication for shunting were r and omly assigned to prophylaxis with ceftriaxone ( n = 50 ) or SXT ( 55 ) , each administered as a single dose during anesthesia and two divided doses postoperatively . Patients were followed up for at least one year . RESULTS The mean age of patients was 15 months , and 85 % were aged 6 months or younger . During the first postoperative year , meningitis occurred in 13.5 % of patients receiving ceftriaxone and 14.5 % of the SXT group , with no statistically significant difference between the groups . Younger age , presence of cerebrospinal fluid leakage and aqueductal stenosis as a cause of hydrocephalus showed significant correlation with meningitis occurrence on univariate analysis . However , only the latter 2 factors were associated with meningitis on multivariate analysis . The risk of shunt infection did not correlate with the gender of the patient , time of VP shunt surgery , or duration of hospitalization for shunting . CONCLUSION Ceftriaxone and SXT showed similar efficacy in preventing shunt infection . Cerebrospinal fluid leakage before or after VP shunt placement and aqueductal stenosis were independent risk factors for meningitis after VP shunt",
"International guidelines suggest that a high prevalence of meticillin-resistant Staphylococcus aureus ( MRSA ) infections should influence the use of vancomycin for surgical prophylaxis . In order to compare the efficacy and adverse effects of vancomycin versus cefazolin as antimicrobial prophylaxis for insertion of cerebrospinal fluid ( CSF ) shunts , a r and omised prospect i ve clinical trial was performed . Over a 16-month period , all consecutive adult patients who underwent CSF shunt insertion at a university hospital with a high prevalence of MRSA infections were included . Patients were r and omly allocated to receive either vancomycin or cefazolin before surgery and followed-up for four weeks for the development of infections . Of the 176 patients included in the study , 88 received vancomycin and 88 cefazolin . Shunt infections were significantly less likely to be observed in patients who were on vancomycin prophylaxis ( 4 % vs 14 % ; P=0.03 ) . All isolated staphylococci were resistant to meticillin . Mortality of patients with post-surgical infections was higher in the cefazolin group ( P=0.02 ) . Our data suggest that use of vancomycin as prophylactic agent for cerebrospinal shunt placement reduces the rate of shunt infections in the context of high prevalence of MRSA",
"OBJECT Quality improvement techniques are being implemented in many areas of medicine . In an effort to reduce the ventriculoperitoneal shunt infection rate , a st and ardized protocol was developed and implemented at 4 centers of the Hydrocephalus Clinical Research Network ( HCRN ) . METHODS The protocol was developed sequentially by HCRN members using the current literature and prior institutional experience until consensus was obtained . The protocol was prospect ively applied at each HCRN center to all children undergoing a shunt insertion or revision procedure . Infections were defined on the basis of CSF , wound , or pseudocyst cultures ; wound breakdown ; abdominal pseudocyst ; or positive blood cultures in the presence of a ventriculoatrial shunt . Procedures and infections were measured before and after protocol implementation . RESULTS Twenty-one surgeons at 4 centers performed 1571 procedures between June 1 , 2007 , and February 28 , 2009 . The minimum follow-up was 6 months . The Network infection rate decreased from 8.8 % prior to the protocol to 5.7 % while using the protocol ( p = 0.0028 , absolute risk reduction 3.15 % , relative risk reduction 36 % ) . Three of 4 centers lowered their infection rate . Shunt surgery after external ventricular drainage ( with or without prior infection ) had the highest infection rate . Overall protocol compliance was 74.5 % and improved over the course of the observation period . Based on logistic regression analysis , the use of BioGlide catheters ( odds ratio [ OR ] 1.91 , 95 % CI 1.19 - 3.05 ; p = 0.007 ) and the use of antiseptic cream by any members of the surgical team ( instead of a formal surgical scrub by all members of the surgical team ; OR 4.53 , 95 % CI 1.43 - 14.41 ; p = 0.01 ) were associated with an increased risk of infection . CONCLUSIONS The st and ardized protocol for shunt surgery significantly reduced shunt infection across the HCRN . Overall protocol compliance was good . The protocol has established a common baseline within the Network , which will facilitate assessment of new treatments . Identification of factors associated with infection will allow further protocol refinement in the future",
"BACKGROUND A double-blind r and omised control study was conducted on all patients who were admitted or referred to the Department of Neurosurgery , Sultanah Aminah Hospital , Johor Bahru , with a diagnosis of hydrocephalus where a ventriculoperitoneal shunt was indicated . METHODS The period of study was from November 2005 to May 2007 , and the follow-up period was 3 months after surgery . R and omisation was carried out in the operating room prior to the procedure . The scrub nurse selected a sealed envelope , which contained the assignment of each patient to 1 of 2 treatment groups : Group 1 patients were treated with topical methicillin , and Group 2 patients were not treated with topical methicillin . Prophylactic antibiotic , cefuroxime ( 25 mg/kg ) was given intravenously at induction . St and ard sterile operative technique was followed in preparing and draping the patients . RESULTS A total of 90 patients were recruited in the study , and 13 ( 14.4 % ) patients developed an infection within 3 months post-operation . Group 1 had a 8.9 % risk of infection , and Group 2 had a 20 % risk ; however , there was no statistically significant post-operative ventriculoperitoneal shunt ( VPS ) infection reduction with the use of topical methicillin in VPS surgery ( P = 0.230 ) . Multivariate analysis showed that only duration of surgery had a significant influence on the incidence of post-operative VPS infection in the non-methicillin group ( P = 0.02 ) . The non-methicillin group had an 8 times greater risk of developing post-operative VPS infection than the methicillin group if surgery lasted longer than 1 hour . CONCLUSION Topical methicillin had no significance in the reduction of post-operative VPS infection",
"OBJECTIVE Infection remains the most significant complication of ventriculoperitoneal shunt surgery and the reported rates of cerebrospinal fluid shunt infection vary widely across studies in patients with hydrocephalus . The objective of this study is to review and evaluate the infections complicating ventriculoperitoneal shunt surgery in patients with hydrocephalus . METHODS Patients who underwent ventriculoperitoneal shunt surgery for hydrocephalus between 1961 and 2010 were included . Medical charts , operative reports , imaging studies , and clinical follow-up evaluations were review ed and analyzed retrospectively . RESULTS A total of 1015 patients with hydrocephalus who underwent ventriculoperitoneal shunt surgery were included . The mean and median follow-up was 9.2 and 6.5 years , respectively . The median age of the patients at the time of ventriculoperitoneal shunt placement was 41.6 years . Pediatric patients ( A total 1224 shunt revisions occurred in 1015 patients . Of the 1224 shunt revisions , 162 were due to infection , which occurred in a total of 107 patients . Single infection episodes occurred in 67 patients ( 6.6 % ) , and multiple infection episodes occurred in 40 patients ( 3.9 % ) . The overall infection rate was 7.2 % per procedure and 10.5 % per patient . The overall infection rate was 9.5 % in pediatric patients and 5.1 % in adult patients per procedure . Gender , age , and etiology of hydrocephalus were significantly associated with shunt infection . Pediatric patients had significantly lower infection-free survival than adults ( 79.9 % vs. 94.4 % , P ventriculoperitoneal shunt surgery . The findings of this retrospective study show that gender , age , and etiology of hydrocephalus significantly correlated independently with the incidence of infection . Prospect i ve studies are needed to assess the observed associations between the risk factors and incidence of infection in hydrocephalus patients treated with ventriculoperitoneal shunt surgery",
"Hydrocephalic patients undergo repetitive surgical procedures , most of which involve the scalp . 141 shaveless operations involving scalp incisions for cerebrospinal fluid ( CSF ) shunts as well as 218 historical controls were review ed after the senior author ceased shaving the scalp . The study population has been followed for a mean of 13.4 months and the control population for a mean of 38.6 months . The actuarial rate of infection at 1 year was 3.3 % in the study population and 6.9 % in the control population . Anesthesia times were not significantly different . Shaving of the scalp is not a critical step in the prevention of CSF shunt infection",
"OBJECT Reported rates of CSF shunt infection vary widely across studies . The study objective was to determine the CSF shunt infection rates after initial shunt placement at multiple US pediatric hospitals . The authors hypothesized that infection rates between hospitals would vary widely even after adjustment for patient , hospital , and surgeon factors . METHODS This retrospective cohort study included children 0 - 18 years of age with uncomplicated initial CSF shunt placement performed between January 1 , 2001 , and December 31 , 2005 , and recorded in the Pediatric Health Information System ( PHIS ) longitudinal administrative data base from 41 children 's hospitals . For each child with 24 months of follow-up , subsequent CSF shunt infections and procedures were determined . RESULTS The PHIS data base included 7071 children with uncomplicated initial CSF shunt placement during this time period . During the 24 months of follow-up , these patients had a total of 825 shunt infections and 4434 subsequent shunt procedures . Overall unadjusted 24-month CSF shunt infection rates were 11.7 % per patient and 7.2 % per procedure . Unadjusted 24-month cumulative incidence rates for each hospital ranged from 4.1 to 20.5 % per patient and 2.5 - 12.3 % per procedure . Factors significantly associated with infection ( p procedures , hospital volume , and surgeon case volume . Malignant lesions and trauma as etiologies were protective . Infection rates for each hospital adjusted for these factors decreased to 8.8 - 12.8 % per patient and 1.4 - 5.3 % per procedure . CONCLUSIONS Infections developed in > 11 % of children who underwent uncomplicated initial CSF shunt placements within 24 months . Patient , hospital , and surgeon factors contributed somewhat to the wide variation in CSF shunt infection rates across hospitals . Additional factors may contribute to variation in CSF shunt infection rates between centers , but further study is needed . Benchmarking and future prospect i ve multicenter studies of CSF shunt infection will need to incorporate these and other patient , hospital , and surgeon factors"
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4116d31e-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND In the process of conducting a systematic review on interventions for skin lesions due to neuritis in leprosy , we assessed several primary papers with respect to the quality of reporting and methods used in the studies . Awareness of what constitutes weak points in previously conducted studies may be used to improve the planning , conducting and reporting of future clinical trials . AIMS To assess the quality of reporting and of methodology in studies of interventions for skin lesions due to neuritis in leprosy . METHODS Items of importance for preventing selection bias , detection bias , attrition bias and performance bias were among items assessed . The items for assessing method ological quality were used as a basis for making the checklist to assess the quality of reporting . RESULTS Out of the 854 references that we inspected eight studies were included on the basis of the inclusion criteria . The interventions tested were dressings , topical agents and footwear and in all studies healing of ulcers was the main outcome measure . Reporting of both , methods and results suffered from underreporting and disorganization . The most under-reported items were concealment of allocation , blinding of patients and outcome assessors , intention to treat and validation of outcomes . CONCLUSION There is an apparent need to improve the method ological quality as well as the quality of reporting of trials in leprosy ulcer treatment . The most important threat in existing studies is the threat of selection bias . For the reporting of future studies , journals could promote and encourage the use of the CONSORT statement checklist by expecting and requiring that authors adhere to it in their reporting
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[
"PURPOSE To assess the reporting quality of r and omized controlled trials ( RCTs ) in the primary treatment of brain tumors and to identify significant predictors of quality . PATIENTS AND METHODS Two investigators search ed MEDLINE , EMBASE , and bibliographies of retrieved articles for RCTs in the primary treatment of brain tumors published between January 1990 and December 2004 . We assessed the quality of overall reporting and key method ologic factors reporting ( allocation concealment , blinding , and intention to treat [ ITT ] ) . Two investigators also rated articles independently using items from the revised Consoli date d St and ards of Reporting Trials statement . A generalized estimated equation was used to generate regression models that identified significant factors associated with quality of reporting . RESULTS We retrieved 74 relevant RCTs that r and omly assigned 14,498 brain tumor patients . The quality of overall reporting has improved during the last 15 years , but eight of the 15 method ologic items were reported in less than 50 % of trials . In the appraisal of the reporting quality of key method ologies , allocation concealment , blinding , and adherence to the ITT principle were reported in less than 30 % of articles . Multivariable regression models revealed that an impact factor more than 1.66 , publication after 1995 , and sample size more than 280 were significant factors associated with better overall reporting , whereas complete industrial funding , impact factors more than 2.64 , and positive primary outcomes were predictors of higher ratings of the three most important method ologic qualities . CONCLUSION Despite improvement in general reporting quality , key method ologies that safeguard against biases may still benefit from better description . Significant factors associated with better reporting may act as surrogates for other characteristics",
"In this investigation the effectiveness was studied of adhesive zinc oxide tape , as additional therapy to the usual application of povidone iodine ( 10 % ) , for leprosy patients with plantar ulcers in Sulawesi Tengah , Indonesia . The effectiveness ( degree of wound healing measured as surface reduction ) of this experimental therapy was compared with that of the usual therapy alone . At the same time the influence of the physical activity level on the effectiveness of both therapies was studied . During six weeks 38 leprosy patients with simple ulcers were treated with either one of the therapies . The average wound healing of the experimental group and the control group was 388 mm2 ( SD 498 ) and 260 mm2 ( SD 260 ) respectively . Using the t-test , there was no statistically significant difference in wound healing between the two therapies ( p = 1.7 ) . The average wound healing of the experimental group with a high and a low activity level was 342 mm2 ( SD 226 ) and 405 mm2 ( SD 571 ) respectively . The average wound healing of the control group with a high and low activity level was 246 mm2 ( SD 289 ) and 275 mm2 ( SD 232 ) respectively . Using analyses of variance , there was no statistically significant influence on the effectiveness of the therapies ( p greater than 0.1 ) . Method ological problems possibly influenced on the results . Different problems which may be encountered during research in third world countries are mentioned",
"OBJECTIVE : To evaluate and compare two strengths of topical phenytoin sodium suspension ( 2 % and 4 % ) with normal saline in the healing of acute trophic ulcers in leprosy patients . METHODS : A prospect i ve , parallel , double‐blind , r and omized study was conducted in 45 leprosy in patients with acute trophic ulcers . Patients were r and omized to receive 2 % , 4 % or normal saline dressing on their ulcers once daily for 4 weeks . Efficacy parameters such as a reduction in the surface area of the ulcer , bacterial culture of the ulcer swab , appearance of healthy granulation tissue , cessation of ulcer discharge and overall gradation of clinical healing and safety were assessed at weekly intervals . RESULTS : The ulcer area reduction was greater in the 2 % and 4 % phenytoin groups compared with the normal saline group ( p Appearance of healthy granulation tissue and cessation of ulcer discharge was also observed earlier in the two phenytoin groups . At the end of 4 weeks , 11 ulcers each had healed completely in both the 2 % and 4 % phenytoin groups compared with none in the control group . There were no statistical differences between the 2 % and 4 % phenytoin groups . No side effects were reported by any patient . CONCLUSION : Topical phenytoin appears to be an effective , safe and cheap therapeutic option for the healing of trophic ulcers in leprosy patients",
"A comparative study was carried out in which 66 leprosy patients with ulcers were r and omly divided in two groups of 33 patients each : Group A ( experimental group ) was treated with ketanserin gel ( 2 % ) and group B with clioquinol cream and /or Lassar paste during a three month period . At the end of the study , when ulcer sizes in the two groups were compared , the group treated with topical ketanserin showed superior results ( p Kolmogorov-Smirnov 's test ) . We conclude that the drug is useful as coadjuavant treatment for healing ulcers in these patients",
"R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task",
"BACKGROUND Trophic ulceration , one of the most common complications of leprosy , is disabling , distressing , and demoralizing for the patient . METHODS The wound healing effects of topical phenytoin powder were compared with those of normal saline in a controlled in-patient study of 100 patients with 110 trophic leprosy ulcers of varying chronicity , over a 4-week study period . Fifty patients were assigned to the topical phenytoin group and 50 to saline therapy group . Ten patients had two ulcers each , and , in these cases , one ulcer was treated with phenytoin and the other with saline . RESULTS Over the 4-week treatment period healthy granulation tissue appeared earlier , and mean percentage of ulcer volume reduction was greater , in the phenytoin group ( 72.1 + /- 19.9 % versus 55.5 + /- 21.6 % ) compared with the control group . CONCLUSIONS This difference was statistically significant at the level of P Phenytoin appears to be a useful agent for the promotion of healing of trophic leprosy ulcers",
"OBJECTIVE This r and omised controlled clinical trial compared a capillary dressing ( Drawtex , now rebr and ed as Vibriant RCD [ Vibriant Technology Services ] ) with routine practice for exuding wounds greater than 2.5 x 2.5 cm . METHOD The target population was 300 control and 300 test subjects across three sites in the UK , but recruitment difficulties result ed in only 125 patients being evaluable . Wound progress was recorded by nurses ' perception of the progress of wound healing and by objective digital imaging . In the final analysis digital images were r and omised ( in time order ) and a panel of nurses who were not otherwise involved in the research project grade d the wound 's progress . RESULTS After deconvolution of the data , the subjective ( nurse perception ) method of evaluation determined that the new dressing result ed in wound improvement in 12.7 % more patients than did routine practice , but the blinded assessment method ( based on the digital images ) showed that routine practice was better by 6.6 % . CONCLUSION Evaluation of wound progress is clearly difficult . Human nature makes us favour novelty if we believe it is going to be better . Making interpretation more objective removed that bias and did not demonstrate a significant advantage for the test dressing . The findings suggest that unblinded assessment by trial nurses is unacceptable on its own . Blinded assessment s may miss finer nuances of wound progression , but are likely to be more accurate . The authors suggest that the true result lies somewhere in the middle , with the trial dressing likely to be as effective as , but not more effective than , a st and ard dressing"
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4116d35a-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES : We conducted a systematic review to determine the effectiveness of psychological interventions including psychodrama , cognitive behavioral therapy , relaxation therapy , guided imagery , or hypnosis in the improvement of dyspepsia symptoms in patients with nonulcer dyspepsia ( NUD ) . DESIGN : Trials were identified through electronic search es of the Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , EMBASE , CINAHL , and PsycLIT , using appropriate subject headings and text words and search ing bibliographies of retrieved articles . All r and omized controlled trials ( RCTs ) or quasi-r and omized studies were eligible . RESULTS : The four eligible trials all used different psychological interventions including applied relaxation therapy , psychodynamic psychotherapy , cognitive therapy , and hypnotherapy . Trials did not present data in a form that could be synthesized . All reported an improvement in the dyspepsia symptom scores at the end of treatment and at 1 yr in the intervention arm compared with controls . All studies only achieved statistically significant results through adjusting for baseline differences between groups . This reflects the small sample sizes of the trials . There were also problems with assumptions made in the statistical analyses used to achieve statistical significance . The studies highlighted problems with recruitment and compliance . CONCLUSIONS : There was insufficient evidence on the efficacy of psychological therapies in NUD . This emphasizes the need for appropriately powered well- design ed trials in this area
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"Abstract Objective : To examine the additional effect of cognitive behavioural therapy for patients with medically unexplained physical symptoms in comparison with optimised medical care . Design : R and omised controlled trial with follow up assessment s six and 12 months after the baseline evaluation . Setting : General medical outpatient clinic in a university hospital . Subjects : An intervention group of 39 patients and a control group of 40 patients . Interventions : The intervention group received between six and 16 sessions of cognitive behavioural therapy . Therapeutic techniques used included identification and modification of dysfunctional automatic thoughts and behavioural experiments aim ed at breaking the vicious cycles of the symptoms and their consequences . The control group received optimised medical care . Main outcome measures : The degree of change , frequency and intensity of the presenting symptoms , psychological distress , functional impairment , hypochondriacal beliefs and attitudes , and ( at 12 months of follow up ) number of visits to the general practitioner . Results : At six months of follow up the intervention group reported a higher recovery rate ( odds ratio 0.40 ; 95 % confidence interval 0.16 to 1.00 ) , a lower mean intensity of the physical symptoms ( difference −1.2 ; −2.0 to −0.3 ) , and less impairment of sleep ( odds ratio 0.38 ; 0.15 to 0.94 ) than the controls . After adjustment for coincidental baseline differences the intervention and control groups also differed with regard to frequency of the symptoms ( 0.32 ; 0.13 to 0.77 ) , limitations in social ( 0.35 ; 0.14 to 0.85 ) and leisure ( 0.36 ; 0.14 to 0.93 ) activities , and illness behaviour ( difference −2.5 ; −4.6 to −0.5 ) . At 12 months of follow up the differences between the groups were largely maintained . Conclusion : Cognitive behavioural therapy seems to be a feasible and effective treatment in general medical patients with unexplained physical symptoms",
" A total of 117 depressed clients , stratified for severity , completed 8 or 16 sessions of manualized treatment , either cognitive-behavioral psychotherapy ( CB ) or psychodynamic-interpersonal psychotherapy ( PI ) . Each of 5 clinician-investigators treated clients in all 4 treatment conditions . On most measures , CB and PI were equally effective , irrespective of the severity of depression or the duration of treatment . However , there was evidence of some advantage to CB on the Beck Depression Inventory ( Beck , Ward , Mendelson , Mock , & Erbaugh , 1961 ) . There was no evidence that CB 's effects were more rapid than those of PI , nor did the effects of each treatment method vary according to the severity of depression . There was no overall advantage to 16-session treatment over 8-session treatment . However , those presenting with relatively severe depression improved substantially more after 16 than after 8 sessions",
"30 patients with severe refractory irritable-bowel syndrome were r and omly allocated to treatment with either hypnotherapy or psychotherapy and placebo . The psychotherapy patients showed a small but significant improvement in abdominal pain , abdominal distension , and general well-being but not in bowel habit . The hypnotherapy patients showed a dramatic improvement in all features , the difference between the two groups being highly significant . In the hypnotherapy group no relapses were recorded during the 3-month follow-up period , and no substitution symptoms were observed",
"Gastrointestinal ( GI ) complaints are among the most common symptoms in primary care yet are frequently unexplained and often lead to costly diagnostic testing . We sought to determine the prevalence of psychiatric disorders in patients with unexplained GI complaints undergoing upper endoscopy , and the likelihood of endoscopic abnormalities in patients with and without psychiatric diagnoses . We prospect ively evaluated 116 adult patients who were undergoing upper endoscopy to evaluate GI complaints . All subjects received a structured psychiatric interview prior to endoscopy using PRIME-MD , and endoscopists were blinded to the PRIME-MD results . Psychiatric disorders were detected in 70 ( 60 % ) patients . Overall , there were 113 diagnoses ( some patients had multiple disorders ) with the most common being somatoform ( 44 % ) , depressive ( 29 % ) , and anxiety ( 19 % ) disorders . Only 29 patients had major endoscopic abnormalities , including esophageal disease ( 14 ) , peptic ulcer ( 9 ) , severe gastritis ( 4 ) , gastric cancer ( 1 ) , and esophageal cancer ( 1 ) . There was a much higher prevalence of psychiatric disorders in patients without major endoscopic abnormalities ( 74 % vs. 21 % , p Psychiatric disease was strongly predictive of endoscopic findings ( OR for major abnormality = 0.11 in women , and 0.40 in men ) , especially if somatoform disorder was present ( OR = 0.15 ) . We conclude that , with a simple question naire , psychiatric disorders can be diagnosed in a large proportion of patients with unexplained GI complaints who are referred for upper endoscopy . The presence of a psychiatric disorder , particularly if somatoform , makes it unlikely that endoscopy will reveal significant GI disease",
"One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy , relaxation , and st and ard medical treatment compared with st and ard medical treatment alone . Patients were only selected if their symptoms had not improved with st and ard medical treatment over the previous 6 months . At 3 months , the treatment group showed significantly greater improvement than the controls on both gastroenterologists ' and patients ' ratings of diarrhea and abdominal pain , but constipation changed little . Good prognostic factors included overt psychiatric symptoms and intermittent pain exacerbated by stress , whereas those with constant abdominal pain were helped little by this treatment . This study has demonstrated that psychological treatment is feasible and effective in two thirds of those patients with irritable bowel syndrome who do not respond to st and ard medical treatment",
"BACKGROUND & AIMS This study aim ed to determine whether brief psychodynamic-interpersonal ( PI ) psychotherapy is more efficacious than a psychological control for patients with chronic , intractable functional dyspepsia ( FD ) , and whether patients with abnormal gastric function respond differently than those with normal gastric function . METHODS Ninety-five consecutive patients with chronic symptoms of FD who had failed to respond to conventional pharmacologic treatments were approached . Thirty-seven received PI psychotherapy , and 36 the control condition ( supportive therapy ) . Patients completed self-report question naires before and after treatment and 12 months later . The patients ' gastroenterologists , who were blind to the study groups , conducted independent ratings before and after treatment . Forty-nine patients also underwent a radioisotope gastric emptying study . An intention-to-treat analysis was used with baseline scores as covariates . RESULTS At the end of treatment , there were significant advantages for PI psychotherapy compared with controls for the gastroenterologists ' ( P = 0.002 ) and patients ' total symptom score ( P = 0.015 ) . One year after treatment , the symptomatic scores were similar . However , a sub analysis showed that PI therapy was superior to the control condition at 1 year , when patients with severe heartburn were excluded . There was no difference in outcome between patients with normal and abnormal gastric emptying . CONCLUSIONS PI therapy may have both short- and long-term effects in patients with dyspepsia , but further evaluation is required . Its cost-effectiveness needs to be determined",
"BACKGROUND & AIMS We have shown hypnotherapy ( HT ) to be effective in irritable bowel syndrome , with long-term improvements in symptomatology and quality of life ( QOL ) . This study aim ed to assess the efficacy of HT in functional dyspepsia ( FD ) . METHODS A total of 126 FD patients were r and omized to HT , supportive therapy plus placebo medication , or medical treatment for 16 weeks . Percentage change in symptomatology from baseline was assessed after the 16-week treatment phase ( short-term ) and after 56 weeks ( long-term ) with 26 HT , 24 supportive therapy , and 29 medical treatment patients completing all phases of the study . QOL was measured as a secondary outcome . RESULTS Short-term symptom scores improved more in the HT group ( median , 59 % ) than in the supportive ( 41 % ; P = 0.01 ) or medical treatment ( 33 % ; P = 0.057 ) groups . HT also benefited QOL ( 42 % ) compared with either supportive therapy ( 10 % [ P HT significantly improved symptoms ( 73 % ) compared with supportive therapy ( 34 % [ P QOL improved significantly more with HT ( 44 % ) than with medical treatment ( 20 % [ P QOL did improve in the supportive therapy ( 43 % ) group , but 5 of these patients commenced taking antidepressants during follow-up . A total of 90 % of the patients in the medical treatment group and 82 % of the patients in the supportive therapy group commenced medication during follow-up , whereas none in the HT group did so ( P visited their general practitioner or gastroenterologist significantly less ( median , 1 ) than did those in the supportive therapy ( median , 4 ) and medical treatment ( median , 4 ) groups during follow-up ( P HT is highly effective in the long-term management of FD . Furthermore , the dramatic reduction in medication use and consultation rate provide major economic advantages",
"Nonulcer dyspepsia ( NUD ) is a common syndrome , but the optimal treatments have yet to be established . This study was performed to determine the most effectivetreatment for NUD . Subjects were recruited through the Department of General InternalMedicine at the Kyushu University Hospital because oftheir somatic symptoms . When no organic lesions werefound , the patients were directed to consult ourdepartment ( Psychosomatic Medicine ) ; 194 consecutive NUD patients were studied . All subjects were assessedpsychiatrically with the Structured Clinical Interviewfor DSM-III-R(SCID ) . Patients with serious NUD were hospitalized , and r and omly divided into control(N = 42 ) and experimental groups ( N = 86 ) . The controlswere treated with physical treatment alone . Theexperimental group received psychiatric treatment inaddition , based on the results of SCID . The experimentalgroup showed a significant improvement compared with thecontrols ( P < 0.0001 ) . The treatment for NUD takinginto consideration both the physical and psychiatric conditions is highly effective",
"Patients with functional dyspepsia were assigned at r and om to cognitive psychotherapy ( 10 sessions of 50 min duration , n = 50 ) or to a control group ( no treatment , n = 50 ) . Before treatment all patients were assessed on psychological , somatic and lifestyle factors . If allocated to the therapy group all patients were also asked to define the main problems they wanted to discuss in therapy ( ' target complaints ' ) . The patients were evaluated at the end of therapy ( after 4 months ) and at 1 yr follow-up . Outcome measures were dyspeptic symptoms , scores on ' target complaints ' and psychological parameters . Both groups showed improvement in dyspeptic and psychological parameters after 1 yr . The improvement in the control group was attributed to a non- specific effect of increased interest and attention . The therapy group showed greater reduction than the control group on dyspeptic symptoms [ days of epigastric pain ( p = 0.050 ) , nausea ( p = 0.024 ) , heartburn ( p = 0.021 ) , diarrhoea ( p = 0.002 ) and constipation ( p = 0.047 ) ] ; and on scores on ' target complaints ' ( p = 0.001 )",
"There is currently no vali date d question naire that assesses both the presence and severity of dyspepsia "
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4116d396-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND In recent years the Enhanced Recovery after Surgery ( ERAS ) postoperative pathway in (ileo-)colorectal surgery , aim ing at improving perioperative care and decreasing postoperative complications , has become more common . OBJECTIVES We investigated the effectiveness and safety of the ERAS multimodal strategy , compared to conventional care after (ileo-)colorectal surgery . The primary research question was whether ERAS protocol s lead to less morbidity and secondary whether length of stay was reduced . SEARCH STRATEGY To answer the research question we entered search strings containing keywords like " fast track " , " colorectal and surgery " and " enhanced recovery " into major data bases . We also h and search ed references in identified review s concerning ERAS . SELECTION CRITERIA We included published r and omised clinical trials , in any language , comparing ERAS to conventional treatment in patients with ( ileo- ) colorectal disease requiring a resection . RCT 's including at least 7 ERAS items in the ERAS group and no more than 2 in the conventional arm were included . DATA COLLECTION AND ANALYSIS Data of included trials were independently extracted by the review ers . Analyses were performed using " REVMAN 5.0.22 " . Data were pooled and rate differences as well as weighted mean differences with their 95 % confidence intervals were calculated using either fixed or r and om effects models , depending on heterogeneity ( I(2 ) ) . MAIN RESULTS 4 RCTs were included and analysed . Method ological quality of included studies was considered low , when scored according to GRADE methodology . Total numbers of inclusion were limited . The trials included in primary analysis reported 237 patients , ( 119 ERAS vs 118 conventional ) . Baseline characteristics were comparable . The primary outcome measure , complications , showed a significant risk reduction for all complications ( RR 0.50 ; 95 % CI 0.35 to 0.72 ) . This difference was not due to reduction in major complications . Length of hospital stay was significantly reduced in the ERAS group ( MD -2.94 days ; 95 % CI -3.69 to -2.19 ) , and readmission rates were equal in both groups . Other outcome parameters were unsuitable for meta- analysis , but seemed to favour ERAS . AUTHORS ' CONCLUSIONS The quantity and especially quality of data are low . Analysis shows a reduction in overall complications , but major complications were not reduced . Length of stay was reduced significantly . We state that ERAS seems safe , but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the st and ard of care . Within ERAS protocol s included , no answer regarding the role for minimally invasive surgery ( i.e. laparoscopy ) was found . Furthermore , protocol compliance within ERAS programs has not been investigated , while this seems a known problem in the field . Therefore , more specific and large RCT 's are needed
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"CONTEXT Laparoscopic-assisted colectomy ( LAC ) has emerged as the preferred minimally invasive surgical strategy for diseases of the colon . The safety and efficacy of LAC for colon cancer are unknown , and the nature and magnitude of any quality -of-life ( QOL ) benefit result ing from LAC for colon cancer is also unknown . OBJECTIVE To compare short-term QOL outcomes after LAC vs open colectomy for colon cancer . DESIGN , SETTING , AND PARTICIPANTS Multicenter , r and omized controlled trial ( Clinical Outcomes of Surgical Therapy [ COST ] ) . Between September 1994 and February 1999 , 37 of 48 centers provided data for the QOL component of the trial for 449 consecutive patients with clinical ly resectable colon cancer . MAIN OUTCOME MEASURES Scores on the Symptoms Distress Scale ( SDS ) , Quality of Life Index , and a single-item global rating scale at 2 days , 2 weeks , and 2 months postoperative ; duration of postoperative in-hospital analgesic use ; and length of stay . RESULTS Of 449 patients , 428 provided QOL data . In an intention-to-treat analysis comparing SDS pain intensity , SDS summary , QOL Index summary , and global rating scale scores at each time point , the only statistically significant difference observed between groups was the global rating scale score for 2 weeks postsurgery . The mean ( median ) global rating scale scores for 2 weeks postsurgery were 76.9 ( 80 ) for LAC vs 74.4 ( 75 ) for open colectomy ( P = .009 ) . While in the hospital , patients assigned to LAC required fewer days of both parenteral analgesics compared with patients assigned to open colectomy ( mean [ median ] , 3.2 [ 3 ] vs 4.0 [ 4 ] days ; P short-term QOL benefits were found with LAC for colon cancer compared with st and ard open colectomy . Until ongoing trials establish that LAC is as effective as open colectomy in preventing recurrence and death from colon cancer , this procedure should not be offered to patients with colon cancer",
"Background The present developments in colon surgery are characterized by two innovations : the introduction of the laparoscopic operation technique and fast recovery programs such as the Enhanced Recovery After Surgery ( ERAS ) recovery program . The Tapas- study was conceived to determine which of the three treatment programs : open conventional surgery , open ' ERAS ' surgery or laparoscopic ' ERAS ' surgery for patients with colon carcinomas is most cost minimizing ? Method / design The Tapas- study is a three-arm multicenter prospect i ve cohort study .All patients with colon carcinoma , eligible for surgical treatment within the study period in four general teaching hospitals and one university hospital will be included . This design produces three cohorts : Conventional open surgery is the control exposure ( cohort 1 ) . Open surgery with ERAS recovery ( cohort 2 ) and laparoscopic surgery with ERAS recovery ( cohort 3 ) are the alternative exposures . Three separate time periods are used in order to prevent attrition bias . Primary outcome parameters are the two main cost factors : direct medical costs ( real cost price calculation ) and the indirect non medical costs ( friction method ) . Secondary outcome parameters are mortality , complications , surgical-oncological resection margins , hospital stay , readmission rates , time back to work/recovery , health status and quality of life . Based on an estimated difference in direct medical costs ( highest cost factor ) of 38 % between open and laparoscopic surgery ( alfa = 0.01 , beta = 0.05 ) , a group size of 3 × 40 = 120 patients is calculated . Discussion The Tapas- study is three-arm multicenter cohort study that will provide a cost evaluation of three treatment programs for patients with colon carcinoma , which may serve as a guideline for choice of treatment and investment strategies in hospitals . Trial registration IS RCT N44649165",
"BACKGROUND Studies have shown the value of using fast-track postoperative recovery . St and ard procedures ( non-fast-track strategies ) remain in common use for perioperative care . Few prospect i ve reports exist on the outcome of fast-tracking in Central Europe . The aim of our study was to assess the effect and safety of our own fast-track protocol with regard to the postoperative period after open bowel resection . PATIENTS AND METHODS One hundred and five patients with ASA score I-II scheduled for open intestinal resection in the period April 2005-December 2007 were r and omly selected for the fast-track group ( FT ) and non-fast-track group ( non-FT ) . A design ed protocol was used in the FT group with the emphasis on an interdisciplinary approach . The control group ( non-FT ) was treated by st and ard established procedures . Postoperative pain , rehabilitation , gastrointestinal functions , postoperative complications , and post-op length of stay were recorded . RESULTS Of 105 patients , 103 were statistically analyzed . Patients in the FT group ( n=51 ) and non-FT group ( n=52 ) did not differ in age , surgical diagnosis , or procedure . The fast-track procedure led to significantly better control of postoperative pain and faster restoration of GI functions ( bowel movement after 1.3 days vs. 3.1 , p Food tolerance was significantly better in the FT group and rehabilitation was also faster . Hospital stay was shorter in the FT group - median seven days ( 95 % CI 7.0 - 7.7 ) versus ten days ( 95 % CI 9.5 - 11.3 ) in non-FT ( p Postoperative complications within 30 postoperative days were also significantly lower in the FT group ( 21.6 vs. 48.1 % , p=0.003 ) . There were no deaths and no patients were readmitted within 30 days . CONCLUSIONS Following the FT protocol helped to reduce frequency of postoperative complications and reduced hospital stay . We conclude that the FT strategy is safe and effective in improving postoperative outcomes",
"The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing a wide range of colorectal procedures",
"BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings",
"Background and aims Evidence demonstrating improved short-term outcomes with laparoscopic surgery compared with open surgery for colorectal cancer is accumulating . In addition , programmes optimising peri-operative care for major abdominal surgery are becoming widespread . Evaluating laparoscopic surgery and enhanced recovery programmes usually focuses on short-term recovery . The aim of this study was to compare recovery after laparoscopic and open surgery for colorectal cancer up to 1 year post-operatively , using a combination of self-report and observer data . Patients / Methods From January 2002 to March 2004 , 62 patients were r and omised ( 2:1 ) to receive laparoscopic ( n = 43 ) or open surgery ( n = 19 ) within an enhanced recovery programme . Functional outcomes up to 1 year were assessed using interview-administered question naires . Results / Findings Question naire and health-related quality of life data were obtained in over 85 % of patients . Patients undergoing laparoscopic surgery felt fully recovered and resumed driving more quickly than those having open surgery ( p = 0.016 and p = 0.048 respectively ) . Fifty-eight percent of patients having open surgery felt fully recovered by 12 months versus 88 % of laparoscopic patients .Interpretation/ Conclusion Within an enhanced recovery programme , patients undergoing laparoscopic surgery recovered more quickly than after open resection . Both approaches however , were associated with slow recovery despite a relatively short hospital stay",
"BACKGROUND Evidence -based guidelines on optimal perioperative fluid management have not been established , and recent r and omized trials in major abdominal surgery suggest that large amounts of fluid may increase morbidity and hospital stay . However , no information is available on detailed functional outcomes or with fast-track surgery . Therefore , we investigated the effects of two regimens of intraoperative fluids with physiological recovery as the primary outcome measure after fast-track colonic surgery . METHODS In a double-blind study , 32 ASA I-III patients undergoing elective colonic surgery were r and omized to ' restrictive ' ( Group 1 ) or ' liberal ' ( Group 2 ) perioperative fluid administration . Fluid algorithms were based on fixed rates of crystalloid infusions and a st and ardized volume of colloid . Pulmonary function ( spirometry ) was the primary outcome measure , with secondary outcomes of exercise capacity ( submaximal exercise test ) , orthostatic tolerance , cardiovascular hormonal responses , postoperative ileus ( transit of radio-opaque markers ) , postoperative nocturnal hypoxaemia , and overall recovery within a well-defined multimodal , fast-track recovery programme . Hospital stay and complications were also noted . RESULTS ' Restrictive ' ( median 1640 ml , range 935 - 2250 ml ) compared with ' liberal ' fluid administration ( median 5050 ml , range 3563 - 8050 ml ) led to significant improvement in pulmonary function and postoperative hypoxaemia . In contrast , we found significantly reduced concentrations of cardiovascularly active hormones ( renin , aldosterone , and angiotensin II ) in Group 2 . The number of patients with complications was not significantly different between the groups [ 1 ( ' liberal ' group ) [ corrected ] vs 6 ( ' restrictive ' group ) [ corrected ] patients , P = 0.08 ] . CONCLUSIONS A ' restrictive ' [ corrected ] fluid regimen led to a transient improvement in pulmonary function and postoperative hypoxaemia but no other differences in all-over physiological recovery compared with a ' liberal ' [ corrected ] fluid regimen after fast-track colonic surgery . Since morbidity tended to be increased with the ' restrictive ' fluid regimen , future studies should focus on the effect of individualized ' goal -directed ' fluid administration strategies rather than fixed fluid amounts on postoperative outcome",
"Background : Laparoscopic colonic surgery has been cl aim ed to hasten recovery and reduce hospital stay compared with open operation . Recently , enforced multimodal rehabilitation ( fast-track surgery ) has improved recovery and reduced hospital stay in both laparoscopic and open colonic surgery . Since no comparative data between laparoscopic and open colonic resection with multimodal rehabilitation are available , the value of laparoscopy per se is unknown . Methods : In a r and omized , observer- and -patient , blinded trial , 60 patients ( median age 75 years ) underwent elective laparoscopic or open colonic resection with fast-track rehabilitation and planned discharge after 48 hours . Functional recovery was assessed in detail during the first postoperative month . Results : Median postoperative hospital stay was 2 days in both groups , with early and similar recovery to normal activities as assessed by hours of mobilization per day , computerized monitoring of motor activity assessed , pulmonary function , cardiovascular response to treadmill exercise , pain , sleep quality , fatigue , and return to normal gastrointestinal function . There were no significant differences in postoperative morbidity , mortality , or readmissions , although 3 patients died in the open versus nil in the laparoscopic group . Conclusion : Functional recovery after colonic resection is rapid with a multimodal rehabilitation regimen and without differences between open and laparoscopic operation . Further large-scale studies are required on potential differences in serious morbidity and mortality",
"OBJECTIVE To evaluate the effect of the fast track programs ( FT ) on the postoperative recovery of patients with rectum carcinoma after rectal cancer resection . METHODS Eighty-three patients , undergone elective rectal carcinoma resection in our hospital , were r and omly divided into two groups . FT group ( 44 cases ) received the perioperative FT programs care , including bowel preparation reduction , preoperative normal intake , early removal of the nasogastric tube and bladder catheter , early postoperative feeding , early mobilization , and no routine drainage . Control group ( 39 cases ) received the conventional program care . The postoperative hospital stay , surgical complications and readmission rate within 30 days postoperatively were compared between the two groups . RESULTS The data of two groups such as gender , surgical procedures , complications , TNM stage of tumor , age , operation time and intra-operative blood loss were similar . The mean postoperative hospital stay in FT group was significantly shorter than that in control group [ ( 4.7+/-2.6 ) d vs ( 8.9+/-2.8 ) d ] ( P surgical complications within 30 days postoperatively in FT group were significantly less than those in control group ( P readmission rate was not significant between the two groups ( P=0.326 ) . CONCLUSION The colorectal surgical fast track programs applied to the perioperative period care of rectal carcinoma resection can decrease the hospital stay and surgical complications with no obvious change in readmission rate , so the postoperative recovery of patients with rectal carcinoma resection can be improved",
"Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful .",
" Multimodal optimization of surgical care has been associated with reduced hospital stay and improved physical function . The aim of this r and omized trial was to compare multimodal optimization with st and ard care in patients undergoing colonic resection",
"Background Laparoscopic colorectal resection improves patient outcome by reducing pain , postoperative pulmonary dysfunction , gastrointestinal paralysis , and fatigue . A multimodal rehabilitation program ( “ fast-track ” ) with epidural analgesia , early oral feeding , and enforced mobilization may further improve the excellent results of laparoscopic colorectal resection , enabling early ambulation of these patients . Methods Fifty two consecutive patients underwent laparoscopic sigmoidectomy with st and ardized regular perioperative treatment ( st and ard ) or multimodal rehabilitation program ( “ fast-track ” ) . Outcome measures included pulmonary function , duration of postoperative ileus , pain perception , fatigue , morbidity , and mortality . Results Twenty nine st and ard-care patients ( 19 men and 10 women ) and 23 fast-track patients ( 15 men and eight women ) were evaluated . Demographic and operative data were similar for the two groups . On the 1st postoperative day , pulmonary function was improved ( p = 0.01 ) in fast-track patients . Oral feeding was achieved earlier ( p defecation occurred earlier ( p Visual analogue scale scores for pain were similar for the two groups ( p > 0.05 ) , but fatigue was increased in the st and ard-care group on the 1st ( p = 0.06 ) and 2nd ( p Morbidity was not different for the two groups . Fast-track patients were discharged on day 4 ( range , 3–6 ) and st and ard-care patients on day 7 ( range , 4–14 ) ( p laparoscopic sigmoidectomy and decrease the postoperative hospital stay",
"Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument",
"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",
"BACKGROUND & AIMS Fast track protocol s have been successfully used in abdominal surgery but there are no r and omized trials on fast track after appendectomy . The aim of this study was to evaluate the safety and feasibility of fast track perioperative care protocol including early feeding with opioid-sparing analgesia after open appendectomy . METHODS We r and omly allocated 62 consecutive patients who underwent appendectomy to an early feeding with opioid-sparing analgesia and traditional care group . The study was not blinded regarding the mode of postoperative rehabilitation . Clinical primary endpoint was length of postoperative hospital stay . Secondary endpoints were morbidity rate , time to bowel sounds and passage of flatus or stools , tolerance of solid diet and facial visual pain score . RESULTS The mean length of primary hospital stay was significantly shorter in the early feeding with opioid-sparing analgesia than in traditional care group ( 2.2 versus 4.0 days , P demographics , degree of pathological changes in the appendix , and in the secondary endpoints such as morbidity , frequency of vomiting , visual facial pain score , time to first flatus or stools , resumption of bowel sounds and toleration of solid diet . CONCLUSIONS This study indicates that early feeding and opioid-sparing analgesia after open appendectomy is safe and reduces length of hospital stay without deterioration of pain control",
"Objective Recent prospect i ve studies have shown that ‘ fast track ’ postoperative care protocol s ( FT ) can reduce hospitalization after major intestinal surgery to 4.5 days , as compared to the 7–10 days with traditional management ( TR ) and 2.5 days after laparoscopic surgery ( LC ) . We used computerized actigraphy ( CA ) to evaluate physical activity using TR , FT and LC approaches",
"Abstract INTRODUCTION : In an era of dwindling hospital re sources and increasing medical costs , safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare re sources . Although several protocol s have been reported to reduce postoperative stay , no Level I evidence exists for their use in routine clinical practice . METHODS : Sixty-four patients undergoing laparotomy and intestinal or rectal resection were r and omly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care . Time to discharge from hospital , complication and readmission rates , pain level , quality of life , and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery . Subgroups were defined to evaluate those who derived the optimal benefit from the protocol . RESULTS : Pathway patients spent less total time in the hospital after surgery ( 5.4 vs. 7.1 days ; P = 0.02 ) and less time in the hospital during the primary admission than traditional patients . Patients younger than 70 years old had greater benefits than the overall study group ( 5 vs. 7.1 days ; P = 0.01 ) . Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway ( P = 0.01 ) . There was no difference between pathway and traditional patients for readmission or complication rates , pain score , quality of life after surgery , or overall satisfaction with the hospital stay . CONCLUSIONS : Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet . Pathway patients have a shorter hospital stay , with no adverse effect on patient satisfaction , pain scores , or complication rates . Patients younger than 70 years of age derive the optimal benefit , and increased surgeon experience improves outcome",
"Objective : A prospect i ve r and omized controlled trial ( RCT ) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer . Aims : This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT . Methods : Patients for elective resection for colorectal cancer were offered trial entry . Participants were stratified by sex and requirement for a total mesorectal excision and central ly r and omized . Multimodal patients received intravenous fluid restriction , unrestricted oral intake with prokinetic agents , early ambulation , and fixed regimen epidural analgesia . Control patients received intravenous fluids to prevent oliguria , restricted oral intake until return of bowel motility , and weaning regimen epidural analgesia . Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets . Discharge decision was made using preagreed criteria . The primary endpoint was postoperative stay , and achievement of independence milestones . Secondary endpoints were postoperative complications , readmission rates , and mortality . Analysis was by intention to treat . Results : Seventy patients were recruited . Approximately one fourth underwent TME . Median ages were similar ( 69.3 vs. 73.0 years ) . The median stay was significantly reduced in the multimodal group ( 5 vs. 7 days ; P control arm were 2.5 times as likely to require a postoperative stay of more than 5 days . Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions . There were 2 deaths , both controls . Conclusions : This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery . Morbidity and mortality are not increased",
"BACKGROUND Multimodal postoperative care regimens accelerate recovery after abdominal surgery . The benefit of thoracic epidural ( TE ) analgesia over patient-controlled analgesia ( PCA ) remains unproven when used with a fast-track postoperative care plan . METHODS Fifty-six patients undergoing major intestinal resection , and on a fast-track postoperative care plan , were r and omized to preemptive TE or PCA . Patients were evaluated at st and ard time points for pain score , quality of life ( Short Form-36 ) , and complications . Oral analgesia was substituted for TE and PCA on the second postoperative day . Discharge criteria were identical for both groups . RESULTS Six patients ( 20.6 % ) had a failed epidural . There was no difference in length of stay ( 5.8 versus 6.2 days , TE versus PCA , P = .55 ) , total length of stay ( including readmissions ) , pain scores , quality of life , complications , or hospital costs at any time point . CONCLUSION TE offers no advantage over PCA for patients undergoing major intestinal resections who are on a fast-track postoperative care plan using PCA",
"BACKGROUND & AIMS A fast-track program is a multimodal approach for patients undergoing colonic surgery that combines stringent regimens of perioperative care ( fluid restriction , optimized analgesia , forced mobilization , and early oral feeding ) to reduce perioperative morbidity , hospital stay , and cost . We investigated the impact of a fast-track protocol on postoperative morbidity in patients after open colonic surgery . METHODS A r and omized trial of patients in 4 teaching hospitals in Switzerl and included 156 patients undergoing elective open colonic surgery who were assigned to either a fast-track program or st and ard care . The primary end point was the 30-day complication rate . Secondary end points were severity of complications , hospital stay , and compliance with the fast-track protocol . RESULTS The fast-track protocol significantly decreased the number of complications ( 16 of 76 in the fast-track group vs 37 of 75 in the st and ard care group ; P = .0014 ) , result ing in shorter hospital stays ( median , 5 days ; range , 2 - 30 vs 9 days , respectively ; range , 6 - 30 ; P severe complications in the fast-track group . A multiple logistic regression analysis revealed fluid administration greater than the restriction limits ( odds ratio , 4.198 ; 95 % confidence interval , 1.7 - 10.366 ; P = .002 ) and a nonfunctioning epidural analgesia ( odds ratio , 3.365 ; 95 % confidence interval , 1.367 - 8.283 ; P = .008 ) as independent predictors of postoperative complications . CONCLUSIONS The fast-track program reduces the rate of postoperative complications and length of hospital stay and should be considered as st and ard care . Fluid restriction and an effective epidural analgesia are the key factors that determine outcome of the fast-track program",
"OBJECTIVE To evaluate enhanced recovery after surgery(ERAS ) protocol in colorectal surgery . METHODS From september 2006 to February 2007 , 74 patients with colorectal cancer were r and omly assigned to ERAS group and control group . The stress index , nutrition and metabolism index , intraoperative index and postoperative index were evaluated . RESULTS Six patients were excluded , 3 in ERAS group ( 2 cases received hepatectomy concomitantly and 1 case received partial ileum resection ) , and 3 in control group ( 1 case received hepatectomy and 1 case received colorectomy concomitantly , another presented asthma paroxysm ) . So there were 34 cases in ERAS group and 34 cases in control , with no statistical differences in sex , age , BMI index and operation types . Deviation of HOMA-IR index of ERAS was lower than the control ( P>0.05 ) , the same as plasma cortisol at the 1st day after operation ( P plasma glucagons in the operation of ERAS group was higher than that of control ( P Plasma glucose 1st day after operation of ERAS group was lower than control ( P plasma triglyceride intraoperation , at 1st day , 2nd day after operation of ERAS was higher than control ( P Nitrogen negative balance of ERAS group was higher than control at 2nd day after surgery , but is lower intraoperation and at 6th day after operation ( P time of exhaust gas and stool , time to eat fluidity and semi-fluidity , out-of-bed time and exercise time per-day , residual time and complication rate in ERAS group were better than those of control ( P Post-operative expenses of ERAS was lower than that of control ( P ERAS can decrease surgical stress , increase functional recovery and reduce complication rate",
"Postoperative organ dysfunction contributes to morbidity , hospital stay and convalescence . Multimodal rehabilitation with epidural analgesia , early oral feeding , mobilization and laxative use after colonic resection has reduced ileus and hospital stay ",
"Background Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs . Both focus on a faster recovery and shorter hospital stay . The r and omized controlled multicenter LAFA-trial ( LAparoscopy and /or FAst track multimodal management versus st and ard care ) was conceived to determine whether laparoscopic surgery , fast track perioperative care or a combination of both is to be preferred over open surgery with st and ard care in patients having segmental colectomy for malignant disease . Methods / design The LAFA-trial is a double blinded , multicenter trial with a 2 × 2 balanced factorial design . Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be r and omized to either open or laparoscopic colectomy , and to either st and ard care or the fast track program . This factorial design produces four treatment groups ; open colectomy with st and ard care ( a ) , open colectomy with fast track program ( b ) , laparoscopic colectomy with st and ard care ( c ) , and laparoscopic surgery with fast track program ( d ) . Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days . Secondary outcome parameters are quality of life two and four weeks after surgery , overall hospital costs , morbidity , patient satisfaction and readmission rate . Based on a mean postoperative hospital stay of 9 + /- 2.5 days a group size of 400 patients ( 100 each arm ) can reliably detect a minimum difference of 1 day between the four arms ( alfa = 0.95 , beta = 0.8 ) . With 100 patients in each arm a difference of 10 % in subscales of the Short Form 36 ( SF-36 ) question naire and social functioning can be detected . Discussion The LAFA-trial is a r and omized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease"
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Background and Purpose : Systematic review s of research evidence describing the quality and methods for administering st and ardized outcome measures are essential to developing recommendations for their clinical application . The purpose of this systematic review was to synthesize the research literature describing test protocol s and measurement properties of time-limited walk tests in people poststroke . Methods : Following an electronic search of 7 bibliographic data -bases , 2 authors independently screened titles and abstract s. One author identified eligible articles , and performed quality appraisal and data extraction . Results : Of 12 180 records identified , 43 articles were included . Among 5 walk tests described , the 6-minute walk test ( 6MWT ) was most frequently evaluated ( n = 36 ) . Only 5 articles included participants in the acute phase ( Within tests , protocol s varied . Walkway length and walking aid , but not turning direction , influenced 6MWT performance . Intraclass correlation coefficients for reliability were 0.68 to 0.71 ( 12MWT ) and 0.80 to 1.00 ( 2- , 3- , 5- and 6MWT ) . Minimal detectable change values at the 90 % confidence level were 11.4 m ( 2MWT ) , 24.4 m ( 5MWT ) , and 27.7 to 52.1 m ( 6MWT ; n = 6 ) . Moderate-to-strong correlations ( ≥0.5 ) between 6MWT distance and balance , motor function , walking speed , mobility , and stair capacity were consistently observed ( n = 33 ) . Moderate-to-strong correlations between 5MWT performance and walking speed/independence ( n = 1 ) , and between 12MWT performance and balance , motor function , and walking speed ( n = 1 ) were reported . Discussion and Conclusions : Strong evidence of the reliability and construct validity of using the 6MWT poststroke exists ; studies in the acute phase are lacking . Because protocol variations influence performance , a st and ardized 6MWT protocol poststroke for use across the care continuum is needed . Video Abstract available for more insights from the authors ( see Supplemental Digital Content 1 , http://links.lww.com/JNPT/A150 )
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"BACKGROUND The protocol used for the 6-min walk test ( 6MWT ) influences its results . The only study to examine the effect of modifying track layout performed a retrospective analysis and concluded that institutions using continuous tracks yield greater distances than those using straight tracks . Agreement between the distances measured on different tracks could not be examined . We evaluated the effect of modifying track layout on walk distance and examined the agreement and repeatability of distances measured on different tracks . METHODS In a prospect i ve , r and omized , cross-over study , 27 COPD subjects ( FEV(1 ) , 38 + /- 14 % [ mean + /- SD ] ; 15 men ) attended three separate test sessions , completing six 6MWTs . To familiarize all subjects with both tracks , the first two sessions comprised two 6MWTs on either a circular or straight track . During the final session , each subject was tested once on the straight and once on the circular track . RESULTS The distance walked on the circular track exceeded the straight track by 13 + /- 17 m ( p limit of agreement between tracks was 33 m. Coefficient of repeatability values when the test was completed on different days for the straight and circular tracks were 51 m and 65 m , respectively . CONCLUSIONS When evaluating changes in 6-min walk distance in groups of patients , track layout should be st and ardized . However , the effect of modifying track layout on an individual 's walking distance is small compared to their daily variability in walk distance . Therefore , st and ardizing track layout for any given individual may be inconsequential when evaluating the change in distances from tests performed on different days",
"Objective . To assess walking capacity and physical activity using clinical measures and to explore their relationships with motor impairment late after stroke . Subjects . A nonr and omised sample of 22 men and 9 women with a mean age of 60 years , 7–10 years after stroke . Methods . Fugl-Meyer Assessment , maximum walking speed , 6 min walk test , perceived exertion , and heart rate were measured , and the Physiological Cost Index was calculated . Physical activity was reported using The Physical Activity Scale for the Elderly . Results . Mean ( SD ) 6 min walking distance was 352 ( ±136 ) m , and Physiological Cost Index was 0.60 ( ±0.41 ) . Self-reported physical activity was 70 % of the reference . Motor impairment correlated with walking capacity but not with the physical activity level . Conclusion . It may be essential to enhance physical activity even late after stroke since in fairly young subjects both walking capacity and the physical activity level were lower than the reference",
"Rating scales are increasingly used in neurologic research and trials . A key question relating to their use across the range of neurologic diseases , both common and rare , is what sample sizes provide meaningful estimates of reliability and validity . Here , we address two questions : ( 1 ) to what extent does sample size influence the stability of reliability and validity estimates ; and ( 2 ) to what extent does sample size influence the inferences made from reliability and validity testing ? We examined data from two studies . In Study 1 , we retrospectively reduced the total sample r and omly and nonr and omly by decrements of approximately 50 % to generate sub- sample s from n = 713–20 . In Study 2 , we prospect ively generated sub- sample s from n = 20–320 , by entry time into study . In all sample s we estimated reliability ( internal consistency , item total correlations , test – retest ) and validity ( within scale correlations , convergent and discriminant construct validity ) . Reliability estimates were stable in magnitude and interpretation in all sub- sample s of both studies . Validity estimates were stable in sample s of n ≥ 80 , for 75 % of scales in sample s of n = 40 , and for 50 % of scales in sample s of n = 20 . In this study , sample sizes of a minimum of 20 for reliability and 80 for validity provided estimates highly representative of the main study sample s. These findings should be considered provisional and more work is needed to determine if these estimates are generalisable , consistent , and useful",
"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",
"OBJECTIVE To compare the effectiveness of circuit class therapy and individual physiotherapy ( PT ) sessions in improving walking ability and functional balance for people recovering from stroke . DESIGN Nonr and omized , single-blind controlled trial . SETTING Medical rehabilitation ward of a rehabilitation hospital . PARTICIPANTS Sixty-eight persons receiving inpatient rehabilitation after a stroke . INTERVENTIONS Subjects received group circuit class therapy or individual treatment sessions as the sole method of PT service delivery for the duration of their inpatient stay . MAIN OUTCOME MEASURES Five-meter walk test ( 5MWT ) , two-minute walk test ( 2MWT ) , and the Berg Balance Scale ( BBS ) measured 4 weeks after admission . Secondary outcome measures included the Iowa Level of Assistance Scale , Motor Assessment Scale upper-limb items , and patient satisfaction . Measures were taken on admission and 4 weeks later . RESULTS Subjects in both groups showed significant improvements between admission and week 4 in all primary outcome measures . There were no significant between group differences in the primary outcome measures at week 4 ( 5MWT mean difference , .07 m/s ; 2MWT mean difference , 1.8 m ; BBS mean difference , 3.9 points ) . A significantly higher proportion of subjects in the circuit class therapy group were able to walk independently at discharge ( P=.01 ) and were satisfied with the amount of therapy received ( P=.007 ) . CONCLUSIONS Circuit class therapy appeared as effective as individual PT sessions for this sample of subjects receiving inpatient rehabilitation poststroke . Favorable results for circuit classes in terms of increased walking independence and patient satisfaction suggest this model of service delivery warrants further investigation",
"Purpose . After stroke , impaired walking ability may affect activity and participation . The aim was to investigate whether self-reported activity and participation were associated with walking endurance late after stroke . Method . A non-r and omised sample of 31 persons with a mean age of 59.7 years and time since stroke of 7–10 years was studied . Walking endurance was measured by the 6-minute walk test ( 6MWT ) . Self-reported activity and participation were measured by the Physical Activity Scale for the Elderly and the Stroke Impact Scale . Relationships were analysed with linear regression . Results . A regression model including activities of daily living and 6MWT explained 44%% , mobility and 6MWT explained 25%% and a model including physical activity level and 6MWT explained 21%% of the variation in activity . Regarding participation , the explanatory level of the model of participation and 6MWT was 30%% . Conclusions . Walking distance several years after stroke was partly associated with self-reported difficulties in activity and participation ",
"Background : St and ardized instruments for measuring patients ' activity limitations and participation restrictions have been advocated for use by rehabilitation professionals for many years . The available literature provides few recent reports of the use of these measures by physical therapists in the United States . Objective : The primary purpose of this study was to determine : ( 1 ) the extent of the use of st and ardized outcome measures and ( 2 ) perceptions regarding their benefits and barriers to their use . A secondary purpose was to examine factors associated with their use among physical therapists in clinical practice . Design : The study used an observational design . Methods : A survey question naire comprising items regarding the use and perceived benefits and barriers of st and ardized outcome measures was sent to 1,000 r and omly selected members of the American Physical Therapy Association ( APTA ) . Results : Forty-eight percent of participants used st and ardized outcome measures . The majority of participants ( > 90 % ) who used such measures believed that they enhanced communication with patients and helped direct the plan of care . The most frequently reported reasons for not using such measures included length of time for patients to complete them , length of time for clinicians to analyze the data , and difficulty for patients in completing them independently . Use of st and ardized outcome measures was related to specialty certification status , practice setting , and the age of the majority of patients treated . Limitations : The limitations included an unvali date d survey for data collection and a sample limited to APTA members . Conclusions : Despite more than a decade of development and testing of st and ardized outcome measures appropriate for various conditions and practice setting s , physical therapists have some distance to go in implementing their use routinely in most clinical setting s. Based on the perceived barriers , alterations in practice management strategies and the instruments themselves may be necessary to increase their use",
"Background and Purpose — Functional walk tests such as the 6- and 12-Minute Walk Test ( ie , 6MWT and 12MWT , respectively ) are submaximal measures used to determine functional capacity in individuals with compromised ability . The purpose of this study was to determine the relationship between these walk tests and measures of exertion ( perceived and myocardial ) , in addition to impairment in individuals with stroke . The relationship among the 6MWT , 12MWT , and the more traditionally assessed measure of self-paced gait speed ( generally assessed over a short distance , eg , 10 m ) was also evaluated . Methods — Twenty-five community-dwelling individuals with stroke were evaluated for the following : 12MWT distance , 6MWT distance , self-paced gait speed over 8 m , plantarflexion strength , Berg Balance Scale , Ashworth Scale of Spasticity , and Chedoke-McMaster Stroke Assessment . Heart rate ( HR ) , rate-pressure product ( RPP ) , and perceived exertion were assessed during the functional walk tests . Correlational analysis quantified the relationship between gait , impairment measures , and physiological responses during the functional walk tests . Results — HR reached a steady state after 6 minutes and reflected a moderate exercise intensity of 63 % of age-predicted maximum HR . The 6MWT , 12MWT , and self-paced gait speed were all highly correlated with one another ( r > 0.90 ) and were all also related to the severity of impairments . The functional walk distances did not relate either to perceived exertion or actual exertion ( increase in the myocardial oxygen dem and as measured by RPP ) . Conclusions — Stroke-specific impairments are the major limitations to the distance walked in individuals with stroke . If the functional walk test is used to assess performance of an individual over time ( eg , in response to an intervention ) , we recommend that both exertion ( eg , increase in RPP or HR ) and distance be measured",
"OBJECTIVES To estimate the level of balance self-efficacy among community-dwelling subjects with stroke and to determine the relative importance of balance self-efficacy compared with functional walking capacity in predicting physical function and perceived health status . DESIGN Secondary analysis of baseline , postintervention , and 6-month follow-up data from a r and omized trial . SETTING General community . PARTICIPANTS Ninety-one subjects with a first or recurrent stroke , discharged from rehabilitation therapy with a residual walking deficit . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The Activities-Specific Balance Confidence ( ABC ) Scale , Medical Outcomes Study 36-Item Short-Form Health Survey physical function scale , and the EQ-5D visual analog scale of perceived health status . RESULTS Average balance self-efficacy was 59 out of 100 points on the ABC scale ( 95 % confidence interval , 55 - 64 ; n=89 ) . After adjusting for age and sex , functional walking capacity explained 32 % and 0 % of the respective variability in physical function and perceived health status scores obtained 6 months later . After adjustment for age , sex , and functional walking capacity , balance self-efficacy explained 3 % and 19 % of variation in 6-month physical function and perceived health status scores , respectively . CONCLUSIONS Subjects living in the community after stroke experience impaired balance self-efficacy . Enhancing balance self-efficacy in addition to functional walking capacity may lead to greater improvement , primarily in perceived health status , but also in physical function , than the enhancement of functional walking capacity alone",
"OBJECTIVE To examine the effects of 3 different walking aids on walking capacity , temporo-spatial gait parameters , and patient satisfaction . DESIGN Observational study . SETTING University Hospital of Geneva . PARTICIPANTS Hemiparetic in patients ( N=25 ) with impaired gait , at an early stage of rehabilitation , unfamiliar with any of the walking aids tested . INTERVENTIONS On 3 consecutive days subjects used , in r and om order , 1 of 3 walking aids : 4-point cane , simple cane with ergonomic h and grip , and Nordic stick . MAIN OUTCOME MEASURES Maximal walking distance in 6 minutes , temporo-spatial gait parameters determined with a commercial electronic gait analysis system , and patients ' preference on a subjective ranking scale . RESULTS Walking distance was greatest with the simple cane with an ergonomic h and grip , followed by the 4-point cane and the Nordic walking stick . Walking velocity was highest with the simple cane , which was also indicated as the preferred walking aid by the patients . There was no significant difference in step length symmetry . CONCLUSIONS The simple cane with the ergonomic h and grip was not only preferred by patients , but was also the most efficient among 3 commonly used walking aids . It appears justified to take patients ' subjective preference into account when prescribing a walking aid",
"OBJECTIVES To determine whether a practice effect occurs across 2 trials of the six-minute walk test ( 6MWT ) among community-dwelling people within 1 year poststroke and to identify characteristics distinguishing people who show a practice effect from those who do not . DESIGN Secondary analysis of scores on 2 trials of the 6MWT administered approximately 30 minutes apart at baseline in a r and omized controlled trial . SETTING General community . PARTICIPANTS People ( N=91 ) living in the community with a residual walking deficit within the first year of a first or recurrent stroke . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURE Distance walked on the 6MWT . RESULTS Mean 6MWT scores + /- SD for trials 1 and 2 were 196+/-119 m and 197+/-126 m , respectively ( n=83 ) . The mean difference in 6MWT performance across trials was 0+/-35 m ( 95 % confidence interval [ CI ] , -7 to 8 m ) . The Pearson correlation coefficient between 6MWT distances was .96 ( P 6MWT in individuals within 1 year poststroke . Thus , a practice walk does not appear necessary . Further research is recommended to evaluate the influence of young age , acute stroke , and mild-to-moderate gait deficit on practice effects",
"Background : Body system impairments following stroke have a complex relationship with functional activities . Although gait and balance deficits are well-documented in people after stroke , the overlapping influence of body impairments makes it difficult to prioritize interventions . Objective : This study examined the relationship between prospect ively selected measures of body function and structure ( body mass index , muscle strength , sensation , and cognition ) and activity ( gait speed , gait endurance , and functional balance ) in people with chronic stroke . Design : This was a cross-sectional , observational study . Methods : Twenty-six individuals with mean ( SD ) age of 57.6 ( 11 ) years and time after stroke of 45.4 ( 43 ) months participated . Four variables ( body mass index , muscle strength difference between the lower extremities , sensation difference between the lower extremities , and Mini-Mental Status Exam score ) were entered into linear regression models for gait speed , Six-Minute Walk Test distance , and Berg Balance Scale score . Results : Lower-extremity strength difference was a significant individual predictor for gait speed , gait endurance , and functional balance . Cognition significantly predicted only gait speed . Limitations : The authors did not include all possible factors in the model that may have influenced gait and balance in these individuals . Conclusions : Strength deficits in the hemiparetic lower extremity should be an important target for clinical interventions to improve function in people with chronic stroke",
"OBJECTIVES To ( 1 ) examine the relationships between multiple poststroke mobility variables ( gait speed , walking capacity , balance , balance self-efficacy , and falls self-efficacy ) and activity and participation ; and ( 2 ) determine which poststroke mobility variables are independently associated with activity and participation . DESIGN This is the primary analysis of a prospect i ve cross-sectional study completed to underst and the impact of mobility on activity and participation in people with chronic stroke . SETTING University-based research laboratory , hospitals , and stroke support groups . PARTICIPANTS People ( N=77 ) with stroke greater than 6 months ago were included in the study if they were referred to occupational or physical therapy for physical deficits as a result of the stroke , completed all stroke related inpatient rehabilitation , had residual functional disability , scored a ≥4 out of 6 on the short , 6-item Mini-Mental State Examination , and were between the ages of 50 and 85 . INTERVENTIONS Not applicable , this is a cross-sectional data collection of 1 timepoint . MAIN OUTCOME MEASURES We measured activity and participation with the vali date d International Classification of Functioning , Disability and Health Measure of Participation and Activities . Other variables included gait speed ( 10-meter walk ) , walking capacity ( 6-minute walk ) , balance ( Berg Balance Scale ) , balance self-efficacy ( Activities Specific Balance Confidence Scale ) , and falls self-efficacy ( Modified Falls Efficacy Scale ) . RESULTS Only balance self-efficacy was found to be independently associated with poststroke activity ( β=-.430 , P ) and participation ( β=-.439 , P people with chronic stroke , balance self-efficacy , not physical aspects of gait , was independently associated with activity and participation . While gait training continues to be important , this study indicates a need to further evaluate and address the psychological factors of balance and falls self-efficacy to obtain the best stroke recovery",
"OBJECTIVE To establish the test-retest reliability and concurrent validity with maximum oxygen consumption ( VO2max ) for 3 submaximal exercise tests in persons with chronic stroke : ( 1 ) submaximal treadmill test , ( 2 ) submaximal cycle ergometer test , and ( 3 ) 6-minute walk test ( 6MWT ) . DESIGN Prospect i ve study using a convenience sample . SETTING Free-st and ing tertiary rehabilitation center . PARTICIPANTS A volunteer sample of 12 community-dwelling individuals who had a stroke with moderate motor deficits . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Heart rate , blood pressure , and oxygen consumption ( VO2 ) were assessed during the exercise tests . RESULTS Test-retest reliability was good to excellent for the exercise tests ( maximal and submaximal tests ) . VO2 for all submaximal measures related to VO2max ( r range , .66-.80 ) . Neither the 6MWT distance , self-selected gait speed , nor hemodynamic measures related to VO2max . CONCLUSION The VO2 measures of the submaximal exercise tests had excellent reliability and good concurrent validity with VO2max . Submaximal exercise tests may be a method by which to monitor the effects of interventions after a screening test ( eg , symptom-limited grade d exercise test , dobutamine stress echocardiograph )",
"BACKGROUND After stroke , the early and persistent decline in aerobic capacity leads to diminish walking capacities . The aim of the study is to investigate the effects of aerobic cycloergometer interval-training on the walking performances in subacute and chronic stroke survivors . METHOD A prospect i ve design was used . Fourteen patients whose stroke had occurred more than 3 months and less than 2 years performed an aerobic training session with a cycloergometer for 8 weeks . A maximal exercise test , a 6-min walking test , a 20-m test and an isokinetic muscle strength test were realized before and after training session . RESULTS There was a significant increase after aerobic training in maximal power ( Pmax ) ( mean 23.2 % , P VO(2peak ) ( mean 14.8 % , P=0.04 ) , and in the knee extension and flexion muscle peak torque on the nonparetic side and extension on the paretic side in isokinetic mode ( mean from 13 to 29 % , P = from 0.019 to P=0.0007 ) and in the walking performances on the 6-min walk test ( mean 15.8 % , P=0.0002 ) . CONCLUSION Patients with subacute and chronic stroke can improve aerobic capacity , muscle strength and walking performances after cycloergometer interval-training . Although these results must be interpreted with caution considering the small size of our sample , they suggest that aerobic training is a safe and potentially effective training after stroke and an alternative to walking treadmill training",
"Objective : To examine the effectiveness of task-oriented progressive resistance strength training on lower extremity strength and functional performance in chronic stroke subjects . Design : Single-blind , r and omized controlled trial . Setting : Medical centre and district hospital . Subjects : Forty-eight subjects at least one year post stroke . Interventions : Participants r and omly allocated to two groups , control ( n-/24 ) and experimental ( n-/24 ) . Subjects in the control group did not receive any rehabilitation training . Subjects in the experimental group were put on a four-week task-oriented progressive resistance strength training . Main measures : Lower extremity muscle strength , gait velocity , cadence , stride length , six-minute walk test , step test , and timed up and go test . Results : Muscle strength significantly improved in the experimental group for strong side muscle groups ( ranged from 23.9 % to 36.5 % ) and paretic side muscle groups ( ranged from 10.1 % to 77.9 % ) . In the control group muscle strength changes ranged from 6.7 % gain to 11.2 % decline . The experimental group showed significant improvement in all selected measures of functional performance except for the step test . In the control group , the number of repetitions of the step test significantly decreased ( -20.3 % ) with no change in other functional tests . There was a significant difference between groups for muscle strength and all functional measures . The strength gain was significantly associated with gain in the functional tests . Conclusions : The task-oriented progressive resistance strength training programme could improve lower extremity muscle strength in individuals with chronic stroke and could carry over into improvement in functional abilities",
"OBJECTIVES To investigate the feasibility of an outdoor 6-minute walk test ( 6MWT ) as a measure of functional status among individuals with chronic obstructive pulmonary disease ( COPD ) , and to examine the relationship between performance on an indoor and an outdoor 6MWT . DESIGN An experimental , repeated- measures crossover design . Subjects were studied on 2 separate days in the same week . Two 6MWTs-one indoors and the other outdoors-were performed on each study day , with a rest in between . The test order was r and omly selected on the first day and reversed on the second day . Outdoor tests were performed on days of moderate weather conditions ( mean temperature + /- st and ard deviation , 21 degrees + /-3 degrees C ; mean wind speed , 15+/-7 km/h ; no precipitation ) and on a flat surface ( sidewalk ) . SETTING Outpatient rehabilitation program in Ontario . PARTICIPANTS Eighteen subjects with COPD ( 10 men , 8 women ; age , 70+/-8y ) , 5 using supplemental oxygen at rest ( forced expiratory volume in 1s , 1.0+/-0.3L ; 42%+/-8 % of predicted ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Distance walked in 6 minutes ( in meters ) , duration of rest ( in seconds ) , and change in rate of perceived dyspnea . RESULTS There was no significant effect of setting ( indoors vs outdoors ) on distance walked ( 394+/-86 m vs 398+/-84 m , P=0.4 ) , duration of rest ( 13+/-28s vs 9+/-20s , P=0.4 ) , or change in rate of perceived dyspnea ( 2.3+/-1.7 vs 2.3+/-2.0 , P=0.8 ) . Testing day had no significant effect on walk test performance ( all P>0.1 ) . CONCLUSIONS The results indicate that the 6MWT performed outdoors within reasonable climatic parameters may be reflective of 6MWT performance indoors"
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Background The aim of this review was to qualitatively synthesis e studies that have investigated characteristics of the first metatarsophalangeal joint ( 1st MTP ) in gout and to undertake a meta- analysis to estimate the average prevalence of acute 1st MTP arthritis across studies in people with gout . Methods Studies published in English were included if they involved participants who had a diagnosis of gout and presented original findings relating to the following outcome measures associated with the 1st MTP : epidemiology ; clinical features ; structural and functional characteristics ; and microscopic and imaging features . Results Forty-five studies were included in the qualitative synthesis . 1st MTP pain was a prominent feature in people with gout . People with 1st MTP gout reported walking- and general-disability . Structural and functional characteristics of 1st MTP gout included hallux valgus , osteoarthritis , and restricted joint motion . Successful crystal aspiration ranged from 81 to 91 % and positive crystal identification via microscopy ranged from 83 to 93 % in patients with a history of 1st MTP gout . Imaging features were common at the 1st MTP including the double contour sign , tophi and erosions . Eleven studies involving 2,325 participants were included in the meta- analysis , providing an estimate of the average prevalence of acute 1st MTP arthritis across studies of 73 % ( 95 % prediction interval 40–92 % ; range 48–97 % ; I2 = 93 % ) . Conclusions 1st MTP acute arthritis is highly prevalent in people with gout and has a substantial impact on patient-reported pain and disability . Gout affects the structure and function of the 1st MTP . Microscopic and imaging studies have demonstrated crystal deposition and joint damage at the 1st MTP in people with gout
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"T HE characteristics of a disease as it appears in the general population are likely to be quite different from its characteristics in a hospital population , since only patients who are severely afflicted or in whom complications have developed are likely to be found in the hospital population . Analysis of a hospital population , therefore , will give an exaggerated idea of the usual severity of the disease and of the frequency with which complications occur . A similar bias may be introduced when patients coming to the hospital with other complaints are used as controls , and an even greater bias introduced when autopsy series are used . This paper presents some observations of a forward-going study of an adult population sample in respect to the characteristics of hyperuricemia and gouty arthritis . The characteristics investigated include ( 1 ) the prevalence of hyperuricemia and its relationship to age ; ( 2 ) the prevalence of secondary hyperuricemia ; ( 3 ) the prevalence of gouty arthritis ; ( 4 ) the incidence of gouty arthritis and its relationship to age ; ( 5 ) the relationship of gouty arthritis to hyperuricemia and the risk of developing gouty arthritis for each uric acid level ; ( 6 ) the clinical features of gouty arthritis in this population ; and ( 7 ) the prevalence of complications related to gouty arthritis and to hyperuricemia . In the Town of Framingham , Massachusetts , a population was selected by r and om sampling for the studp of coronaryartery disease and hJ , pertension . This population has been described in detail elsewhere [ /--31 . A total of 5,127 subjects ( 2,283 men and 2,844 women ) , age thirtythrough fifty-nine , free of evidence of coronary heart disease on initial examination , were included in the sample ( hereinafter referred to as the population ) . The mean age on admission was forty-four . Biennial examination included history , physical examination , electrocardiogram , roentgenograms and various laboratory tests . The results of these examinations , transcripts of admission to the community hospital , and information obtained from physicians and hospitals outside the community formed the record of each subject . At the time of this report the population had been examined an average of seven times for a follow-up period of twelve years . A few subjects have died , moved away or have missed one or two examinations for various reasons . Some have had eight examinations . The current health status of approxiluately 95 per cent of the original 5,127 subjects is known and only 0.7 per cent are considered lost to follow-up [ J ]",
"This study aim ed at determining whether lowering serum urate ( SU ) to less than 6 mg/dl in patients with gout affects ultrasonographic findings . Seven joints in five patients with monosodium urate ( MSU ) crystal proven gout and hyperuricemia were examined over time with serial ultrasonography . Four of the five patients were treated with urate lowering drugs ( ULDs ) ( allopurinol , n = 3 ; probenecid , n = 1 ) . One patient was treated with colchicine alone . Attention was given to changes in a hyperechoic , irregular coating of the hyaline cartilage in the examined joints ( double contour sign or “ urate icing ” ) . This coating was considered to represent precipitate of MSU crystals . Index joints included metacarpophalangeal ( MCP ) joints ( n = 2 ) , knee joints ( n = 3 ) , and first metatarsophalangeal ( MTP ) joints ( n = 2 ) . The interval between baseline and follow-up images ranged from 7 to 18 months . Serial SU levels were obtained during the follow-up period . During the follow-up period , three patients treated with ULD ( allopurinol , n = 2 ; probenecid , n = 1 ) achieved a SU level of SU levels remained above 6 mg/dl ( treated with allopurinol , n = 1 ; treated with colchicine , n = 1 ) . At baseline , the double contour sign was seen in all patients . In those patients who achieved SU levels of Disappearance of the double contour sign was seen in two knee joints , two first MTP joints , and one MCP joint . In contrast , disappearance of the double contour sign was not seen in patients who maintained a SU level ≥7 mg/dl . In one patient treated with allopurinol , SU levels improved from 13 to 7 mg/dl during the follow-up period . Decrease , but not resolution of the hyperechoic coating was seen in this patient . In the patient treated with colchicine alone , SU levels remained > 8 mg/dl , and no sonographic change was observed . In our patients , sonographic signs of deposition of MSU crystals on the surface of hyaline cartilage disappeared completely if sustained normouricemia was achieved . This is the first report showing that characteristic sonographic changes are influenced by ULDs once SU levels remain ≤6 mg/dl for 7 months or more . Sonographic changes of gout correlate with SU levels and may be a non-invasive means to track changes in the uric acid pool . Larger prospect i ve studies are needed to further assess these potentially important findings",
"Introduction Gout is the most prevalent arthritis and significantly impacts on function and quality of life . Given that gout associates with disabling comorbid conditions , it is not clear whether such a complex of diseases accounts for the increased disability or if gout may play a role by itself . This study aims to evaluate the specific influence of gout and disease-related features on functional disability and health-related quality of life ( HRQoL ) in patients with gout followed in rheumatology clinics . Methods A r and om sample of patients was drawn from clinical registries of 30 rheumatology clinics across Italy . Sociodemographic , general health and gout-specific variables were collected . Functional disability and HRQoL were assessed by the health assessment question naire ( HAQ ) and the Physical and Mental Component Summary scores ( PCS and MCS ) of the Short Form-36 ( SF-36 ) . Crude and adjusted ordinal logistic and linear regression models were applied to investigate the specific contribution of different variables on HAQ and SF-36 scores . Results are presented as odds ratio ( OR ) or mean difference ( MD ) and 95 % confidence intervals . Results Out of 446 patients with gout , 90 % were males with a mean age of 63.9 years and median disease duration of 3.8 years ; the majority of patients were overweight or obese , and with several comorbidities ; 21.1 % showed at least moderate disability ; the PCS score was significantly lower than expected age- and gender-matched sample s in the general population , while MCS score was not . After adjusting for potential sociodemographic and general-health confounders , gout-specific variables significantly impacted on HAQ , including polyarticular involvement OR 3.82 ( 1.63 , 8.95 ) , presence of tophi OR 1.92 ( 1.07 , 3.43 ) and recent attacks OR 2.20 ( 1.27 , 3.81 ) . Consistent results were found for PCS . The impairment of PCS compared to the general population was limited to patients with features of chronic gout . MCS was only affected by recent attacks ( MD -2.72 [ -4.58 , -0.86 ] ) and corticosteroid treatment ( -3.39 [ -5.30,-1.48 ] ) . Conclusions The data from the KING study confirm that gout impacts on disability and provide evidence for an independent association of gout and gout-related features with functional outcome and HRQoL. This result supports the need to improve specific treatment in gout",
"Background There is limited evidence on non-pharmacological interventions for gout . The aim of the study was to determine whether a footwear intervention can reduce foot pain and musculoskeletal disability in people with gout . Methods Thirty-six people with gout participated in a prospect i ve intervention study over 8 weeks . Participants selected one of 4 pairs of shoes and thereafter wore the shoes for 8 weeks . The primary outcome was foot pain using a 100 mm visual analogue scale . Secondary outcomes related to function and disability were also analysed . Results The Cardio Zip shoe was selected by 58 % of participants . Compared with baseline , overall scores for all shoes at 8-weeks demonstrated a decrease in foot pain ( p = 0.03 ) , general pain ( p = 0.012 ) , Health Assessment Question naire (HAQ)-II ( p = 0.016 ) and Leeds Foot Impact Scale ( LFIS ) impairment subscale ( p = 0.03 ) . No significant differences were observed in other patient reported outcomes including patient global assessment , LFIS activity subscale , and Lower Limb Task Question naire subscales ( all p > 0.10 ) . We observed significant improvements between baseline measurements using the participants ’ own shoes and the Cardio Zip for foot pain ( p = 0.002 ) , general pain ( p = 0.001 ) , HAQ-II ( p = 0.002 ) and LFIS impairment subscale ( p = 0.004 ) after 8 weeks . The other three shoes did not improve pain or disability . Conclusions Footwear with good cushioning , and motion control may reduce foot pain and disability in people with gout",
"OBJECTIVES To develop a method of scoring bone erosion in the feet of patients with gout using CT as an outcome measure for chronic gout studies , consistent with the components of the OMERACT filter . METHODS Clinical assessment , plain radiographs and CT scans of both feet were obtained from 25 patients with chronic gout . CT scans were scored for bone erosion using a semi-quantitative method based on the Rheumatoid Arthritis MRI Scoring System ( RAMRIS ) . CT bone erosion was assessed at 22 bones in each foot ( total 1100 bones ) by two independent radiologists . A number of different models were assessed to determine the optimal CT scoring system for bone erosion , incorporating the frequency of involvement and inter-reader reliability for individual bones . RESULTS An optimal model was identified with low number of bones required for scoring ( seven bones/foot ) , inclusion of bones over the entire foot , high reliability and ability to capture a high proportion of disease . This model included the following bones in each foot : first metatarsal ( MT ) head , second to fourth MT base , cuboid , middle cuneiform and distal tibia ( range 0 - 140 ) . Scores from this model correlated with plain radiographic damage scores ( r = 0.86 , P disease duration ( r = 0.42 , P bone erosion in gout using conventional CT . Further testing of this method is now required , ideally in prospect i ve studies to allow analysis of the sensitivity to change of the measure",
"Objective The primary objective of this prospect i ve case-control study was to assess the diagnostic value of several intra-articular and periarticular ultrasound (US)-detected abnormalities in the upper and lower limbs in gout . The secondary objective was to test the concurrent validity of US abnormalities using as gold st and ard the microscopic demonstration of monosodium urate ( MSU ) crystals . Methods Ninety-one men with gout and 42 age-matched controls were prospect ively recruited . All patients with gout and controls underwent US assessment of several US abnormalities in 26 joints , six bursae , eight tendons , 20 tendon compartments , four ligaments , and 18 articular cartilages by experts in US blinded to the patients ’ group . Patients with gout and controls with US abnormalities were asked to undergo US-guided aspiration for microscopic identification of MSU crystals . Interobserver and intraobserver reliability of the US assessment was evaluated in a web-based exercise . Results The assessment of one joint ( ie , radiocarpal joint ) for hyperechoic aggregates ( HAGs ) , two tendons ( ie , patellar tendon and triceps tendon ) for HAGs and three articular cartilages ( ie , first metatarsal , talar and second metacarpal/femoral ) for double contour sign showed the best balance between sensitivity and specificity ( 84.6 % and 83.3 % , respectively ) . Intraobserver reliability was good ( mean κ 0.75 ) and interobserver reliability was moderate ( κ 0.52 ) . The aspirated material from HAGs was positive for MSU crystals in 77.6 % of patients with gout and negative in all controls . Conclusions Our results suggest that US bilateral assessment of one joint , three articular cartilages and two tendons may be valid for diagnosing gout with acceptable sensitivity and specificity",
"OBJECTIVES To establish the usefulness of ultrasonography ( US ) for diagnosing gout and to determine whether there are sonographic features that are characteristic for gout but not for other arthropathies . METHODS We retrospectively compared joint images of gout patients with matching images from patients with other rheumatic conditions . Images of 37 joints of 23 patients with monosodium urate ( MSU ) crystal-proven gout were review ed . MSU crystals were identified in at least one joint in each patient . Our control group had 23 r and omly selected patients with 33 examined joints with rheumatic conditions other than gout . RESULTS Specific diagnostic features included a hyperechoic , irregular b and over the superficial margin of the articular cartilage described as a double contour sign in 92 % of gouty joints and in none of the controls ( P hypoechoic to hyperechoic , inhomogeneous material surrounded by a small anechoic rim , representing tophaceous material , was seen in all gouty metatarsophalangeal ( MTP ) joints , in all metacarpophalangeal ( MCP ) joints and in none of the controls ( P erosions adjacent to tophaceous material were seen in 65 % of MTP joints and in 25 % of MCP joints . One erosion was seen in a MTP joint in a control patient with psoriatic arthritis . CONCLUSIONS US can detect deposition of MSU crystals on cartilaginous surfaces ( P < 0.001 ) as well as tophaceous material and typical erosions . US may serve as a non-invasive means to diagnose gout",
"OBJECTIVES This study aims to investigate the relationship between clinical and US findings together with the prevalence and distribution of US findings indicative of monosodium urate ( MSU ) crystal deposition within the foot in patients with gout . METHODS A total of 50 patients with gout attending the in-patient and the out-patient clinics of the Rheumatology Departments were prospect ively enrolled in this multi-centre study . Multiplanar examination of the following 15 joints was performed : talo-navicular , navicular-cuneiform ( medial , intermediate and lateral ) , calcaneo-cuboid , medial , intermediate and lateral cuneiform-metatarsal , cuboid-4th metatarsal , cuboid-5th metatarsal and all five metatarsophalangeal ( MTP ) joints . RESULTS The following US findings were indicative of gout : enhancement of the superficial margin of the hyaline cartilage , intra-articular tophus , and extraarticular tophus . In 46 patients , a total of 1380 foot joints were investigated . In 1309 joints that were not clinical ly involved , US detected signs indicative of joint inflammation in 9 % ( 121/1309 ) . Talo-navicular joint and the first MTP joint were the joints in which the highest number of US findings were found at mid-foot and fore-foot , respectively . At MTP joint level , dorsal scans allowed the detection of a higher number of US findings indicative of joint inflammation , and MSU crystal deposits rather than on the volar plane . CONCLUSIONS This study demonstrated that US detected a higher number of inflamed foot joints than clinical examination , and that the first MTP and the talo-navicular joints were the anatomic sites with the highest prevalence of US signs of MSU crystal aggregates",
"OBJECTIVE We aim ed to determine the ability of ultrasonography ( US ) to show decrease or disappearance of urate deposits in gouty patients requiring urate-lowering therapy ( ULT ) . METHODS To be included in this prospect i ve single-centre study , patients needed toexhibit ( 1 ) proven gout by monosodic urate ( MSU ) crystals in synovial fluid and ( 2 ) US- evidence d urate deposits ( double contour [ DC ] sign and /or tophi ) before starting ULT ( allopurinol [ n=4 ] , febuxostat [ n=12 ] ) . At baseline and after six months of ULT , one trained ultrasonographer assessed the knee and first metatarsophalangeal ( MTP1s ) joints . Serum uric-acid ( SUA ) level was assessed at baseline and at three and six months after ULT initiation . Correlation between US findings and achievement of SUA level objective ( 16 patients ( all males , mean age 61.0±18.3 years ) . The mean disease duration was 7.1±6.2 years . Tophi were found at clinical examination in 56 % of patients . Baseline SUA levels were 688±153μmol/L. At baseline , US revealed tophi or a DC sign among 62.5 to 75 % of patients in knees and 87.5 % in MTP1s . After six months of ULT , none of the four patients , not achieving the SUA level objective , had disappearance of US features . Among the remaining 12 patients , US features ( tophi or DC sign ) disappeared or decreased in all but one with a stable DC sign in one MTP1 . The correlation between the whole US examination and SUA level was excellent ( κ=0.875 ) . CONCLUSIONS US could show disappearance of urate deposits after ULT and appears to be well correlated with efficacy of ULT",
"1 The natural history of acute gouty arthritis was studied in 11 volunteers with podagra . 2 Two patients withdrew from the study on day 4 because of severe persistent pain . Of the remaining patients all showed some improvement in pain by day 5 and in swelling by day 7 . Tenderness improved in seven patients by day 7 but two continued to experience the same amount of discomfort as at trial entry . In spite of these improvements only three patients noted resolution of their pain during the study period . 3 These data indicate that while the majority of patients show spontaneous improvement , resolution is unlikely over a period of 7 days without the use of effective non-steroidal anti-inflammatory medication . 4 Documentation of the natural history of the acute gouty attack may assist clinical investigators in interpreting the results of uncontrolled evaluations of non-steroidal anti-inflammatory drugs",
"Objectives The aim of this work was to examine the relationship between joint damage and monosodium urate ( MSU ) crystal deposition in gout . Methods Plain radiographs and dual-energy CT ( DECT ) scans of the feet were prospect ively obtained from 92 people with tophaceous gout . Subcutaneous tophus count was recorded . The ten metatarsophalangeal joints were scored on plain radiography for Sharp – van der Heijde erosion and joint space narrowing ( JSN ) scores , and presence of spur , osteophyte , periosteal new bone and sclerosis ( 920 total joints ) . DECT scans were analysed for the presence of MSU crystal deposition at the same joints . Results DECT MSU crystal deposition was more frequently observed in joints with erosion ( OR ( 95 % CI ) 8.5 ( 5.5 to 13.1 ) ) , JSN ( 4.2 ( 2.7 to 6.7 % ) ) , spur ( 7.9 ( 4.9 to 12.8 ) ) , osteophyte ( 3.9 ( 2.5 to 6.0 ) ) , periosteal new bone ( 7.0 ( 4.0 to 12.2 ) ) and sclerosis ( 6.9 ( 4.6 to 10.2 ) ) , p crystals with radiographic erosion score ( p MSU crystal deposition correlated with all features of radiographic joint damage ( r>0.88 , p MSU crystal deposition and all radiographic changes except JSN and osteophytes persisted after adjusting for subcutaneous tophus count , serum urate concentration and disease duration . Conclusions MSU crystals are frequently present in joints affected by radiographic damage in gout . These findings support the concept that MSU crystals interact with articular tissues to influence the development of structural joint damage in this disease"
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4116d44a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Exercise programmes are a relatively inexpensive , low-risk option compared with other more invasive therapies for leg pain on walking ( intermittent claudication ( IC ) ) . OBJECTIVES To determine the effects of exercise programmes on IC , particularly in respect of reduction of symptoms on walking and improvement in quality of life . SEARCH STRATEGY The Cochrane Peripheral Vascular Diseases Group search ed their Specialised Register ( last search February 2008 ) and the Cochrane Central Register of Controlled Trials ( CENTRAL ) in The Cochrane Library 2008 , Issue 1 . SELECTION CRITERIA R and omised controlled trials of exercise regimens in people with IC due to peripheral arterial disease . DATA COLLECTION AND ANALYSIS Two authors independently extracted data and assessed trial quality . MAIN RESULTS Twenty-two trials met the inclusion criteria involving a total of 1200 participants with stable leg pain . Follow-up period was from two weeks to two years . There was some variation in the exercise regimens used , all recommended at least two sessions weekly of mostly supervised exercise . All trials used a treadmill walking test for one of the outcome measures . Quality of the included trials was good , though the majority of trials were small with 20 to 49 participants . Fourteen trials compared exercise with usual care or placebo ; patients with various medical conditions or other pre-existing limitations to their exercise capacity were generally excluded . Compared with usual care or placebo , exercise significantly improved maximal walking time : mean difference ( MD ) 5.12 minutes ( 95 % confidence interval ( CI ) 4.51 to 5.72 ; ) with an overall improvement in walking ability of approximately 50 % to 200 % ; exercise did not affect the ankle brachial pressure index ( ABPI ) ( MD -0.01 , 95 % CI -0.05 to 0.04 ) . Walking distances were also significantly improved : pain-free walking distance MD 82.19 metres ( 95 % CI 71.73 to 92.65 ) and maximum walking distance MD 113.20 metres ( 95 % CI 94.96 to 131.43 ) . Improvements were seen for up to two years . The effect of exercise compared with placebo or usual care was inconclusive on mortality , amputation and peak exercise calf blood flow due to limited data . Evidence was generally limited for exercise compared with surgical intervention , angioplasty , antiplatelet therapy , pentoxifylline , iloprost and pneumatic foot and calf compression due to small numbers of trials and participants . Angioplasty may produce greater improvements than exercise in the short term but this effect may not be sustained . AUTHORS ' CONCLUSIONS Exercise programmes were of significant benefit compared with placebo or usual care in improving walking time and distance in selected patients with leg pain from IC
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[
"1 . The activities of phosphofructokinase ( PFK ) , citrate synthetase ( CS ) , lactate dehydrogenase ( LDH ) , 3-hydroxyacyl-CoA dehydrogenase ( ACDH ) and cytochrome-c oxidase(Cyt-ox ) in the calf muscle tissue were compared in subjects with intermittent claudication ( n = 38 ) and controls ( n = 20 ) . The activities of CS , ACDH and Cyt-ox were increased and the activity of Cytox was positively correlated to the maximal walking distance ( MWD ) in the patients . 2 . Thirty-three patients with intermittent claudication were r and omized to three treatment groups : ( 1 ) operative surgery , ( 2 ) operative surgery supplemented with physical training and ( 3 ) physical training alone . Before and after 6 - 12 months of treatment , symptom-free walking distance ( SFWD ) , MWD , ankle-brachial blood pressure quotient ( ankle index ) , maximal plethysmographic calf blood flow ( MPBF ) and the activities of PFK , CS , LDH , ACDH and Cyt-ox were measured . 3 . SFWD and MWD increased in all three groups . Ankle index and MPBF increased in groups 1 and 2 , but were unchanged in group 3 . The activities of Cyt-ox and CS decreased with operation , but the activity of Cyt-ox was further augmented with training in group 3 . Overall , the change in ankle index explained 80 - 90 % of the variability in walking performance . In a separate analysis , the increased activity of Cyt-ox in group 3 was positively correlated to , and explained 31 % of the variability in , the improvement in SFWD . 4 . These findings indicate that both physical activity and a reduced calf blood flow are necessary conditions for the enzymatic adaptation to take place . A causal relationship between metabolic adaptation in the muscle tissue and walking performance is suggested . ( ABSTRACT TRUNCATED AT 250 WORDS",
"PURPOSE There is a need to evaluate patients with peripheral arterial disease ( PAD ) with a limited or extended walking distance . We aim ed to enable an estimation of walking distance as measured on a frequently used \" st and ard \" grade d ( 3.2 km·h(-1 ) , 2 % increase per 2 min ) protocol for walking distances measured on protocol s with a lower or higher workload . METHODS Patients with PAD and an absolute claudication distance ( ACD ) of \" st and ard \" protocol were included . Four grade d study treadmill protocol s , two with lower and two with higher workload than the \" st and ard \" protocol , were developed . Two study protocol s ( low or high ) and the \" st and ard \" protocol were repeated in r and om order . Quality was determined with the intraclass correlation coefficient and the coefficient of variation . Orthogonal regression analysis was used to predict walking distances on the st and ard protocol on the basis of the study protocol s. RESULTS Forty-three patients with an ACD Because feasibility from the protocol s with 2.0 km·h(-1 ) and 2 % increase every 2 min and 4.4 km·h(-1 ) and 2 % increase every minute was highest , they were calibrated against the \" st and ard \" protocol , and reliability was comparable with the \" st and ard \" protocol . The coefficient of variation between the prediction of walking distance on the \" st and ard \" protocol on the basis of the new protocol s and the measured distances were in the same range ( 22%-25 % ) as the variation measured performing the same treadmill test twice . CONCLUSIONS An accurate estimate of walking distance as measured on a \" st and ard \" treadmill protocol can be derived from a protocol with a lower or higher workload",
"BACKGROUND The optimal first-line treatment for intermittent claudication is currently unclear . OBJECTIVE To compare the cost-effectiveness of endovascular revascularization vs supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period . DESIGN R and omized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient . SETTING A large community hospital . PARTICIPANTS Patients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion ( 293 ) who fulfilled the inclusion criteria ( 151 ) were recruited . Excluded were , for example , patients with lesions unsuitable for revascularization ( iliac or femoropopliteal TASC-type D and some TASC type-B/C. INTERVENTION Participants were r and omly assigned to endovascular revascularization ( 76 patients ) or supervised hospital-based exercise ( 75 patients ) . MEASUREMENTS Mean improvement of health-related quality -of-life and functional capacity over a 12-month period , cumulative 12-month costs , and incremental costs per quality -adjusted life year ( QALY ) were assessed from the societal perspective . RESULTS In the endovascular revascularization group , 73 % ( 55 patients ) had iliac disease vs 27 % ( 20 patients ) femoral disease . Stents were used in 46/71 iliac lesions ( 34 patients ) and in 20/40 femoral lesions ( 16 patients ) . In the supervised hospital-based exercise group , 68 % ( 51 patients ) had iliac disease vs 32 % ( 24 patients ) with femoral disease . There was a non-significant difference in the adjusted 6- and 12-month EuroQol , rating scale , and SF36-physical functioning values between the treatment groups . The gain in total mean QALYs accumulated during 12 months , adjusted for baseline values , was not statistically different between the groups ( mean difference revascularization versus exercise 0.01 ; 99 % CI -0.05 , 0.07 ; P = .73 ) . The total mean cumulative costs per patient was significantly higher in the revascularization group ( mean difference euro2318 ; 99 % CI 2130 euros , 2506 euros ; P incremental cost per QALY was 231 800 euro/QALY adjusted for the baseline variables . One-way sensitivity analysis demonstrated improved effectiveness after revascularization ( mean difference 0.03 ; CI 0.02 , 0.05 ; P incremental costs 75 208 euro/QALY . CONCLUSION In conclusion , there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up , any gains with endovascular revascularization found were non-significant , and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value , which favors exercise",
"OBJECTIVE To analyze the effects of strength training ( ST ) in walking capacity in patients with intermittent claudication ( IC ) compared with walking training ( WT ) effects . METHODS Thirty patients with IC were r and omized into ST and WT . Both groups trained twice a week for 12 weeks at the same rate of perceived exertion . ST consisted of three sets of 10 repetitions of whole body exercises . WT consisted of 15 bouts of 2-minute walking . Before and after the training program walking capacity , peak VO(2 ) , VO(2 ) at the first stage of treadmill test , ankle brachial index , ischemic window , and knee extension strength were measured . RESULTS ST improved initial claudication distance ( 358 + /- 224 vs 504 + /- 276 meters ; P total walking distance ( 618 + /- 282 to 775 + /- 334 meters ; P VO(2 ) at the first stage of treadmill test ( 9.7 + /- 2.6 vs 8.1 + /- 1.7 mL.kg(-1).minute ; P ischemic window ( 0.81 + /- 1.16 vs 0.43 + /- 0.47 mm Hg minute meters(-1 ) ; P = .04 ) , and knee extension strength ( 19 + /- 9 vs 21 + /- 8 kg and 21 + /- 9 vs 23 + /- 9 ; P Strength increases correlated with the increase in initial claudication distance ( r = 0.64 ; P = .01 ) and with the decrease in VO(2 ) measured at the first stage of the treadmill test ( r = -0.52 ; P = .04 and r = -0.55 ; P = .03 ) . Adaptations following ST were similar to the ones observed after WT ; however , patients reported lower pain during ST than WT ( P ST improves functional limitation similarly to WT but it produces lower pain , suggesting that this type of exercise could be useful and should be considered in patients with IC",
"PURPOSE To compare treadmill and shuttle walk tests for assessing functional capacity in patients with intermittent claudication , with respect to test-retest reliability , cardiovascular responses , and patient preferences . METHODS Patients with stable intermittent claudication ( N = 55 , ages 52 - 85 yr , median age 68 yr ) were recruited from the Sheffield Vascular Institute at the Northern General Hospital , Sheffield , UK . Each patient performed an incremental shuttle walk test , a constant-pace shuttle walk test , and a st and ardized treadmill test ( 3.2 km x h(-1 ) , 12 % gradient ) , each on three occasions . The incremental shuttle walk began at 3 km x h(-1 ) and increased by 0.5 km x h(-1 ) every minute , whereas the constant-pace shuttle walk was performed at the fixed pace of 4 km x h(-1 ) . Claudication distance ( CD ) , maximum walking distance ( MWD ) , heart rate ( HR ) , and blood pressure were assessed in each testing session . The patients also completed a test preference question naire . RESULTS CD and MWD for both shuttle walks were greater than the corresponding walking distances achieved in the treadmill test ( P Average coefficients of variation for repeated incremental shuttle walk , constant-pace shuttle walk , and treadmill tests were 15.9 % , 21.1 % , and 18.7 % , respectively , for MWD , corresponding to average intraclass correlation coefficients of 0.87 , 0.82 , and 0.87 . Treadmill walking evoked greater increases in HR and blood pressure ( P preference for it ( 24 vs 43 % for shuttle walking ) . CONCLUSION These findings indicated that shuttle walk testing exhibits similar test-retest reliability as treadmill testing , but that it evoked a lower level of cardiovascular stress and is preferred to treadmill testing by a large proportion of patients",
"Objective : To compare the outcomes of home-based ( using the Heart Manual ) and centre-based cardiac rehabilitation programmes . Design : R and omised controlled trial and parallel economic evaluation . Setting : Predominantly inner-city , multi-ethnic population in the West Midl and s , Engl and . Patients : 525 patients referred to four hospitals for cardiac rehabilitation following myocardial infa rct ion or coronary revascularisation . Interventions : A home-based cardiac rehabilitation programme compared with centre-based programmes . Main outcome measures : Smoking cessation , blood pressure ( systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) ) , total cholesterol ( TC ) and high-density lipoprotein (HDL)-cholesterol , psychological status ( HADS anxiety and depression ) and exercise capacity ( incremental shuttle walking test , ISWT ) measured at 12 months . Health service re source use , quality of life utility and costs were quantified . Results : There were no significant differences in the main outcomes when the home-based was compared with the centre-based programme at 12 months . Adjusted mean difference ( 95 % CI ) for SBP was 1.94 mm Hg ( −1.1 to 5.0 ) ; DBP 0.42 mm Hg ( −1.25 to 2.1 ) ; TC 0.1 mmol/l ( −0.05 to 0.24 ) ; HADS anxiety −0.02 ( −0.69 to 0.65 ) ; HADS depression −0.35 ( −0.95 to 0.25 ) ; distance on ISWT −21.5 m ( −48.3 to 5.2 ) . The relative risk of being a smoker in the home arm was 0.90 . The cost per patient to the NHS was significantly higher in the home arm at £ 198 , ( 95 % CI 189 to 208 ) compared to £ 157 ( 95 % CI 139 to 175 ) in the centre-based arm . However when the patients ’ cost of travel was included , these differences were no longer significant . Conclusions A home-based cardiac rehabilitation programme does not produce inferior outcomes when compared to traditional centre-based programmes as provided in the United Kingdom"
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4116d486-06ff-11f0-808a-c43d1ab1c353
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Recent years have witnessed a substantial increase in the number of seric determinations of vitamin D , in a worldwide basis . At Hospital das Clínicas of Faculdade de Medicina of Universidade de São Paulo that increase reached 700 % over the last four years . Nevertheless there are many controversies on the literature about the role of vitamin D in conditions unrelated to the musculoskeletal system . In this study the metabolism , sources and actions of vitamin D on the body are review ed . Observational studies , clinical trials , systematic review s and met analysis which focused on the relationship between the vitamin and conditions such as cancer , cardiovascular disease , diabetes and falls were search ed on the literature , analyzed and discussed . Results are presented as quiz and answer , tables and a figure . The role of vitamin D on the above-mentioned conditions is discussed , and the controversial issues stressed
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"An unexplained loss of muscle strength occurs with aging . Vitamin D deficiency can cause myopathy and administration of 1,25-dihydroxyvitamin D3 [ 1,25-(OH2)D3 ] to persons with low serum concentrations can improve strength . To test the hypothesis that the weakness associated with aging is in part due to inadequate serum concentrations of [ 1,25-(OH2)D3 ] , we conducted a r and omized , controlled , double blinded trial in 98 men and women volunteers over 69 yr old . Treatment consisted of 0.25 micrograms 1,25-(OH)2D3 , orally , twice per day or identical placebo for 6 months . Leg muscle strength of the quadriceps was measured with an isokinetic dynamometer . There was no difference between the two groups at 1 week , 1 month , or 6 months of treatment in any of the measures of muscle strength . We conclude that oral administration of 0.5 micrograms 1,25-(OH)2D3/day does not improve muscle strength in older persons . Further research is needed to determine the etiology of the decline in muscle strength associated with aging",
"Vitamin D ( VitD ) supplementation has been advocated for cardiovascular risk reduction ; however , supporting data are sparse . The objective of this study was to determine whether VitD supplementation reduces cardiovascular risk . Subjects in this prospect i ve , r and omized , double-blind , placebo-controlled trial of post-menopausal women with serum 25-hydroxyvitamin D concentrations > 10 and to Vitamin D3 2500 IU or placebo , daily for 4 months . Primary endpoints were changes in brachial artery flow-mediated vasodilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and aortic augmentation index ( AIx ) . The 114 subjects were mean ( st and ard deviation ) 63.9 ( 3.0 ) years old with a 25-hydroxyvitamin D level of 31.3 ( 10.6 ) ng/mL. Low VitD ( higher body-mass index , systolic blood pressure , glucose , CRP , and lower FMD ( all p 4 months , 25-hydroxyvitamin D levels increased by 15.7 ( 9.3 ) ng/mL on vitamin D3 vs. −0.2 ( 6.1 ) ng/mL on placebo ( p in changes in FMD ( 0.3 [ 3.4 ] vs. 0.3 [ 2.6 ] % , p = 0.77 ) , PWV ( 0.00 [ 1.06 ] vs. 0.05 [ 0.92 ] m/s , p = 0.65 ) , AIx ( 2.7 [ 6.3 ] vs. 0.9 [ 5.6 ] % , p = 0.10 ) , or CRP ( 0.3 [ 1.9 ] vs. 0.3 [ 4.2 ] mg/L , p = 0.97 ) . Multivariable models showed no significant interactions between treatment group and low VitD status ( for changes in FMD ( p = 0.65 ) , PWV ( p = 0.93 ) , AIx ( p = 0.97 ) , or CRP ( p = 0.26).In conclusion , VitD supplementation did not improve endothelial function , arterial stiffness , or inflammation . These observations do not support use of VitD supplementation to reduce cardiovascular disease risk . Trial Registration Clinical Trials.gov NCT00690417 Trial Registration Clinical Trials.gov",
" The Cohort Consortium Vitamin D Pooling Project of Rarer Cancers ( VDPP ) brought together 10 cohorts to conduct a prospect i ve study of the association between vitamin D status , measured as serum concentrations of 25-hydroxyvitamin D ( 25(OH)D ) , and the development of 7 rarer cancer sites : endometrial , esophageal , gastric , kidney , non-Hodgkin lymphoma , ovarian , and pancreatic cancers . The cohorts come from 3 continents , with participants from a wide range of latitude who are racially diverse . Across each cancer site , there was no evidence of a protective association between higher concentrations of 25-hydroxyvitamin D ( > 75 nmol/L ) and cancer outcome . An increased risk at very high levels ( ≥100 nmol/L ) was noted for pancreatic cancer , confirming previous reports . The articles included in this issue detail the overall design and governance of the project , correlates of vitamin D status , and results from the cancer site-specific investigations . The Vitamin D Pooling Project realizes a major goal of consortium efforts , namely , to rigorously test hypotheses for rarer cancer outcomes that may not be adequately addressed in any one prospect i ve cohort study . The results of this study have application for the planning and conduct of intervention trials , especially in determining potential risks",
"Objective Low serum 25(OH)D levels are associated with cardiovascular risk factors , and also predict future myocardial infa rct ion ( MI ) , type 2 diabetes ( T2DM ) , cancer and all-cause mortality . Recently several single nucleotide polymorphisms ( SNPs ) associated with serum 25-hydroxyvitamin D ( 25(OH)D ) level have been identified . If these relations are causal one would expect a similar association between these SNPs and health . Methods DNA was prepared from subjects who participated in the fourth survey of the Tromsø Study in 1994–1995 and who were registered with the endpoints MI , T2DM , cancer or death as well as a r and omly selected control group . The endpoint registers were complete up to 2007–2010 . Genotyping was performed for 17 SNPs related to the serum 25(OH)D level . Results A total of 9528 subjects were selected for genetic analyses which were successfully performed for at least one SNP in 9471 subjects . Among these , 2025 were registered with MI , 1092 with T2DM , 2924 with cancer and 3828 had died . The mean differences in serum 25(OH)D levels between SNP genotypes with the lowest and highest serum 25(OH)D levels varied from 0.1 to 7.8 nmol/L. A genotype score based on weighted risk alleles regarding low serum 25(OH)D levels was established . There was no consistent association between the genotype score or individuals SNPs and MI , T2DM , cancer , mortality or risk factors for disease . However , for rs6013897 genotypes ( located at the 24-hydroxylase gene ( CYP24A1 ) ) there was a significant association with breast cancer ( P between serum 25(OH)D levels and MI , T2DM , cancer or mortality , and our observation on breast cancer needs confirmation . Further genetic studies are warranted , particularly in population s with vitamin D deficiency . Trial Registration Clinical Trials.gov",
"CONTEXT Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures ; however , adherence to daily supplementation is typically poor . OBJECTIVE To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture . DESIGN , SETTING , AND PARTICIPANTS A double-blind , placebo-controlled trial of 2256 community-dwelling women , aged 70 years or older , considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were r and omly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years . The study concluded in 2008 . INTERVENTION 500,000 IU of cholecalciferol or placebo . MAIN OUTCOME MEASURES Falls and fractures were ascertained using monthly calendars ; details were confirmed by telephone interview . Fractures were radiologically confirmed . In a sub study , 137 r and omly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels . RESULTS Women in the cholecalciferol ( vitamin D ) group had 171 fractures vs 135 in the placebo group ; 837 women in the vitamin D group fell 2892 times ( rate , 83.4 per 100 person-years ) while 769 women in the placebo group fell 2512 times ( rate , 72.7 per 100 person-years ; incidence rate ratio [ RR ] , 1.15 ; 95 % confidence interval [ CI ] , 1.02 - 1.30 ; P = .03 ) . The incidence RR for fracture in the vitamin D group was 1.26 ( 95 % CI , 1.00 - 1.59 ; P = .047 ) vs the placebo group ( rates per 100 person-years , 4.9 vitamin D vs 3.9 placebo ) . A temporal pattern was observed in a post hoc analysis of falls . The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months ( test for homogeneity ; P = .02 ) . In the sub study , the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3 % of the sub study participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group , 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L , were approximately 90 nmol/L at 3 months , and remained higher than the placebo group 12 months after dosing . CONCLUSION Among older community-dwelling women , annual oral administration of high-dose cholecalciferol result ed in an increased risk of falls and fractures . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000658617 ; is rct n.org Identifier : IS RCT N83409867",
"BACKGROUND vitamin D supplementation reduces the incidence of fractures in older adults . This may be partly mediated by effects of vitamin D on neuromuscular function . OBJECTIVE to determine the effects of vitamin D supplementation on aspects of neuromuscular function known to be risk factors for falls and fractures . DESIGN r and omised , double-blind , placebo-controlled study . SETTING falls clinic taking referrals from general practitioners and accident and emergency department . SUBJECTS 139 ambulatory subjects ( > /=65 years ) with a history of falls and 25-hydroxyvitamin D ( 25OHD ) INTERVENTION patients were r and omised to receive a single intramuscular injection of 600,000 i.u . ergocalciferol or placebo . OUTCOME MEASURES assessment s including biochemistry , postural sway , choice reaction time ( CRT ) , aggregate functional performance time ( AFPT ) , and quadriceps strength were carried out at baseline and 6 months post-intervention . RESULTS baseline characteristics were comparable between both groups . 25OHD in the treatment group increased significantly at 6 months . AFPT deteriorated in the control group and improved in the intervention group , representing a significant difference between groups ( + 6.6 s versus -2.0 s , t = 2.80 , P CRT ( -0.06 s versus + 0.41 s , t = -2.52 , P postural sway ( + 0.0025 versus -0.0138 , t = 2.35 , P muscle strength change between groups ( -10 N versus -2 N , t = -1.26 , ns ) . A significant correlation between change in AFPT and change in 25OHD levels was observed ( r = 0.19 , P = 0.03 ) . There was no significant difference in the number of falls ( 0.39 versus 0.24 , t = 1.08 , P = 0.28 ) or fallers ( 14 versus 11 , P = 0.52 ) between two groups . CONCLUSIONS vitamin D supplementation , in fallers with vitamin D insufficiency , has a significant beneficial effect on functional performance , reaction time and balance , but not muscle strength . This suggests that vitamin D supplementation improves neuromuscular or neuroprotective function , which may in part explain the mechanism whereby vitamin D reduces falls and fractures",
"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 . )",
"A r and omized double-blind controlled trial of the effect of vitamin D supplementation on the abilities of elderly hospital patients to carry out basic activities of daily life is described . Those patients included in the trial had plasma 25-hydroxyvitamin D concentrations which were low or low normal as judged by the normal range in young adults . After 2 to 9 months on the trial there was no significant difference in the performance of the control and treatment groups",
"BACKGROUND Vitamin D testing is increasing worldwide . Recently several diagnostic manufacturers including Abbott and Siemens have launched automated 25-hydroxy vitamin D ( 25OH-D ) immunoassays . Furthermore , preexisting assays from DiaSorin and Roche have recently been modified . We compared the performance of 5 automated immunoassays , an RIA and 2 liquid chromatography-t and em mass spectrometry ( LC-MS/MS ) methods . METHODS Aliquots of 170 r and omly selected patient sample s were prepared and 25OH-D was measured by 2 LC-MS/MS methods , an RIA ( DiaSorin ) , and automated immunoassays from Abbott ( Architect ) , DiaSorin ( LIAISON ) , IDS ( ISYS ) , Roche ( E170 , monoclonal 25OH-D(3 ) assay ) , and Siemens ( Centaur ) . Within-run and between-run imprecision were evaluated by measurement of 5 replicates of 2 serum pools on 5 consecutive days . RESULTS The LC-MS/MS methods agreed , with a concordance correlation coefficient ( CCC ) of 0.99 and bias of 0.56 μg/L ( 1.4 nmol/L ) . The RIA assay showed a performance comparable to LC-MS/MS , with a CCC of 0.97 and a mean bias of 1.1 μg/L ( 2.7 nmo/L ) . All immunoassays measured total 25OH-D ( including D(3 ) and D(2 ) ) , with the exception of the Roche assay ( D(3 ) only ) . Among the immunoassays detecting total 25OH-D , the CCCs varied between 0.85 ( Abbott ) to 0.95 ( LIAISON ) . The mean bias ranged between 0.2 μg/L ( 0.5 nmol/L ) ( LIAISON ) and 4.56 μg/L ( 11.4 nmol/L ) ( Abbott ) . The Roche 25OH-D(3 ) assay demonstrated small mean bias [ -2.7 μg/L ( -6.7 nmol/L ) ] [ -2.7 μg/L ( -6.7 nmol/L ) ] but a low CCC of just 0.66 . Most assays demonstrated good intra- and interassay precision , with CV < 10 % . CONCLUSIONS Automated immunoassays demonstrated variable performance and not all tests met our minimum performance goals . It is important that laboratories be aware of the limitations of their assay",
"In this prospect i ve study , the authors determined intrinsic risk factors for falls and recurrent falls and constructed a risk profile that indicated the relative contribution of each risk factor and also estimated the probabilities of falls and recurrent falls . In 1992 , over a 28-week period , falls were recorded among 354 elderly subjects aged 70 years or over who were living in homes or apartments for the elderly in Amsterdam and the vicinity . During the study period , 251 falls were reported by 126 subjects ( 36 % ) , and recurrent falls ( > or = 2 falls ) were reported by 57 subjects ( 16 % ) . Associations of falls and recurrent falls with potential risk factors were identified in logistic regression models . Mobility impairment regarding one or more of the tested items ( i.e. , impairment of balance , leg-extension strength , and gait ) was associated with falls ( adjusted odds ratio ( OR ) = 2.6 ) and was strongly associated with recurrent falls ( OR = 5.0 ) . Dizziness upon st and ing was associated with falls ( OR = 2.1 ) and recurrent falls ( OR = 2.1 ) . However , several risk factors were associated with recurrent falls only : history of stroke ( OR = 3.4 ) , poor mental state ( OR = 2.4 ) , and postural hypotension ( OR = 2.0 ) . The authors constructed a risk profile for recurrent falls that included the five risk factors mentioned above . Inclusion of all risk factors in the profile implied an 84 % probability of recurrent falls over a period of 28 weeks , compared with 3 % when no risk factor was present . The probability of recurrent falls ranged only from 11 % to 29 % when predicted by number of falls occurring in the previous year . Physical activity , use of high-risk medication , and the use of vitamin D3 , which was r and omly allocated to the participants , were not strongly related to either falls or recurrent falls . In conclusion , a large range of probabilities of falls , especially of recurrent falls , was estimated by the risk profiles , in which mobility impairment was the major risk factor . Recurrent fallers may therefore be especially amenable to prevention based on mobility improvement",
"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",
"To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling",
"BACKGROUND Inadequate dietary intake of calcium and vitamin D may contribute to the high prevalence of osteoporosis among older persons . METHODS We studied the effects of three years of dietary supplementation with calcium and vitamin D on bone mineral density , biochemical measures of bone metabolism , and the incidence of nonvertebral fractures in 176 men and 213 women 65 years of age or older who were living at home . They received either 500 mg of calcium plus 700 IU of vitamin D3 ( cholecalciferol ) per day or placebo . Bone mineral density was measured by dual-energy x-ray absorptiometry , blood and urine were analyzed every six months , and cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records . RESULTS The mean ( + /-SD ) changes in bone mineral density in the calcium-vitamin D and placebo groups were as follows : femoral neck , + 0.50+/-4.80 and -0.70+/-5.03 percent , respectively ( P=0.02 ) ; spine,+2.12+/-4.06 and + 1.22+/-4.25 percent ( P=0.04 ) ; and total body , + 0.06+/-1.83 and -1.09+/-1.71 percent ( P calcium-vitamin D and placebo groups was significant at all skeletal sites after one year , but it was significant only for total-body bone mineral density in the second and third years . Of 37 subjects who had nonvertebral fractures , 26 were in the placebo group and 11 were in the calcium-vitamin D group ( P=0.02 ) . CONCLUSIONS In men and women 65 years of age or older who are living in the community , dietary supplementation with calcium and vitamin D moderately reduced bone loss measured in the femoral neck , spine , and total body over the three-year study period and reduced the incidence of nonvertebral fractures",
" A cross-section of an elderly population was assessed in a double-blind trial for the effects of prophylactic vitamin D. The subjects who completed the trial were assessed clinical ly , by physiotherapy tests of muscle function and by biochemical analysis , before and after a course of vitamin D or placebo . A significant fall in serum phosphate was found in the placebo group but not in the vitamin D group . The fall was maximal between the months of October and March which correspond to maximum and minimum amounts of circulating 25-hydroxy-vitamin D during the year . No difference in muscle function between treated and untreated groups was shown . Two out of 63 individuals on vitamin D developed hypercalcaemia . It is concluded that , although there appears to be improvement in the phosphate status of treated patients over the short term of this trial , hypercalcaemia after vitamin D administration precludes the continuous prophylactic use of vitamin D at the levels employed in this trial"
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Purpose of review This systematic review reports the most recent literature regarding the effects of physical exercise on muscle strength , body composition , physical functioning and inflammation in older adults . All articles were assessed for method ological quality and where possible effect size was calculated . Recent findings Thirty-four articles were included – four involving frail , 24 healthy and five older adults with a specific disease . One reported on both frail and nonfrail patients . Several types of exercise were used : resistance training , aerobic training , combined resistance training and aerobic training and others . In frail older persons , moderate-to-large beneficial exercise effects were noted on inflammation , muscle strength and physical functioning . In healthy older persons , effects of resistance training ( most frequently investigated ) on inflammation or muscle strength can be influenced by the exercise modalities ( intensity and rest interval between sets ) . Muscle strength seemed the most frequently used outcome measure , with moderate-to-large effects obtained regardless the exercise intervention studied . Similar effects were found in patients with specific diseases . Summary Exercise has moderate-to-large effects on muscle strength , body composition , physical functioning and inflammation in older adults . Future studies should focus on the influence of specific exercise modalities and target the frail population more
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"The aim of the study was to assess the effect of eccentric training using a constant load with longer exposure time at the eccentric phase on knee extensor muscle strength and functional capacity of elderly subjects in comparison with a conventional resistance training program . Twenty-six healthy elderly women ( age = 67 ± 6 years ) were r and omly assigned to an eccentric-focused training group ( ETG ; n = 13 ) or a conventional training group ( CTG ; n = 13 ) . Subjects underwent 12 weeks of resistance training twice a week . For the ETG , concentric and eccentric phases were performed using 1.5 and 4.5 s , respectively , while for CTG , each phase lasted 1.5 s. Maximum dynamic strength was assessed by the one-repetition maximum ( 1RM ) test in the leg press and knee extension exercises , and for functional capacity , subjects performed specific tests ( 6-m walk test , timed up- and -go test , stair-climbing test , and chair-rising test ) . Both groups improved knee extension 1RM ( 24–26 % ; p = 0.021 ) , timed up- and -go test ( 11–16 % ; p ( 9–12 % ; p = 0.004 ) , stair-climbing test ( 8–13 % ; p = 0.007 ) , and chair-rising test ( 15–16 % ; p the exposure time at the eccentric phase of movement using the same training volume and intensity does not promote different adaptations in strength or functional capacity compared to conventional resistance training in elderly woman",
"Background The current recommendations on resistance training involving older adults have reported an improvement of body composition variables . Despite this , there is a lack of knowledge on how elastic resistance training ( ERT ) affects the muscle mass in older adults population . The purpose of this study was to determine the effects of a short-term ERT on muscle mass of health and untrained older adults . Methods Forty older adults were r and omized into two groups of 20 individuals each : Control Group ( CG = 66.2 ± 6.6 years ) and Training Group ( TG = 69.1 ± 6.3 years ) . TG underwent an ERT twice a week during 8 weeks and control group did not receive any specific intervention . The primary outcome was the upper and lower limbs muscle mass , measured by Dual-energy x-ray absorptiometry . The secondary outcomes were knee isokinetic peak torque ( PT ) at 60 ° /s and 120 ° /s speeds and isometric h and grip strength . A 2 × 2 mixed model ( group [ TG and CG ] × time [ pre and post ] ) analysis of variance ( ANOVA ) was applied to determine the effect on primary and secondary outcomes . Results The results of the ANOVA showed no significant effects in group x time interaction for ( 1 ) upper limbs fat free mass ( F [ 1.38 ] = 1.80 , p = 0.19 , effect size [ ES ] = 0.1 ) and for ( 2 ) lower limbs fat free mass ( F [ 1.38 ] = 0.03 , p = 0.88 , ES = 0.02 ) . Regarding muscle strength , the ANOVA showed no significant effects in group x time interaction for ( 3 ) PT at 60 ° /s ( F [ 1.38 ] = 0.33 , p = 0.56 , ES = 3.0 ) , for ( 4 ) PT at 120 ° /s ( F [ 1.38 ] = 0.80 , p = 0.38 , ES = 4.1 ) and for h and grip strength ( F [ 1.38 ] = 0.65 , p = 0.42-value , ES = 0.9 ) . Analysis of PT in TG showed a significant change of 4.5 % , but only at 120 ° /s ( p = 0.01 ) when comparing pre and post-training ( time interaction ) . Conclusions Eight weeks of ERT did not show significant changes in muscle mass and strength of untrained older adults . Trial registration NCT02253615 ( 09/25/14",
"BACKGROUND whole-body vibration training may improve neuromuscular function , falls risk and bone density , but previous studies have had conflicting findings . OBJECTIVE this study aim ed to evaluate the influence of vertical vibration ( VV ) and side-alternating vibration ( SV ) on musculoskeletal health in older people at risk of falls . DESIGN single-blind , r and omised , controlled trial comparing vibration training to sham vibration ( Sham ) in addition to usual care . PARTICIPANTS participants were 61 older people ( 37 women and 24 men ) , aged 80.2 + 6.5 years , referred to an outpatient falls prevention service . METHODS participants were r and omly assigned to VV , SV or Sham in addition to the usual falls prevention programme . Participants were requested to attend three vibration sessions per week for 12 weeks , with sessions increasing to six , 1 min bouts of vibration . Falls risk factors and neuromuscular tests were assessed , and blood sample s collected for determination of bone turnover , at baseline and following the intervention . RESULTS chair st and time , timed-up- and -go time , fear of falling , NEADL index and postural sway with eyes open improved in the Sham group . There were significantly greater gains in leg power in the VV than in the Sham group and in bone formation in SV and VV compared with the Sham group . Conversely , body sway improved less in the VV than in the Sham group . Changes in falls risk factors did not differ between the groups . CONCLUSIONS whole-body vibration increased leg power and bone formation , but it did not provide any additional benefits to balance or fall risk factors beyond a falls prevention programme in older people at risk of falls",
"The term “ bilateral deficit ” ( BLD ) has been used to describe a reduction in performance during bilateral contractions when compared to the sum of identical unilateral contractions . In old age , maximal isometric force production ( MIF ) decreases and BLD increases indicating the need for training interventions to mitigate this impact in seniors . In a cross-sectional approach , we examined age-related differences in MIF and BLD in young ( age : 20–30 years ) and old adults ( age : > 65 years ) . In addition , a r and omized-controlled trial was conducted to investigate training-specific effects of resistance vs. balance training on MIF and BLD of the leg extensors in old adults . Subjects were r and omly assigned to resistance training ( n = 19 ) , balance training ( n = 14 ) , or a control group ( n = 20 ) . Bilateral heavy-resistance training for the lower extremities was performed for 13 weeks ( 3 × / week ) at 80 % of the one repetition maximum . Balance training was conducted using predominately unilateral exercises on wobble boards , soft mats , and uneven surfaces for the same duration . Pre- and post-tests included uni- and bilateral measurements of maximal isometric leg extension force . At baseline , young subjects outperformed older adults in uni- and bilateral MIF ( all p measures of BLD ( p increases in uni- and bilateral MIF after resistance training ( all p addition , BLD decreased following resistance ( p increased MIF and decreased BLD of the leg extensors ( HRT-group more than BAL-group ) , almost reaching the levels of young adults ",
"Abstract This study determined the effect of 6 months of low-load very high-repetition resistance training on bone mineral density ( BMD ) and body composition in nonosteoporotic middle-aged and older women . Fifty healthy , active community-dwelling women aged 56–75 years took part in the two-group , repeated- measures r and omized controlled trial . Participants either undertook 6 months of low-load very high-repetition resistance training in the form of BodyPump ™ or served as control participants . Outcome measures included BMD at the lumbar spine , hip , and total body ; total fat mass ; fat-free soft tissue mass and maximal isotonic strength . Significant group-by-time interactions were found for lumbar spine BMD and maximal strength in favor of the BodyPump ™ group . No favorable effects were found for hip BMD , total body BMD , total fat mass , or fat-free soft tissue mass . Three participants withdrew from the intervention group due to injury or fear of injury associated with training . Under the conditions used in this research , low-load very high-repetition resistance training is effective at attenuating losses in lumbar spine BMD compared to controls in healthy , active women aged over 55 years but did not influence hip and total body BMD or fat mass and fat-free soft tissue mass ",
"Objective The main purpose of the investigation reported here was to analyze the effect of resistance training ( RT ) performed at different weekly frequencies on flexibility in older women . Participants and methods Fifty-three older women ( ≥60 years old ) were r and omly assigned to perform RT either two ( n=28 ; group “ G2x ” ) , or three ( n=25 ; group “ G3x ” ) times per week . The RT program comprised eight exercises in which the participants performed one set of 10–15 repetitions maximum for a period of 12 weeks . Anthropometric , body-composition , and flexibility measurements were made at baseline and post- study . The flexibility measurements were obtained by a fleximeter . Results A significant group-by-time interaction ( P for frontal hip flexion , in which G3x showed a higher increase than G2x ( + 12.8 % and + 3.0 % , respectively ) . Both groups increased flexibility in cervical extension ( G2x=+19.1 % , G3x=+20.0 % ) , right hip flexion ( G2x=+14.6 % , G3x=+15.9 % ) , and left hip flexion ( G2x=+25.7 % , G3x=+19.2 % ) , with no statistical difference between groups . No statistically significant differences were noted for the increase in skeletal muscle mass between training three versus two times a week ( + 7.4 % vs + 4.4 % , respectively ) . Conclusion Twelve weeks of RT improves the flexibility of different joint movements in older women , and the higher frequency induces greater increases for frontal hip flexion ",
"The aim of this r and omized controlled trial was to determine the effects of 8-week exercise-intervention on cognition and related serum biochemical markers in nonagenarians . We also studied the effects of a 4-week training cessation ( ' detraining ' ) period on our study variables . Participants were r and omly allocated to a st and ard-care ( control ) or intervention ( exercise ) group [ n=20 ( 16 women)/group ] . The intervention focused on supervised , light-to-moderate-intensity aerobic and resistance exercises ( mainly leg press ) , and included 3 weekly sessions . Cognitive status was determined by the mini-mental state examination and geriatric depression scale . We analysed proteins with reported relation with mechanisms behind cognition changes such as serum levels of angiotensin converting enzyme , amyloid-precursor protein , epidermal growth factor , brain-derived neural factor and tumor necrosis factor . No significant change ( P>0.05 ) in any of the variables studied was found following the exercise intervention compared with the st and ard-care group . Similarly , no significant changes ( P>0.05 ) were observed following the detraining period compared with the st and ard-care group . Overall changes after the exercise intervention in serum biomarkers were not associated with changes in functional capacity and cognitive measures . An 8-week exercise intervention focusing on resistance exercises neither benefits cognitive function nor affects the levels of the serum proteins analysed in nonagenarians",
"Purpose To determine if 8 weeks of periodized strength resistance training ( RT ) utilizing relatively short rest interval lengths ( RI ) in between sets ( SS ) would induce greater improvements in body composition and muscular performance , compared to the same RT program utilizing extended RI ( SL ) . Methods 22 male volunteers ( SS : n = 11 , 65.6 ± 3.4 years ; SL : n = 11 , 70.3 ± 4.9 years ) were assigned to one of two strength RT groups , following 4 weeks of periodized hypertrophic RT ( PHRT ) : strength RT with 60-s RI ( SS ) or strength RT with 4-min RI ( SL ) . Prior to r and omization , all 22 study participants trained 3 days/week , for 4 weeks , targeting hypertrophy ; from week 4 to week 12 , SS and SL followed the same periodized strength RT program for 8 weeks , with RI the only difference in their RT prescription . Results Following PHRT , all study participants experienced increases in lean body mass ( LBM ) ( p 0.01 ) , upper and lower body strength ( p 0.001 ) , and dynamic power ( p well as decreases in percentage body fat ( p greater increases in LBM ( p = 0.001 ) , flat machine bench press 1-RM ( p 0.001 ) , bilateral leg press 1-RM ( p 0.001 ) , narrow/neutral grip lat pulldown ( p , and Margaria stair-climbing power ( p strength RT with shortened RI induces significantly greater enhancements in body composition , muscular performance , and functional performance , compared to the same RT prescription with extended RI , in older men . Applied professionals may optimize certain RT-induced adaptations , by incorporating shortened RI",
"Abstract The purpose of this study was to investigate the influence of whole-body vibration ( WBV ) training without visual feedback on balance and lower-extremity muscle strength in the elderly . Elderly subjects who did not exercise regularly participated in this study . Subjects were r and omly divided into a WBV with eyes open group , a visual feedback-deprived plus WBV ( VFDWBV ) group , and a control group ( 0 Hz , eyes open ) . WBV training was provided over a 3-month period , 3 times per week for 5 min each session . Balance performance was measured with the limits of stability test , and muscle strength was measured with an isokinetic dynamometer . A total of 45 elderly subjects with an average age of 69.22 ± 3.97 years , divided into a WBV group ( n = 14 ) , a VFDWBV group ( n = 17 ) , and a control group ( n = 14 ) , completed the trial . Statistically significant differences were found in the balance performance of the 3 groups at different time points ( time × group interaction : F = 13.213 , P improvement in balance than the WBV and control groups . The strength of the knee extensor and flexor muscles had time × group interactions : F = 29.604 , P more improvement on lower-extremity muscle strength than the WBV and control groups . The 6-month follow-up showed that the rates of hospital visits for medical services due to falls were 0 % in the WBV group ( 0/14 ) , 0 % in the VFDWBV group ( 0/17 ) , and 28.57 % in the control group ( 4/14 ) . Results showed that WBV training at 20 Hz without visual feedback can significantly improve the balance performance and lower-extremity muscle strength of the elderly",
"BACKGROUND We compared the effects of two uniquely different lower extremity power training interventions on changes in muscle power , physical performance , neuromuscular activation , and muscle cross sectional area in mobility-limited older adults . METHODS Fifty-two subjects ( 78±5 years , short physical performance battery score : 8.1±1 ) were r and omized to either 16 weeks of progressive high velocity resistance training performed at low external resistance ( 40 % of the 1-repetition maximum [ 1-RM ] [ LO ] ) or high external resistance ( 70 % of 1RM [ HI ] ) . Both groups completed three sets of leg and knee extension exercises at maximum voluntary velocity , two times per week . Neuromuscular activation was assessed using surface electromyography and muscle cross sectional area ( CSA ) was measured using computed tomography . RESULTS At 16 weeks , LO and HI exhibited significant and similar within-group increases of leg extensor peak power ( ~34 % vs ~42 % ) , strength ( ~13 % vs ~19 % ) , and SPPB score ( 1.4±0.3 vs 1.8±0.3 units ) , respectively ( all P ) . Improvements in neuromuscular activation occurred in LO ( P = .03 ) while small gains in mid-thigh muscle CSA were detected in LO ( 1.6 % , P = .35 ) and HI ( 2.1 % , P = .17 ) . No significant between-group differences were evident for any measured parameters ( all P > .25 ) . CONCLUSIONS High velocity resistance training with low external resistance yields similar improvements in muscle power and physical performance compared to training with high external resistance in mobility-limited elders . These findings may have important implication s for optimizing exercise interventions for older adults with mobility limitations",
" The effects of 52 weeks of soccer or resistance training were investigated in untrained elderly men . The subjects aged 68.1±2.1 yrs were r and omised into a soccer ( SG ; n = 9 ) , a resistance ( RG ; n = 9 ) and a control group ( CG ; n = 8) . The subjects in SG and RG , respectively , trained 1.7±0.3 and 1.8±0.3 times weekly on average during the intervention period . Muscle function and body composition were determined before and after 16 and 52 weeks of the intervention period . In SG , BMI was reduced by 1.5 % and 3.0 % ( p the response to a glucose tolerance test was 16 % lower ( p SG , superoxide dismutase-2 expression was 59 % higher ( p RG , upper body lean mass was 3 and 2 % higher ( p RG , Akt-2 expression increased by 28 % ( p and follistatin expression decreased by 38 % ( p Thus , long-term soccer training reduces BMI and improves anti-oxidative capacity , while long-term resistance training impacts muscle protein enzyme expression and increases lean body mass in elderly men . Trial Registration Clinical Trials.gov :",
"OBJECTIVE The aim of the Intervention by Nutrition and Exercise ( INE ) study was to investigate the effects of a mail-based intervention for sarcopenia prevention on muscle mass and anabolic hormones in community-dwelling older adults . DESIGN A cluster-r and omized controlled trial . SETTING AND PARTICIPANTS This trial recruited community-dwelling adults aged 65 years and older in Japan . The 227 participants were cluster r and omized into a walking and nutrition ( W/N ) group ( n = 79 ) , a walking ( W ) group ( n = 71 ) , and a control ( C ) group ( n = 77 ) . We analyzed the physical and biochemical measurements in this sub study . INTERVENTION Six months of mail-based intervention ( a pedometer-based walking program and nutritional supplementation ) . MEASUREMENTS The skeletal muscle mass index ( SMI ) using the bioelectrical impedance data acquisition system , biochemical measurements , such as those of insulinlike growth factor ( IGF-1 ) , dehydroepi and rosterone sulfate ( DHEA-S ) , and 25-hydroxy vitamin D ( 25[OH]D ) , as well as frailty , were assessed by the Cardiovascular Health Study criteria . RESULTS Participants in the W/N and W groups had significantly greater improvements in SMI , IGF-1 , and 25(OH)D ( P DHEA-S ( P frail , older adults . CONCLUSION These results suggest that the mail-based walking intervention of the remote monitoring type for sarcopenia prevention can increase anabolic hormone levels and SMI in community-dwelling older adults , particularly in those who are frail",
"The purpose of this study was to investigate the effects of short term resistance exercise on neuromuscular fatigue threshold ( PWCFT ) , strength , functional performance , and body composition in older adults . Twenty-three participants ( 71.2 ± 6.0 yr ) were r and omly assigned to 6 weeks of resistance exercise ( EXE ) or control ( CONT ) . A submaximal cycle ergometer test , physical working capacity at fatigue threshold , was used to determine PWCFT . Strength was assessed with predicted leg extension 1-RM and functional performance with time to complete 5 chair rises ( CHAIR ) and walk an 8-ft course ( WALK ) . PWCFT , 1-RM and CHAIR significantly ( p respectively . The results of this study suggest that short term EXE improved strength , functionality and the capacity to delay the onset of neuromuscular fatigue in older adults",
"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",
"The aim of this study was to compare the effect of resistance training ( RT ) performed with different frequencies followed by a detraining period on muscular strength and oxidative stress ( OS ) biomarkers in older women . Twenty-seven physically independent women ( 68.8 ± 4.8 years , 69.1 ± 14.3 kg , 156.0 ± 6.5 cm , and 28.3 ± 4.9 to kg.m−2 ) were r and omly assigned to perform a RT program for 2 or 3 days per week ( G2X = 13 vs. G3X = 14 ) for 12 weeks followed by 12 weeks of detraining period . One repetition maximum ( 1RM ) tests were used as measures of muscular strength ( three exercises , three attempts for each exercise , 3–5 min of rest between attempts , and 5 min of rest between exercises ) . Advanced oxidized protein products ( AOPP ) and total radical-trapping antioxidant parameter ( TRAP ) were used as oxidative stress indicators . Both groups increased muscular strength after 12 weeks of training ( P in chest press ( G2X = + 11.9 % vs. G3X = + 27.5 % , P knee extension ( G2X = + 18.4 % vs. G3X = + 16.7 % , P > 0.05 ) , and preacher curl ( G2X = + 37.6 % vs. G3X = + 36.7 % , P > 0.05 ) . On the other h and , 12 weeks of detraining were not sufficient to eliminate the major effects produced by RT on muscular strength , although a significant decrease ( P observed for chest press ( G3X = −9.1 % vs. G2X = −10.2 % , P > 0.05 ) , knee extension ( G2X = −14.9 % vs. G3X = −12.1 % , P > 0.05 ) , and preacher curl ( G2X = −20.5 % vs. G3X = −17.4 % , P > 0.05 ) . Pre- to post-training , both groups showed significant ( P TRAP ( G2X = + 6.9 % vs. G3X = + 15.1 % ) with no statistical significant difference between the groups ( P > 0.05 ) , and the scores remained elevated compared to pre-training after 12 weeks of detraining . AOPP was not changed by RT or detraining ( P > 0.05 ) . The results suggest that a 12-week RT program with a frequency of 2 days per week may be sufficient to improve muscular strength and OS in older women and detraining for 12 weeks does not completely reverse the changes induced by RT",
"The delivery of efficient nonpharmacological treatment to prevent the loss of muscle mass in older adults is a major challenge , and information on the combined effects of training and diet is particularly important . Here we aim ed to evaluate the effects of 24 wk of resistance training combined with a healthy dietary approach ( n-6/n-3 ratio population of healthy and physically active older women ( 65 - 70 years ) . The three-armed r and omized controlled trial included a resistance training + healthy diet group ( RT-HD ) , a resistance training group ( RT ) , and controls ( CON ) . All subjects included in the study were physically active and had low levels of serum inflammatory markers . In accordance with the dietary goals , the n-6/n-3 ratio dietary intake significantly decreased only in RT-HD by 42 % . An increase in 1 repetition maximum in leg extension occurred in RT ( + 20.4 % ) and RT-HD ( + 20.8 % ) , but not in CON . Interestingly , leg lean mass significantly increased only in RT-HD ( + 1.8 % ) . While there were no changes in serum C-reactive protein and IL-6 levels , a significant decrease in serum level of the pro-inflammatory precursor arachidonic acid ( -5.3 ± 9.4 % ) together with an increase in serum n-3 docosahexaenoic acid ( + 8.3 % ) occurred only in RT-HD . Altogether , this study demonstrates that the effects of resistance training on muscle mass in healthy older adults can be optimized by the adoption of a healthy diet",
"INTRODUCTION Although h and grip strength is considered a strong predictor of negative health outcomes , it is unclear whether h and grip strength represents a useful measure to evaluate changes in muscle strength following resistance-type exercise training in older people . We assessed whether measuring h and grip strength provides proper insight in the efficacy of resistance-type exercise training to increase muscle mass , strength , and physical performance in frail older people . METHODS Prefrail and frail older people ( ≥ 65 y ) were either conducting a 24-week resistance-type exercise training or no exercise training . Before , during , and after the intervention , h and grip strength ( JAMAR ) , lean body mass ( DXA ) , leg strength ( 1-RM ) , and physical performance ( SPPB ) were assessed . RESULTS H and grip strength correlated with appendicular lean mass ( r = 0.68 ; p and leg strength ( r = 0.67 ; p whole body resistance-type exercise training , leg extension strength improved significantly better when compared with the control group ( 57 ± 2 - 78 ± 3 kg vs 57 ± 3 - 65 ± 3 kg : p ) . Moreover , physical performance improved significantly more in the exercise group ( 8.0 ± 0.4 - 9.3 ± 0.4 points ) when compared with the control group ( 8.3 ± 0.4 - 8.9 ± 0.4 points : p changes in h and grip strength ( 26.3 ± 1.2 - 27.6 ± 1.2 kg in the exercise group vs 26.6 ± 1.2 - 26.3 ± 1.3 kg in the control group : p = .71 ) . CONCLUSION Although h and grip strength strongly correlates with muscle mass and leg strength in frail older people , h and grip strength does not provide a valid means to evaluate the efficacy of exercise intervention programs to increase muscle mass or strength in an older population",
"OBJECTIVES To assess the efficacy of an exercise program on a whole-body vibration platform ( WBV ) in improving body balance and muscle performance and preventing falls in institutionalized elderly people . DESIGN / SETTING / PARTICIPANTS A multicentre r and omized parallel assessor-blinded clinical trial was conducted in elderly persons living in nursing homes . INTERVENTIONS Participants were r and omized to an exercise program performed either on a whole body vibratory platform ( WBV plus exercise group ) or on a stationary surface ( exercise group ) . The exercise program for both groups consisted of static and dynamic exercises ( balance and strength training over a 6-week training period of 3 sessions per week ) . The frequency applied on the vibratory platform was 30 to 35 Hz and amplitude was 2 to 4 mm . MEASUREMENTS The primary outcome measurement was static/dynamic body balance . Secondary outcomes were muscle strength and number of falls . Efficacy was analyzed on an intention-to-treat basis and per protocol . The effects of the intervention were evaluated using the t test , Mann-Whitney test , or chi-square test , depending on the type of outcome . Follow-up measurements were collected 6 weeks and 6 months after r and omization . RESULTS A total of 159 participants from 10 centers were included : 81 in the WBV plus exercise group and 78 in the control group . Mean age was 82 years , and 67.29 % were women . The Tinetti test score showed a significant overall improvement in both groups ( P Timed Up and Go test did not improve ( P = .599 ) in either group over time , and no significant differences were found between groups at week 6 ( P = .757 ) or month 6 ( P = .959 ) . Muscle performance results from the 5 Sit-To-St and tests improved significantly across time ( P = .001 ) , but no statistically significant differences were found between groups at week 6 ( P = .709 ) or month 6 ( P = .841 ) . A total of 57 falls ( 35.8 % ) were recorded during the follow-up period , with no differences between groups ( P = .406 ) . CONCLUSION Exercise program on a vibratory platform provides benefits similar to those with exercise program on a stationary surface in relation to body balance , gait , functional mobility , and muscle strength in institutionalized elderly people . Longer studies in larger sample s are needed to assess falls",
"Background : Whole body vibration training ( WBVT ) improves muscle force in healthy subjects . Resistance training ( RT ) is an important component of a pulmonary program . Aim : To investigate the effects of either 12 weeks WBVT or RT , both provided after 15 min of aerobic training as warming up . Methods : COPD patients , referred for pulmonary rehabilitation , were r and omized to either a WBVT or a conventional RT group . Primary outcome was the change in 6 Minute Walking Distance ( 6MWD ) after 12 weeks . Maximum exercise capacity ( Wmax ) , quadriceps force ( QF ) , quality of life ( QoL ) and number of responders , defined as the percentage of patients reaching the minimally clinical ly important difference ( MCID ) for the aforementioned outcome measurements were the secondary outcomes . Data are expressed as medians ( interquartile range ) . Results : 62 patients with COPD were included . After WBVT , 6MWD improved by 35 ( -14 - 76 ) m ( p = 0.003 ) , Wmax by 7 ( 2 - 23 ) Watt ( p = 0.001 ) , QoL by 13 ( 4 - 25 ) points ( p = 0.002 ) and QF by 9 ( -16 - 29 ) Nm ( NS ) . In the RT-group , 6MWD , Wmax , QoL and QF increased significantly , with 60 ( -13 - 96 ) m ( p 6MWD ( 54 m ) was reached by 8/26 patients in the WBVT-group and by 16/25 patients in RT-group ( p = 0.05 ) . No significant differences between groups were observed for the primary and secondary outcomes . Conclusions : WBVT after 15 min aerobic training enhances 6MWD , Wmax and QoL in COPD patients ; however only 30 % of patients reached the MCID for 6MWD",
"CONTEXT Skeletal muscle from sedentary older adults exhibits reduced mitochondrial abundance and oxidative capacity . OBJECTIVE The primary objective was to determine whether 8 weeks of combined training ( CT ) has a more robust effect than endurance training ( ET ) or resistance training ( RT ) on mitochondrial physiology in healthy young ( 18 - 30 years ) and older ( ≥ 65 years ) adults . INTERVENTION Thirty-four young and 31 older adults were r and omly assigned to 8 weeks of ET , RT , and control/CT . Control subjects completed 8 weeks of no exercise ( control ) followed by 8 weeks of CT . Body composition , skeletal muscle strength , and peak oxygen uptake were measured before and after the intervention . Vastus lateralis muscle biopsy sample s were obtained before and 48 hours after the intervention . Mitochondrial physiology was evaluated by high-resolution respirometry and expression of mitochondrial proteins and transcription factors by quantitative PCR and immunoblotting . RESULTS ET and CT significantly increased oxidative capacity and expression of mitochondrial proteins and transcription factors . All training modalities improved body composition , cardiorespiratory fitness , and skeletal muscle strength . CT induced the most robust improvements in mitochondria-related outcomes and physical characteristics despite lower training volumes for the ET and RT components . Importantly , most of the adaptations to training occurred independent of age . CONCLUSION Collectively , these results demonstrate that both ET and CT increase muscle mitochondrial abundance and capacity although CT induced the most robust improvements in the outcomes measured . In conclusion , CT provides a robust exercise regimen to improve muscle mitochondrial outcomes and physical characteristics independent of age",
"BACKGROUND Little is known about the effects of resistance training ( RT ) on circulating cytokines in older adults . Also , dose-response relationships remain unclear . This study investigated the impact of RT at different external loads on circulating inflammatory mediators in older community-dwelling individuals . METHODS Fifty-six community-dwelling older ( 68 ± 5 years ) volunteers were r and omized to 12 weeks of supervised RT ( ×3/week ) at either high-resistance training [ 8 males , 10 females , 2 × 10 - 15 repetitions at 80 % 1 repetition maximum ( RM ) ] , low-resistance training ( 9 males , 10 females , 1 × 80 - 100 repetitions at 20 % 1 RM ) , or mixed low-resistance training ( 9 males , 10 females , 1 × 60 repetitions at 20 % 1 RM followed by 1 × 10 - 20 repetitions at 40 % 1 RM ) . Serum was available from 51 out of 56 participants at baseline and after 12 weeks for determination of interleukin (IL)-6 , IL-8 , IL-10 , IL-1β , soluble tumor necrosis factor receptor (sTNFR)1 , granulocyte macrophage colony-stimulating factor , and IL-1 receptor antagonist ( ra ) . RESULTS Twelve weeks of RT significantly increased sTNFR1 from 2.48 ± 0.57 ng/mL to 2.58 ± 0.59 ng/mL ( overall time-effect P = .033 ) and Log IL-8 from 0.38 ± 0.18 pg/mL to 0.53 ± 0.32 pg/mL ( overall time-effect P = .007 ) . No time X group interaction ( P = .916 ) was observed . In males of the high-resistance training group , there was an increase in Log IL-8 ( from 0.45 ± 0.16 pg/mL to 0.68 ± 0.19 pg/mL ; P = .005 ) and IL-1ra ( from 68.60 ± 24.12 pg/mL to 79.56 ± 29.07 pg/mL ; P = .007 ) . No significant changes were found for the other markers . CONCLUSIONS Our results show that 12 weeks of supervised RT induced an overall significant increase of circulating IL-8 and sTNFR1 , independently from the external load applied . We suggest that exercising until volitional fatigue is the main trigger for exercise-induced responses . However , training at high external load also increased anti-inflammatory IL-1ra in male participants , which might be beneficial in combating low- grade inflammation",
"Skeletal muscle quadriceps low-frequency fatigue ( LFF ) during exercise promotes improvements in exercise capacity with exercise training . In healthy subjects , eccentric muscle work induced by downhill walking ( DW ) generates higher muscular stress , whilst metabolic cost is lower compared to level walking ( LW ) . We investigated quadriceps LFF and metabolic cost of DW in patients with chronic obstructive pulmonary disease . Ten participants ( 67 ± 7 years , FEV1 51 ± 15 % predicted ) performed DW , DW carrying a load ( DWL ) of 10 % body weight via vest and LW , in r and om order . Quadriceps potentiated twitch force ( TWqpot ) was assessed before and after each walk , and muscle damage was assessed before and 24 hours after each walk via serum creatine kinase ( CK ) levels . Ventilation ( VE ) and oxygen consumption ( VO2 ) were measured via breath-by-breath analysis during each walk . DW and DWL result ed in a greater decrease in TWqpot ( −30 ± 14 N in DW , p −3 ± 21 N , p > 0.05 ) . CK levels only increased 24 hours following DW and DWL ( p showed lower VE and VO2 than LW ( p enhanced quadriceps LFF and lower cardiorespiratory costs than LW . The addition of a chest load to DW does not seem to enhance these effects",
"PURPOSE The purpose of the current study was to investigate the effects of a 12-week home-based bench step exercise program on inflammatory cytokines and lipid profiles in elderly females . METHODS Sixty-two postmenopausal females ( 65 - 85 years of age ) were r and omized to either the bench step exercise group ( n=31 ) or the control group ( n=31 ) . The subjects in the bench step exercise group were instructed to perform bench step exercises at the exercise intensity corresponding to lactate threshold ( LT ) , three times per day 10 - 20 min each session , for a goal of ≥140 min/week at home for 12 weeks . At baseline and 12 weeks , circulating levels of nine inflammatory cytokines ( high-molecular-weight adiponectin , interleukin-4 [ IL-4 ] , IL-5 , IL-6 , IL-8 , IL-15 , tumor necrosis factor-α [ TNF-α ] , TNF-β and interferon-γ [ IFN-γ ] ) and serum lipids including high-density lipoprotein cholesterol ( HDL-C ) were measured . RESULTS The bench step training at the LT significantly increased HDL-C levels and decreased IFN-γ concentrations in the subjects with lower ( baseline HDL-C levels ( p change in IFN-γ inversely correlated with the change in HDL-C in the exercise group ( ρ=-0.56 , p changes in HDL-C in the exercise group . CONCLUSION The bench step exercise-induced reduction in the IFN-γ levels may partially explain the degree of improvement in the HDL-C levels with the exercise program",
"This study evaluates the separate effect and retention of 12-week traditional ( TE ) and horse ( HE ) exercise programs on physical function in healthy older participants ( 61 to 87 years old ) . Thirty-eight participants were r and omly assigned to three groups : TE ( n = 17 ) , HE ( n = 10 ) , and control group ( n = 11 ) . TE and HE underwent a supervised exercise program ( 3 day/week ) . Maximal gait speed , muscle strength , and body balance were assessed at weeks 0 , 12 , and 16 . Only TE and HE displayed significant improvements ( P knee extensor strength , and only HE had faster gait speed . Marginal balance improvements were found only in HE in the medial-lateral direction . However , TE showed larger improvements in h and grip than HE . The largest retention was in knee extensor strength but most of the exercise effects were lost in the follow-up . Besides TE , exercise with a horse may be an alternative option to older adults , provided that they want to interact with the animal",
"Purpose Older cancer survivors are a vulnerable population due to an increased risk for chronic diseases ( e.g. , cardiovascular disease ) compounded with treatment late-effects and declines in physical functioning . Therefore , interventions that reduce chronic disease risk factors ( i.e. , blood pressure , chronic inflammation , and cortisol ) are important in this population . Tai chi chih ( TCC ) is a mind-body exercise associated with reductions in chronic disease risk factors , but has not been examined with older cancer survivors . In a feasibility r and omized controlled trial of TCC , we examined secondary outcomes of blood pressure , salivary cortisol , and inflammatory cytokines ( interleukin (IL)-6 , IL-12 , tumor necrosis factor-α , IL-10 , IL-4 ) due to their implication s in chronic diseases . Methods Sixty-three senior female cancer survivors ( M age = 67 years , SD = 7.15 ) with physical functioning limitations ( SF-12 physical functioning ≤80 or role-physical ≤72 ) were r and omized to 12-weeks ( 60-min , three times a week ) of TCC or Health Education control ( HEC ) classes . Resting blood pressure , 1-day salivary cortisol sample s , and fasting plasma sample s for cytokine multiplex assays were collected at baseline and 1-week post-intervention . Results Controlling for baseline values , the TCC group had significantly lower systolic blood pressure ( SBP , p = 0.002 ) and cortisol area-under-curve ( AUC , p = 0.02 ) at post-intervention than the HEC group . There was no intervention effect on inflammatory cytokines ( p ’s > 0.05 ) . Conclusions This TCC feasibility trial was associated with significant reductions in SBP and cortisol AUC in senior female cancer survivors . Larger , definitive trials are needed to confirm these findings . Implication s for Cancer SurvivorsSenior survivors ’ have an increased risk for chronic diseases ; however , TCC interventions may help reduce associated risk factors",
"This study aim ed to investigate the effects of training on health-related quality of life ( HRQoL ) , body composition , and function in older adults . Fifty participants were r and omized into aerobic training ( AT—70%-80 % HRreserve ) , resistance training ( RT—80 % 1RM ) , or controls . They had HRQoL , body composition , and function assessed before and after 8 months . Training groups reduced body fat , increased performance in the stair ascent , 8-ft up- and -go and sit-to-st and five-times tests , and improved their physical component score ( PCS ; p ≤ .03 ) . AT increased performance in the 6MWT test , and improved general and mental health ( MH ) domains when compared to controls ( p with changes in bodily pain , MH , and mental component score ( p ≤ .04 ) , while changes in h and grip strength were associated with changes in physical role and MH ( p = .03 ) . AT and RT were effective interventions for decreasing body fat and improving functionality and the PCS in older adults ",
"Muscle adaptations can be induced by high-resistance exercise . Despite being potentially more suitable for older adults , low-resistance exercise protocol s have been less investigated . We compared the effects of high- and low-resistance training on muscle volume , muscle strength , and force-velocity characteristics . Fifty-six older adults were r and omly assigned to 12 weeks of leg press and leg extension training at either HIGH ( 2 × 10 - 15 repetitions at 80 % of one repetition maximum ( 1RM ) ) , LOW ( 1 × 80 - 100 repetitions at 20 % of 1RM ) , or LOW+ ( 1 × 60 repetitions at 20 % of 1RM , followed by 1 × 10 - 20 repetitions at 40 % of 1RM ) . All protocol s ended with muscle failure . Leg press and leg extension of 1RM were measured at baseline and post intervention and before the first training session in weeks 5 and 9 . At baseline and post intervention , muscle volume ( MV ) was measured by CT-scan . A Biodex dynamometer evaluated knee extensor static peak torque in different knee angles ( PT(stat90 ° ) , PT(stat120 ° ) , PT(stat150 ° ) ) , dynamic peak torque at different speeds ( PT(dyn60 ° s)(-1 ) , PT(dyn180 ° s)(-1 ) , PT(dyn240 ° s)(-1 ) ) , and speed of movement at 20 % ( S20 ) , 40 % ( S40 ) , and 60 % ( S60 ) of PTstat90 ° . HIGH and LOW+ result ed in greater improvements in 1RM strength than LOW ( p groups in MV , PT(stat ) , PT(dyn60 ° s)(-1 ) , and PT(dyn180 ° s)(-1 ) . No changes were reported in speed of movement . HIGH tended to improve PT(dyn240 ° s)(-1 ) more than LOW or LOW+ ( p=0.064 ) . In conclusion , high- and low-resistance exercises ending with muscle failure may be similarly effective for hypertrophy . High-resistance training led to a higher increase in 1RM strength than low-resistance training ( 20 % of 1RM ) , but this difference disappeared when using a mixed low-resistance protocol in which the resistance was intensified within a single exercise set ( 40 % of 1RM ) . Our findings support the need for more research on low-resistance programs in older age , in particular long-term training studies and studies focusing on residual effects after training cessation",
"OBJECTIVES To investigate whether functionally based resistance exercise could improve strength , physical function , and disability among prostate cancer survivors ( PCS ) on and rogen deprivation therapy ( ADT ) ; and to explore potential mediators of changes in outcomes from exercise . DESIGN R and omized controlled trial . SETTING Academic medical center . PARTICIPANTS PCS ( N=51 ; mean age , 70.2y ) on ADT . INTERVENTION PCS were r and omized to moderate to vigorous intensity resistance training or stretching ( placebo control ) for 1 year . MAIN OUTCOME MEASURES Maximal leg press and bench press strength , objective and self-reported physical function , and self-reported disability . Hierarchical linear modeling was used to test for significant group × time differences adjusting for covariates . RESULTS Retention in the study was 84 % , and median attendance to supervised classes was 84 % in the resistance group . No study -related injuries occurred . Maximal leg strength ( P=.032 ) and bench press strength ( P=.027 ) were improved after 1 year of resistance training , whereas little change occurred from stretching . Self-reported physical function improved with resistance training , whereas decreases occurred from stretching ( P=.016 ) . Disability lessened more with resistance training than stretching ( P=.018 ) . One-year change in leg press strength mediated the relation between groups ( resistance or stretching ) and 1-year change in self-reported disability ( P resistance training improved muscle strength in and rogen-deprived PCS . Strengthening muscles using functional movement patterns may be an important feature of exercise programs design ed to improve perceptions of physical function and disability . Findings from this study contribute to the mounting evidence that exercise should become a routine part of clinical care in older men with advanced prostate cancer",
"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 Aging is associated with decline in physical function that could result in the development of physical impairment and disability . Hence , interventions that simultaneously challenge balance ability , trunk ( core ) and extremity strength of older adults could be particularly effective in preserving and enhancing these physical functions . OBJECTIVE The purpose of this study was to compare the effects of feedback-based balance and core resistance training utilizing the a special computer-controlled device ( Huber ® ) with the conventional Pilates training on balance ability , neuromuscular function and body composition of healthy older women . METHODS Thirty-four older women ( age : 70±4 years ) were r and omly assigned to a Huber group ( n=17 ) or Pilates group ( n=17 ) . Both groups trained for 8 weeks , 3 times a week . Maximal isometric strength of the trunk flexors , extensors , and lateral flexors , leg power , upper-body strength , single- and dual-task static balance , and body composition were measured before and after the intervention programs . RESULTS Significant group × time interactions and main effects of time ( p for body composition , balance ability in st and ard and dual-task conditions , all trunk muscle strength variables , and leg power in favor of the Huber group . The observed improvements in balance ability under both st and ard and dual-task conditions in the Huber group were mainly the result of enhanced postural control in medial-lateral direction ( p CONCLUSION Feedback-based balance and core resistance training proved to be more effective in improving single- and dual-task balance ability , trunk muscle strength , leg power , and body composition of healthy older women than the traditional Pilates training",
"Background and aims Decline in muscle endurance and strength as well as attenuated cardiac function with aging not only leads to overall physical function decline but also has a close relationship with cardiovascular disease occurrence . This study examined the effects of an 8-week combined training program ( i.e. , consisting of both aerobic and resistance training ) on body composition , isokinetic strength , and cardiovascular disease ( CVD ) risk factors in older women . Methods Nineteen women , aged 65–75 years , were r and omly assigned to either a combined training ( CT , n = 9 ) or an aerobic training ( AT , n = 10 ) group . Body composition and isokinetic strength were assessed before and after the exercise program . Blood sample s were collected to identify CVD risk factors . Results At the end of the training program , body mass , body fat mass , percent body fat , and body mass index decreased significantly and lean mass increased significantly in the CT group compared with those in the AT group ( p . Isokinetic strength was also significantly greater in the CT group than in the AT group ( p the C-reactive protein level was significantly lower in the CT group than in the AT group , whereas interleukin-6 , tumor necrosis factor-α , and total cholesterol levels were significantly lower in both groups ( p combined exercise program benefits body composition , especially lean mass , and positively affects isokinetic strength and CVD risk factors . Therefore , increasing lean mass and strength by continuously participating in a combined exercise program may be an effective treatment for preventing and improving CVD in older women",
"There is a relationship between high levels of inflammatory markers and low adhesion to the practice of physical activity in the older population . The objective of the present study was to compare the effect of two types of exercise programs , i.e. , aerobic training and aerobic plus resistance training on the plasma levels of interleukin-6 ( IL-6 ) and tumor necrosis factor alpha ( TNF-α ) of elderly hypertensive subjects . Hypertensive older volunteers in use of antihypertensive drugs were r and omized to three groups : aerobic group ( AG ) , resistance and aerobic group ( RAG ) and control group ( CG ) . Training lasted 10 weeks , with sessions held three times a week . Blood sample s were collected before training and 24 h after completion of the 30 sessions for the determination of serum IL-6 and TNF-α levels . Body mass index was obtained before and after 10 weeks . After intervention , BMI values were lower in AG and RAG compared to CG ( p IL-6 was reduced in AG compared to CG ( p = 0.04 ) , and TNF-α levels were lower only in RAG compared to CG ( p = 0.01 ) . Concluding , both types of training were effective in reducing BMI values in hypertensive older subjects . Aerobic exercise produced the reduction of plasma IL-6 levels . However , the combination of aerobic and resistance exercise , which would be more indicated for the prevention of loss of functionality with aging , showed lower TNF-α mediator after training than control group and a greater fall of TNF-α levels associated to higher BMI reduction",
"The aim of this present study was to investigate on the effects of concurrent training with blood flow restriction ( BFR-CT ) and concurrent training ( CT ) on the aerobic fitness , muscle mass and muscle strength in a cohort of older individuals . 25 healthy older adults ( 64.7±4.1 years ; 69.33±10.8 kg ; 1.6±0.1 m ) were r and omly assigned to experimental groups : CT ( n=8 , endurance training ( ET ) , 2 days/week for 30 - 40 min , 50 - 80 % VO(2peak ) and RT , 2 days/week , leg press with 4 sets of 10 reps at 70 - 80 % of 1-RM with 60 s rest ) , BFR-CT ( n=10 , ET , similar to CT , but resistance training with blood flow restriction : 2 days/week , leg press with 1 set of 30 and 3 sets of 15 reps at 20 - 30 % 1-RM with 60 s rest ) or control group ( n=7 ) . Quadriceps cross-sectional area ( CSAq ) , 1-RM and VO(2peak ) were assessed pre- and post-examination ( 12 wk ) . The CT and BFR-CT showed similar increases in CSAq post-test ( 7.3 % , P respectively ) , 1-RM ( 38.1 % , P respectively ) and VO(2peak ) ( 9.5 % , P=0.04 ; 10.3 % , P=0.02 , respectively ) . The BFR-CT promotes similar neuromuscular and cardiorespiratory adaptations as CT",
"BACKGROUND Arterial stiffness have shown an independent predictive value for cardiovascular and all-cause mortality . OBJECTIVE This study sought to evaluate the effects of an 8-week exercise-based cardiac rehabilitation program ( ECR ) on arterial stiffness , and on inflammatory and endothelial dysfunction biomarkers . Additionally , it was assessed two potential confounding variables , daily physical activity and dietary intake . METHODS In this parallel-group trial , 96 patients ( 56 ± 10 years ) were r and omized to either the exercise group ( EG ) or control group ( CG ) 4 weeks after suffering acute myocardial infa rct ion ( MI ) . ECR consisted of 8 weeks of aerobic exercise at 70 - 85 % of maximal heart rate during 3 sessions weekly , plus usual care . CG participants received only usual care . Baseline and final assessment s included arterial stiffness through carotid-femoral pulse wave velocity ( cf-PWV ) , inflammatory and endothelial dysfunction biomarkers , daily physical activity , and dietary intake . ( Clinical Trials.gov : NCT01432639 ) . RESULTS After 8 weeks , no significant changes were found between groups in cf-PWV , inflammatory and endothelial dysfunction biomarkers , daily physical activity , or dietary intake . Excluding those patients ( n = 7 ) who did not attend , at least 80 % of the exercise sessions provided similar results , excepting a significant reduction in cf-PWV in the EG compared to the CG . CONCLUSIONS A short-term ECR does not seem to reduce arterial stiffness and inflammatory and endothelial dysfunction biomarkers of post-MI patients under optimized medication . Nevertheless , the decrease of cf-PWV observed in the EG , when considering only those patients who attended at least 80 % of exercise sessions , warrants further investigation",
"IMPORTANCE In older adults reduced mobility is common and is an independent risk factor for morbidity , hospitalization , disability , and mortality . Limited evidence suggests that physical activity may help prevent mobility disability ; however , there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability . OBJECTIVE To test the hypothesis that a long-term structured physical activity program is more effective than a health education program ( also referred to as a successful aging program ) in reducing the risk of major mobility disability . DESIGN , SETTING , AND PARTICIPANTS The Lifestyle Interventions and Independence for Elders ( LIFE ) study was a multicenter , r and omized trial that enrolled participants between February 2010 and December 2011 , who participated for an average of 2.6 years . Follow-up ended in December 2013 . Outcome assessors were blinded to the intervention assignment . Participants were recruited from urban , suburban , and rural communities at 8 centers throughout the United States . We r and omized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations , defined as a score on the Short Physical Performance Battery of 9 or below , but were able to walk 400 m. INTERVENTIONS Participants were r and omized to a structured , moderate-intensity physical activity program ( n = 818 ) conducted in a center ( twice/wk ) and at home ( 3 - 4 times/wk ) that included aerobic , resistance , and flexibility training activities or to a health education program ( n = 817 ) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises . MAIN OUTCOMES AND MEASURES The primary outcome was major mobility disability objective ly defined by loss of ability to walk 400 m. RESULTS Incident major mobility disability occurred in 30.1 % ( 246 participants ) of the physical activity group and 35.5 % ( 290 participants ) of the health education group ( hazard ratio [ HR ] , 0.82 [ 95 % CI , 0.69 - 0.98 ] , P = .03).Persistent mobility disability was experienced by 120 participants ( 14.7 % ) in the physical activity group and 162 participants ( 19.8 % ) in the health education group ( HR , 0.72 [ 95 % CI , 0.57 - 0.91 ] ; P = .006 ) . Serious adverse events were reported by 404 participants ( 49.4 % ) in the physical activity group and 373 participants ( 45.7 % ) in the health education group ( risk ratio , 1.08 [ 95 % CI , 0.98 - 1.20 ] ) . CONCLUSIONS AND RELEVANCE A structured , moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability . These findings suggest mobility benefit from such a program in vulnerable older adults . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01072500",
"Abstract Perchthaler , D , Grau , S , and Hein , T. Evaluation of a 6-week whole-body vibration intervention on neuromuscular performance in older adults . J Strength Cond Res 29(1 ) : 86–95 , 2015— Research in the field of whole-body vibration ( WBV ) for the enhancement of neuromuscular performance is becoming increasingly popular . However , additional underst and ing of optimal WBV training protocol s is still necessary to develop optimal and effective training and prevention concepts , especially for elderly people . The intention of this study was to evaluate a 6-week WBV intervention program based on optimal vibration loads adapted from the literature on lower-limb strength parameters and performance , as well as on perceived exertion according to a subjective rating . A total of 21 older adults were allocated r and omly into either a WBV training or control group ( CO ) . Before and after the intervention period , jump height was measured during a countermovement jump . In addition , isolated isokinetic maximal knee extension and flexion strength , mean power , and work were recorded using a motor-driven dynamometer . Borg 's scale for rating of perceived exertion was used to evaluate the intensity of WBV exercises within each training session . After the intervention period , jump height increased by 18.55 % ( p isokinetic maximal strength , mean power , or work values in knee extension or flexion ( all p > 0.05 ) . Finally , the subjective perceived exertion of the WBV exercises and respective training parameters ranged between moderate rating levels of 7 and 13 of Borg 's scale . Our data show that WBV is a feasible and safe training program for elderly people to increase multijoint strength performance of the lower limbs during a countermovement jump . This could help to determine the potential of WBV programs in training of the elderly to prevent age-related reduction of neuromuscular performance"
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Background In the light of demographic developments health promotion interventions for older people are gaining importance . In addition to method ological challenges arising from the economic evaluation of health promotion interventions in general , there are specific method ological problems for the particular target group of older people . There are especially four main method ological challenges that are discussed in the literature . They concern measurement and valuation of informal caregiving , accounting for productivity costs , effects of unrelated cost in added life years and the inclusion of ‘ beyond-health ’ benefits . This paper focuses on the question whether and to what extent specific method ological requirements are actually met in applied health economic evaluations . Methods Following a systematic review of pertinent health economic evaluations , the included studies are analysed on the basis of four assessment criteria that are derived from method ological debates on the economic evaluation of health promotion interventions in general and economic evaluations targeting older people in particular . Results Of the 37 studies included in the systematic review , only very few include cost and outcome categories discussed as being of specific relevance to the assessment of health promotion interventions for older people . The few studies that consider these aspects use very heterogeneous methods , thus there is no common method ological st and ard . Conclusion There is a strong need for the development of guidelines to achieve better comparability and to include cost categories and outcomes that are relevant for older people . Disregarding these method ological obstacles could implicitly lead to discrimination against the elderly in terms of health promotion and disease prevention and , hence , an age-based rationing of public health care
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"Aims : There is ongoing debate over the effectiveness of preventive home visits ( PHVs ) for the elderly . A municipality in the north of Sweden carried out a controlled trial of such visits . Healthy seniors aged 75 years and over received two PHVs per year over 2 years . The aim of this study was to do a cost utility analysis of the intervention . Methods : The intervention group ( n=196 ) was compared with a control group ( n=346 ) , and a cost utility analysis was performed . The analysis was carried out with three different time perspectives . Data were source d from official documents and medical and social records . Results : From a societal perspective , using a time period of 4 years , the analysis of PHVs to healthy seniors showed net savings . When including estimated future costs for health and elderly care during gained life years , the result changed from a net saving to a cost of Euro 200,000 . A lifetime perspective also result ed in net savings if the costs of future health and elderly care were not included in the analysis . In this case , the total costs rose to approximately Euro 900,000 . The cost could also be expressed as Euro 14,200 per quality -adjusted life year gained if future costs for elderly care and healthcare were included . Conclusions : PHVs represent a cost-effective intervention in this setting . The costs are justified by the outcomes",
"Background : multifactorial falls prevention programmes for older people have been proved to reduce falls . However , evidence of their cost-effectiveness is mixed . Design : economic evaluation alongside pragmatic r and omised controlled trial . Intervention : r and omised trial of 364 people aged ≥70 , living in the community , recruited via GP and identified as high risk of falling . Both arms received a falls prevention information leaflet . The intervention arm were also offered a ( day hospital ) multidisciplinary falls prevention programme , including physiotherapy , occupational therapy , nurse , medical review and referral to other specialists . Measurements : self-reported falls , as collected in 12 monthly diaries . Levels of health re source use associated with the falls prevention programme , screening ( both attributed to intervention arm only ) and other health-care contacts were monitored . Mean NHS costs and falls per person per year were estimated for both arms , along with the incremental cost-effectiveness ratio ( ICER ) and cost effectiveness acceptability curve . Results : in the base-case analysis , the mean falls programme cost was £ 349 per person . This , coupled with higher screening and other health-care costs , result ed in a mean incremental cost of £ 578 for the intervention arm . The mean falls rate was lower in the intervention arm ( 2.07 per person/year ) , compared with the control arm ( 2.24 ) . The estimated ICER was £ 3,320 per fall averted . Conclusions : the estimated ICER was £ 3,320 per fall averted . Future research should focus on adherence to the intervention and an assessment of impact on quality of life ",
"OBJECTIVE To assess the incremental costs and cost effectiveness of implementing a home based muscle strengthening and balance retraining programme that reduced falls and injuries in older women . DESIGN An economic evaluation carried out within a r and omised controlled trial with two years of follow up . Participants were individually prescribed an exercise programme ( exercise group , n=116 ) or received usual care and social visits ( control group , n=117 ) . SETTING 17 general practice s in Dunedin , New Zeal and . PARTICIPANTS Women aged 80 years and older living in the community and invited by their general practitioner to take part . MAIN OUTCOME MEASURES Number of falls and injuries related to falls , costs of implementing the intervention , healthcare service costs result ing from falls and total healthcare service costs during the trial . Cost effectiveness was measured as the incremental cost of implementing the exercise programme per fall event prevented . MAIN RESULTS 27 % of total hospital costs during the trial were related to falls . However , there were no significant differences in health service costs between the two groups . Implementing the exercise programme for one and two years respectively cost $ 314 and $ 265 ( 1995 New Zeal and dollars ) per fall prevented , and $ 457 and $ 426 per fall result ing in a moderate or serious injury prevented . CONCLUSIONS The costs result ing from falls make up a substantial proportion of the hospital costs for older people . Despite a reduction in falls as a result of this home exercise programme there was no significant reduction in healthcare costs . However , the results reported will provide information on the cost effectiveness of the programme for those making decisions on falls prevention strategies",
"BACKGROUND Mild frailty or pre-frailty is common and yet is potentially reversible . Preventing progression to worsening frailty may benefit individuals and lower health/social care costs . However , we know little about effective approaches to preventing frailty progression . OBJECTIVES ( 1 ) To develop an evidence - and theory-based home-based health promotion intervention for older people with mild frailty . ( 2 ) To assess feasibility , costs and acceptability of ( i ) the intervention and ( ii ) a full-scale clinical effectiveness and cost-effectiveness r and omised controlled trial ( RCT ) . DESIGN Evidence review s , qualitative studies , intervention development and a feasibility RCT with process evaluation . INTERVENTION DEVELOPMENT Two systematic review s ( including systematic search es of 14 data bases and registries , 1990 - 2016 and 1980 - 2014 ) , a state-of-the-art review ( from inception to 2015 ) and policy review identified effective components for our intervention . We collected data on health priorities and potential intervention components from semistructured interviews and focus groups with older people ( aged 65 - 94 years ) ( n = 44 ) , carers ( n = 12 ) and health/social care professionals ( n = 27 ) . These data , and our evidence review s , fed into development of the ' HomeHealth ' intervention in collaboration with older people and multidisciplinary stakeholders . ' HomeHealth ' comprised 3 - 6 sessions with a support worker trained in behaviour change techniques , communication skills , exercise , nutrition and mood . Participants addressed self-directed independence and well-being goals , supported through education , skills training , enabling individuals to overcome barriers , providing feedback , maximising motivation and promoting habit formation . FEASIBILITY RCT Single-blind RCT , individually r and omised to ' HomeHealth ' or treatment as usual ( TAU ) . SETTING Community setting s in London and Hertfordshire , UK . PARTICIPANTS A total of 51 community-dwelling adults aged ≥ 65 years with mild frailty . MAIN OUTCOME MEASURES Feasibility - recruitment , retention , acceptability and intervention costs . Clinical and health economic outcome data at 6 months included functioning , frailty status , well-being , psychological distress , quality of life , capability and NHS and societal service utilisation/costs . RESULTS We successfully recruited to target , with good 6-month retention ( 94 % ) . Trial procedures were acceptable with minimal missing data . Individual r and omisation was feasible . The intervention was acceptable , with good fidelity and modest delivery costs ( £ 307 per patient ) . A total of 96 % of participants identified at least one goal , which were mostly exercise related ( 73 % ) . We found significantly better functioning ( Barthel Index + 1.68 ; p = 0.004 ) , better grip strength ( + 6.48 kg ; p = 0.02 ) , reduced psychological distress ( 12-item General Health Question naire -3.92 ; p = 0.01 ) and increased capability-adjusted life-years [ + 0.017 ; 95 % confidence interval ( CI ) 0.001 to 0.031 ] at 6 months in the intervention arm than the TAU arm , with no differences in other outcomes . NHS and carer support costs were variable but , overall , were lower in the intervention arm than the TAU arm . The main limitation was difficulty maintaining outcome assessor blinding . CONCLUSIONS Evidence is lacking to inform frailty prevention service design , with no large-scale trials of multidomain interventions . From stakeholder/public perspectives , new frailty prevention services should be personalised and encompass multiple domains , particularly socialising and mobility , and can be delivered by trained non-specialists . Our multicomponent health promotion intervention was acceptable and delivered at modest cost . Our small study shows promise for improving clinical outcomes , including functioning and independence . A full-scale individually RCT is feasible . FUTURE WORK A large , definitive RCT of the HomeHealth service is warranted . STUDY REGISTRATION This study is registered as PROSPERO CRD42014010370 and Current Controlled Trials IS RCT N11986672 . 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. 73 . See the NIHR Journals Library website for further project information",
"OBJECTIVE This longitudinal study was design ed to assess the effect of an educational training package for primary health care teams in accident prevention for older people , with reference to the incidence of accidents and their associated economic consequence . METHODS Nineteen general practice s in the West Midl and s serving a population of 138 397 were allocated r and omly at the practice level either to receive training or continue normal practice . Study data was collated from the initial telephone call , reporting an accident , to the surgery , advice/treatment given at the practice and /or the community , casualty , inpatient care , written correspondence to the patient 's GP and any subsequent follow-up visits for accidents to people aged 65 years or older . RESULTS One thous and , six hundred and sixty-six ( 8.2 % ) patients aged 65 years or older registered with the participating practice s experienced one accident or more , costing the NHS pound 1.4 million . Extrapolated nationally , annual costs to the NHS for accidents to older people amount to pound 568 million . The educational package had no significant impact on the incidence of accidents . A paucity of general safety advice was given [ 48 ( 1.8 % ) occasions ] . CONCLUSIONS Budgets are being eroded and patients are suffering unnecessarily due to lack of accident prevention advice . This should be considered a priority within the primary health care team . Educational packages alone do not appear to be a cost-effective approach to accident prevention in primary care",
"OBJECTIVES To perform an economic evaluation of a primary care-based physical activity counseling intervention that improved physical activity levels and rapid gait speed in older veterans . DESIGN Secondary objective of r and omized trial that assessed the effect of exercise counseling ( relative to usual care ) on physical performance , physical activity , function , disability , and medical re source use and cost . SETTING Veterans Affairs Medical Center , Durham , North Carolina . PARTICIPANTS Male veterans aged ≥70 years ( n = 398 ) . INTERVENTION An experienced health counselor provided baseline in-person exercise counseling , followed by telephone counseling at 2 , 4 , and 6 weeks , and monthly thereafter through one year . Each participant 's primary care physician provided initial endorsement of the intervention , followed by monthly automated telephone messages tailored to the patient . Individualized progress reports were mailed quarterly . MEASUREMENTS Intervention costs were assessed . Health care re source use and costs were estimated from enrollment through one year follow-up . The incremental cost of achieving clinical ly significant changes in major trial endpoints was calculated . RESULTS The total direct cost of the intervention per participant was $ 459 , 85 % of which was counselor effort . With overhead , program cost totaled $ 696 per participant . Medical costs during follow-up reached $ 10,418 with the intervention , versus $ 12,052 with usual care ( difference = -$1,634 ( 95 % confidence interval = -$4,683 to $ 1,416 ; P = .29 ) ) . Expressed in terms of short-term clinical outcomes , the intervention cost $ 4,971 per additional patient reaching target exercise levels , or $ 4,640 per patient achieving a clinical ly significant change in rapid gait speed . CONCLUSION Improvements in physical activity and rapid gait speed in the physical activity counseling group were obtained at a cost that represents a small fraction of patients ' annual health care costs",
"BACKGROUND Losing the ability to walk safely and independently is a major concern for many older adults . The Lifestyle Interventions and Independence for Elders study recently demonstrated that a physical activity ( PA ) intervention can delay the onset of major mobility disability . Our objective is to examine the re sources required to deliver the PA intervention and calculate the incremental cost-effectiveness compared with a health education intervention . METHODS The Lifestyle Interventions and Independence for Elders study enrolled 1,635 older adults at risk for mobility disability . They were recruited at eight field centers and r and omly assigned to either PA or health education . The PA program consisted of 50-minute center-based exercise 2 × weekly , augmented with home-based activity to achieve a goal of 150 min/wk of PA . Health education consisted of weekly workshops for 26 weeks , and monthly sessions thereafter . Analyses were conducted from a health system perspective , with a 2.6-year time horizon . RESULTS The average cost per participant over 2.6 years was US$ 3,302 and US$ 1,001 for the PA and health education interventions , respectively . PA participants accrued 0.047 per person more Quality -Adjusted Life-Years ( QALYs ) than health education participants . PA interventions costs were slightly higher than other recent PA interventions . The incremental cost-effectiveness ratios were US$ 42,376/major mobility disability prevented and US$ 49,167/QALY . Sensitivity analyses indicated that results were relatively robust to varied assumptions . CONCLUSIONS The PA intervention costs and QALYs gained are comparable to those found in other studies . The ICERS are less than many commonly recommended medical treatments . Implementing the intervention in non- research setting s may reduce costs further",
"Abstract Objectives to test whether an occupation-based lifestyle intervention can sustain and improve the mental well-being of adults aged 65 years or over compared to usual care , using an individually r and omised controlled trial . Participants 288 independently living adults aged 65 years or over , with normal cognition , were recruited from two UK sites between December 2011 and November 2015 . Interventions lifestyle Matters is a National Institute for Health and Care Excellence recommended multi-component preventive intervention design ed to improve the mental well-being of community living older people at risk of decline . It involves weekly group sessions over 4 months and one to one sessions . Main outcome measures the primary outcome was mental well-being at 6 months ( mental health ( MH ) dimension of the SF-36 ) . Secondary outcomes included physical health dimensions of the SF-36 , extent of depression ( PHQ-9 ) , quality of life ( EQ-5D ) and loneliness ( de Jong Gierveld Loneliness Scale ) , assessed at 6 and 24 months . Results data on 262 ( intervention = 136 ; usual care = 126 ) participants were analysed using intention to treat analysis . Mean SF-36 MH scores at 6 months differed by 2.3 points ( 95 CI : −1.3 to 5.9 ; P = 0.209 ) after adjustments . Conclusions analysis shows little evidence of clinical or cost-effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline . The results pose questions regarding how preventive interventions to promote well-being in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline . Trial Registration IS RCT N67209155",
"Background Falls among older people are of growing concern globally . Implementing cost-effective strategies for their prevention is of utmost importance given the ageing population and associated potential for increased costs of fall-related injury over the next decades . The purpose of this study was to undertake a cost-utility analysis and secondary cost-effectiveness analysis from a healthcare system perspective , of a group-based exercise program compared to routine care for falls prevention in an older community-dwelling population . Methods A decision analysis using a decision tree model was based on the results of a previously published r and omised controlled trial with a community-dwelling population aged over 70 . Measures of falls , fall-related injuries and re source use were directly obtained from trial data and supplemented by literature -based utility measures . A sub-group analysis was performed of women only . Cost estimates are reported in 2010 British Pound Sterling ( GBP ) . Results The ICER of GBP£51,483 per QALY for the base case analysis was well above the accepted cost-effectiveness threshold of GBP£20,000 to £ 30,000 per QALY , but in a sensitivity analysis with minimised program implementation the incremental cost reached GBP£25,678 per QALY . The ICER value at 95 % confidence in the base case analysis was GBP£99,664 per QALY and GBP£50,549 per QALY in the lower cost analysis . Males had a 44 % lower injury rate if they fell , compared to females result ing in a more favourable ICER for the women only analysis . For women only the ICER was GBP£22,986 per QALY in the base case and was below the cost-effectiveness threshold for all other variations of program implementation . The ICER value at 95 % confidence was GBP£48,212 in the women only base case analysis and GBP£23,645 in the lower cost analysis . The base case incremental cost per fall averted was GBP£652 ( GBP£616 for women only ) . A threshold analysis indicates that this exercise program can not realistically break even . Conclusions The results suggest that this exercise program is cost-effective for women only . There is no evidence to support its cost-effectiveness in a group of mixed gender unless the costs of program implementation are minimal . Conservative assumptions may have underestimated the true cost-effectiveness of the program",
"OBJECTIVES To model the incremental cost-utility of seven interventions reported as effective for preventing falls in older adults . DESIGN Mathematical epidemiological model populated by data based on direct clinical experience and a critical review of the literature . SETTING Model represents population level interventions . PARTICIPANTS No human subjects were involved in the study . MEASUREMENS : The last Cochrane data base review and meta-analyses of r and omized controlled trials categorized effective fall-prevention interventions into seven groups : medical management ( withdrawal ) of psychotropics , group tai chi , vitamin D supplementation , muscle and balance exercises , home modifications , multifactorial individualized programs for all elderly people , and multifactorial individualized treatments for high-risk frail elderly people . Fall-related hip fracture incidence was obtained from the literature . Salary figures for health professionals were based on Bureau of Labor Statistics data . Using an integrated healthcare system perspective , healthcare costs were estimated based on practice and studies on falls in older adults . Base case incremental cost utility ratios were calculated , and probabilistic sensitivity analyses were conducted . RESULTS Medical management of psychotropics and group tai chi were the least-costly , most-effective options , but they were also the least studied . Excluding these interventions , the least-expensive , most-effective options are vitamin D supplementation and home modifications . Vitamin D supplementation costs less than home modifications , but home modifications cost only $ 14,794/ quality -adjusted life year ( QALY ) gained more than vitamin D. In probabilistic sensitivity analyses excluding management of psychotropics and tai chi , home modification is most likely to have the highest economic benefit when QALYs are valued at $ 50,000 or $ 100,000 . CONCLUSION Of single interventions studied , management of psychotropics and tai chi reduces costs the most . Of more-studied interventions , home modifications provide the best value . These results must be interpreted in the context of the multifactorial nature of falls",
"Objective : To assess the cost effectiveness of a community based exercise programme as a population wide public health intervention for older adults . Design : Pragmatic , cluster r and omised community intervention trial . Setting : 12 general practice s in Sheffield ; four r and omly selected as intervention population s , and eight as control population s. Participants : All those aged 65 and over in the least active four fifths of the population responding to a baseline survey . There were 2283 eligible participants from intervention practice s and 4137 from control practice s. Intervention : Eligible subjects were invited to free locally held exercise classes , made available for two years . Main outcome measures : All cause and exercise related cause specific mortality and hospital service use at two years , and health status assessed at baseline , one , and two years using the SF-36 . A cost utility analysis was also undertaken . Results : Twenty six per cent of the eligible intervention practice population attended one or more exercise sessions . There were no significant differences in mortality rates , survival times , or admissions . After adjusting for baseline characteristics , patients in intervention practice s had a lower decline in health status , although this reached significance only for the energy dimension and two composite scores ( p incremental average QALY gain of 0.011 per person in the intervention population result ed in an incremental cost per QALY ratio of € 17 174 ( 95 % CI = € 8300 to € 87 120 ) . Conclusions : Despite a low level of adherence to the exercise programme , there were significant gains in health related quality of life . The programme was more cost effective than many existing medical interventions , and would be practical for primary care commissioning agencies to implement",
"We examined the costs of a physical activity ( PA ) and an educational comparison intervention . 424 older adults at risk for mobility disability were r and omly assigned to either condition . The PA program consisted of center-based exercise sessions 3x weekly for 8 weeks , 2x weekly for weeks 9 to 24 and weekly behavioral counseling for 10 weeks . Optional sessions were offered during maintenance weeks ( 25 - 52 ) . The comparison intervention consisted of weekly education meetings for 24 weeks , and then monthly for 6 months . Cost analyses were conducted from the \" payer 's \" perspective , with a 1-year time horizon . Intervention costs were estimated by tracking personnel activities and material s used for each intervention and multiplying by national unit cost averages . The average cost/participant was $ 1134 and $ 175 for the PA and the comparison interventions , respectively . A preliminary cost/effectiveness analysis gauged the cost/disability avoided to be $ 28,206 . Costs for this PA program for older adults are comparable to those of other PA interventions . The results are preliminary and a longer study is required to fully assess the costs and health benefits of these interventions",
"This prospect i ve observational data collection study assessed the cost and quality of life related to hip , vertebral and wrist fracture 1 year after the fracture , based on a patient sample consisting of 635 male and female patients surviving a year after fracture . Data regarding re source use and quality of life related to fractures was collected by question naires at baseline , 4 months and 12 months . Information was collected by the use of patients ’ records , register sources and by asking the patient . Quality of life was estimated with the EQ-5D question naire . Costs were estimated from a societal perspective , including direct and indirect costs . The mean fracture-related cost the year after a hip , vertebral and wrist fracture were estimated , in euros ( € ) , at € 14,221 , € 12,544 and € 2,147 , respectively [ converted from Swedish krona ( SEK ) at an exchange rate of 9.1268 SEK/€ ] . The mean reduction in quality of life was estimated at 0.17 , 0.26 and 0.06 for hip , vertebral and wrist fracture , respectively . Based on the results , the yearly burden of osteoporosis in Sweden could be estimated at € 0.5 billion ( SEK 4.6 billion ) . The patient sample for vertebral fracture was fairly small and included a high proportion of fractures leading to hospitalization , but they indicate a higher cost and loss of quality of life related to vertebral fracture than previously perceived",
"INTRODUCTION One out of three persons aged 65 and older falls annually and 20 % to 30 % of falls result in injury . The purpose of this cost-benefit analysis was to identify community-based fall interventions that were feasible , effective , and provided a positive return on investment ( ROI ) . METHODS A third-party payer perspective was used to determine the costs and benefits of three effective fall interventions . Intervention effectiveness was based on r and omized controlled trial results . National data were used to estimate the average annual benefits from averting the direct medical costs of a fall . The net benefit and ROI were estimated for each of the interventions . RESULTS For the Otago Exercise Program delivered to persons aged 65 and older , the net benefit was $ 121.85 per participant and the ROI was 36 % for each dollar invested . For Otago delivered to persons aged 80 and older , the net benefit was $ 429.18 and the ROI was 127 % . Tai chi : Moving for Better Balance had a net benefit of $ 529.86 and an ROI of 509 % and Stepping On had a net benefit of $ 134.37 and an ROI of 64 % . CONCLUSIONS All three fall interventions provided positive net benefits . The ROIs showed that the benefits not only covered the implementation costs but also exceeded the expected direct program delivery costs . These results can help health care funders and other community organizations select appropriate and effective fall interventions that also can provide positive returns on investment",
"OBJECTIVES Multidisciplinary and multifactorial interventions seem to be effective in preventing falls . We aim ed to assess the cost-effectiveness of a multidisciplinary fall prevention program compared with usual Dutch healthcare in community-dwelling people 65 years of age or older who experienced a fall . METHODS Cost-effectiveness and cost-utility analysis were performed from a societal perspective . Falls and healthcare utilization were continuously measured for 12 months . Daily functioning and quality of life were measured at baseline , after 4 and 12 months . Bootstrap analyses were performed to estimate uncertainty of the findings and sensitivity analysis to assess the generalizability of assumptions made . RESULTS One hundred sixty-six participants were r and omly allocated to the experimental group and 167 to the control group . The overall response rate was 74 percent . Healthcare and patient and family costs of both groups were comparable . Our analyses showed no effect of the intervention program on falls , daily functioning , or quality of life measures . CONCLUSIONS The multidisciplinary intervention program to prevent falls was not cost-effective compared with usual care in the Netherl and s. Notwithst and ing our findings , however , falls still have an important impact on society and individuals in terms of costs and effects . Economic evaluations study ing promising interventions to prevent falls , therefore , remain necessary",
"Summary The purpose of this study was to analyze the cost-effectiveness of a multifactorial fall prevention program in nursing home residents . Given a willingness-to-pay ( WTP ) of 50,000 EUR per year free of femoral fracture , the probability that the intervention is cost-effective is 83 % . Introduction Despite their increased risk of falls and fractures , nursing home residents have been neglected in economic evaluations of fall prevention programs so far . The purpose of this study was to analyze , for the first time , the cost-effectiveness of a multifactorial fall prevention program in nursing home residents . Methods This study is part of a prospect i ve , unblinded , cluster , nonr and omized , controlled study focusing on the transfer of an efficacious fall prevention program into a real-world setting . The analyzed sub sample was derived from cl aims data and consisted of data on intervention ( n = 256 , residents n = 10,178 ) and control homes ( n = 893 , residents n = 22,974 ) , representing all insurants of a sickness fund ( AOK Bavaria , Germany ) who were 65 years or older , residing in a nursing home on the 31st of March 2007 and had a level of care of ≥1 according to the classification of the statutory long-term care insurance . Time free of femoral fracture ( ICD-10 , S72 ) was used as measure of health effects . Femoral fracture-related costs and intervention costs were measured from a payer perspective . Multivariate regression models were applied . Sensitivity analyses were performed and cost-effectiveness acceptability curves computed . Results Within the first year of the intervention , femoral fracture rate was significantly reduced , result ing in a nonsignificant incremental mean time of 1.41 days free of femoral fracture . Incremental mean total direct costs were 29 EUR per resident , which was not significant . The incremental cost-effectiveness ratio ( ICER ) was 7,481 EUR per year free of femoral fracture . The probability of an ICER of femoral fracture was 83 % . Conclusion Depending on the amount the decision-maker is willing to pay for the incremental effect , the fall prevention program might be cost-effective within the first year . Future studies should exp and the range of costs and effects measured",
"We evaluated the cost effectiveness of preventive home visits to elderly persons in Denmark alongside a 3-year r and omized controlled study . The main outcome measure was incremental costs per active life-year gained . The number of active life-years was defined as those during which the person is able independently to transfer , walk indoors , go outdoors , walk outdoors in both pleasant and poor weather , and climb stairs . In 17 of 34 municipalities health visitors and general practitioners were offered geriatric training , which focused on early signs of disability , physical activity , and interdisciplinary follow-up . The remaining 17 municipalities offered preventive home visits as usual . Outcomes were measured in 4,034 persons aged 75 or 80 years old and dwelling at home . The difference in mean total costs between the intervention and the control group discounted at 3 % was € −856 ( 95 % CI −2,455 to 744 ) in 75-year-olds and € 694 ( −2,684 to 4,071 ) in 80-year-olds . The discounted difference in mean active life-years was 0.034 ( −0.058 to 0.125 ) and 0.197 ( 0.013 to 0.380 ) , respectively . The study did not provide conclusive evidence on the cost effectiveness of the programs under consideration",
"Abstract Objectives : To assess the effectiveness of a trained district nurse individually prescribing a home based exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme . Design : R and omised controlled trial with one year 's follow up . Setting : Community health service at a New Zeal and hospital . Participants : 240 women and men aged 75 years and older . Intervention : 121 participants received the exercise programme ( exercise group ) and 119 received usual care ( control group ) ; 90 % ( 211 of 233 ) completed the trial . Main outcome measures : Number of falls , number of injuries result ing from falls , costs of implementing the programme , and hospital costs as a result of falls . Results : Falls were reduced by 46 % ( incidence rate ratio 0.54 , 95 % confidence interval 0.32 to 0.90 ) . Five hospital admissions were due to injuries caused by falls in the control group and none in the exercise group . The programme cost $ NZ1803 ( £ 523 ) ( at 1998 prices ) per fall prevented for delivering the programme and $ NZ155 per fall prevented when hospital costs averted were considered . Conclusion : A home exercise programme , previously shown to be successful when delivered by a physiotherapist , was also effective in reducing falls when delivered by a trained nurse from within a home health service . Serious injuries and hospital admissions due to falls were also reduced . The programme was cost effective in participants aged 80 years and older compared with younger participants",
"Abstract Objectives : To assess the effectiveness of trained nurses based in general practice s individually prescribing a home exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme . Design : Controlled trial with one year 's follow up . Setting : 32 general practice s in seven southern New Zeal and centres . Participants : 450 women and men aged 80 years and older . Intervention : 330 participants received the exercise programme ( exercise centres ) and 120 received usual care ( control centres ) ; 87 % ( 371 of 426 ) completed the trial . Main outcome measures : Number of falls , number of injuries result ing from falls , costs of implementing the programme , and hospital costs as a result of falls . Results : Falls were reduced by 30 % in the exercise centres ( incidence rate ratio 0.70 , 95 % confidence interval 0.59 to 0.84 ) . The programme was equally effective in men and women . The programme cost $ NZ418 ( £ 121 ) ( at 1998 prices ) per person to deliver for one year or $ NZ1519 ( £ 441 ) per fall prevented . Fewer participants had falls result ing in injuries , but there was no difference in the number who had serious injuries and no difference in hospital costs result ing from falls in exercise centres compared with control centres . Conclusions : An individually tailored exercise programme , delivered by trained nurses from within general practice s , was effective in reducing falls in three different centres . This strategy should be combined with other successful interventions to form part of home programmes to prevent falls in elderly people",
"Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care . Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster r and omized trial with one-year follow-up . Participants were aged ≥ 70 years and at increased risk of functional decline . Participants in the intervention group ( n = 1209 ) received a comprehensive geriatric assessment and individually tailored multifactorial interventions coordinated by a community-care registered nurse with multiple follow-up visits . The control group ( n = 1074 ) received usual care . Costs were assessed from a healthcare perspective . Outcome measures included disability ( modified Katz-Activities of Daily Living ( ADL ) index score ) , and quality -adjusted life-years ( QALYs ) . Statistical uncertainty surrounding Incremental Cost-Effectiveness Ratios ( ICERs ) was estimated using bootstrapped bivariate regression models while adjusting for confounders . Results There were no statistically significant differences in Katz-ADL index score and QALYs between the two groups . Total mean costs were significantly higher in the intervention group ( EUR 6518 ( SE 472 ) compared with usual care ( EUR 5214 ( SE 338 ) ; adjusted mean difference € 1457 ( 95 % CI : 572 ; 2537 ) . Cost-effectiveness acceptability curves showed that the maximum probability of the intervention being cost-effective was 0.14 at a willingness to pay ( WTP ) of EUR 50,000 per one point improvement on the Katz-ADL index score and 0.04 at a WTP of EUR 50,000 per QALY gained . Conclusion The current intervention was not cost-effective compared to usual care to prevent or postpone new disabilities over a one-year period . Based on these findings , implementation of the evaluated multifactorial nurse-led care model is not to be recommended",
"BACKGROUND Regular physical activity ( PA ) reduces the risk of falls and hip fractures , and mortality from all causes . However , PA levels are low in the older population and previous intervention studies have demonstrated only modest , short-term improvements . OBJECTIVE To evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years . DESIGN The ProAct65 + study was a pragmatic , three-arm parallel design , cluster r and omised controlled trial of class-based exercise [ Falls Management Exercise ( FaME ) programme ] , home-based exercise [ Otago Exercise Programme ( OEP ) ] and usual care among older people ( aged ≥ 65 years ) in primary care . SETTING Forty-three UK-based general practice s in London and Nottingham/Derby . PARTICIPANTS A total of 1256 people ≥ 65 years were recruited through their general practice s to take part in the trial . INTERVENTIONS The FaME programme and OEP . FaME included weekly classes plus home exercises for 24 weeks and encouraged walking . OEP included home exercises supported by peer mentors ( PMs ) for 24 weeks , and encouraged walking . MAIN OUTCOME MEASURES The primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity ( MVPA ) per week , 12 months after cessation of the intervention . Secondary outcomes included functional assessment s of balance and falls risk , the incidence of falls , fear of falling , quality of life , social networks and self-efficacy . An economic evaluation including participant and NHS costs was embedded in the clinical trial . RESULTS In total , 20,507 patients from 43 general practice s were invited to participate . Expressions of interest were received from 2752 ( 13 % ) and 1256 ( 6 % ) consented to join the trial ; 387 were allocated to the FaME arm , 411 to the OEP arm and 458 to usual care . Primary outcome data were available at 12 months after the end of the intervention period for 830 ( 66 % ) of the study participants . The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40 % to 49 % in the FaME arm , from 41 % to 43 % in the OEP arm and from 37.5 % to 38.0 % in the usual-care arm . A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [ adjusted odds ratio ( AOR ) 1.78 , 95 % confidence interval ( CI ) 1.11 to 2.87 ; p = 0.02 ] . There was no significant difference in MVPA between OEP and usual care ( AOR 1.17 , 95 % CI 0.72 to 1.92 ; p = 0.52 ) . Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level . In the 12 months after the close of the intervention phase , there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm ( incidence rate ratio 0.74 , 95 % CI 0.55 to 0.99 ; p = 0.042 ) . Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care , as did perceptions of benefits from exercise . Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm . There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes , including quality -adjusted life-years . FaME is more expensive than OEP delivered with PMs ( £ 269 vs. £ 88 per participant in London ; £ 218 vs. £ 117 in Nottingham ) . The cost per extra person exercising at , or above , target was £ 1919.64 in London and £ 1560.21 in Nottingham ( mean £ 1739.93 ) . CONCLUSION The FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention , and significantly reduced falls . Both the FaME and OEP interventions appeared to be safe , with no significant differences in adverse reactions between study arms . TRIAL REGISTRATION This trial is registered as IS RCT N43453770 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 18 , No. 49 . See the NIHR Journals Library website for further project information",
"BACKGROUND : The effectiveness of individual components ( other than exercise ) of multifactorial intervention packages aim ed to reduce the incidence of falls in older people is uncertain . There have been no r and omised trials of home modifications alone for the prevention of falls"
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Gender differences in substance use/abuse have been the focus of research in the last 15 years . Initiation , use patterns , acceleration of disease course , and help-seeking patterns are known to be influenced by gender differences with regard to biological , psychological , cultural and socioeconomic factors . This paper presents a systematic review of published data on gender differences in the use/abuse of psychoactive and psychotic drugs , focusing on the importance of a multidisciplinary approach . The basis for this paper was obtained by Medline search es using the search terms " human " and " gender " , combined with individual drug names or " drugs of abuse " . The reference lists of these papers were further checked for other relevant studies . The gender difference in drug abuse is more evident in adults than in adolescents ( 13 - 19 years ) : adult men are 2 - 3 times more likely than women to develop drug abuse/dependence disorders and approximately 4 times as likely to have an alcohol use disorder . Such prevalence rates have not been observed in adolescents . Differences between men and women involve : ( i ) the biological response to the drug , ( ii ) the progression to drug dependence , and ( iii ) the comorbid psychiatric diagnoses , which may be due to both sociocultural factors and innate biological differences . A crucial role played by ovarian hormones ( oestrogens and progesterone ) has been documented in both human and animal model studies . Epidemiological data on how particular psychobiological and physiological characteristics in females influence vulnerability to both drug addiction and toxicological consequences of drugs are still in their infancy . Significant gaps remain in our knowledge , which are primarily attributable to the lack of empirical data that only a systematic and multidisciplinary approach to the topic can generate . The introduction of gender into forensic toxicological evaluations may help eluci date the relationship between the body 's absorption of abused drugs ( alone or in combination ) and the onset of intoxications , both lethal and none
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"Smoking a single 1-g marihuana cigarette containing 1.8 % delta 9-tetrahydrocannabinol induced a 30 % suppression of plasma luteinizing hormone levels ( P less than .02 ) in women during the luteal phase of the menstrual cycle . After marihuana placebo cigarette smoking , no luteinizing hormone suppression was observed in the same women under double-blind conditions . Marihuana may have adverse effects upon reproductive function during the luteal phase of the menstrual cycle as a consequence of gonadotropin inhibition",
"OBJECTIVES Fluctuations in progesterone levels during the menstrual cycle have been shown to affect physiological and subjective effects of cocaine . Furthermore , our laboratory has demonstrated that following drug-cue exposure , cocaine dependent women with high levels of circulating progesterone display lower diastolic and systolic blood pressure responses and report lower levels of anxiety and drug craving compared to cocaine dependent women with low levels of progesterone . In the current study we examined the role of the progesterone derived neuroactive steroid allopregnanolone ( ALLO ) on stress arousal , inhibitory control and drug craving in cocaine dependent subjects . METHODS Plasma levels of ALLO were measured using GC/MS in 46 treatment-seeking cocaine dependent men and women on day 5 of a 7-day treatment regimen of micronized progesterone ( 15M/8F ) ( 400mg/day ) or placebo ( 14M/9F ) administered in a double blind , r and omized manner . As a control , levels of the testosterone derived neurosteroid and rostanediol ( ADIOL ) were also measured . All subjects participated in laboratory sessions on days 5 - 7 of progesterone/placebo administration in which they were exposed to a series of 5-min personalized guided imagery of either a stressful situation , cocaine use or of a neutral setting and dependent variables including subjective craving , mood , Stroop task as a measure of inhibitory control performance and plasma cortisol were assessed . Participants were grouped by high or low ALLO level and levels of dependent variables compared between ALLO groups . RESULTS Progesterone relative to placebo significantly increased ALLO levels with no sex differences . There were no effects of micronized progesterone on the testosterone derived ADIOL . Individuals in the high versus the low ALLO group showed decreased levels of cortisol at baseline , and a higher cortisol response to stress ; higher positive mood scores at baseline and improved Stroop performance in the drug-cue and stress conditions , and reduced cocaine craving across all imagery conditions . CONCLUSIONS As expected , cocaine dependent individuals administered progesterone showed significantly higher ALLO plasma levels . High levels of ALLO appeared to normalize basal and stress response levels of cortisol , decrease cocaine craving and also contribute to improvements in positive emotion and Stroop performance in response to stress and drug-cue exposures . These findings suggest that the neuroactive steroid ALLO plays a significant role in mediating the positive effects of progesterone on stress arousal , cognitive performance and drug craving in cocaine dependence"
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4116d580-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The proportion of total healthcare expenditures spent on drugs has continued to grow in countries of all income categories . Policy-makers are under pressure to control pharmaceutical expenditures without adversely affecting quality of care . Financial incentives seeking to influence prescribers ' behaviour include budgetary arrangements at primary care and hospital setting s ( pharmaceutical budget caps or targets ) , financial rewards for target behaviours or outcomes ( pay for performance interventions ) and reduced benefit margin for prescribers based on medicine sales and prescriptions ( pharmaceutical reimbursement rate reduction policies ) . This is the first up date of the original version of this review . OBJECTIVES To determine the effects of pharmaceutical policies using financial incentives to influence prescribers ' practice s on drug use , healthcare utilisation , health outcomes and costs ( expenditures ) . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) ( search ed 29/01/2015 ) ; MEDLINE , Ovid SP ( search ed 29/01/2015 ) ; EMBASE , Ovid SP ( search ed 29/01/2015 ) ; International Network for Rational Use of Drugs ( INRUD ) Bibliography ( search ed 29/01/2015 ) ; National Health Service ( NHS ) Economic Evaluation Data base ( search ed 29/01/2015 ) ; EconLit - ProQuest ( search ed 02/02/2015 ) ; and Science Citation Index and Social Sciences Citation Index , Institute for Scientific Information ( ISI ) Web of Knowledge ( citation search for included studies search ed 10/02/2015 ) . We screened the reference lists of relevant reports and contacted study authors and organisations to identify additional studies . SELECTION CRITERIA We included policies that intend to affect prescribing by means of financial incentives for prescribers . Included in this category are pharmaceutical budget caps or targets , pay for performance and drug reimbursement rate reductions and other financial policies , if they were specifically targeted at prescribing or drug utilisation . Policies in this review were defined as laws , rules , regulations and financial and administrative orders made or implemented by payers such as national or local governments , non-government organisations , private or social insurers and insurance-like organisations . One of the following outcomes had to be reported : drug use , healthcare utilisation , health outcomes or costs . The study had to be a r and omised or non-r and omised trial , an interrupted time series ( ITS ) analysis , a repeated measures study or a controlled before-after ( CBA ) study . DATA COLLECTION AND ANALYSIS At least two review authors independently assessed eligibility for inclusion of studies and risks of bias using Cochrane Effective Practice and Organisation of Care ( EPOC ) criteria and extracted data from the included studies . For CBA studies , we reported relative effects ( e.g. adjusted relative change ) . The review team re-analysed all ITS results . When possible , the review team also re-analysed CBA data as ITS data . MAIN RESULTS Eighteen evaluations ( six new studies ) of pharmaceutical policies from six high-income countries met our inclusion criteria . Fourteen studies evaluated pharmaceutical budget policies in the UK ( nine studies ) , two in Germany and Irel and and one each in Sweden and Taiwan . Three studies assessed pay for performance policies in the UK ( two ) and the Netherl and s ( one ) . One study from Taiwan assessed a reimbursement rate reduction policy . ITS analyses had some limitations . All CBA studies had serious limitations . No study from low-income or middle-income countries met the inclusion criteria .Pharmaceutical budgets may lead to a modest reduction in drug use ( median relative change -2.8 % ; low-certainty evidence ) . We are uncertain of the effects of the policy on drug costs or healthcare utilisation , as the certainty of such evidence has been assessed as very low . Effects of this policy on health outcomes were not reported . Effects of pay for performance policies on drug use and health outcomes are uncertain , as the certainty of such evidence has been assessed as very low . Effects of this policy on drug costs and healthcare utilisation have not been measured . Effects of the reimbursement rate reduction policy on drug use and drug costs are uncertain , as the certainty of such evidence has been assessed as very low . No included study assessed the effects of this policy on healthcare utilisation or health outcomes . Administration costs of the policies were not reported in any of the included studies . AUTHORS ' CONCLUSIONS Although financial incentives are considered an important element in strategies to change prescribing patterns , limited evidence of their effects can be found . Effects of policies , including pay for performance policies , in improving quality of care and health outcomes remain uncertain . Because pharmaceutical policies have uncertain effects , and because they might cause harm as well as benefit , proper evaluation of these policies is needed . Future studies should consider the impact of these policies on health outcomes , drug use and overall healthcare expenditures , as well as on drug expenditures
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"BACKGROUND Generic dispensing ratio ( GDR ) is an important measure of efficiency in pharmacy benefit management . A few studies have examined the effects of academic detailing or generic drug sample s on GDR . On July 1 , 2007 , a physician-hospital organization ( PHO ) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts . No published studies have examined the role of generic medication vouchers in promoting generic drug utilization . OBJECTIVE To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone . METHODS The intervention took place over the 9-month period from July 1 , 2007 , through March 31 , 2008 . Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain . The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians ( 900 primary care providers [ PCPs ] and 2,000 specialists ) . Of the approximately 300 PCP practice s , 21 practice s with at least 2 physicians each were selected on the basis of high prescription volume ( more than 500 pharmacy cl aims for the practice over a 12-month pre-baseline period ) and low GDR ( practice GDR less than 55 % in the 12-month pre-baseline period ) . These 21 practice s were then r and omized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers . One of 10 intervention groups declined to participate , and 2 of 11 control groups dropped out of the PHO . GDR was calculated monthly for all pharmacy cl aims including the 8 voucher medications . GDR was defined as the ratio of the total number of paid generic pharmacy cl aims divided by the total number of paid pharmacy cl aims for 108 prescriber identification numbers ( Drug Enforcement Administration [ DEA ] or National Provider Identifier [ NPI ] ) for 9 intervention groups [ n = 53 PCPs ] and 9 control groups [ n = 55 PCPs ] ) . For both intervention and control arms , the GDR for each month from July 2007 ( start of 2007 Q3 , intervention start date ) through September 2008 ( end of 2008 Q3 , 6 months after intervention end date ) was compared with the same month in the previous year . A descriptive analysis compared a 9-month baseline period from 2006 Q3 through 2007 Q1 with a 9-month voucher period from 2007 Q3 to 2008 Q1 . A panel data regression analysis assessed GDR for 18 practice s over 27 months ( 12 months pre-intervention and 15 months post-intervention ) . RESULTS A total of 656 vouchers were redeemed over the 9-month voucher period from July 1 , 2007 , through March 31 , 2008 , for an average of about 12 vouchers per participating physician ; approximately one-third of the redeemed vouchers were for generic simvastatin . The GDR increase for all drugs , including the 8 voucher drugs , was 7.4 points for the 9 PCP group practice s with access to generic medication vouchers , from 53.4 % in the 9-month baseline period to 60.8 % in the 9-month voucher period , compared with a 6.2 point increase for the control group from 55.9 % during baseline to 62.1 % during the voucher period . The panel data regression model estimated that the medication voucher program was associated with a 1.77-point increase in overall GDR compared with academic detailing alone ( P = 0.047 ) . CONCLUSION Compared with academic detailing alone , a generic medication voucher program providing a 30-day supply of 8 specific medications in addition to academic detailing in PCP groups with low GDR and high prescribing volume in an outpatient setting was associated with a small but statistically significant increase in adjusted overall GDR ",
"Abstract Objective To compare the results of a r and omised and an observational evaluation of the same policy that restricted reimbursement for nebulised respiratory medications in adult patients in a community setting . Design s Cluster r and omised controlled trial and observational time series with historical controls . Setting Pharmacare , the government funded drug benefits plan for elderly people and patients receiving social assistance in British Columbia , Canada . Participants In the r and omised controlled trial 104 clusters of medical practice s , pair matched by geography and approximately by practice size , were r and omised to the intervention group ( 449 patients affected by the policy on 1 March 1999 ) , and the control group ( offered a six month exemption , affecting 386 patients ) . The observational analysis included all Pharmacare beneficiaries ( excluding the 386 exempt patients ) who had used any nebulised drugs six months before the policy ( 4624 patients ) . Intervention Pharmacare restricted reimbursement for nebulised bronchodilators , steroids , and cromoglycate to patients whose doctors applied for an individual patient 's exemption , giving an appropriate clinical reason . Main outcome measures Number of contacts with doctors and services , emergency admissions to hospital , and utilisation of and expenditure for respiratory drugs in data bases of British Columbia 's Ministry of Health . Results Contacts with doctors or emergency admissions to hospital did not increase in association with the restriction , regardless of the analytical approach . In the observational analysis , we found a reduction of $ C24 per patient month in all nebulised drug use ( 95 % confidence interval 19 to 29 ) and an increase of $ C3 per patient month in all expenditure for inhalers ( 1.4 to 4.5 ) . The r and omised evaluation found savings of $ C8 per patient month for nebulisers ( P = 0.24 ) and no increase in spending on inhalers ( P = 0.79 ) . Correcting for 60 % non-compliance by exempt doctors in a sensitivity analysis yielded similar results as the observational evaluation . Conclusions Observational as well as r and omised analyses found moderate net savings and no increase in unintended healthcare outcomes after restricting reimbursement for nebulised respiratory drugs . R and omised policy trials are feasible and , if carefully implemented , likely to be concordant with observational evaluations",
"Background Official guidelines that promote evidence -based and cost-effective prescribing are of main relevance for obvious reasons . However , to what extent these guidelines are followed and their conditioning factors at different levels of the health care system are still insufficiently known . In January 2004 , a de central ized drug budget was implemented in the county of Scania , Sweden . Focusing on lipid-lowering drugs ( i.e. , statins ) , we evaluated the effect of this intervention across a 25-month period . We expected that increased local economic responsibility would promote prescribing of recommended statins . Methods We performed two separate multilevel regression analyses ; on 110 827 individual prescriptions issued at 136 publicly-administered health care centres ( HCCs ) nested within 14 administrative areas ( HCAs ) , and on 72 012 individual prescriptions issued by 115 privately-administered HCCs . Temporal trends in the prevalence of prescription of recommended statins were investigated by r and om slope analysis . Differences ( i.e. , variance ) between HCCs and between HCAs were expressed by median odds ratio ( MOR ) . Results After the implementation of the de central ized drug budget , adherence to guidelines increased continuously . At the end of the observation period , however , practice variation remained high . Prescription of recommended statins presented a high degree of clustering within both publicly ( i.e. , MORHCC = 2.18 and MORHCA = 1.31 respectively ) and privately administered facilities ( MORHCC = 3.47 ) . Conclusion A de central ized drug budget seems to promote adherence to guidelines for statin prescription . However , the high practice differences at the end of the observation period may reflect inefficient therapeutic traditions , and indicates that rational statin prescription could be further improved",
"CONTEXT Maintenance antidepressant pharmacotherapy in late life prevents recurrent episodes of major depression . The coverage gap in Medicare Part D could increase the likelihood of reducing appropriate use of antidepressants , thereby exposing older adults to an increased risk for relapse of depressive episodes . OBJECTIVES To determine whether ( 1 ) beneficiaries reduce antidepressant use in the gap , ( 2 ) the reduction in antidepressant use is similar to the reduction in heart failure medications and antidiabetics , ( 3 ) the provision of generic coverage reduces the risk of reduction of medication use , and ( 4 ) medical spending increases in the gap . DESIGN Observational before-after study with a comparison group design . SETTING AND PATIENTS A 5 % r and om sample of US Medicare beneficiaries 65 years or older with depression ( n = 65,223 ) enrolled in st and -alone Part D plans in 2007 . MAIN OUTCOME MEASURES Antidepressant pharmacotherapy , physician , outpatient , and inpatient spending . RESULTS Being in the gap was associated with comparable reductions in the use of antidepressants , heart failure medications , and antidiabetics . Relative to the comparison group ( those who had full coverage in the gap because of Medicare coverage or low-income subsidies ) , the no-coverage group reduced their monthly antidepressant prescriptions by 12.1 % ( 95 % CI , 9.9%-14.3 % ) from the pregap level , whereas they reduced use of heart failure drugs and antidiabetics by 12.9 % and 13.4 % , respectively . Those with generic drug coverage in the gap reduced their monthly antidepressant prescriptions by 6.9 % ( 95 % CI , 4.8%-9.1 % ) ; this decrease was entirely attributable to the reduction in the use of br and -name antidepressants . Medicare spending on medical care did not increase for either group relative to the comparison group . CONCLUSIONS The Medicare Part D coverage gap was associated with modest reductions in the use of antidepressants . Those with generic coverage reduced their use of br and -name drugs and did not switch from br and -name to generic drugs . The reduction in antidepressant use was not associated with an increase in nondrug medical spending",
"Background The UK 's Quality and Outcomes Framework ( QOF ) was introduced in 2004/5 , linking remuneration for general practice s to recorded quality of care for chronic conditions , including diabetes mellitus . We assessed the effect of the incentives on recorded quality of care for diabetes patients and its variation by patient and practice characteristics . Methods Using the General Practice Research Data base we selected a stratified sample of 148 English general practice s in Engl and , contributing data from 2000/1 to 2006/7 , and obtained a r and om sample of 653 500 patients in which 23 920 diabetes patients identified . We quantified annually recorded quality of care at the patient-level , as measured by the 17 QOF diabetes indicators , in a composite score and analysed it longitudinally using an Interrupted Time Series design . Results Recorded quality of care improved for all subgroups in the pre-incentive period . In the first year of the incentives , composite quality improved over- and -above this pre-incentive trend by 14.2 % ( 13.7–14.6 % ) . By the third year the improvement above trend was smaller , but still statistically significant , at 7.3 % ( 6.7–8.0 % ) . After 3 years of the incentives , recorded levels of care varied significantly for patient gender , age , years of previous care , number of co-morbid conditions and practice diabetes prevalence . Conclusions The introduction of financial incentives was associated with improvements in the recorded quality of diabetes care in the first year . These improvements included some measures of disease control , but most captured only documentation of recommended aspects of clinical assessment , not patient management or outcomes of care . Improvements in subsequent years were more modest . Variation in care between population groups diminished under the incentives , but remained substantial in some cases",
"BACKGROUND An earlier paper published in this journal suggested that fundholding practice s in Lincolnshire had managed to constrain the growth in their prescribing costs more successfully than had non-fundholders , largely on the basis of restricting the number of items prescribed per patient . At that time , insufficient data were available to explore the impact of a change in status from non-fundholding to fundholding on prescribing behaviour . METHOD Time-series prescribing data for the fourth-wave of Lincolnshire fundholders are analysed , and comparisons are made between this group , non-fundholders and the fundholders of the earlier waves . RESULTS In their first year of fundholding , fourth-wave practice s adopted the prescribing strategies employed previously by existing fundholders , namely , reductions in the number of items prescribed per patient and substantial increases in generic prescribing . The hypothesis that prospect i ve fundholders inflate their prescribing budget before attaining fundholding status is not generally supported by the Lincolnshire data . Evidence is presented which suggests that the prescribing cost economies accruing to fundholding status may be short term . CONCLUSIONS With the acquisition of fundholding status , the structure of incentives facing practice s changes . Our results suggest that , with respect to prescribing , practice s adjust rapidly to the new incentive structure",
"An empirical study in Lower Saxony aim ed to investigate any changes in primary care physicians ' diagnostic and therapeutic strategies as a result of Germany 's 1993 health reform act ( known as the Gesundheitsstruktur Gesetz or GSG ) , which included the countrywide implementation of a strict drug budget . A sentinel network consisting of a 37 % sample of 350 r and omly selected doctors ( n = 130 , GPs , general internists ) was established in Lower Saxony . Four cross sectional surveys , each focussing on one group of health problems , were carried out during 1993 . These aim ed to show whether sentinel practice networks are suitable for reporting physicians ' attitudes towards health care cost containment policies and , secondly , changes in physicians ' quantitative and qualitative assessment s of the 1993 reform act during its first year of implementation . Participating physicians reported patient consultations ( n = 3728 ) . St and ardised question naires ascertained sociodemographic variables and major reasons for the patients ' visit . Data on the diagnoses associated with the patient 's main reason for the consultation , the doctor 's assessment of the severity of the problem , and diagnostic and treatment strategies were also recorded . The question naire focussed on changes in therapy made by the physician together with the reasons for these changes . A number of treatment changes made with regard to cost containment were recorded . During the course of 1993 a decrease in reported changes in treatment was noticed . As expected , some doctors recorded a reduction in successful outcomes of treatment and ascribed this to the reform act . Differences between the four surveys with regard to the influence of the health reform act on the frequency of changes in treatment and the physicians ' expectations can not be explained sufficiently by the physicians ' adaptation to the cost containment policies within the year",
"Abstract Objective : To examine possible differential changes in outpatient referrals to orthopaedic clinics , attendances , and waiting times between fundholding and non-fundholding general practitioners . Design : Observational controlled study of referrals by general practitioners to orthopaedic out patients between April 1991 and March 1995 . Setting : District health authority in south west Engl and . Subjects : 10 fundholding practice s with 108 300 registered patients ; 22 control practice s with 159 900 registered patients . Main outcome measures : Changes in age st and ardised referral and outpatient attendance ratios for the year before and the two years after achieving fundholder status ; changes in outpatient waiting times . Results : In the year before achieving fundholding status both groups were referring more patients than were being seen . Two years later , referral and attendance ratios had increased by 13 % and 36 % respectively for fundholders and 32 % and 59 % for controls , and both groups were referring fewer patients than were being seen . Attendances represented 112 % of referrals for fundholders and 104 % for controls . In 1991 - 2 , a similar proportion of patients in the two groups was seen within three months of referral . The two hospitals that set up specific clinics exclusively for fundholders showed faster access for patients of fundholders by 1993 - 4 , as did a third hospital without such clinics by 1994 - 5 . Conclusions : Fundholders increased their orthopaedic referrals less than did controls and achieved a better balance between outpatient appointments and referrals . Their patients were likely to be seen more quickly , particularly if the hospital provided special clinics exclusively for fundholders . Lack of case mix information makes it impossible to judge whether these differences benefit or disadvantage patients . Key messages Patients of fundholders had no better access than patients of non-fundholders to orthopaedic services before the practice s became fundholding Fundholders controlled their referrals better than non-fundholders and achieved a better balance between referrals and attendances Fundholders ' patients were more likely to be seen quickly , especially if the receiving hospital laid on specific clinics exclusively for fundholders Information on case mix is needed to identify whether the lower referral rate among fundholders benefits or disadvantages",
"With computerised data on drug prescriptions , which were collected among a sample of 362 internist , general and medical practitioners throughout Germany , the effects of the drug budget , based on the German Health Care Structure Reform Act ( GSG ) , on diabetic patients were analysed . The data of 3053 diabetic patients ( 10 % r and om sample ) were compared with the same number of nondiabetic patients for the period of July 1992 to December 1994 . The frequency of consultations per patient increased in both groups during the study period ( p contacts with the physicians than nondiabetic subjects ( p prescriptions and costs among the patients with diabetes decreased in the first six month of 1993 ( -10%/ -16 % ) . In the following time costs increased and exceeded the values of 1992 by about 13 % . The costs per prescription decreased during the study period about 10 % . The data show that costs as well as prescriptions per consultation between diabetic and nondiabetic patients remained in the same ratio . The proportion of consultations with > or = 1 prescription increased in diabetic patients after the GSG . A refusal to prescribe drugs in primary health care practice s among diabetic patients was not observed . There was also no restriction on prescription drug use among diabetic patients compared with nondiabetics",
"Abstract Objective : To compare outpatient referral patterns in fundholding and non-fundholding practice s before and after the NHS reforms in April 1991 . Design : Prospect i ve collection of data on general practitioners ' referrals to specialist outpatient clinics between June 1990 and January 1994 and detailed comparisons of three phases -- October 1990 to March 1991 ( phase 1 ) , October 1991 to March 1992 ( phase 2 ) , and October 1993 to January 1994 ( phase 3 ) . Setting : 10 first wave fundholding practice s and six non-fundholding practice s in the Oxford region . Subjects : Patients referred to consultant outpatient clinics . Results : NHS referral rates increased in fundholding practice s in phase 2 and phase 3 of the study by 8.1/1000 patients a year ( 95 % confidence interval 5.7 to 10.5 ) , anincrease of 7.5 % from phase 1 ( 107.3/1000 ) to phase 3 ( 115.4/1000 ) . Non-fundholders ' rates increased significantly , by 25.3/1000 patients ( 22.5 - 28.1 ) , an increase of 26.6 % from phase 1 ( 95.0/1000 ) to phase 3 ( 120.3/1000 ) . The fundholders ' referral rates to private clinics decreased by 8.8 % , whereas those from non-fundholding practice s increased by 12.2 % . The proportion of referrals going outside district boundaries did not change significantly . Three of the four practice s entering the third and fourth wave of fundholding increased their referral rates significantly in the year before becoming fundholders . Conclusions : No evidence existed that budgetary pressures caused first wave fundholders to reduce referral rates , although the method of budget allocation may have encouraged general practitioners to inflate their referral rates in the preparatory year . Despite investment in new practice based facilities , no evidence yet exists that fundholdingencourages a shift away from specialist care",
"OBJECTIVE To examine the effects of incentive payment frequency on quality measures in a physician-specific pay-for-performance ( P4P ) experiment . STUDY SETTING A multispecialty physician group practice . STUDY DESIGN In 2007 , all primary care physicians ( n=179 ) were r and omized into two study arms differing by the frequency of incentive payment , either four quarterly bonus checks or a single year-end bonus ( maximum of U.S.$5,000/year for both arms ) . DATA COLLECTION / EXTRACTION METHODS Data were extracted from electronic health records . Quality measure scores between the two arms over four quarters were compared . PRINCIPAL FINDINGS There was no difference between the two arms in average quality measure score or in total bonus amount earned . CONCLUSIONS Physicians ' responses to a P4P program with a small maximum bonus do not differ by frequency of bonus payment",
"Abstract Objectives : To observe changes in prescribing practice that occurred after the introduction of fundholding in first wave practice s and to contrast these with changes occurring in similar nonfundholding practice s. Design : Prospect i ve observational study . Setting : Oxford region fundholding study . Subjects : Eight first wave fundholding practice s and five practice s that were not interested in fundholding in 1990 - 1 , which were similar in terms of practice size , training status , locality , and urban rural mix . Three of the fundholding and none of the non-fundholding practice s were dispensing practice s. Main outcome measures : Changes in prescribing practice as measured by net cost per prescribing unit , cost per item , number of items prescribed , and substitution rates for generic drugs three years after the introduction of fundholding . Data for fundholding practice s were analysed separately according to whether they were dispensing or non-dispensing practice s. Results : Prescribing costs rose by a third or more in all types of practice . The patterns of change observed in this cohort after one year of fundholding were reversed . No evidence existed that fundholding had controlled prescribing costs among non-dispensing fundholders ; costs among dispensing fundholders rose least , but the differences were small compared with the overall increase in costs . Conclusions : Early reports of the effectiveness of fundholding in curbing prescribing costs have not been confirmed in this longer term study"
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Introduction The aim of the study was to undertake a systematic review and meta- analysis of prospect i ve studies to determine the effect of magnesium ( Mg ) supplementation on C-reactive protein ( CRP ) . Design : Systematic review and meta- analysis of r and omised controlled trials ( RCTs ) . Material and methods Data sources : PubMed - Medline , Web of Science , Cochrane Data base , and Google Scholar data bases were search ed ( up until December 2016 ) . Eligibility criteria : R and omized controlled trials evaluating the impact of Mg supplementation on CRP . We used r and om effects models meta- analysis for quantitative data synthesis . For sensitivity analysis was used the leave-one-out method . Heterogeneity was quantitatively assessed using the I2 index . Main outcome : Level of CRP after Mg supplementation . Results From a total of 96 entries identified via search es , eight studies were included in the final selection . The meta- analysis indicated a significant reduction in serum CRP concentrations following Mg supplementation ( weighted mean difference ( WMD ) -1.33 mg/l ; 95 % CI : -2.63 to -0.02 , heterogeneity p WMD for interleukin 6 was -0.16 pg/dl ( 95 % CI : -3.52 to 3.26 , heterogeneity p = 0.802 ; I2 = 2.3 % ) , and 0.61 mg/dl ( 95 % CI : -2.72 to 1.48 , p = 0.182 , heterogeneity p = 0.742 ; I2 = 6.1 % ) for fasting blood glucose . These findings were robust in sensitivity analyses . R and om-effects meta-regression revealed that changes in serum CRP levels were independent of the dosage of Mg supplementation ( slope : -0.004 ; 95 % CI : -0.03 , 0.02 ; p = 0.720 ) or duration of follow-up ( slope : -0.06 ; 95 % CI : -0.37 , 0.24 ; p = 0.681 ) . Conclusions This meta- analysis suggests that Mg supplementation significantly reduces serum CRP level . RCTs with a larger sample size and a longer follow-up period should be considered for future investigations to give an unequivocal answer
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"Low magnesium status has been associated with numerous conditions characterized as having a chronic inflammatory stress component . Some animal findings indicate that a moderate magnesium deficiency , similar to which apparently commonly occurs in humans , may enhance inflammatory or oxidative stress induced by other factors , including disrupted sleep/sleep deprivation . Thus , an experiment was performed with 100 adults ( 22 males and 78 females ) aged 59 ± 8 years ( range 51 to 85 years ) with poor sleep quality revealed by a Pittsburg Sleep Quality Index ( PSQI ) score higher than five . The participants were r and omly assigned to two groups matched by gender , age , and overall PSQI score . After baseline assessment ( week one ) of body mass index ( BMI ) , diet , blood and urine biochemical variables , and sleep quality , one group was given a 320 mg magnesium/day supplement as magnesium citrate and the other group a sodium citrate placebo for seven weeks . Final assessment s were made five and seven weeks ( which were combined for statistical analysis to reduce intra-individual variation ) after supplement initiation for the 96 participants who completed the study as design ed . Based on food diaries , 58 % of the participants were consuming less than the US . Estimated Average Requirement ( EAR ) for magnesium . Consuming less than the EAR was associated with a significantly higher BMI and plasma C-reactive protein ( CRP ) concentration . Only 40 participants had plasma CRP concentrations higher than 3.0 mg/L ( an indication of chronic inflammatory stress ) . Overall PSQI scores improved ( 10.4 to 6.6 , p and erythrocyte magnesium increased ( 4.75 to 5.05 pg/cell , p = 0.01 ) regardless of magnesium or placebo supplementation . Magnesium vs placebo supplementation did not significantly affect serum magnesium when all participants were included in the analysis . When only the 37 participants with serum magnesium concentrations , magnesium supplementation , but not the placebo , increased serum magnesium concentrations . Magnesium supplementation vs placebo decreased plasma CRP in participants with baseline values > 3.0 mg/L. The findings show that many individuals have a low magnesium status associated with increased chronic inflammatory stress that could be alleviated by increased magnesium intake . Because dietary magnesium intake did not change during the experimental period , another factor , possibly a placebo effect , improved sleep quality , which result ed in increased erythrocyte magnesium . This factor prevented the determination of whether magnesium deficiency contributes to poor sleep quality . The findings , however , suggest an association between magnesium status and sleep quality that needs further study to definitively determine whether a low magnesium status is a cause or an effect of poor sleep quality",
"AIM To assess the relationship between dietary magnesium intake and the risk of coronary heart disease ( CHD ) . METHODS A conducted case-control study included 290 r and omly selected cases ( mean age 59.98 + /- 10.03 years ) with first event of an acute coronary syndrome and 290 selected controls paired by sex , age and region ( mean age 59.43 + /- 10.10 years ) admitted to the same hospitals without any suspicion of coronary disease . A diet was assessed by an interviewer-administered semi-quantitative food frequency question naire , and magnesium intake was derived from the nutrient data base . RESULTS Subjects with coronary heart disease had significantly lower intake of foods containing high levels of magnesium like whole grain ( p Lower dietary magnesium intake was found to be positively associated with risk of coronary heart disease ( 0.027 ) . CONCLUSIONS Our findings suggest that dietary intake of magnesium was associated with reduced risk of coronary heart disease among Serbian population",
"Background The calcium-channel blocking effect of magnesium might have protective effects in patients undergoing cardiopulmonary bypass surgery . We assessed the effects of magnesium on hearts undergoing coronary artery bypass surgery with intermittent warm blood hyperkalemic cardioplegia in the ante grade fashion . Patients and Methods Twenty patients undergoing coronary bypass surgery were r and omly divided into two groups , a control group who received intermittent ante grade warm blood hyperkalemic cardioplegia for myocardial protection , and a study group who received the same solution with the addition of magnesium to the cardioplegia . Extracellular substrates ( creatinine Phosphokinase , creatinine phosphokinase-MB group , lactate dehydrogenase , c-reactive protein , and cardiac troponin I were measured preoperatively and postoperatively . Results There were significant differences in the post-operative concentrations of creatinine phosphokinase , creatinine phosphokinase-MB group , c-reactive protein , and lactate dehydrogenase after cardiopulmonary bypass ( P Cardiac troponin I levels were also significantly lower in the study group after cardiopulmonary bypass ( P<0.005 ) . Conclusions Our study indicates that if magnesium is added to intermittent ante grade warm blood hyperkalemic cardioplegia , blood levels of many markers of cardiac myocardial injury after cardiopulmonary bypass are lowered . This finding may have implication s for myocardial protection",
"BACKGROUND AND AIMS It has been suggested that magnesium deficiency is associated with the triggering of acute phase response , which may contribute to type 2 diabetes and cardiovascular disease risk . We undertook this study to determine whether oral magnesium supplementation modifies serum levels of high-sensitivity C-reactive protein ( hsCRP ) in apparently healthy subjects with prediabetes and hypomagnesemia . METHODS A total of 62 men and non-pregnant women aged 18 - 65 year , with new diagnosis of prediabetes ( glucose 5.6 were enrolled in a clinical double-blind placebo-controlled trial and r and omly allocated to receive either magnesium chloride ( 30 mL of MgCl2 5 % solution ) or NaHCO3 0.1 % solution , once daily for 3 months . RESULTS At basal conditions , anthropometric and biochemical variables were similarly distributed in both groups . At the end of follow-up , participants who received magnesium chloride showed higher serum magnesium levels ( 0.86 ± 0.08 vs. 0.69 ± 0.16 mmol/L , p = 0.002 ) and lower hsCRP levels ( 4.8 ± 15.2 vs. 17.1 ± 21.0 nmol/L , p = 0.01 ) compared with participants in the control group . CONCLUSIONS Oral magnesium supplementation decreases hsCRP levels in apparently healthy subjects with prediabetes and hypomagnesemia",
"To evaluate the effect of oral supplementation with magnesium chloride on the systemic and hepatic inflammation , 38 non-hypertensive obese women aged 30 to 65 years were allocated into groups with and without hypomagnesemia . Hypomagnesemic women drank 50 mL of 5 % solution of MgCl2 equivalent to 450 mg of elemental magnesium . Low-carbohydrate diets and physical activity were indicated for women in both groups . Chronic diarrhea , alcohol intake , use of diuretics , previous oral magnesium supplementation , hepatic disease , and renal damage were exclusion criteria . Hypomagnesemia is defined by serum magnesium concentrations hepatic inflammation by serum alanine aminotransferase ( ALT ) levels > or=40 U/L , and systemic inflammation by serum high-sensitivity C reactive protein ( hs-CRP ) concentration > or=3 mg/L. At baseline ( p=0.06 ) and final of follow-up ( p=0.80 ) , there were no significant differences by body mass index between the groups in the study . In the same way , at baseline ALT ( 48.1+/-25.5 and 34.6+/-24.1 U/L , p=0.14 ) and hs-CRP ( 9.4+/-6.0 and 7.9+/-5.9 mg/dL , p=0.47 ) levels were similar in the supplemented and non-supplemented women . In the magnesium group , ALT ( 24.3+/-10.3 and 34.8+/-13.6 U/L , p=0.02 ) levels , but not hs-CRP ( 5.2+/-1.9 and 8.0+/-5.6 mg/L , p=0.08 ) reached significantly lower levels , in the fourth month of treatment , than in women in the control group . The adjusted odds ratios between the improvement in serum magnesium and reduction in ALT and hs-CRP levels were 0.56 ( 95 % CI : 0.3 - 0.9 ) and 0.93 ( 95 % CI : 0.6 - 29.9 ) , respectively . Results of this study show that in hypomagnesemic obese women , oral supplementation with magnesium chloride reduces plasma ALT levels ; hs-CRP levels only show a reduction trend",
"To determine whether oral magnesium supplementation modifies serum levels of high-sensitivity C-reactive protein ( hsCRP ) , TNF-alpha , IL-6 , and IL-10 in subjects with prediabetes , inflammation , and hypomagnesemia , a total of 26 subjects men and non-pregnant women were included and r and omly allocated to receive 30 ml of MgCl(2 ) 5 % solution ( equivalent to 382 mg of magnesium ) or placebo , daily during three months . At baseline conditions , there were not significant statistical differences between the groups . At end of the study , hsCRP levels were significantly lower in the intervention group ( 3.3 ± 2.5 vs 8.0 ± 5.9 mg/L , p = 0.03 ) , as compared with the control group . However , the intra-group analysis of the individuals who received magnesium , did not shows significant statistical differences between baseline and final conditions ( 4.1 ± 3.0 and 3.3 ± 2.5 , p = 0.45 ) . In addition , TNF-alpha ( 1.2 ± 0.3 vs 1.1 ± 0.3 pg/mL , p = 0.69 ) , IL-6 ( 0.3 ± 0.3 vs 5.0 ± 7.7 pg/mL , p = 0.08 ) , and IL-10 ( 1.8 ± 0.4 vs 1.8 ± 0.5 pg/mL , p = 0.89 ) serum levels were not significantly different between the groups . Our results do not show a beneficial effect of oral magnesium supplementation on hsCRP , IL-6 , TNF-alpha , and IL-10 levels in prediabetic subjects with hypomagnesemia and inflammation . Further studies with large sample sizes and longer time of follow-up are necessaries to verify the results of our pilot study",
"Background : Epidemiological data shows low dietary magnesium(Mg ) may be related to incidence and progression of asthma . Objective To determine if long term(6.5 month ) treatment with oral Mg would improve asthma control and increase serum measures of Mg status in men and women with mild-to-moderate asthma . Subjects : 55 males and females aged 21 to 55 years with mild to moderate asthma according to the 2002 National Heart , Lung , and Blood Institute(NHLBI ) and Asthma Education and Prevention Program(NAEPP ) guidelines and who used only beta-agonists or inhaled corticosteroids(ICS ) as asthma medications were enrolled . Design : Subjects were r and omly assigned to consume 340 mg(170 mg twice a day ) of Mg or a placebo for 6.5 months . Measurements : Multiple measures of Mg status including serum , erythrocyte , urine , dietary , ionized and IV Mg were measured . Objective : markers of asthma control were : methacholine challenge test(MCCT ) and pulmonary function test(PFT ) results . Subjective vali date d question naires on asthma quality of life(AQLQ ) and control(ACQ ) were completed by participants . Markers of inflammation , including c-reactive protein(CRP ) and exhaled nitric oxide(eNO ) were determined . Results : The concentration of methacholine required to cause a 20 % drop in forced expiratory volume in in minute(FEV1 ) increased significantly from baseline to month 6 within the Mg group . Peak expiratory flow rate(PEFR ) showed a 5.8 % predicted improvement over time(P = 0.03 ) in those consuming the Mg . There was significant improvement in AQLQ mean score units(P overall ACQ score only in the Mg group(P = 0.05 ) after 6.5 months of supplementation . Despite these improvements , there were no significant changes in any of the markers of Mg status . Conclusion : Adults who received oral Mg supplements showed improvement in objective measures of bronchial reactivity to methacholine and PEFR and in subjective measures of asthma control and quality of life",
"Objectives : The aim of the present study was to determine the efficacy of oral magnesium ( Mg ) supplementation on endothelial function through evaluation of carotid intima-media thickness ( cIMT ) , brachial artery flow-mediated dilatation ( FMD ) , and C-reactive protein ( CRP ) among hemodialysis ( HD ) patients . Methods : This r and omized , controlled , double-blind clinical trial consisted of 54 patients on HD . One group was treated orally with 440 mg of Mg oxide 3 times per week for 6 months ( n = 29 ) . The control group ( n = 25 ) was given placebo using the same administration protocol . cIMT , FMD , serum calcium levels , phosphorus , lipid , CRP , and bicarbonate were measured at baseline and at 6 months in both groups . Results : At 6 months , cIMT was significantly decreased in the Mg group ( 0.84 ± 0.13 mm at baseline and 0.76 ± 0.13 mm at 6 months , p = 0.001 ) . However , in the placebo group , cIMT was significantly increased ( 0.73 ± 0.13 and 0.79 ± 0.12 mm , respectively , p = 0.003 ) . When hypertension , diabetes mellitus , smoking , hyperlipidemia , and systemic lupus erythematosus were controlled for in the analysis , the effect of Mg remained significant in both groups ( p = 0.000 ) . Conclusion : Our results indicate that Mg might not improve endothelial function ( CRP level and FMD ) and that a decreased cIMT as a marker of atherosclerosis may be due to the inhibition of calcification through the regulation parathormone , calcium , and phosphorus",
"To assess the hypothesis that magnesium intake is beneficial in the primary prevention of hypertension , 28,349 female United States health professionals aged > or = 45 years participating in the Women 's Health Study ( WHS ) , who initially reported normal blood pressure ( systolic blood pressure , were prospect ively studied . A semi-quantitative food frequency question naire was used to estimate magnesium intake . During a median follow-up of 9.8 years , 8,544 women developed incident hypertension . After adjustment for age and r and omized treatment , magnesium intake was inversely associated with the risk for developing hypertension ; women in the highest quintile ( median 434 mg/day ) had a decreased risk for hypertension ( relative risk 0.87 , 95 % confidence interval [ CI ] 0.81 to 0.93 , p for trend relative risks were 1.00 ( 95 % CI 0.95 to 1.10 ) , 1.02 ( 95 % CI 0.95 to 1.10 ) , 0.96 ( 95 % CI 0.89 to 1.03 ) , and 0.93 ( 95 % CI 0.86 to 1.02 ) ( p for trend = 0.03 ) . Similar associations were observed for women who never smoked and reported no history of high cholesterol or diabetes at baseline . In conclusion , the results suggest that higher intake of dietary magnesium may have a modest effect on the development of hypertension in women"
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The evidence -based pharmacotherapy of panic disorder continues to evolve . This paper review s data on first-line pharmacotherapy , evidence for maintenance treatment , and management options for treatment-refractory patients . A Medline search of research on pharmacotherapy was undertaken , and a previous systematic review on the evidence -based pharmacotherapy of panic disorder was up date d. Selective serotonin reuptake inhibitors remain a first-line pharmacotherapy of panic disorder , with the serotonin noradrenaline reuptake inhibitor venlafaxine also an acceptable early option . Temporary co-administration of benzodiazepines can be considered . Maintenance treatment reduces relapse rates , but further research to determine optimal duration is needed . For patients not responding to first-line agents several pharmacotherapy options are available , but there is a notable paucity of data on the optimal choice
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"The efficacy of tricyclics and benzodiazepines in the short term ( approximately 2 - 4 months ) treatment of panic disorder is well demonstrated , but efficacy over the longer term is not considered established . The present study provided systematic data from a double blind comparison of maintenance therapy ( up to 8 months ) of panic disorder with or without agoraphobia with alprazolam , imipramine , or placebo in 181 patients who had responded to the same regimen in a r and omized 8-week treatment trial . All three groups had improved during the first 2 months ( active treatments more than placebo and about equal to each other ) , and all maintained or extended their improvement over the next 6 months without any significant change in dose . More than twice as many alprazolam and imipramine than placebo patients ( 15 % ) remained in treatment for the full 8 months and did slightly better on symptom measures than the remaining placebo patients . Both medications were well tolerated during the maintenance period . The data suggest sustained efficacy and safety of imipramine and alprazolam over an extended period . More specifically , they suggest that tolerance does not develop to the therapeutic effects of either drug",
"Paroxetine has been shown to be effective in panic disorder in three 10- to 12-week studies . This trial studied the longer term effects of paroxetine in patients with DSM-III-R defined panic disorder . Patients who satisfactorily completed a 12-week , double-blind , placebo-controlled study of paroxetine and clomipramine could choose to continue receiving their r and omized treatment for a further 36 weeks . Efficacy assessment s included the daily panic attack diary , the Clinical Global Impression Scale , the Hamilton Anxiety Rating Scale , the Marks Sheehan Phobia Scale and the Sheehan Disability Scale . In total , 176 patients were included in the intention-to-treat population . The number of full panic attacks decreased in all three groups during the 12-week study , and improvements continued with long-term therapy . Paroxetine was statistically significantly more effective than placebo throughout the long-term study with respect to reduction from baseline of full panic attacks , and at the end of treatment with respect to the proportion of patients who eventually experienced no panic attacks . There were no significant differences between paroxetine and clomipramine . The proportion of patients who withdrew from the study due to adverse effects was greater in the clomipramine group ( 19 % ) than in either the paroxetine group ( 7 % ) or the placebo group ( 9 % ) . Paroxetine was significantly more effective than placebo and as effective as ( but better tolerated than ) clomipramine in the long-term treatment of panic disorder . Not only was efficacy maintained , but continued improvement was also seen , indicating the importance of long-term treatment in patients with panic disorder",
"BACKGROUND The serotonin selective reuptake inhibitors are increasingly being used for the treatment of panic disorder . We examined the efficacy and safety of the serotonin selective reuptake inhibitor sertraline hydrochloride in patients with panic disorder . METHODS One hundred seventy-six nondepressed out patients with panic disorder , with or without agoraphobia , from 10 sites followed identical protocol s that used a flexible-dose design . After 2 weeks of single-blind placebo , patients were r and omly assigned to 10 weeks of double-blind , flexible-dose treatment with either sertraline hydrochloride ( 50 - 200 mg/d ) or placebo . RESULTS Sertraline-treated patients exhibited significantly greater improvement ( P=.01 ) at end point than did patients treated with placebo for the primary outcome variable , panic attack frequency . Significant differences between groups were also evident for clinician and patient assessment s of improvement as measured by the Clinical Global Impression Improvement ( P=.01 ) and Severity ( P=.009 ) Scales , Panic Disorder Severity Scale ratings ( P=.03 ) , high end-state function assessment ( P=.03 ) , Patient Global Evaluation rating ( P=.01 ) , and quality of life scores ( P=.003 ) . Adverse events , generally characterized as either mild or moderate , were not significantly different in overall incidence between the sertraline and placebo groups . CONCLUSION Results support the safety and efficacy of sertraline for the short-term treatment of patients with panic disorder",
"Regular physical activity is anxiolytic in both healthy subjects and patients with panic disorder . In contrast , acute exercise may induce acute panic attacks or increase subjective anxiety in patients with panic disorder more than in other people . The effects of quiet rest or an aerobic treadmill exercise ( 30 min at an intensity of 70 % of the maximal oxygen uptake , VO2max ) on cholecystokinin tetrapeptide ( CCK-4 ) induced panic attacks were studied in a crossover design in 12 patients with panic disorder and 12 matched healthy subjects . The effects of CCK-4 ( 25 microg in patients and 50 microg in control subjects ) were measured with the Acute Panic Inventory ( API ) score , comparing panic attack frequencies , total score , and subscores for anxiety and somatic symptoms . CCK-4-induced panic attacks were less frequent after prior exercise : they occurred in 15 ( 62.5 % ) subjects after rest ( 9 patients and 6 control subjects ) , but only 5 ( 20.8 % ) subjects after exercise ( 4 patients and 1 control subject ) . In both conditions , CCK-4 administration induced a significant increase in the total API score and the anxiety and somatic symptoms subsores . However , compared to prior rest , exercise result ed in a significantly reduced CCK-4-induced increase of the total API score and the anxiety subscore . In patients with panic disorder exercise increased the total API score and the somatic symptoms subscale but not the anxiety subscore . Patients with panic disorder showed increased somatic but not anxiety symptoms after an acute bout of exercise . Severity of CCK-4-induced panic and anxiety , on the other h and was reduced by exercise . These findings suggest that in addition to exercise training an acute bout of exercise may be used to reduce anxiety and panic attack frequency and intensity in panic disorder patients",
"Several reports suggest that selective serotonin reuptake blockers are helpful in the treatment of panic disorder . The aim of the study was to compare fluvoxamine with placebo in 50 panic disorder patients by using an 8-week , double-blind , parallel-groups design . Weekly assessment included a panic attack diary ( frequency and severity ) , the Montgomery-Asberg Depression Scale , the Clinical Anxiety Scale , and the Sheehan Disability Scale . Although both groups improved on all measures , the fluvoxamine group experienced significantly less frequent major panic attacks from the third week on and significantly lower ratings on anxiety , depression , and disability from the sixth week on . Mean ratings of the severity of major and the severity and frequency of minor attacks were not affected differently by fluvoxamine and placebo . At the end of the study , significantly more patients on fluvoxamine were free of major and minor panic attacks . The results indicate that : ( 1 ) the administration of fluvoxamine , as compared with placebo , led to a significant reduction in the number of panic attacks . ( 2 ) The severity of panic attacks was not affected by fluvoxamine . ( 3 ) The effect of fluvoxamine on anxiety , depressive mood , and disability differed from placebo only after 6 weeks of treatment , after which the placebo group showed either no further improvement or a reversal of symptoms . ( 4 ) Participation in a drug study , even without additional psychotherapy , led to significant improvement in all patients",
"BACKGROUND Escitalopram , the therapeutically active isomer of the racemic selective serotonin reuptake inhibitor antidepressant citalopram , has shown significant anxiolytic effects in placebo-controlled clinical trials of social anxiety disorder , generalized anxiety disorder , and anxiety symptoms associated with major depression . This study evaluated the safety and efficacy of escitalopram in out patients diagnosed with panic disorder . METHOD Male and female out patients between 18 and 80 years of age meeting DSM-IV criteria for panic disorder , with or without agoraphobia , were r and omly assigned to 10 weeks of double-blind treatment with escitalopram , citalopram , or placebo in a study conducted from September 1999 to July 2001 . The primary measure of efficacy was panic attack frequency at week 10 relative to baseline , as assessed by the Modified Sheehan Panic and Anticipatory Anxiety Scale . RESULTS A total of 366 subjects ( 128 escitalopram patients , 119 citalopram patients , and 119 placebo patients ) received at least 1 dose of double-blind treatment . The frequency of panic attacks was statistically significantly improved ( p = .04 ) , and the increase in percentage of patients with zero panic attacks reached borderline significance ( p = .051 ) , in the escitalopram-treated group relative to the placebo-treated group . Both escitalopram and citalopram statistically significantly reduced panic disorder symptoms and severity versus placebo at endpoint ( p Panic and Agoraphobia Scale total score , the Clinical Global Impressions scale , the Patient Global Evaluation , and the Quality of Life Enjoyment and Satisfaction Question naire . Treatment with escitalopram was safe and well tolerated , with a similar incidence of the most common adverse events for the escitalopram and placebo groups . The rate of discontinuation for adverse events was 6.3 % for escitalopram , 8.4 % for citalopram , and 7.6 % for placebo . CONCLUSION Escitalopram is efficacious , safe , and well tolerated in the treatment of panic disorder",
"RATIONALE Few r and omized , placebo-controlled trials have evaluated the comparative efficacy and tolerability of more than one pharmacological agent for panic disorder . OBJECTIVES The primary objective of this study was to compare the efficacy and tolerability of venlafaxine extended release ( ER ) with placebo in treating panic disorder . Secondary objectives included comparing paroxetine with venlafaxine ER and placebo . METHODS Out patients aged > or = 18 years ( placebo , n = 157 ; venlafaxine ER 75 mg , n = 156 ; venlafaxine ER 225 mg , n = 160 ; paroxetine , n = 151 ) , with a primary diagnosis of panic disorder ( + /-agoraphobia ) based on the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) criteria for > or =3 months were r and omly assigned to receive venlafaxine ER ( titrated to 75 mg/day or 225 mg/day ) , paroxetine ( titrated to 40 mg/day ) , or placebo for 12 weeks . The primary efficacy measure was the percentage of patients free of full-symptom panic attacks ( > or = four symptoms ) at endpoint . Key secondary outcomes included the Panic Disorder Severity Scale ( PDSS ) mean score change and response . RESULTS At endpoint , all active treatment groups showed a significantly ( P free of full-symptom panic attacks , compared with placebo , and were superior ( P venlafaxine ER 225 mg group had significantly ( P mean PDSS score improvement than the paroxetine group ( -12.58 vs -11.87 ) and a significantly higher proportion of patients free of full symptom panic attacks ( 70.0 vs 58.3 % ) . Both drugs were generally well tolerated . CONCLUSION Venlafaxine ER 75 mg/days and 225 mg/days and paroxetine 40 mg/day were both well tolerated and effective for short-term treatment of panic disorder",
"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",
"CONTEXT Previous studies have documented an association of depression and phobic anxiety with cardiovascular morbidity and mortality , but little is known about the cardiovascular sequelae of panic anxiety . OBJECTIVE To determine whether panic attacks are associated with risk of cardiovascular morbidity and mortality in postmenopausal women . DESIGN Prospect i ve cohort survey . SETTING Ten clinical centers of the 40-center Women 's Health Initiative . PARTICIPANTS A total of 3369 community-dwelling , generally healthy postmenopausal women ( aged 51 - 83 years ) enrolled between 1997 and 2000 in the Myocardial Ischemia and Migraine Study who completed a question naire about occurrence of panic attacks in the previous 6 months . MAIN OUTCOME MEASURES Cardiovascular/cerebrovascular outcomes ( fatal and nonfatal myocardial infa rct ion and stroke ) and all-cause mortality were ascertained after a mean of 5.3 years of follow-up . RESULTS A 6-month history of full-blown panic attacks , endorsed by 10 % of postmenopausal women in this cohort , was associated with both coronary heart disease ( hazard ratio , 4.20 ; 95 % confidence interval , 1.76 - 9.99 ) and the combined end point of coronary heart disease or stroke ( hazard ratio , 3.08 ; 95 % confidence interval , 1.60 - 5.94 ) after controlling for multiple potential confounders . The hazard ratio for all-cause mortality , excluding those with a history of cardiovascular/cerebrovascular events , was 1.75 ( 95 % confidence interval , 1.04 - 2.94 ) . CONCLUSION Panic attacks are relatively common among postmenopausal women and appear to be an independent risk factor for cardiovascular morbidity and mortality in older women",
"Both noradrenergic and serotonergic systems have been implicated in the pathophysiology of panic disorder . The advent of selective serotonin ( 5-HT ) reuptake inhibitors ( SSRIs ) ( e.g. citalopram ) and , more recently , selective noradrenergic ( NA ) reuptake inhibitors ( NRIs ) ( e.g. reboxetine ) has provided potentially important avenues of treatment for the disorder . To date , the comparative efficacy of selective NA and 5-HT reuptake inhibitors for panic disorder remains unresolved . Nineteen patients with panic disorder were r and omized in a single-blind , cross-over design to either citalopram or reboxetine for 8 weeks and after a 2-week washout were switched to the other study drug . At week 18 , seven of 13 patients ( 54 % ) in the intent-to-treat sample responded to reboxetine and nine of 11 patients responded to citalopram ( 82 % ) . Both citalopram and reboxetine led to significant improvements in panic attack severity with no apparent between-drug differences in efficacy . However , citalopram demonstrated superior efficacy in treating depressive symptoms . One non-responder to citalopram responded to reboxetine and three non-responders to reboxetine responded to citalopram . Although SSRIs are viewed as a first-line treatment for panic disorder , these results suggest that a NA agent such as reboxetine may also have a role . These data also suggest an advantage for citalopram in treating comorbid depressive symptoms , although some patients may respond preferentially to an SSRI and other patients to an NRI",
"There is considerable evidence that people with panic disorder utilise the physical health care system more frequently than people in the general community and so incur for themselves , and impose on the public health care system , considerably greater costs . Although this is probably because of specific characteristics to do with panic disorder , it may also be a function of having any anxiety disorder where panic is prominent . This study represents one of the few comparisons of medical utilisation and costs incurred by people with panic disorder to those incurred by people with another anxiety disorder , in this case , social phobia . Before treatment , 41 people with panic disorder , 15 with social phobia and 43 nonanxious controls were interviewed about their use of the medical care system over the previous 12 months . As expected , people with panic disorder had significantly higher utilisation rates than either the nonanxious controls or the socially phobic subjects , and incurred substantially higher costs . Adequate screening for panic disorder at the primary medical care level together with appropriate treatment referral therefore have the potential to substantially reduce the personal and community costs incurred by people with panic disorder",
"Panic disorder with or without agoraphobia is a common , often chronic and refractory anxiety disorder . Although a number of pharmacotherapies are now indicated for panic disorder , many patients do not respond to available interventions . We hypothesized that duloxetine , a serotonin‐norepinephrine reuptake inhibitor ( SNRI ) that has greater initial noradrenergic effects than venlafaxine , would have broad efficacy for individuals with panic disorder . Fifteen individuals with panic disorder with or without agoraphobia received 8 weeks of open label duloxetine flexibly dosed from 60 to 120 mg per day . Duloxetine treatment result ed in significant anxiolysis as measured by the primary outcome measure , the Panic Disorder Severity Scale ( PDSS ) ( paired t(df ) = 4.02(14 ) , P= 0.0013 ) , as well as measures of generalized anxiety , depression and quality of life ( all P < 0.05 ) . Although definitive conclusions are limited due to its small open‐label nature , this first prospect i ve study provides preliminary support for the efficacy of duloxetine for panic disorder and suggests larger r and omized controlled study is warranted",
"BACKGROUND There is debate about combining benzodiazepines with selective serotonin reuptake inhibitors in the acute treatment of panic disorder . Although this medication combination is widely used in clinical practice , there is no well-tested , optimal method of coadministering these medications for the treatment of panic disorder . The purpose of this study was to test the efficacy of early coadministration of clonazepam with sertraline in the treatment of panic disorder . METHODS Fifty patients with panic disorder were r and omized into a double-blind clinical trial . Patients received open-label sertraline for 12 weeks ( target dose , 100 mg/d ) , and in addition were r and omized to groups receiving either 0.5 mg of active clonazepam 3 times daily or placebo clonazepam for the first 4 weeks of the trial . The clonazepam dose was then tapered during 3 weeks and discontinued . RESULTS Thirty-four ( 68 % ) of 50 patients completed the trial . Drop-out rates were similar in the sertraline/placebo vs the sertraline/clonazepam group ( 38 % vs 25 % ) ( P = .5 ) . An intent-to-treat analysis ( on last observation carried forward data ) revealed a much greater proportion of responders in the sertraline/clonazepam compared with the sertraline/placebo group at the end of week 1 of the trial ( 41 % vs 4 % ) ( P = .003 ) . There was also a significant between-group difference at the end of week 3 with 14 ( 63 % ) of 22 of the sertraline/clonazepam group responding to treatment vs 8 ( 32 % ) of 25 of the sertraline/placebo group ( P = .05 ) . This difference was not observed at other times during the trial . CONCLUSION These data indicate that rapid stabilization of panic symptoms can be safely achieved with a sertraline/clonazepam combination , supporting the clinical utility of this type of regimen for facilitating early improvement of panic symptoms relative to sertraline alone",
"Objective : To investigate the long‐term efficacy , prevention of relapse and safety of sertraline in the treatment of panic disorder",
"A r and omized , double-blind , placebo-controlled , parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of panic disorder . One hundred three patients were r and omly assigned to receive double-blind treatment with either gabapentin ( dosed flexibly between 600 and 3,600 mg/day ) or placebo for 8 weeks . No overall drug/placebo difference was observed in scores on the Panic and Agoraphobia Scale ( PAS ) ( p = 0.606 ) . A post hoc analysis was used to evaluate the more severely ill patients as defined by the primary outcome measure ( PAS score > or = 20 ) . In this population , the gabapentin-treated patients showed significant improvement in the PAS change score ( p = 0.04 ) . In patients with a PAS score of 20 or greater , women showed a greater response than men regardless of treatment . Adverse events were consistent with the known side effect profile of gabapentin and included somnolence , headache , and dizziness . One patient experienced a serious adverse event during the study . No deaths were reported . The results of this study suggest that gabapentin may have anxiolytic effects in more severely ill patients with panic disorder",
"INTRODUCTION Serotonergic agents have greater effectiveness than noradrenergic ones in the treatment of Panic Disorder ( PD ) . However preliminary studies suggested that reboxetine might be effective in the treatment of PD . We compared the effectiveness and tolerability of reboxetine and paroxetine in the treatment of PD . METHODS Sixty-eight patients with PD were assigned to treatment groups in a single-blind , r and omized design . Each patient was assessed at day 0 and 90 by the Panic Associated Symptoms Scale ( PASS ) , the Sheehan Disability Scale ( SDS ) and the Fear Question naire ( FQ ) . Side effects were also recorded . RESULTS Reduction of PASS scores was significantly greater in the paroxetine group than in the reboxetine one . Vice versa we did not find any significant differences for other outcome measures . Sexual dysfunction and weight gain were significantly less frequent in the reboxetine group . CONCLUSIONS The results showed a greater effect of paroxetine on panic attacks than reboxetine , while no differences for anticipatory anxiety and avoidance were found , suggesting a different role of noradrenaline and serotonin in the treatment of PD",
" Several issues remain to be ascertained beyond the acute response to imipramine hydrochloride in patients with panic disorder . Study 1 consisted of a prospect i ve , systematic characterization of half-dose 12-month maintenance in patients with panic disorder with agoraphobia who had shown marked and stable response to 6 months of acute-phase treatment with imipramine . Study 2 assessed the 6-month cumulative relapse rate following discontinuation of acute-phase imipramine treatment in a comparable sample of patients . The same assessment battery was used in both studies , and the integrity of experimental drug conditions was verified by plasma drug level determinations . In contrast to the high relapse rate following discontinuation of acute-phase treatment , none of the patients showed relapse or had sustained worsening in panic or phobia measures during the half-dose maintenance period . The results underscore the importance of pharmacological prophylaxis and provide empirical guidelines for a successful low-dose maintenance regimen for patients with panic disorder and agoraphobia who respond markedly to imipramine",
"The present study examined a relapse prevention ( RP ) program delivered via bibliotherapy in the treatment of individuals with panic attacks . Compared with a wait list control group , individuals receiving RP exhibited significant reductions on measures of frequency of panic attacks , panic cognitions , anticipatory anxiety , avoidance , and depression . In addition , individuals in the RP group were more likely to attain a \" clinical ly significant change \" in status on both panic-free status and level of avoidance more frequently than individuals in the control group . When compared with treatment effects evaluated in two prior phases of the study , the obtained results appear to be the product of a synchronous effect of bibliotherapy and minimal phone contact during the 6-month follow-up period . The results reflect the importance of brief therapist contact in increasing motivation for active participation in bibliotherapy interventions",
"OBJECTIVE To examine the safety and efficacy of the anticonvulsant levetiracetam in the treatment of patients with panic disorder . METHOD In an open-label , fixed-flexible dose study , 18 patients with panic disorder with or without agoraphobia ( DSM-IV diagnostic criteria ) were treated with levetiracetam for 12 weeks . Outcome was assessed with st and ard rating instruments ( Clinical Global Impressions-Severity of Illness scale [ CGI-S ] , Clinical Global Impressions-Improvement scale [ CGI-I ] , and the 14-item Hamilton Rating Scale for Anxiety [ HAM-A ] ) and by the number of panic attacks during the previous week . The study was conducted in 2 outpatient clinics in New York City from January 2004 through July 2005 . RESULTS Of the 13 patients completing the study , 11 were rated \" very much \" or \" much \" improved on the CGI-I. Panic attack frequency , anxiety ( HAM-A ) , and global severity ( CGI-S ) ratings also demonstrated significant improvement ( all p benefits were apparent after only 1 to 2 weeks of treatment . Levetiracetam was well tolerated with minimal side effects . CONCLUSION Given its favorable pharmacokinetics , side effect profile , and , if confirmed , early onset of action and efficacy , levetiracetam might represent significant progress in the pharmacologic management of panic disorder",
"BACKGROUND AND OBJECTIVE Selective serotonin reuptake inhibitors ( SSRIs ) are currently the first-line treatment for panic disorder , although up to 30 % of patients either do not respond to SSRIs or withdraw due to adverse events . Reboxetine , a selective norepinephrine reuptake inhibitor ( selective NRI ) , is effective in treating depression and may alleviate depression-related anxiety . This study aim ed to investigate the efficacy of reboxetine in the treatment of patients with panic disorder who did not respond to SSRIs . METHOD In this 6-week , open-label study , 29 adult out patients with panic disorder who had previously failed to respond to SSRI treatment received reboxetine 2 mg/day , titrated to a maximum of 8 mg/day over the first 10 days . Efficacy was assessed using the Panic Self- Question naire ( PSQ ) , the Hamilton Rating Scale for Anxiety ( HAM-A ) , the 17-item Hamilton Rating Scale for Depression ( HRSD ) and the Global Assessment of Functioning ( GAF ) Scale . RESULTS The 24 patients who completed the study responded well to reboxetine treatment . Significant improvement ( p number of daily panic attacks , and on the scales measuring anxiety , depression and functioning . Reboxetine was generally well tolerated . Five patients withdrew due to adverse events . CONCLUSIONS Reboxetine appears to be effective in the treatment of SSRI-refractory panic disorder patients and warrants further clinical investigation",
"BACKGROUND There has been little systematic work done regarding the long-term treatment of panic disorders . The aim of the present study was to assess the 12-month cumulative risk of relapse specifically due to discontinuation of imipramine and to test the hypothesis that maintenance treatment with imipramine protects patients with panic disorder and agoraphobia from such reversals . METHOD Following an acute-phase open trial with imipramine ( 2.25 mg/kg per day ) involving 110 patients for 6 months , the 56 patients who were in stable remission , did not require additional treatment , and consented to be r and omly assigned to double-blind maintenance ( n = 29 ) or discontinuation ( n = 27 ) conditions were followed up with planned assessment s every 2 months during a 1-year period . There were no behaviorally oriented interventions or instructions at any time during the 18 months of the study . RESULTS Maintenance treatment ( 1 relapse ) and discontinuation ( 10 relapses ) conditions had significantly different survival curves ( Mantel-Cox statistic chi(2)1 = 10.47 , P = .001 ) . None of the additional 10 variables from demographic , clinical , and open-treatment domains considered in the proportional hazard model disrupted the significant relationship between experimental drug condition and relapse ; other things being equal , a patient receiving imipramine maintenance was 92.5 % lower in the hazard rate of relapse than a patient receiving placebo . CONCLUSION The results confirm the very high degree of prophylactic effectiveness of maintenance imipramine treatment and demonstrate that relapse , although substantial , occurs in a minority of patients with panic disorder and agoraphobia who are in stable remission prior to treatment discontinuation",
"Cognitive behavioral treatment ( CBT ) has been shown to reduce risk for adverse reactions ( e.g. , rebound panic ) following benzodiazepine taper for patients with panic disorder ( PD ) . This study evaluated the effects of antidepressant discontinuation for patients with PD in the context of CBT . Patients with PD ( n=21 ) on a stable dose of antidepressants completed a 12-week group CBT treatment and were r and omly assigned to discontinue antidepressants during week 8 of the treatment . There were no statistically significant differences between groups at posttreatment or 6-month follow-up . Data indicate no apparent immediate or long-term adverse effects for antidepressant discontinuation for patients with PD receiving CBT",
"The purpose of our study was to evaluate the efficacy and tolerability of low-dose olanzapine augmentation in selective serotonin reuptake inhibitor (SSRI)-resistant panic disorder ( PD ) with or without agoraphobia . In this 12-week , open-label study , 31 adult out patients with treatment-resistant PD who had previously failed to respond to SSRI treatment were treated with fixed dose of olanzapine ( 5 mg/d ) in addition to SSRI . Efficacy was assessed using the Panic Attack and Anticipatory Anxiety Scale ( PAAAS ) , the Agoraphobic Cognitions Question naire ( ACQ ) , the Hamilton Rating Scale for Anxiety ( HAM-A ) , the Hamilton Rating Scale for Depression ( HAM-D ) , the Global Assessment of Functioning Scale ( GAF ) , and the Clinical Global Impression of Improvement ( CGI-I ) . Twenty-six patients completed the trial period with a dropout rate of 16.1 % . At week 12 , 21 patients were responders ( 81.8 % ) , and an overall improvement on all rating scales was observed in all patients both with or without agoraphobia . Fifteen patients ( 57.7 % ) achieved remission . Olanzapine was well tolerated and the most frequent adverse effects were mild-to-moderate weight gain and drowsiness . No extrapyramidal symptoms were reported . Olanzapine appears to be effective as augmentation strategy in the treatment of SSRI-resistant PD , but study limitations must be considered and placebo-controlled studies are needed",
"OBJECTIVE To assess the efficacy and tolerability of controlled-release paroxetine ( paroxetine CR ) in the treatment of adults with panic disorder . METHOD Paroxetine CR ( 25 - 75 mg/day ; N = 444 ) was compared with placebo ( N = 445 ) in patients with DSM-IV panic disorder with or without agoraphobia in 3 identical , double-blind , placebo-controlled , 10-week clinical trials that were pooled for analysis . RESULTS Paroxetine CR was statistically superior to placebo in the primary outcome measure , percentage of patients who were free of panic attacks in the 2 weeks prior to endpoint . Of the total population that completed or prematurely terminated treatment , 63 % and 53 % of paroxetine CR- and placebo-treated patients , respectively , were panic-free during the final 2 weeks ( p paroxetine CR- and placebo-treated patients , respectively , were panic-free at week 10 ( p Paroxetine CR was also statistically superior to placebo on the global improvement and severity items of the Clinical Global Impressions scale and in reducing anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety total score and total fear and avoidance on the Marks-Sheehan Phobia Scale . Adverse events leading to study withdrawal were minimal and occurred in 11 % of the paroxetine CR group and 6 % of the placebo group . Most of the treatment-emergent adverse events were rated as mild to moderate in severity and occurred early in the study . There were no unexpected adverse events , and serious adverse events were uncommon ( 10 [ 2.3 % ] of the 444 patients treated with paroxetine CR vs. 8 [ 1.8 % ] of the 445 patients treated with placebo ) . CONCLUSION Paroxetine CR is an effective and well-tolerated treatment for panic disorder . Paroxetine CR is associated with low rates of treatment-emergent anxiety as well as low dropout rates from adverse events",
"OBJECTIVE The purpose of this study was to compare the therapeutic effect of exercise for patients with panic disorder to a drug treatment of proven efficacy and to placebo . METHOD Forty-six out patients suffering from moderate to severe panic disorder with or without agoraphobia ( DSM-III-R criteria ) were r and omly assigned to a 10-week treatment protocol of regular aerobic exercise ( running ) , clomipramine ( 112.5 mg/day ) , or placebo pills . RESULTS The dropout rate was 31 % for the exercise group , 27 % for the placebo group , and 0 % for the clomipramine group . In comparison with placebo , both exercise and clomipramine led to a significant decrease in symptoms according to all main efficacy measures ( analysis of variance , last-observation-carried-forward method and completer analysis ) . A direct comparison of exercise and clomipramine revealed that the drug treatment improved anxiety symptoms significantly earlier and more effectively . Depressive symptoms were also significantly improved by exercise and clomipramine treatment . CONCLUSIONS These results suggest that regular aerobic exercise alone , in comparison with placebo , is associated with significant clinical improvement in patients suffering from panic disorder , but that it is less effective than treatment with clomipramine",
"BACKGROUND As part of a longitudinal study , prevalence findings of DSM-IV disorders are presented for a r and om sample of 3021 respondents aged 14 to 24 , with response rate 71 % . METHOD Assessment included various subtypes of disorders , subthreshold conditions and disorders that have only rarely been studied in other epidemiological surveys . The computer-assisted Munich-Composite International Diagnostic Interview ( M-CIDI ) was used to derive DSM-IV diagnoses . RESULTS Substance disorders were the most frequent ( lifetime 17.7 % ; 12-month 11.4 % ) , with abuse being considerably more frequent than dependence . Other mental disorders had a lifetime prevalence of 27.5 % ( 12-month , 17.5 % ) with depressive disorders ( 16.8 % ) being more frequent than anxiety disorders ( 14.4 % ) . Eating disorders ( 3.0 % ) and threshold somatoform disorders ( 1.2 % ) were rare disorders . Subthreshold anxiety and somatoform disorders , however , were more frequent than threshold disorders . Prevalence of disorders was equally high for males and females , although specific disorder prevalence varied significantly by gender . The co-occurrence of disorders ( co-morbidity ) was substantial and was significantly related to greater reductions in work productivity and increased rates of professional helpseeking behaviour . CONCLUSIONS Findings underline that mental disorders in young adults are frequent and impairing , limiting work and education ability and social interaction . Given the fact that adolescents and young adults are in a key phase of socialization in terms of professional career and interpersonal relationships , our findings indicate a considerable risk potential for an accumulation of complicating factors and future chronicity . This paper is the first report of this ongoing longitudinal study about early developmental conditions of mental disorders",
" The present research evaluated patients from 2 previous studies ( 1 conducted in Peoria , the other at Dartmouth ) during a 2- to 5-year posttreatment period . Results showed that 75 % of the Peoria sample and 76 % of the Dartmouth sample were able to discontinue alprazolam therapy , remain abstinent of any type of treatment for panic disorder , and maintain their acute-treatment clinical gains over this follow-up period . The degree to which patients ' anxiety sensitivity declined during treatment predicted relapse versus survival during the 1st 6 months of follow-up , when most relapses occurred . Implication s of these findings for benzodiazepine discontinuation , combined pharmacotherapy and psychotherapy , and relapse prevention in panic disorder are discussed",
"OBJECTIVE The authors investigated whether cognitive behavioral treatment could facilitate discontinuation of alprazolam therapy and maintenance of drug abstinence among panic disorder patients treated with alprazolam doses sufficient to suppress spontaneous panic attacks . METHOD Twenty-one out patients who met DSM-III-R criteria for panic disorder with mild to severe agoraphobia were made panic-free with alprazolam ( mean dose = 2.2 mg/day ) and were then r and omly assigned to receive either supportive drug maintenance and slow , flexible drug taper or an identical medication treatment plus 12 weeks of concurrent , individual cognitive behavioral treatment . Taper in the combined treatment group was sequenced to conclude before cognitive behavioral treatment ended . RESULTS Twenty subjects completed the study . There was no significant difference between groups in the rate of alprazolam discontinuation ( 80 % and 90 % , respectively , in the alprazolam-only group and the combined treatment group ) . However , during the 6-month follow-up period , half of the subjects who discontinued alprazolam without cognitive behavior therapy , but none of those who were given cognitive behavior therapy , relapsed and resumed alprazolam treatment . CONCLUSIONS Cognitive behavioral treatment administered in parallel with alprazolam maintenance and taper was effective in preventing relapse after drug discontinuation . The results warrant further research on the thoughtful integration of these two therapeutic modalities",
"Despite the widespread application of combined selective serotonin reuptake inhibitors ( SSRI ) and benzodiazepine treatment for panic disorder , there has been relatively little systematic assessment of the safety and efficacy of this therapeutic strategy . Although the limited number of studies to date suggest a more rapid onset of benefit with combined treatment , this study is the first to address the critical question of whether continued combined treatment confers superior efficacy . This study is a r and omized , double-blind , three-arm study in patients with panic disorder ( n = 60 ) , comparing the efficacy and safety of paroxetine and placebo ( PP ) , paroxetine coadministered with clonazepam followed by a tapered benzodiazepine discontinuation phase ( PC-D ) , and ongoing combination treatment ( PC-M ) . All treatment groups demonstrated significant improvement by endpoint . There was a significant advantage for the combined treatment groups early in treatment but , subsequently , outcome in all three groups was similar . A trend towards greater achievement of endpoint remission status for the PC-D group was attenuated when variability in baseline severity was considered . The results of this study should be interpreted in the context of a relatively moderate sample size and higher rates of early dropout . Combined treatment with paroxetine and clonazepam result ed in more rapid response than with the SSRI alone , but there was no differential benefit beyond the initial few weeks of therapy . Initiating combined treatment followed by benzodiazepine taper after a few weeks may provide early benefit while avoiding the potential adverse consequences of long-term combination therapy",
"It was proposed that pre-post regression slopes be used to index treatment response when the effect of baseline scores differed among treatments ( interaction between treatment and baseline score ) . Reanalyses of two studies using imipramine and fluoxetine in panic disorder showed doserelated decreases in pre-post slopes for the frequency of unexpected panic attacks , but not for the frequency of situational panic attacks or measures of agoraphobia . This report presents similar analyses of data from a study using moclobemide . Patients ( N = 452 ) with panic disorder were r and omized to placebo or a fixed dose of moclobemide ( 75 , 150 , 300 , 600 , or 900 mg/day ) . They were treated double-blindly and evaluated at baseline and 1 , 2 , 3 , 4 , 6 , and 8 weeks later . The authors analyzed the frequency of unexpected and situational panic attacks compiled from a daily diary , and fear and avoidance ratings based on the patient ’s main phobia using baseline ( pre ) and end-point ( post ) values for all r and omized patients . Adjoining dose groups were combined . Both unexpected and situational panic attacks showed systematic doserelated suppression of pre-post treatment slopes . Neither pre-post slopes nor adjusted posttreatment means for fear and avoidance differed reliably between treatment arms . This study replicates the authors ’ earlier findings , except for situational panic attacks , which probably were not reliably identified . Antidepressants selectively suppress panic attacks , especially unexpected attacks , but not agoraphobia . The findings are consistent with the hypothesis that panic disorder with agoraphobia has clinical ly separable biologic and cognitive components that respond differentially to treatment . Antidepressants benefit primarily patients with many unexpected panic attacks . Investigators should evaluate pre-post treatment slopes before comparing adjusted posttreatment means ( analysis of covariance )",
"BACKGROUND More data are needed to guide next-step interventions for panic disorder refractory to initial intervention . METHOD This 24-week r and omized clinical trial ( RCT ) enrolled 46 patients with DSM-IV-defined panic disorder from November 2000 to April 2005 and consisted of 3 phases . Patients who failed to meet remission criteria were eligible for r and omization in the next treatment phase . Phase 1 was a 6-week lead-in with open-label sertraline flexibly dosed to 100 mg ( or escitalopram equivalent ) to prospect ively define treatment refractoriness ( lack of remission ) . Phase 2 was a 6-week double-blind RCT of ( 1 ) increased-dose selective serotonin reuptake inhibitor ( SSRI ) versus ( 2 ) continued SSRI plus placebo . Phase 3 was a 12-week RCT of added cognitive-behavioral therapy ( CBT ) compared to \" medication optimization \" with SSRI plus clonazepam . Primary endpoints were remission and change in Panic Disorder Severity Scale ( PDSS ) score in the intent-to-treat sample in each phase . RESULTS In phase 1 , 20.5 % ( 8/39 ) of the patients achieved remission , and only baseline severity predicted endpoint PDSS score ( beta [ SE ] = 1.04 [ 0.15 ] , t = 6.76 , P improvement or remission rates ( placebo 15 % [ n = 2 ] vs increased dose 9 % [ n = 1 ] : Fisher exact test P = NS ) . In phase 3 , remission was minimal ( medication optimization = 11 % [ n = 1 ] ; CBT = 10 % [ n = 1 ] ) , with a lack of group difference in PDSS score reduction ( t(17 ) = 0.51 , P > .60 ) consistent with a small effect size ( d = 0.24 ) . CONCLUSIONS Although power was limited and larger studies are needed , we failed to find evidence for greater benefit of increased SSRI dose versus continuation of current dose for panic disorder symptomatic after 6 weeks at moderate dose . Further , augmentation with CBT or medication optimization with clonazepam augmentation in nonremitted panic after 12 weeks of an SSRI did not differ , suggesting that both are reasonable next-step options . However , low overall remission rates in this comorbid refractory population suggest that better predictors of response to specific treatments over time and additional interventions are needed . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00118417",
"BACKGROUND Chronic exercise has been shown to have therapeutic effects in panic disorder ( PD ) . The mechanism of these effects is unknown . Acute exercise reduces the effect of a panic challenge in healthy volunteers . Such an effect has not yet been demonstrated in PD patients . The present study aim ed at exploring the antipanic effects of acute exercise on a 35 % CO2 panic provocation in treatment-naïve PD patients to further eluci date the mechanisms of the beneficial effects of exercise on panic . METHODS Eighteen PD patients performed either moderate/hard exercise or very-light exercise before a 35 % CO2 challenge in a r and omized , between-group design . The reactivity to CO2 was assessed with the Visual Analogue Anxiety Scale and the DSM-IV Panic Symptom List . RESULTS Panic reactions to CO2 were smaller in patients that performed moderate/hard exercise in contrast to those that performed very-light exercise . Increments in both measurements and panic rates were consistently reduced by intense exercise . LIMITATIONS Since this study focuses on the acute effects of exercise on CO2 sensitivity in patients with PD , the results of repetitive exercise sessions on the rate of spontaneous panic attacks and overall symptoms are warranted . The small sample size and other limitations are addressed . CONCLUSIONS Exercise reduced the panicogenic effects of a CO2 challenge . In addition to its therapeutic potential , exercise may also be useful as a laboratory maneuver with heuristic value in experimental research into the mechanisms of antipanic treatment",
"A cross-national r and omised trial of alprazolam for chronic panic disorder with agoraphobia was run . Compared with previous trials it had three new features : an exposure therapy contrast group , a six-month treatment-free follow-up , and a low rate of early placebo drop-outs ( ' non-evaluables ' ) . The dose of alprazolam was high ( 5 mg/day ) . The 154 patients had eight weeks of : alprazolam and exposure ( combined treatment ) ; or alprazolam and relaxation ( a psychological placebo ) ; or placebo and exposure ; or placebo and relaxation ( double placebo ) . Drug taper was from weeks 8 to 16 . Follow-up was to week 43 . Results were similar at both sites . Treatment integrity was good . All four treatment groups , including double placebo , improved well on panic throughout . On non-panic measures , by the end of treatment , both alprazolam and exposure were effective , but exposure had twice the effect size of alprazolam . During taper and follow-up , gains after alprazolam were lost , while gains after exposure were maintained . Combining alprazolam with exposure marginally enhanced gains during treatment , but impaired improvement thereafter . The new features put previous trails in a fresh light . By the end of treatment , though gains on alprazolam were largely as in previous studies , on phobias and disability they were half those with exposure . Relapse was usual after alprazolam was stopped , whereas gains persisted to six-month follow-up after exposure ceased . Panic improved as much with placebo as with alprazolam or exposure",
"Endogenous anxiety ( anxiety hysteria , agoraphobia with panic attacks ) is characterized by sudden , spontaneous panic attacks accompanied by multiple autonomic symptoms , overwhelming fear , a flight response , and polyphobic behavior . Psychotherapy , behavior therapy , and tranquillizers have been of limited success in treating this syndrome . Fifty-seven patients severely disabled by the syndrome for a mean period of 13 years completed the three-month study . R and omly assigned in a double-blind , placebo-controlled design to imipramine hydrochloride , pheneizine sulfate , or placebo , they were seen in supportive group therapy every two weeks . Patients in the pheneizine and imipramine cells showed significant improvement ovehe persistent trend for pheneizine to be superior to imipramine achieved significance only on the Work and Social Disability Scale and the Sympton Severity and Phobic Avoidance Scale . The implication s for classification and theory are discussed",
"Objective : To examine prospect ively the relationship between a diagnosis of panic disorder and the risk of acute myocardial infa rct ion within 1 year of follow-up . Panic disorder is associated prospect ively with coronary artery disease , but the risk of acute myocardial infa rct ion associated with panic disorder has not been specifically investigated . Method : This nationwide population -based study used data from the Taiwan National Health Insurance Research Data base covering the years 2000 to 2005 . A total of 9641 patients diagnosed with panic disorder in 2004 were included , together with 28,923 matched nonpanic disorder enrollees as a comparison cohort . Cox proportional hazard regressions were conducted to compute hazard ratios , after adjustment for comorbid medical disorders and sociodemographic characteristics . Results : Results indicated that 4.77 % of patients with panic disorder ( approximately one in 21 ) experienced an acute myocardial infa rct ion episode within a year , compared with 2.73 % of patients in the comparison cohort . The adjusted hazard of acute myocardial infa rct ion was significantly higher ( 1.75 times , 95 % Confidence Interval = 1.55 - 1.97 ) for patients with panic disorder , relative to the comparison cohort . The association persisted in further analyses stratified by hypertension , coronary heart diseases , and age . Conclusion : Panic disorder was identified as an independent risk factor for subsequent acute myocardial infa rct ion . Comprehensive multidisciplinary approaches are needed to optimize primary and secondary prevention of acute myocardial infa rct ion among patients with panic disorder . PD = panic disorder ; CHD = coronary heart disease ; AMI = acute myocardial infa rct ion ; MI = myocardial infa rct ion ; NHIRD = National Health Insurance Research Data base ; NHI = National Health Insurance program ; HR = hazard ratio ; CI = Confidence Interval ; HRV = heart rate variability",
"To date , no large-scale , controlled trial comparing a serotonin-norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported . This double-blind study compares the efficacy of venlafaxine extended-release ( ER ) and paroxetine with placebo . A total of 664 nondepressed adult out patients who met DSM-IV criteria for panic disorder ( with or without agoraphobia ) were r and omly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER ( 75 mg/day or 150 mg/day ) , or paroxetine 40 mg/day . The primary measure was the percentage of patients free from full-symptom panic attacks , assessed with the Panic and Anticipatory Anxiety Scale ( PAAS ) . Secondary measures included the Panic Disorder Severity Scale , Clinical Global Impressions -- Severity ( CGI-S ) and --Improvement ( CGI-I ) scales ; response ( CGI-I rating of very much improved or much improved ) , remission ( CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks ) ; and measures of depression , anxiety , phobic fear and avoidance , anticipatory anxiety , functioning , and quality of life . Intent-to-treat , last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo . No significant differences were observed between active treatment groups . Panic-free rates at end point with active treatment ranged from 54 % to 61 % , compared with 35 % for placebo . Approximately 75 % of patients given active treatment were responders , and nearly 45 % achieved remission . The placebo response rate was slightly above 55 % , with remission near 25 % . Adverse events were mild or moderate and similar between active treatment groups . Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder",
"BACKGROUND Controlled trials suggest that clomipramine may be a highly effective antipanic drug . Lowering the starting dose may alleviate troublesome initial side effects and increase acceptability and compliance . METHOD Fifty-eight patients with DSM-III-R panic disorder with or without agoraphobia underwent 13 weeks of clomipramine treatment . Starting at 10 mg/day , the dose was gradually increased to a mean dose of 97 mg/day . RESULTS While completers showed highly significant improvement , the benefits were severely limited by a high dropout rate due to adverse reactions occurring mostly during the first 2 weeks of treatment . CONCLUSION Given the alternatives , clomipramine should not be used as a first-line antipanic medication",
"The aim of this study is to evaluate the efficacy of milnacipran in the acute treatment of patients with panic disorder . Thirty-one patients who met Diagnostic and statistical manual of mental disorders-IV criteria for panic disorder with or without agoraphobia were included in the study . Patients were initially treated with milnacipran 25 mg twice daily and then 50 mg twice daily until the 10th week . The treatment outcome and panic disorder severity were determined by the Panic Disorder Severity Scale , Panic Inventory , Clinical Global Impression and Hamilton Anxiety Scale , all of which were applied during every evaluation interview . Quality of life ( WHOQOL-bref ) was evaluated at baseline and at the end of the study . Missing data were h and led by using the last observation carried forward for all participants who had taken at least one dose of study medication . Intention-to-treat was used in the analyses . Pharmacological treatment result ed in a clinical ly and statistically significant mean reduction in all severity measures . Remission ( Clinical Global Impression≤2 ) was obtained in 58.1 % of the sample . Regarding WHOQOL , we found a significant improvement ( P that milnacipran may be effective for the treatment of panic disorder and justify further research",
"The detailed results are presented of a double-blind controlled trial of phenelzine and placebo in chronic agoraphobic and socially phobic psychiatric out- patients . Forty patients entered the trial and thirty-two of these completed the 8 weeks period of treatment , in which phenelzine or placebo were taken in flexible dosage , 30–90 mg daily . Patients were prospect ively matched in pairs so that clinical response could be assessed in detail . Phenelzine was significantly superior to placebo on a number of measures , particularly for overall assessment ( P phenelzine is not acting as an antidepressant in this population",
"BACKGROUND Citalopram is a serotonin reuptake inhibitor which has been demonstrated to be highly selective and with a superior tolerability profile to the classical tricyclic antidepressants . This study was design ed to test whether there was any difference in efficacy in the management of panic disorder ( PD ) between citalopram and placebo . METHOD This was a double-blind , placebo and clomipramine controlled , parallel group eight-week study . A total of 475 patients with PD , with or without agoraphobia , were r and omised to treatment with either placebo , clomipramine 60 or 90 mg/day , or citalopram 10 or 15 mg/day , or 20 or 30 mg/day , or 40 or 60 mg/day . Doses were increased over the first three weeks , stabilised during the fourth week and fixed between weeks five and eight . RESULTS Treatment with citalopram at 20 or 30 mg , 40 or 60 mg and clomipramine were significantly superior to placebo , judged by the number of patients free of panic attacks in the week prior to the final assessment . All rating scales examined suggested that citalopram 20 or 30 mg was more effective than citalopram 40 or 60 mg . CONCLUSION The most advantageous benefit/risk ratio for the treatment of PD was associated with citalopram 20 or 30 mg/day",
"BACKGROUND Traditional combination strategies of cognitive-behavior therapy plus pharmacotherapy have met with disappointing results for anxiety disorders . Enhancement of cognitive-behavior therapy with d-cycloserine ( DCS ) pharmacotherapy represents a novel strategy for improving therapeutic learning from cognitive-behavior therapy that remains untested in panic disorder . METHOD This is a r and omized , double-blind , placebo-controlled augmentation trial examining the addition of isolated doses of 50 mg d-cycloserine or pill placebo to brief exposure-based cognitive-behavior therapy . R and omized participants were 31 out patients meeting DSM-IV criteria for panic disorder with or without agoraphobia , who were offered five sessions of manualized cognitive-behavior therapy emphasizing exposure to feared internal sensations ( interoceptive exposure ) but also including informational , cognitive , and situational exposure interventions . Doses of study drug were administered 1 hour before cognitive-behavior therapy sessions 3 to 5 . The primary outcome measures were the Panic Disorder Severity Scale ( PDSS ) and Clinicians ' Global Impressions of Severity . RESULTS Results indicated large effect sizes for the additive benefit of d-cycloserine augmentation of cognitive-behavior therapy for panic disorder . At posttreatment and 1 month follow-up , participants who received d-cycloserine versus placebo had better outcomes on the PDSS and global severity of disorder and were significantly more likely to have achieved clinical ly significant change status ( 77 % vs. 33 % ) . There were no significant adverse effects associated with DCS administration . CONCLUSIONS This pilot study extends support for the role of d-cycloserine in enhancing therapeutic learning from exposure-based cognitive-behavior therapy and is the first to do so in a protocol emphasizing exposure to feared internal sensations of anxiety in panic disorder",
"It has been suggested that maintenance treatment of patients who have remitted panic disorder with agoraphobia beyond the six months of acute phase imipramine treatment may decrease the risk of relapse . This study further explores the relationship between relapse and duration of imipramine treatment in this population . Fifty-one patients , all in remission at the end of six months acute phase open trial with imipramine 2.25 mg/kg/day and r and omized to double-blind maintenance or placebo substitution , discontinued imipramine treatment eventually and were followed over a 12-month risk period : 27 during first year placebo substitution , 7 after 12 months of imipramine maintenance in placebo substitution , and 17 after variable duration s of imipramine maintenance in open discontinuation . There were no behaviorally oriented interventions or instructions at any time during the acute and maintenance phases of treatment or during imipramine discontinuation . Duration of imipramine treatment , the method of discontinuation ( open versus placebo substitution ) , or any of the 9 variables from the demographic , clinical , and open treatment domains that were entered in a Cox proportional hazard model did not predict relapse . The rate of relapse after only 6 months of treatment ( 10 out of 27 , 37 % ) was identical to the rate of relapse after 12 to 30 months of treatment ( 9 out of 24 , 37.5 % ) . The results suggest a lack of specific protective effects beyond prophylaxis and underscore the difficulty in predicting relapse in fully remitted panic disorder with agoraphobia patients . Early detection of relapse in patients who discontinue treatment may be a viable alternative to prediction",
"OBJECTIVE Although panic attacks account for only a portion of the morbidity of panic disorder and panic attack frequency assessment s are unreliable , studies of drug efficacy in panic disorder have generally used reduction in panic attack frequency as the primary measure of improvement . The authors studied the efficacy of fluoxetine treatment in panic disorder and measured the relative contributions of changes in symptoms to overall improvement . METHOD Patients with a diagnosis of panic disorder ( N = 243 ) were r and omly assigned to treatment with 10 or 20 mg/day of fluoxetine or placebo . Primary outcome measures were change in panic attack frequency and clinician-rated Clinical Global Impression improvement scores . Other assessment s included a panic attack inventory , clinician-rated and patient-rated versions of the Panic and Phobic Disorder Change Scale , a phobia rating scale , the Hamilton Anxiety Rating Scale , the 21-item Hamilton Depression Rating Scale , and the Sheehan Disability Scale . Correlations were determined between outcomes in individual symptom domains and overall clinical outcome . RESULTS Fluoxetine , particularly the 20-mg/day dose , was associated with more improvement than was placebo in patients with panic disorder across multiple symptom measures , including global improvement , total panic attack frequency , phobic symptoms , and functional impairment . Global improvement was most highly correlated with reductions in overall anxiety and phobic symptoms and least correlated with reduction in panic attacks . Fluoxetine treatment for panic disorder was well tolerated , with a safety profile consistent with that observed for fluoxetine in other disorders . CONCLUSIONS These data provide support for the efficacy and safety of fluoxetine treatment in reducing panic attacks , phobic symptoms , anxiety , and depressive symptoms in patients with panic disorder . Reductions in panic attack frequency in subjects given either fluoxetine or placebo were less closely related to overall clinical improvement than reductions in phobic avoidance , anxiety , depressive symptoms , and functional impairment , suggesting that outcome measures in this disorder should be more broadly based",
"OBJECTIVE To compare the long-term efficacy of venlafaxine extended release ( ER ) with placebo in preventing panic disorder relapse in out-patient treatment responders . METHOD Out patients aged > or = 18 years who met Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria for panic disorder with or without agoraphobia for at least the previous 3 months , with > or = 6 full symptom panic attacks in the 2 weeks prior to screening and > or = 3 in the 2 weeks before baseline and a Clinical Global Impressions-Severity of Illness rating > or = 4 at screen were eligible to participate . Out patients received flexible-dose ( 75 - 225 mg/day ) venla-faxine ER for 12 weeks . Treatment responders were r and omly assigned to venlafaxine ER or placebo for 26 weeks . Criteria for response were time to relapse during double-blind treatment , defined as > or = 2 full symptom panic attacks per week for 2 consecutive weeks or discontinuation due to loss of effectiveness , was evaluated using Kaplan-Meier survival analysis . The study was conducted between December 2001 and August 2003 . RESULTS The intent-to-treat population had 291 patients in the open-label phase and 169 in the double-blind phase ( placebo , N = 80 ; venlafaxine ER , N = 89 ; mean daily dose 165 - 171 mg ) . Time to relapse was significantly longer with venlafaxine ER than placebo ( p panic attack treatment efficacy , quality of life , and disability were significantly better with venlafaxine ER than placebo ( p Venlafaxine ER was safe , well tolerated , and effective in preventing relapse in out patients with panic disorder",
"INTRODUCTION Individuals with anxiety disorders often remain symptomatic despite treatment with a first-line pharmacologic agent . More research examining pharmacotherapy augmentation strategies to improve outcomes is needed . METHODS In an 8-week , open-label , prospect i ve augmentation study , we examined the efficacy and tolerability of the novel antipsychotic agent aripiprazole for adult out patients with generalized anxiety disorder ( n=13 ) or panic disorder ( n=10 ) who remained symptomatic despite treatment for at least 8 weeks with an adequate ( or maximally tolerated ) dose of typical pharmacotherapy . RESULTS Aripiprazole augmentation was associated with a significant reduction in Clinical Global Impressions-Severity scores ( paired t=4.41 , df=22 , P sample of 23 individuals . Three subjects ( 13 % ) discontinued due to sedation , chest discomfort , and restlessness , respectively . CONCLUSION These data provide preliminary evidence that aripiprazole may be a useful augmentation strategy for individuals with generalized anxiety disorder or panic disorder who show a limited response to initial pharmacotherapy",
"Abstract Objectives . Regular aerobic exercise ( running ) has been shown to be superior to a pill placebo in the treatment of panic disorder . Combined drug and exercise treatment has not been investigated in r and omized controlled studies to date . Methods . This is a r and omized , 10-week , controlled , parallel group , pilot study . A total of 75 out patients with panic disorder with or without agoraphobia ( DSM-IV and ICD-10 ) received either ( 1 ) exercise plus paroxetine 40 mg/day ( n=21 ) , ( 2 ) relaxation plus paroxetine ( n=17 ) , ( 3 ) exercise plus pill placebo ( n=20 ) , or ( 4 ) relaxation plus pill placebo ( n=17 ) . Changes in the Panic and Agoraphobia Scale ( P&A ) , and the Clinical Global Impression Scale ( CGI ) underwent repeated measure analysis . Results . Effects sizes were large for all groups ( d=1.53–3.87 ) , however not significantly different . Paroxetine-treated patients were significantly more improved than placebo-treated patients . On the CGI , patients in the exercise groups ( plus paroxetine or placebo ) had a trend toward better improvement compared to relaxation ( P=0.06 ) . Response and remission rates were higher in the paroxetine compared to pill placebo groups . Conclusions . While paroxetine was superior to placebo , aerobic exercise did not differ from relaxation training in most efficacy measures",
"Eighty-one panic disorder patients with or without agoraphobia were treated with flexible doses of clomipramine under single-blind conditions . Fifty-seven ( 70.3 % ) reached operational criteria for full remission in 16.2 ± 6.5 weeks , with a mean dose of 89.1 ± 8.2 mg/day . Fifty-four ( 81 % ) of them received a continuous post-remission maintenance treatment at full doses of clomipramine for 4–6 months . No patient relapsed during the clomipramine maintenance phase . Their medication was then tappered and discontinued with placebo substitution under double-blind conditions . Fifty-one ( 63 % ) patients were followed-up until relapse or recurrence for up to 3 years , with periodic assessment s. Three different outcome groups were identified : the first ( n = 19 , 19 ; 37.2 % ) experienced an early/immediate relapse ( 5.2 ± 4.9 weeks after drug discontinuation ) ; the second group ( n= 22 , 22 ; 43.1 % ) experienced recurrence after 42.9 ± 35 weeks following discontinuation ; and the third group ( n = 10 , 10 ; 19.6 % ) remained assymptomatic and functionally well throughout the follow-up . Predictors of early relapse were : ( 1 ) higher baseline score in the Beck Depression Inventory ; ( 2 ) higher global score on the phobic avoidance scale after the full remission criteria ; and ( 3 ) the need for higher clomipramine doses to reach full remission . The need for long-term or intermittent maintenance for most patients is emphasized",
"BACKGROUND There is a paucity of data to support \" next-step \" treatments for the many patients with anxiety disorders who remain symptomatic after initial pharmacotherapy . METHOD Thirty patients with a primary diagnosis of an anxiety disorder-panic disorder ( PD ) , social anxiety disorder ( SAD ) , or generalized anxiety disorder (GAD)-refractory to initial pharmacotherapy with an adequate ( or maximally tolerated ) antidepressant and /or benzodiazepine trial of at least 8 weeks ' duration prior to study initiation received open-label augmentation with flexibly dosed risperidone for 8 weeks . Participants were diagnosed using the Structured Clinical Interview for DSM-IV . RESULTS Risperidone augmentation at a mean + /- SD dose of 1.12 + /- 0.68 mg/day ( range , 0.25 - 3.00 mg/day ) result ed in a significant reduction in anxiety symptoms across disorders as measured by the Clinical Global Impressions-Severity of Illness scale and Hamilton Rating Scale for Anxiety ( HAM-A ) scores and for each disorder-specific primary outcome measure-the Panic Disorder Severity Scale , the Liebowitz Social Anxiety Scale , and HAM-A-in the intent-to-treat sample . Seventy percent ( 21/30 ) of participants completed the 8-week trial , with premature discontinuation due primarily to sedation and weight gain . CONCLUSIONS Although conclusions are limited by the open-label , relatively brief nature of this trial , our data suggest that augmentation with low-dose risperidone may be a useful option for patients with PD , SAD , or GAD refractory to adequate initial intervention with antidepressants and /or benzodiazepines . Longer-term , controlled safety and efficacy data are needed to underst and the place of risperidone augmentation in the algorithm of treatment options for refractory anxiety disorders",
"BACKGROUND This 12-week , placebo-controlled study was carried out to compare the relative efficacy of paroxetine , clomipramine , and cognitive therapy in the treatment of DSM-III-R-defined panic disorder with or without agoraphobia . METHOD After a 3-week single-blind , placebo run-in period , 131 patients were r and omly assigned to receive double-blind medication or 12 sessions of cognitive therapy based on the model of Clark . Efficacy assessment s included the daily panic attack diary , the Clinical Global Impression scale , the Patient Global Evaluation , the Hamilton Rating Scale for Anxiety , the Marks-Sheehan Phobia Scale , the Montgomery-Asberg Depression Rating Scale , and the Sheehan Disability Scale . RESULTS Comparisons with placebo revealed significant superiority of paroxetine ( 20 - 60 mg/day ) and clomipramine ( 50 - 150 mg/day ) on nearly all outcome measures . On most measures , paroxetine also showed higher efficacy than cognitive therapy . With few exceptions , cognitive therapy did not differ significantly from placebo . The number of subjects becoming panic-free ( 66 % ) was higher and the onset of action was faster in the paroxetine-treated group . Treatment with cognitive therapy yielded the highest drop-out rate ( 26 % ) . CONCLUSION In this short-term study assessing treatment of panic disorder and agoraphobia , paroxetine and clomipramine were consistently superior to pill placebo , whereas cognitive therapy was superior on only a few measures",
"INTRODUCTION There is evidence that a decreased GABAergic tone plays a role in the pathophysiology of panic disorder ( PD ) . Selective GABAergic treatment has been suggested as a new therapeutic strategy in PD . In this pilot- study anxiolytic effects of the GABA reuptake inhibitor tiagabine ( TGB ) were investigated in PD . METHODS A total of 19 patients were treated with TGB ( n=10 ) or placebo ( n=9 ) for 4 weeks . PAS , HAM-A , and CGI ratings were administered every week . To further assess specific antipanic activity , panic challenges with CCK-4 were carried out in single subjects . RESULTS Although there was a significant reduction of clinical rating scores over time , no differences were detected between the groups . However , during challenge experiments TGB treated subjects showed decreased sensitivity to CCK-4 . DISCUSSION Whereas tiagabine did not show beneficial effects on clinical symptoms in PD compared to placebo , results of challenge experiments suggest effects of TGB on sensitivity to experimentally induced panic",
"This article focuses on social morbidity and health care utilization in persons with panic attacks not meeting full diagnostic criteria for panic disorder . The findings are based on data from a r and om sample of over 18,000 adults drawn from five US communities . Panic attacks not meeting full criteria for panic disorder have a relatively high lifetime prevalence ( 3.6 % of the adult population ) . Persons with panic attacks had impairment in perceived physical and emotional health , and in occupational and financial functioning , increased use of health care facilities , emergency departments , and psychoactive drugs . Persons with panic attacks were intermediate in severity between those with panic disorder and those with other psychiatric disorders . The findings could not be explained by comorbidity with other psychiatric disorders . We conclude that panic attacks have clinical significance and are associated with substantial morbidity",
"BACKGROUND Venlafaxine extended-release ( ER ) has proven efficacy in the treatment of anxiety symptoms in major depression , generalised anxiety disorder and social anxiety disorder . AIMS To evaluate the efficacy , safety and tolerability of venlafaxine ER in treating panic disorder . METHOD Adult out- patients ( n=361 ) with panic disorder were r and omly assigned to receive venlafaxine ER ( 75 - 225 mg/day ) or placebo for up to 10 weeks in a double-blind study . RESULTS Venlafaxine ER was not associated with a greater proportion of patients free from full-symptom panic attacks at the final on-therapy evaluation , but was associated with lower mean panic attack frequency and a higher proportion free from limited-symptom panic attacks , higher response and remission rates , and improvements in anticipatory anxiety , fear and avoidance . Adverse events were comparable with those of the drug in depression and anxiety disorders . CONCLUSIONS Venlafaxine ER seems to be effective and well tolerated in the short-term treatment of panic disorder",
"In this report , which is an up date of a guideline published in 2002 ( B and elow et al. 2002 , World J Biol Psychiatry 3:171 ) , recommendations for the pharmacological treatment of anxiety disorder , obsessive-compulsive disorder ( OCD ) and post-traumatic stress disorder ( PTSD ) are presented . Since the publication of the first version of this guideline , a substantial number of new r and omized controlled studies of anxiolytics have been published . In particular , more relapse prevention studies are now available that show sustained efficacy of anxiolytic drugs . The recommendations , developed by the World Federation of Societies of Biological Psychiatry ( WFSBP ) Task Force for the Pharmacological Treatment of Anxiety , Obsessive-Compulsive and Post-traumatic Stress Disorders , a consensus panel of 30 international experts , are now based on 510 published r and omized , placebo- or comparator-controlled clinical studies ( RCTs ) and 130 open studies and case reports . First-line treatments for these disorders are selective serotonin reuptake inhibitors ( SSRIs ) , serotonin-noradrenaline reuptake inhibitors ( SNRIs ) and the calcium channel modulator pregabalin . Tricyclic antidepressants ( TCAs ) are equally effective for some disorders , but many are less well tolerated than the SSRIs/SNRIs . In treatment-resistant cases , benzodiazepines may be used when the patient does not have a history of substance abuse disorders . Potential treatment options for patients unresponsive to st and ard treatments are described in this overview . Although these guidelines focus on medications , non-pharmacological were also considered . Cognitive behavioural therapy ( CBT ) and other variants of behaviour therapy have been sufficiently investigated in controlled studies in patients with anxiety disorders , OCD , and PTSD to support them being recommended either alone or in combination with the above medicines",
"OBJECTIVE To evaluate the efficacy , safety , and tolerability of venlafaxine extended release ( ER ) in short-term treatment of panic disorder . METHOD In this multicenter , double-blind study , conducted from April 2001 to December 2002 , 343 adult out patients who met criteria for panic disorder ( with and without agoraphobia ) according to the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , were r and omly assigned to flexible-dose venlafaxine ER ( 75 - 225 mg/d ) or placebo for 10 weeks ( N = 155 per group , intent-to-treat population ) . The primary outcome measure was the percentage of panic-free patients as assessed using the Sheehan Panic and Anticipatory Anxiety Scale . Key secondary measures included the Panic Disorder Severity Scale ( PDSS ) score and Clinical Global Impressions-Improvement ( CGI-I ) scale response ( score = 1 or 2 ) . Last-observation-carried-forward data were analyzed , and statistical significance was set at p full-symptom panic attacks was 52 % in the venlafaxine ER group and 43 % in the placebo group ( p = .11 ) . Mean change from baseline in PDSS total score was significantly ( p = .006 ) greater for the venlafaxine ER group ( -9.3 ) than for the placebo group ( -7.5 ) , and significantly ( p = .03 ) more venlafaxine ER-treated patients achieved CGI-I response ( 71 % ) than did those receiving placebo ( 59 % ) at week 10 . Treatment with venlafaxine ER was generally safe and well tolerated . Adverse events were the primary or secondary cause for discontinuation for 7 placebo patients ( 4 % ) and 12 venlafaxine ER patients ( 7 % ) . CONCLUSIONS Venlafaxine ER appears to be effective , safe , and well tolerated in short-term treatment of panic disorder , although the results fell just short of significance on the primary outcome measure . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00038896",
"Objectives : Selective serotonin reuptake inhibitors ( SSRIs ) are currently considered as the first drug of choice in the treatment of panic disorder ( PD ) . The aim of this long-term , naturalistic comparison study was to compare 4 SSRIs with respect to tolerability and treatment outcome of PD . Outcome measures included relapse rates and adverse effects . Methods : Two hundred patients with PD were enrolled in our study . All subjects met DSM-IV criteria for PD or PD with agoraphobia ( PDA ) . All patients were assigned to receive SSRI monotherapy for 12 months with either citalopram ( n = 50 ) , fluoxetine ( n = 50 ) , fluvoxamine ( n = 50 ) , or paroxetine ( n = 50 ) in a r and omized , nonblinded fashion . Both the treating psychiatrist and the patients were not blind to the assigned treatment , but the clinician raters were blind to the study medication . The study design allowed for assignment of a particular SSRI as indicated according to the clinical judgment of the study psychiatrists . The Panic Self- Question naire , which is a self-report scale , was administered at baseline and then once per month during the duration of the 12-month study . The visual analog scale and the Clinical Global Impression Scale were administered at baseline and then once per month during the period of the study . Reports of sexual dysfunction were assessed using a nonstructured clinical interview at monthly visits . The body weight of study subjects was measured at baseline , and then at the 12th month visit end point . Results : Of 200 patients who entered the study , 127 patients ( 63.5 % ) completed the full 12-month protocol . Retention rates were highest for paroxetine ( 76 % [ 38/50 ] ) , intermediate for citalopram ( 68 % [ 34/50 ] ) and fluvoxamine ( 60 % [ 30/50 ] ) , and lowest for fluoxetine ( 50 % [ 25/50 ] ) . Patients who completed the 12-month protocol responded favorably to the study treatment . The paroxetine and the citalopram groups had significantly lower rates of panic symptoms as measured at visits on weeks 4 and 8 . At visits on months 3 , 6 , 9 , and 12 , however , there were no statistically significant differences between the 4 groups in relapse rates ( defined as the occurrence of 1 or more panic attacks during the previous week of treatment ) ( F1,127 = 0.17 ; P = 0.13 [ not statistically significant ] ) . At the 12th month end point , patients in all 4 treatment groups had a statistically significant increase in body weight . Body weight among the study population increased by 6.1 + 4.9 kg from a mean weight of 72.4 + 7.3 kg at the onset of treatment . Reports of sexual adverse effects at the 12th month visit were similar in the citalopram , fluoxetine , and paroxetine groups , but the fluvoxamine patient group reported fewer sexual adverse effects at the 12th month visit . Conclusions : Most of our PD patients responded well to 12-month treatment with either citalopram , fluoxetine , fluvoxamine , or paroxetine , and the overall response rate was equal after the first 4 weeks of treatment . Although patients treated with paroxetine had the lowest dropout rates during the initiation phase , they had the highest rate of adverse effects as measured at the 12th month visit . Conversely , patients in the fluvoxamine group had the highest dropout rate ( which was primarily caused by adverse effects in the initiation phase of treatment . ) ; however , patients who were able to tolerate fluvoxamine throughout the full course of the study were observed to have lower rates of sexual dysfunction and weight gain compared with patients treated with the other agents . Overall , when measured at the 12th month visit , monotherapy with paroxetine and citalopram was associated with a higher rate of sexual adverse effects than was treatment with fluoxetine or fluvoxamine . In addition , monotherapy with paroxetine , citalopram , and fluoxetine seemed to cause more weight gain than did treatment with fluvoxamine",
"OBJECTIVE The purpose of this study was to compare the effects of discontinuing treatment with intermediate- and long-acting benzodiazepines . METHOD Fifty patients with panic disorder who had taken part in a double-blind treatment study and had responded to alprazolam , diazepam , or placebo for 8 months were asked to stop taking these medications gradually . RESULTS After a relatively rapid dose reduction , the majority of patients relapsed . Rebound anxiety and withdrawal symptoms were identified in a substantial minority of patients . Those who were taking alprazolam showed earlier and more intense rebound anxiety and withdrawal symptoms than did the patients who received diazepam . Both the level of pretreatment anxiety and the drug the patient was taking predicted the level of anxiety when drug treatment was discontinued . CONCLUSIONS The findings indicate that withdrawal phenomena commonly occur after patients stop taking benzodiazepines and that they are more frequent after discontinuation of treatment with shorter-acting drugs",
"BACKGROUND Tricyclic antidepressants and selective serotonin reuptake inhibitors ( SSRIs ) as well as benzodiazepines have been shown to be effective for the treatment of panic disorder . The introduction of SSRIs has enabled a greater underst and ing of the role of serotonin in the etiology of panic disorder ; however , the role of norepinephrine has been more challenging to ascertain . The aim of this study was to determine the efficacy and tolerability of reboxetine , a novel selective norepinephrine reuptake inhibitor , in patients with panic disorder with and without agoraphobia . METHOD Eighty-two patients ( aged 18 - 65 years ) with DSM-III-R panic disorder , with or without agoraphobia , were r and omly assigned to receive 6 to 8 mg/day of reboxetine ( 42 patients ) or placebo ( 40 patients ) for 8 weeks in this placebo-controlled , parallel-group , double-blind clinical trial . RESULTS Of the 82 patients enrolled in the trial , 75 were considered in the analysis ( 37 patients in the reboxetine group and 38 patients in the placebo group ) . At last assessment , there was a significant reduction in the mean number of panic attacks ( range , 9.3 - 1.2 ) and phobic symptoms ( range , 8.1 - 3.2 ) in the reboxetine group compared with the placebo group ( ranges , 8.5 - 5.8 and 7.7 - 5.2 , respectively ; p Hamilton Rating Scale for Depression , Hopkins Symptom Checklist-90 , and Sheehan Disability Scale scores were also greater in the reboxetine group compared with the placebo group . Adverse events reported more frequently with reboxetine than placebo included dry mouth ( 36 % vs. 16 % ) , constipation ( 27 % vs. 22 % ) , and insomnia ( 26 % vs. 22 % ) . CONCLUSION Reboxetine was effective and well tolerated in the treatment of panic disorder",
"An international , multicentre , double blind parallel group study compared the tolerability and efficacy of moclobemide with the selective serotonin reuptake inhibitor ( SSRI ) fluoxetine for panic disorder . SSRIs have been shown effective for panic . The target dose of moclobemide was 450 mg and of fluoxetine was 20 mg . There were two consecutive studies . An eight week study of acute adverse events , tolerability and efficacy was followed by a long-term extension study to 1 year . The efficacy data showed no significant difference between moclobemide and fluoxetine . Both had acute efficacy , with 63 % moclobemide and 70 % fluoxetine patients ( ns ) panic free at 8 weeks . Both agents were well tolerated to 8 weeks , but moclobemide had fewer severe adverse events ( 5 ) than fluoxetine ( 9 ) . There were no severe adverse events in the extension phase with either drug , and almost all patients completing 1 year extension treatment ( moclobemide 61 patients , fluoxetine 65 ) were much or very much improved . These data suggest moclobemide and fluoxetine are tolerated and effective for both acute panic treatment and maintenance therapy",
"The aim of this 12‐week , double‐blind , parallel group , placebo‐controlled study was to compare paroxetine with clomipramine in 367 patients with DSM‐III‐R defined panic disorder . Efficacy assessment s included the daily panic attack diary , the Clinical Global Impression Scale , the Hamilton Anxiety Rating Scale , the Marks Sheehan Phobia Scale and the Sheehan Disability Scale . Paroxetine produced significant improvements compared with placebo in various measurements of panic attack frequency , and was as effective as clomipramine . However , paroxetine appeared to have a more rapid onset of action than clomipramine in reducing the number of panic attacks to zero . There was an equivalent improvement with both paroxetine and clomipramine in the supportive efficacy variables which assessed associated aspects of therapeutic improvement . Significantly more adverse effects were reported in the clomipramine group compared with the paroxetine group , while there was no difference between the paroxetine and placebo groups",
"BACKGROUND The objective of this study was to evaluate the efficacy and tolerability of citalopram in the long-term treatment of adult out patients with panic disorder with or without agoraphobia . METHOD Patients in this double-blind , parallel-group trial were assigned to 1 of 3 fixed dosage ranges of citalopram ( 10 or 15 mg/day , 20 or 30 mg/day , or 40 or 60 mg/day ) , 1 dosage range of clomipramine ( 60 or 90 mg/day ) , or placebo . After the completed 8-week acute treatment period , the eligible patients could continue the treatment for up to 1 year . Of the 475 patients who were r and omly assigned for the short-term trial , 279 agreed to continue double-blind treatment at their assigned doses . The primary efficacy measure used was the Clinical Anxiety Scale panic attack item , and the response was defined as no panic attacks ( score of 0 or 1 ) . The other key measures used were the Physician 's Global Improvement Scale , the Patient 's Global Improvement Scale , and the Hamilton Rating Scale for Anxiety ( HAM-A ) . RESULTS In all drug-treated groups , except the group receiving the lowest citalopram dose , the treatment outcome was generally better than with placebo . As determined by a life table analysis of response , the probability of response during the 12 months was significantly greater with all treatment regimens than with placebo ( p citalopram 20 or 30 mg/day demonstrating the best response . Panic attacks tended to disappear in all patients remaining in the study until the end of follow-up . Analysis of the difference in the number of patients in different treatment groups remaining in the study ( perhaps the best measure of long-term efficacy ) also demonstrated that the patients treated with citalopram in dosage ranges of 20 or 30 mg/day and 40 or 60 mg/day had better response than placebo-treated patients ( p HAM-A and Global Improvement Scale scores also showed that patients treated with active drug showed greater improvement than placebo-treated patients . All treatment groups showed no new or exceptional adverse event clusters . CONCLUSION Citalopram in the dosage range of 20 to 60 mg/day is effective , well tolerated , and safe in the long-term treatment of patients who have panic disorder",
"BACKGROUND In the treatment of panic disorder with agoraphobia , the efficacy of pharmacological , psychological and combined treatments has been established . Unanswered questions concern the relative efficacy of such treatments . AIMS To demonstrate that moclobemide and cognitive-behavioural therapy ( CBT ) are effective singly and more effective in combination . METHOD Fifty-five patients were r and omly assigned to an eight-week treatment of : moclobemide plus CBT ; moclobemide plus clinical management ( ' psychological placebo ' ) ; placebo plus CBT ; or placebo plus clinical management . RESULTS Comparisons between treatments revealed strong effects for CBT . Moclobemide with clinical management was not superior to placebo . The combination of moclobemide with CBT did not yield significantly better short-term results than CBI with placebo . The CBT results remained stable during a six-month follow-up , although a substantial proportion of patients treated with placebo plus CBT needed additional treatment . CONCLUSIONS CBT was highly effective in the treatment of panic disorder with agoraphobia and reduced agoraphobia to levels that were comparable to those of non- clinical controls",
"BACKGROUND Although panic disorder can be effectively alleviated by drug treatment , the relapse rate is high . By adding brief dynamic psychotherapy focused on the psychosocial vulnerability of patients with panic disorder to an established drug treatment regimen , we hypothesized that this would result in a lower relapse rate after pharmacotherapy . METHODS Patients with panic disorder ( defined by DSM-III-R ) were r and omized to treatment with either clomipramine for 9 months ( n = 20 ) , or clomipramine for 9 months combined with 15 weekly sessions of brief dynamic psychotherapy ( n = 20 ) . Measures of anxiety and depression were collected at intake and at regular intervals . The patients had blind follow-up interviews at 6 , 12 , and 18 months after beginning treatment . RESULTS All patients in both groups became free of panic attacks within 26 weeks of the start of treatment . On termination of pharmacotherapy , the relapse rate was significantly higher in the clomipramine-only group during the follow-up period . There were significantly lower scores for most anxiety measures in the clomipramine plus psychotherapy group at the 9-month follow-up . CONCLUSION The addition of brief dynamic psychotherapy to treatment with clomipramine significantly reduces the relapse rate of panic disorder compared with clomipramine treatment alone",
"Panic disorder is a common and disabling psychiatric disorder . Despite treatment advances , refractory panic disorder requires novel interventions . One such pharmacologic intervention with theoretical and case study support includes olanzapine , a thienobenzodiazepine medication currently approved for schizophrenia in the United States . Ten people with refractory DSM-IV diagnosed panic disorder completed an 8-week , open-label , flexible-dose clinical trial . Baseline , in-treatment , and end-of-treatment data for panic attacks , anticipatory anxiety , phobic avoidance , and impairment were collected . Data were analyzed using SPSS software . Refractory panic disorder patients required a wide dose range averaging 12.3 mg/day of olanzapine to significantly improve or ablate panic attacks . On the average , number of attacks decreased from 6.1/week at baseline to 1.1/week at the end of treatment , and anticipatory anxiety from 32 % of the day to 8 % of the day . At treatment end , 5 of 10 participants ( 50 % ) were panic free , 4 ( 40 % ) had one attack in the previous week , 1 ( 10 % ) had seven attacks in the previous week , and 6 of 10 participants ( 60 % ) were anticipatory anxiety free . There were also statistically and clinical ly significant improvements in impairment over the course of the trial . There were no significant changes in vital signs , emergent side effects , or average weight , although 6 of 10 people did gain weight . Olanzapine is potentially effective and safe in panic disorder . Due to study limitations , further clinical trials are needed to demonstrate effectiveness",
"The mortality of anxiety syndromes between 1972 and 1992 was investigated in a prospect i ve study of a normal population , the 1947 Lundby cohort . 121 persons with anxiety according to the Lundby definition ( Anx ) , and 74 persons with panic disorder with/without agoraphobia ( PD-Ag ) according to the DSM-III-R , all of them developing their first episode between 1947 and 1972 , were analyzed with regard to general mortality and special cause of death . Sex- and age-specific mortality rates for these groups were calculated and compared with the corresponding rates of the cohort 's 1,877 remaining subjects without first episodes of Anx/PD-Ag . In contrast to the females , the annual rates of general mortality in males with Anx/PD-Ag were 1.9/2.2 times higher in the age group 65 - 84 years , compared with the rates of the non-Anx/PD-Ag groups . They also had an increase in death due to circulatory disorders , most pronounced in males with PD-Ag before the age of 65 . There were no suicides in any of the Anx/PD-Ag groups during the observation period",
"Dose escalation is often used in depressed patients who fail to respond to st and ard doses of selective serotonin reuptake inhibitors , but clinical efficacy is equivocal . We aim ed to reassess the efficacy of paroxetine dose escalation and quantify whether paroxetine dose escalation increases occupancy of the serotonin transporter ( SERT ) more than placebo dose escalation in a r and omized controlled trial . We recruited 107 nonpsychotic , unipolar depressed out patients ( 18 - 70 years ; Hamilton Depression Rating Scale ( HDRS(17 ) ) > 18 ) from primary care and psychiatric outpatient departments . After 6 weeks , open-label paroxetine 20 mg per day ( T0 ) , nonresponding patients ( HDRS(17 ) decrease paroxetine ( 30 - 50 mg per day as tolerable ) or placebo dose escalation ( paroxetine 20 mg per day+placebo ) . Patients were followed until 6 weeks after r and omization ( T1 ) . Forty-nine patients , drug free at study entry , underwent single-photon emission-computed tomography ( SPECT ) scanning before treatment and were scanned repeatedly at T0 and T1 . Paroxetine serum concentrations and SERT occupancy were determined at T0 and T1 ( n=32 ) . We terminated the dose-escalation trial after an interim analysis . Thirty nonresponding patients were r and omized to paroxetine ( 46.7+/-5.5 mg per day ) , 27 to placebo dose escalation . Response rates were 10/30 ( 33.3 % ) and 10/27 ( 37.0 % ) , respectively . Repeated measurement analyses showed no significant effect for treatment ( p=0.88 , exceeding a priori stopping rules for futility ( p>0.5 ) ) . Overall dropout was higher for placebo ( 26.7 % ) than paroxetine ( 3.3 % ; p=0.03 ) . Paroxetine dose escalation increased paroxetine serum concentrations ( p paroxetine ( 46.9+/-4.8 mg ) and 14 to placebo dose escalation ) showed no significant increase of midbrain SERT occupancy ( 2.5+/-26.4 % , paroxetine ; 3.1+/-25.8 % placebo ; p=0.687 ) nor in diencephalon ( p=0.529 ) . Paroxetine dose escalation in depressed patients has no clinical benefit over placebo dose escalation . This is explained by the absence of significant increases of SERT occupancy by paroxetine dose escalation , despite increased paroxetine serum concentrations ( IS RCT N44111488 )"
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4116d634-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The objective of this systematic review and meta- analysis was to determine the effects of omega-3 supplementation on adipocytokine levels in adult prediabetic and diabetic individuals . METHODS We search ed PubMed , Medline , EMBASE , Scopus , Web of Science , Google Scholar , Cochrane Trial Register , World Health Organization Clinical Trial Registry Platform , and Clinical trial.gov Registry from inception to August 1 , 2017 for r and omized controlled trials . Pooled effects of interventions were assessed as mean difference using r and om effects model . We conducted a sensitivity , publication bias and subgroup analysis . RESULTS Fourteen studies individuals ( n=685 ) were included in the meta- analysis . Omega-3 supplementation increased levels of adiponectin ( 0.48 μg/mL ; 95 % confidence interval [ CI ] , 0.27 to 0.68 ; P . Tumor necrosis factor α ( TNF-α ) levels were reduced ( -1.71 ; 95 % CI , -3.38 to -0.14 ; P=0.03 , n=8 trials ) . Treatment duration shorter than 12 weeks was associated with greater reduction than longer treatment duration . Levels of other adipocytokines were not significantly affected . Publication bias could generally not be excluded . CONCLUSION Eicosapentaenoic acid and docosahexaenoic acid supplementation may increase adiponectin and reduce TNF-α levels in this population group . However , due to overall study heterogeneity and potential publication bias , a cautious interpretation is needed
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"Increased arterial stiffness is associated with enhanced risk of cardiovascular disease in obese individuals . Whether n3 fatty acid ethyl ester ( FAEE ) supplementation improves arterial stiffness in obese participants on a weight loss diet has not yet been investigated . The objective of the study was to carry out a 12-wk r and omized , single-blind trial to test the effect of a 25 % energy deficit weight loss diet alone ( WL ) ( n = 12 ) or WL plus 4 g/d Omacor ( 46 % EPA and 38 % DHA ) supplementation ( WL+FAEE ) ( n = 13 ) on arterial elasticity in obese adults . Large ( C1 ) and small artery elasticity ( C2 ) were measured by pulse contour analysis of the radial artery . WL alone reduced ( P body weight ( -3 % ) , waist circumference ( -4 % ) , systolic ( -3 % ) and diastolic ( -3 % ) blood pressures , cardiac output ( -4 % ) , plasma TG concentration ( -25 % ) , and the homeostasis model assessment ( HOMA ) score ( -12 % ) and increased plasma HDL cholesterol ( + 9 % ) and adiponectin ( + 18 % ) concentrations . However , WL alone did not alter C1 and C2 . The WL+FAEE intervention significantly reduced body weight ( -4 % ) , waist circumference ( -4 % ) , systolic ( -8 % ) and diastolic ( -5 % ) blood pressures , pulse pressure ( -5 % ) , heart rate ( -8 % ) , plasma TG concentration ( -36 % ) , and HOMA score ( -12 % ) and increased stroke volume ( + 3 % ) , plasma HDL cholesterol ( + 6 % ) and adiponectin concentrations ( + 28 % ) , and C1 ( + 20 % ) and C2 ( + 22 % ) artery elasticity . The changes in systolic blood pressure , heart rate , plasma TGs , C1 , and C2 were significantly greater in the WL+FAEE group than in the WL group . Supplementation with n3 FAEEs improves C1 and C2 independently of weight loss in obese adults",
"BACKGROUND Information is lacking on the potential effect of n-3 polyunsaturated fatty acids ( PUFAs ) on the adipose tissue of patients with type 2 diabetes . OBJECTIVE We evaluated whether n-3 PUFAs have additional effects on adiposity , insulin sensitivity , adipose tissue function ( production of adipokines and inflammatory and atherogenic factors ) , and gene expression in type 2 diabetes . DESIGN Twenty-seven women with type 2 diabetes without hypertriglyceridemia were r and omly allocated in a double-blind parallel design to 2 mo of 3 g/d of either fish oil ( 1.8 g n-3 PUFAs ) or placebo ( paraffin oil ) . RESULTS Although body weight and energy intake measured by use of a food diary were unchanged , total fat mass ( P subcutaneous adipocyte diameter ( P Insulin sensitivity was not significantly different between the 2 groups ( measured by homeostasis model assessment in all patients and by euglycemic-hyperinsulinemic clamp in a subgroup of 5 patients per group ) . By contrast , atherogenic risk factors , including plasma triacylglycerol ( P ratio of triacylglycerol to HDL cholesterol ( atherogenic index , P plasma plasminogen activator inhibitor-1 ( P inflammation-related genes was reduced in subcutaneous adipose tissue after the fish oil , but not the placebo , treatment . CONCLUSIONS A moderate dose of n-3 PUFAs for 2 mo reduced adiposity and atherogenic markers without deterioration of insulin sensitivity in subjects with type 2 diabetes . Some adipose tissue inflammation-related genes were also reduced . These beneficial effects could be linked to morphologic and inflammatory changes in adipose tissue . This trial was registered at clinical trials.gov as NCT0037",
"Aims . To investigate the relationship of body mass index and serum adipokines with incidence of diabetes in men . Material and methods . Ten-year cohort study of a r and om population sample of 1011 men aged 35–69 years from the MONICA-Catalonia survey ( 1986–1988 ) . WHO-MONICA protocol and the US Hispanic NHANES diabetes question naire were applied . Fasting serum glucose and lipids were measured by enzymatic methods , adipokines and insulin by Luminex xMAP technology , and hs-CRP by nephelometry in stored baseline sample s ( –80 ° C ) . Type2 diabetes was defined as fasting glucose ≥ 7.0 mmol/L or diagnosed diabetes . Incident diabetes was defined as absence of these criteria at baseline but presence at re-examination . Cox regression analysis was used . Results . Incidence of diabetes ( n = 85 ) was 10.3/1000 person-years , increasing significantly with BMI but decreasing by quartiles of adiponectin . Incidence increased above median BMI and glucose ( 45.3/1000 person-years , OR = 19.97 ) . Log-adiponectin associated with reduced risk of diabetes after multivariate adjustment ( HR = 0.24 , 95 % CI 0.08–0.72 ) , with significant modification of this effect by baseline glycaemia . C-reactive protein was not a significant factor . Leptin lost strength when adjusted for BMI . Conclusions . In a population with relatively high diabetes incidence , BMI and glucose were strong risk factors , while adiponectin protected against diabetes , especially in men with high glycaemic level ",
"Introduction There is evidence that n-3 polyunsaturated fatty acids ( n-3 PUFAs ) exert beneficial effects to improve type 2 diabetes mellitus ( T2DM ) , but its complications remain poorly understood . Hypoadiponectinemia is one of the important mechanisms responsible for T2DM which necessitates developing novel therapeutic strategies . We aim ed to determine the effect of n-3 PUFA supplementation on circulating adiponectin and mRNA expression of adiponectin receptors ( AdipoR1 , AdipoR2 ) and Sirt-1 in T2DM patients . Material and methods A r and omized , double-blind , placebo-controlled trial of 10-week follow-up of n-3 PUFAs ( 2.7 g/day ) vs. placebo in T2DM patients ( n = 88 ) was conducted . In detail , T2DM patients ( n = 44 ) were treated with n-3 PUFAs and the remainder received placebo . Anthropometric and metabolic characteristics were assessed in all participants . Circulating level of adiponectin and mRNA expression of AdipoR1 , AdipoR2 and Sirt-1 were measured in peripheral blood mononuclear cells ( P BMC ) using real-time polymerase chain reaction before and after the intervention . Results It was found that n-3 PUFAs increased AdipoR1 gene expression ( fold change = 1.321 in n-3 PUFAs vs. 1.037 in placebo ) and AdipoR2 mRNA ( fold change = 1.338 in n-3 PUFAs vs. 1.034 in placebo ) . No significant changes were observed for Sirt-1 expression . The serum level of adiponectin significantly ( p = 0.035 ) increased in n-3 PUFAs ( 5.09 to 5.58 μg/ml ) but remained unchanged in the placebo group . Conclusions Daily supplementation with n-3 PUFAs ( 2.7 g ) was effective to significantly improve gene expression of AdipoR1 and AdipoR2 and the serum level of adiponectin in T2DM patients . Therefore , n-3 PUFAs might emerge as an adjuvant for current antidiabetic therapies . However , confirmatory long-term studies are required",
"Background Eicosapentaenoic acid ( EPA ) may reduce increased risks for ( cardiovascular ) morbidity and mortality in patients with diabetes mellitus ( DM ) and comorbid major depressive depression ( MDD ) . Yet , effects of EPA-supplementation on biological risk factors for adverse outcomes have not been studied in DM- patients with MDD . Methods We performed a r and omized , double-blind trial ( n = 25 ) comparing add-on ethyl-EPA-supplementation to placebo on ( I ) oxidative stress , ( II ) inflammatory , ( III ) hypothalamic-pituitary-adrenal (HPA)-axis , ( IV ) one-carbon-cycle , ( V ) fatty acid metabolism and ( VI ) lipoprotein parameters during 12-weeks ' follow-up . Results Besides increases in supplemented α-tocopherol [ estimate ( 95 % CI ) ; 3.62 ( 1.14–6.11 ) µmol/l ; p = 0.006 ] and plasma and erythrocyte EPA , the intervention did not influence other oxidative stress , inflammatory or one-carbon-cycle parameters compared to placebo . HPA-axis reactivity significantly decreased in the EPA-group ( N = 12 ) [ AUCi : −121.93 ( −240.20–−3.47 ) min × nmol/l ; p = 0.045 ] , not in the placebo-group ( N = 12 ) . Furthermore , EPA-supplementation increased erythrocyte and plasma docosapentaenoic acid , and decreased plasma arachidonic acid ( AA ) concentrations [ −1.61 ( −3.10–−0.11 ) % ; p = 0.036 ] . Finally , EPA had a multivariate influence on lipoprotein concentrations ( p = 0.030 ) , reflected by relative increases in high density lipoprotein [ HDL ; 0.30 ( 0.02–0.58 ) mmol/l ; p = 0.039 ] and total cholesterol concentrations [ 1.01 ( 0.29–1.72 ) mmol/l ; p = 0.008 ] . Conclusion Overall , add-on EPA-supplementation had limited effects on biological risk factors for adverse outcome in this sample of DM- patients with comorbid MDD . Besides increases in concentrations of supplemented α-tocopherol and EPA , AA decreased , and inconclusive effects on HPA-axis (re)activity and lipoprotein concentrations were observed . Therefore , further studies on the alleged beneficial effects of EPA-supplementation on biological risk factors for adverse outcome in DM- patients with comorbid MDD seem warranted , preferably using clinical outcomes such as ( cardiovascular ) DM-complications . Trial Registration Controlled-Trials.com IS RCT N30877831 IS RCT",
"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",
"Eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) are ω3-polyunsaturated fatty acids mainly contained in the blue-backed fish oil , and are effective in decreasing the lipids disorder and the cardiovascular incidence among diabetic patients . Moreover , it has been suggested that EPA and DHA may improve the insulin resistance and glucose metabolism . However , the clinical effects of EPA and DHA on glucose metabolism remain unclear . We aim ed to clarify the effects of EPA/DHA treatment on glycemic control in type 2 diabetes mellitus . This study was a multicenter prospect i ve r and omized controlled trial involving 30 elderly type 2 diabetic patients on a liquid diet . Their exercises were almost zero and the content of their meals was strictly managed and understood well . Therefore , the difference by the individual 's life was a minimum . The subjects were divided into two groups : those receiving EPA/DHA-rich liquid diet [ EPA/DHA ( + ) ] or liquid diet lacking EPA/DHA [ EPA/DHA ( - ) ] . Changes in factors related to glucose and lipid metabolism were assessed after the three-month study . Serum concentrations of EPA rose in EPA/DHA ( + ) , although the levels of DHA and fasting C-peptide remained unchanged in EPA/DHA ( + ) . In addition , there was a significant decline in the fasting plasma glucose ( FPG ) , hemoglobin A1c ( HbA1c ) , fasting remnant-like particles and apolipoprotein ( apo ) B in EPA/DHA ( + ) , compared with the values in EPA/DHA ( - ) . EPA/DHA-rich diet might improve glucose metabolism in elderly type 2 diabetic patients on a liquid diet . This phenomenon may be due to the improved insulin resistance mediated by the rise in serum EPA concentrations",
"Recent evidence suggests that omega-3 polyunsaturated fatty acids [ n-3 PUFAs : eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) ] , improve insulin sensitivity in humans . In a double-blind , placebo-controlled , r and omized , crossover study , we investigated the effects of EPA/DHA on paraoxonase-1 activity as well as fasting and postpr and ial levels of circulating adiponectin and leptin in 34 subjects with type 2 diabetes mellitus who received daily for 6 weeks either 2 g purified EPA/DHA or olive oil ( placebo ) , separated by a 6 weeks washout . At the end of each treatment , measurements were performed in fasting state and 2 , 4 , and 6 h following a st and ardized high-fat meal ( 600 kcal ) . No significant differences in fasting and postpr and ial circulating adiponectin , leptin , and paraoxonase-1 activity were seen between n-3 PUFAs and placebo . Our data do not support an insulin sensitizing effect of n-3 PUFAs by means of influencing circulating adipocytokines in this population . Clinical Trial Register Number : NCT00328536",
"INTRODUCTION Consumption of omega-3 fatty acids can alter the inflammatory response in diabetic patients . This study aim ed to determine the effects of omega-3 fatty acid supplementation on the serum levels of C-reactive protein ( CRP ) , interleukin (IL)-2 and tumour necrosis factor-alpha ( TNF-α ) in type 2 diabetes mellitus patients . METHODS A r and omised , double-blind , placebo-controlled clinical trial was conducted on 84 subjects aged 45 - 85 years with at least a two-year history of type 2 diabetes mellitus . Participants were r and omly assigned to the treatment or control group . Each subject in the treatment group received three omega-3 capsules per day ( eicosapentaenoic acid 1,548 mg ; docosahexaenoic acid 828 mg ; other omega-3 fatty acids 338 mg ) , while each subject in the control group received three placebo capsules ( sunflower oil 2,100 mg ) for a period of eight weeks . At the beginning of the study and post intervention , fasting blood sample s were taken and serum concentrations of IL-2 , TNF-α and CRP were assessed and compared . RESULTS Serum IL-2 and TNF-α levels were significantly reduced in the treatment group compared to the controls ( p in serum CRP levels . CONCLUSION Short-term omega-3 fatty acid supplementation ( 3 g/day for eight weeks ) can decrease the serum levels of TNF-α and IL-2 in diabetic patients , with no change in CRP levels . Consumption of omega-3 fatty acid supplements is highly recommended to alleviate inflammation caused by type 2 diabetes mellitus",
"OBJECTIVE The relationship between fish or omega-3 polyunsaturated fatty acids ( PUFAs ) and type 2 diabetes is inconclusive . Even contaminants in fish , such as mercury , may modify the effects . We investigated the associations between serum omega-3 PUFAs eicosapentaenoic acid ( EPA ) , docosapentaenoic acid ( DPA ) , docosahexaenoic acid ( DHA ) , α-linolenic acid ( ALA ) , hair mercury , and risk of incident type 2 diabetes in middle-aged and older Finnish men . RESEARCH DESIGN AND METHODS A total of 2,212 men from the prospect i ve , population -based Kuopio Ischemic Heart Disease Risk Factor study , aged 42–60 years and free of type 2 diabetes at baseline in 1984–1989 , were investigated . Serum PUFA and hair mercury were used as biomarkers for exposure . Dietary intakes were assessed with 4-day food recording . Type 2 diabetes was assessed by self-administered question naires and fasting and 2-h oral glucose tolerance test blood glucose measurement at re-examination rounds 4 , 11 , and 20 years after the baseline and by record linkage to hospital discharge registry and reimbursement register on diabetes medication expenses . Cox proportional hazards models were used to analyze associations . RESULTS During the average follow-up of 19.3 years , 422 men developed type 2 diabetes . Men in the highest versus the lowest serum EPA + DPA + DHA quartile had 33 % lower multivariate-adjusted risk for type 2 diabetes ( 95 % CI 13–49 ; P trend 0.01 ) . No statistically significant associations were observed with serum or dietary ALA , dietary fish or EPA + DHA , or hair mercury . CONCLUSIONS Serum long-chain omega-3 PUFA concentration , an objective biomarker for fish intake , was associated with long-term lower risk of type 2 diabetes ",
"Background : Obesity , inflammation , insulin resistance and cardiovascular disease ( CVD ) risk are inter-related . Both weight-loss and long-chain n-3 polyunsaturated fatty acids ( LC n-3 PUFA ) are independently known to reduce metabolic risk , but the combined effects are unclear . Objective : This study examines whether addition of LC n-3 PUFA to a low fat/high carbohydrate weight-loss programme results in greater improvements in inflammation , insulin sensitivity and CVD risk , than weight-loss alone . Design : One hundred and sixteen overweight insulin-resistant women entered a 24-week r and omised intervention study . Thirty-nine women were r and omised to a weight-loss programme , with LC n-3 PUFA ( WLFO ) , 38 to a weight-loss programme with placebo oil ( WLPO ) , and 39 to receive placebo oil , with no weight-loss programme ( control ) . Results : Ninety-three women completed the study ( 35 WLFO , 32 WLPO and 26 control ) , with significant weight-loss in WLFO ( 10.8±1.0 % ) and WLPO ( 12.4±1.0 % ) compared to the control group ( P in adipose tissue LC n-3 PUFA ( 0.34±0.20 vs 0.17±0.10 and 0.16±0.10 % DHA , P showed significant improvements in insulin sensitivity ( P ) , lipid profile ( triglycerides P ) and inflammation ( sialic acid P in triglycerides ( P increases in adiponectin ( P triglycerides and adiponectin . Given the current low dietary intake of LC n-3 PUFA , greater attention should be given to increase these fatty acids in the treatment of obesity",
"n-3 fatty acids reduce the risk of cardiovascular disease via a number of possible mechanisms . Despite this , there has been concern that these fatty acids may increase lipid peroxidation . The data in vivo are inconclusive , due in part to limitations in the method ologies . In this regard , the measurement of F2-isoprostanes provides a reliable assessment of in vivo lipid peroxidation and oxidant stress . This study aim ed to assess the effects of supplementation with purified eicosapentaenoic acid ( EPA ) or docosahexaenoic acid ( DHA ) , the two major n-3 fatty acids , on urinary F2-isoprostanes and markers of inflammation , in type 2 diabetic patients . In a double-blind , placebo controlled trial of parallel design , 59 nonsmoking , treated-hypertensive , type 2 diabetic subjects , were r and omized to 4 g daily of purified EPA , DHA , or olive oil for 6 weeks , while maintaining their usual diet . F2-isoprostanes , measured using gas chromatography-mass spectrometry in 24 h urines and C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-alpha ) , were measured before and after intervention . Thirty-nine men and 12 women aged 61.2 + /- 1.2 years , with body mass index ( BMI ) , 29.5 + /- 0.5 kg/m2 ; 24 h blood pressure , 138/73 mmHg ; HbA1c , 7.3 + /- 0.1 % and fasting glucose , 7.9 + /- 0.2 mmol/l completed the intervention . Baseline urinary F2-isoprostanes were positively associated with HbA1c ( p=.011 ) and fasting glucose ( p=.032 ) . Relative to the olive oil group , postintervention urinary F2-isoprostanes were decreased 19 % by EPA ( p=.017 ) and 20 % by DHA ( p=.014 ) . There were no significant changes in CRP , IL-6 , and TNF-alpha following EPA or DHA supplementation . In regression analysis , Delta F2-isoprostanes were positively associated with Delta HbA1c ( p=.007 ) independent of treatment group ; and with Delta TNF-alpha ( p=.034 ) independent of age , gender , BMI , and treatment group . There were no associations with Delta CRP or Delta IL-6 . This study is the first report demonstrating that either EPA or DHA reduce in vivo oxidant stress without changing markers of inflammation , in treated hypertensive , type 2 diabetic subjects"
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Aims Erectile dysfunction ( ED ) is a major care problem worldwide . Tadalafil and sildenafil are the two most common phosphodiesterase 5 inhibitors used to treat ED . This systematic review and meta- analysis were conducted to directly compare tadalafil with sildenafil for the treatment of ED . Methods We design ed a strategy for search ing the PubMed , Embase , EBSCO , Web of Science and Cochrane library data bases ; the reference lists of the retrieved studies were also investigated . A literature review was performed to identify all published r and omized or non-r and omized controlled trials that compared tadalafil with sildenafil for the treatment of ED and to assess the quality of the studies . Two investigators independently and blindly screened the studies for inclusion . The meta- analysis was performed using RevMan 5.0 . Results A total of 16 trials that compared tadalafil with sildenafil for the treatment of ED were included in the meta- analysis . In the meta- analysis , tadalafil and sildenafil appeared to have similar efficacies and overall adverse event rates . However , compared with sildenafil , tadalafil significantly improved psychological outcomes . Furthermore , the patients and their partners preferred tadalafil over sildenafil , and no significant difference was found in the adherence and persistence rates between tadalafil and sildenafil . Additionally , the myalgia and back pain rates were higher and the flushing rate was lower with tadalafil than with sildenafil . Conclusion Tadalafil shares a similar efficacy and safety with sildenafil and significantly improves patients ’ sexual confidence . Furthermore , patients and their partners prefer tadalafil to sildenafil . Hence , tadalafil may be a better choice for ED treatment
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"AIM To evaluate patient preferences for sildenafil citrate or tadalafil ( PDE-5 inhibitors available for the treatment of erectile dysfunction [ ED ] ) and assess potential reasons for these preferences . METHODS This open-label study was conducted on Korean men taking sildenafil , at least 6 weeks prior to study entry , for ED . Following screening , patients continued sildenafil treatment for 4 weeks , then after a 1-week washout period , switched to tadalafil for 8 weeks . Patients then continued with their treatment of choice during an extension phase . Psychosocial factors ( time concern , spontaneity , sexual self-confidence ) were evaluated using Psychological and Interpersonal Relationship Scales ( PAIRS ) , while timing of dose to sexual attempt patterns were assessed from patient diaries . RESULTS The present study enrolled 160 Korean men ( mean age 55 years ) with prior median sildenafil use of 585 days . During the extension phase , 73.7 % of patients elected to take tadalafil , whereas 26.3 % chose sildenafil ( P sildenafil to tadalafil , mean PAIRS time concern scores decreased from 2.54 to 2.42 ( P = 0.002 ) , with no statistically significant differences observed between the sildenafil and tadalafil assessment phases in sexual spontaneity and self-confidence scores . Sexual attempts made > 4 h to =/ sildenafil assessment phase compared with 17.5 % during the tadalafil assessment phase . CONCLUSION After experiencing both sildenafil and tadalafil , the majority of patients exhibited a preference for tadalafil . This preference might be influenced by psychosocial factors , such as decreased time concerns , and a broader window of opportunity available for sexual activity",
"The study was to compare treatment preference , efficacy , and tolerability of sildenafil citrate ( sildenafil ) and tadalafil for treating erectile dysfunction ( ED ) in Chinese men naοve to phosphodiesterase 5 ( PDE5 ) inhibitor therapies . This multicenter , r and omized , open-label , crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil . After a 4 weeks baseline assessment , 383 eligible patients were r and omized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension . Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Question naire ( PITPQ ) . Secondary efficacy was analyzed by PITPQ Question 2 , the International Index of Erectile Function ( IIEF ) erectile function ( EF ) domain , sexual encounter profile ( SEP ) Questions 2 and 3 , and the Drug Attributes Question naire . Three hundred and fifty men ( 91 % ) completed the r and omized treatment phase . Two hundred and forty-two per 350 ( 69.1 % ) patients preferred 20-mg tadalafil , and 108/350 ( 30.9 % ) preferred 100-mg sildenafil ( P tadalafil and 37/108 ( 34.3 % ) strongly the preferred sildenafil . The SEP2 ( penetration ) , SEP3 ( successful intercourse ) , and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups . For patients who preferred tadalafil , getting an erection long after taking the medication was the most reported reason for tadalafil preference . The only treatment-emergent adverse event reported by > 2 % of men was headache . After tadalafil and sildenafil treatments , more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil . Both sildenafil and tadalafil treatments were effective and safe",
"PURPOSE To assess patient preference for erectile dysfunction treatment between either sildenafil or tadalafil , each administered with their respective dosing instructions , and to evaluate preference for either sildenafil or tadalafil dosing instructions during tadalafil therapy . METHODS We conducted a r and omized , double-blind , crossover study consisting of four treatment arms . Because the dosing instructions for sildenafil and tadalafil are different , a unique methodology using sham placebo arms was employed to maintain the blind . To assess drug preference , 219 patients were r and omized to either sildenafil 50 mg or tadalafil 20 mg , with dosing instructions reflecting their respective product profiles . To assess dosing instruction preference during tadalafil therapy , 46 patients were r and omized to tadalafil 20 mg with either tadalafil or sildenafil dosing instructions . After 12 weeks , patients were crossed-over . After 4 weeks of each treatment , all patients following sildenafil dosing instructions were offered the opportunity for an upward dose titration . In a double-blind fashion , all patients who requested an upward titration received additional capsules . To mimic the pattern of dose usage observed in clinical practice , the number of patients who received additional double-blind active medication was limited to 35 % of patients taking sildenafil in each treatment period in each country . Following the crossover treatment period , patients chose their preferred double-blind treatment with dosing instructions to receive in the 12-week extension period . RESULTS In the drug preference assessment , 132 of 181 ( 73 % ) evaluable patients chose to receive tadalafil ( p dosing instruction preference assessment , 24 of 36 ( 67 % ) evaluable patients preferred tadalafil with tadalafil dosing instructions ( p = 0.046 ) . Sildenafil and tadalafil were well tolerated . CONCLUSIONS In the doses utilized in this study , 73 % of patients preferred tadalafil with tadalafil dosing instructions for the treatment of their erectile dysfunction over sildenafil with sildenafil dosing instructions . During tadalafil therapy , 67 % of patients preferred tadalafil dosing instructions over sildenafil dosing instructions",
"Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction ( ED ) . Recent study results indicate that men with ED in China who were naïve to phosphodiesterase inhibitor type 5 ( PDE5 ) therapy prefer tadalafil 20-mg ( on-dem and ) versus sildenafil 100-mg ( on-dem and ) . Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafil . This open-label , r and omized , crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED naïve to PDE5 inhibitor therapy . Eligible patients were r and omized to sequential 20-mg tadalafil/100-mg sildenafil ( n = 190 ) or 100-mg sildenafil/20-mg tadalafil ( n = 193 ) for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase . Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale ( PAIRS ) , Drug Attributes Question naire ( DRAQ ) , and Sexual Life Quality Question naire ( SLQQ ) . When taking tadalafil versus sildenafil , men had a higher mean endpoint score on the PAIRS Spontaneity Domain ( tadalafil = 2.86 vs sildenafil = 2.72 ; P mean endpoint score on the Time Concerns Domain ( tadalafil = 2.41 vs sildenafil = 2.55 ; P the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil ( tadalafil = 2.76 vs sildenafil = 2.72 ; P = 0.102 ) . The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug , and ability to get an erection every time . SLQQ results were comparable between treatment groups . These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial",
"Objectives : To assess the efficacy of tadalafil de-escalation in the therapeutic effects of psychogenic erectile dysfunction ( ED ) during the 3 months extension phase . Methods : A total of 90 men with mild to severe psychogenic ED were r and omly divided into 2 groups : tadalafil 5 mg group and tadalafil de-escalation group . Efficacy assessment s included the 5-item version of International Index of Erectile Function ( IIEF-5 ) , the Sexual Encounter Profile ( SEP ) question naires , Psychological and Interpersonal Relationship Scales ( PAIRS ) , Erection Hardness Score ( EHS ) . Results : Compared with the baseline , tadalafil 5 mg and de-escalation groups enhanced all efficacy outcomes . Patients receiving tadalafil 5 mg and de-escalation experienced a significant mean improvement in the psychogenic erectile function domain of the IIEF-5 from the baseline ( p mean change from baseline was significantly higher for the tadalafil de-escalation group than for the tadalafil 5 mg group ( p Response to SEP3 , PAIRS and EHS was significantly higher in the tadalafil de-escalation group than in the tadalafil 5 mg group ( p severity of ED in the tadalafil de-escalation group had reduced after treatment . It was also significantly better than those in the tadalafil 5 mg group ( p Tadalafil de-escalation significantly improved the erectile function among psychogenic ED patients . This implies that tadalafil de-escalation treatment for psychogenic ED is worthy of further clinical practice and research",
"The impact of erectile dysfunction is distressing to both males and their female partners , but less attention has been paid to identify female partners′ preferred treatment and sexual quality of life outcomes . The present analysis explores female partners′ treatment preference for erectile dysfunction in Chinese Men . This was a phase 4 , r and omized , open-label , multicenter , crossover study in Chinese men with erectile dysfunction who were naïve to phosphodiesterase type 5 inhibitor treatments . Eligible patients were r and omized to sequential 20-mg tadalafil/100-mg sildenafil or 100-mg sildenafil/20-mg tadalafil for 8 weeks each . Of 418 patients , female partners of 64 patients agreed to enter the study ; of 64 patients who entered the study with female partners , 63 were r and omized , and 62 completed the study . Baseline demographics and disease characteristics were comparable between treatment groups . Significantly more couples preferred tadalafil compared with sildenafil overall ( 75.4 % vs 24.6 % ; P improvements in sexual quality of life scores were reported at endpoint ( Visit 8) in male patients and female partners in both tadalafil and sildenafil treatment groups ( P for the erectile function ( P = 0.013 ) and overall satisfaction ( P = 0.019 ) International Index for Erectile Function domains and the spontaneity domain ( P . No major safety concerns were reported during the study . Though both treatments were effective , safe , and tolerable , more couples preferred tadalafil compared with sildenafil ",
"Introduction Erectile dysfunction ( ED ) is currently one of the most common sexual dysfunctions worldwide but it is usually underestimated because it is not a life threatening condition . The associated stigma makes men who have it to suffer in silence . This study was conducted to determine the prevalence of erectile dysfunction and the possible associated risk factors among Nigerian men . Methods The study was a descriptive cross-sectional population based survey among men aged 30 - 80 years in Ogbomoso , South-west , Nigeria . A multistage r and om sampling method was used . The instrument used was the International Index of Erectile Function Question naire-5 ( IIEF-5 ) . Unadjusted odds ratios of possible risk factors were calculated by univariate analyses . Binary logistic regression analysis was used to eliminate the effect of possible confounders on the risk factors to get the adjusted odds ratios . Results The general prevalence of ED in this study was 58.9 % . Sixty-seven ( 47.2 % ) , 16 ( 11.3 % ) and 59(41.5 % ) respondents had mild , moderate and severe ED respectively . Age , hypertension , use of anti-hypertensive drugs , diabetes mellitus and heart disease all had significant unadjusted associations with ED , but their adjusted associations were not statistically significant . Diabetes mellitus maintained a positive statistically significant relationship with ED after adjustment for potential confounders [ OR= 8.31(95 % CI 1.02 - 67.65 ) , P= 0.048 ] . Conclusion The prevalence of ED is high among south-western Nigeria male adults . Physicians , especially primary care ones , need to pay more attention to the sexual history of their patients in order to diagnose and manage ED more frequently",
"OBJECTIVES To develop Patient and Partner versions of a psychometrically sound question naire , the EDITS ( Erectile Dysfunction Inventory of Treatment Satisfaction ) , to assess satisfaction with medical treatments for erectile dysfunction . METHODS Treatment satisfaction differs from treatment efficacy as it focuses on a person 's subjective evaluation of treatment received . Twenty-nine items representing the domain of treatment satisfaction for men and 20 representing partner satisfaction were generated . Two independent sample s of 28 and 29 couples completed all items at two points in time . Spearman rank-order correlations were derived to assess test-retest reliability and couple coefficients of validity . Internal consistency coefficients were calculated for both Patient and Partner versions and a content validity panel was used to analyze content validity . RESULTS Only items that met all the following criteria were selected to comprise the final question naires : ( a ) range of response four or more out of five ; ( b ) test-retest reliability greater than 0.70 ; ( c ) ratings by at least 70 % of the content validity panel as belonging in and being important for the domain ; and ( d ) significant correlation between the subjects ' and partners ' responses . Eleven patient items met criteria and formed the Patient EDITS ; five partner items met criteria and formed the Partner EDITS . Scores on the two inventories were normally distributed with internal consistencies of 0.90 and 0.76 , respectively . Test-retest reliability for the Patient EDITS was 0.98 ; for the Partner EDITS , it was 0.83 . CONCLUSIONS Reliability and validity were well established , enabling the EDITSs to be used to assess satisfaction with treatment modalities for erectile dysfunction and to explore the impact of patient and partner satisfaction on treatment continuation",
"BACKGROUND Tadalafil is a phosphodiesterase 5 ( PDE5 ) inhibitor approved in > 30 countries for the treatment of erectile dysfunction ( ED ) . It has been shown to improve erectile function compared with placebo in Phase III studies , but clinical experience comparing tadalafil with the PDE5 inhibitor sildenafil citrate is lacking . OBJECTIVE This study compared patient preference for tadalafil 20 mg or sildenafil 50 mg during initial treatment for ED . It also compared the tolerability of the 2 agents at these doses . METHODS This r and omized , double-blind , fixed-dose , 2-period crossover trial took place at 13 sites in the United States and Germany . Patients were r and omized 1:1 to receive 4 weeks of treatment with tadalafil 20 mg or sildenafil 50 mg , followed by the alternative treatment , to be taken as needed up to once daily before sexual activity . RESULTS The study enrolled 215 men with ED , 109 r and omized to the tadalafil-sildenafil sequence and 106 to the sildenafil-tadalafil sequence . Their mean age was 49.8 years ; 84.7 % were sildenafil naive and 15.3 % had undergone a previous inadequate trial of sildenafil . Most patients had moderate ED ( 60.5 % ) of > or=1 year 's duration ( 74.9 % ) . Of 190 evaluable patients , 126 ( 66.3 % ) preferred to initiate treatment with tadalafil , compared with 64 ( 33.7 % ) with sildenafil ( P sildenafil exposure . Both medications were well tolerated , with no significant differences in the incidence of treatment-emergent adverse events . Headache ( 11.2 % tadalafil , 8.8 % sildenafil ) , dyspepsia ( 6.0 % and 4.2 % , respectively ) , nasopharyngitis ( 4.7 % and 2.8 % ) , and flushing ( 2.8 % and 4.7 % ) were the most common adverse events . The rate of ocular disturbances was low : 1 patient experienced intermittent bilateral reduction in visual acuity with tadalafil , and 2 exhibited conjunctival hyperemia or eyelid edema with sildenafil . CONCLUSIONS Tadalafil 20 mg was preferred to sildenafil 50 mg for the initiation of ED therapy in this study population . Both medications were well tolerated",
"INTRODUCTION Several preference studies comparing a short-acting with a longer-acting phosphodiesterase type 5 inhibitor have been conducted in men . Most men in those studies preferred tadalafil rather than sildenafil , and recent post hoc analysis of one study described several factors associated with men 's treatment preference . No prospect i ve studies have investigated the woman partners ' preferences . AIM To investigate the treatment preference of women who were partners of men using oral medications for erectile dysfunction ( ED ) in a single-center open-label crossover study . METHODS One hundred heterosexual couples in stable relationships , with male partners having ED based on the erectile function subscale of the International Index of Erectile Function , were r and omly assigned to receive sildenafil or tadalafil for a 12-week phase , followed by another 12-week period using the alternate drug . Male and female participants completed sexual event diaries during both study phases , and the female participants were interviewed at baseline , midpoint , and end of study . MAIN OUTCOME MEASURES Primary outcome data were the women 's final interviews during which they were asked which drug they preferred and their reasons for that preference . RESULTS A total of 79.2 % of the women preferred their partners ' use of tadalafil , while 15.6 % preferred sildenafil . Preference was not affected by age or treatment order r and omization . Women preferring tadalafil reported feeling more relaxed , experiencing less pressure , and enjoying a more natural or spontaneous sexual experience as reasons for their choice . Mean number of tablets used , events recorded , events per week , and days between events were not significantly different during each study phase . CONCLUSION Women 's preferences were similar to men when using these two drugs . While the women 's reasons for preferring tadalafil emphasized relaxed , satisfying , longer-lasting sexual experiences , those preferring sildenafil focused on satisfaction and drug effectiveness for their partner",
"Abstract Background : Erectile dysfunction ( ED ) negatively impacts quality of life . Phosphodiesterase type 5 inhibitors ( PDE5Is ) are effective in treating ED ; however , rates of discontinuation remain high . Objectives : To assess on-dem and PDE5I treatment persistence and adherence through 6 months in Middle Eastern and North African ( MENA ) men with ED in a prospect i ve , non-interventional , observational trial . Research design and methods : Enrolled men were ≥18 years old from Saudi Arabia , Egypt , and the United Arab Emirates , PDE5I naïve , and sexually active . PDE5Is were selected per routine clinical practice . Persistence was defined as use of ≥1 dose during the prior 4 weeks , adherence as compliance with dosing instructions during the most recent dose . Logistic regression models were used to identify factors associated with persistence and adherence . Main outcome measures : Persistence and Adherence Question naire ; Partner Relationship Question naire ; Self-Esteem and Relationship Question naire ; International Index of Erectile Function ( IIEF ) ; Erectile Dysfunction Inventory of Treatment Satisfaction . Results : Patients ’ ( n = 493 ) mean age was 49.8 years , mean BMI was 29.3 , and the majority ( n = 354 , 71.8 % ) were from Saudi Arabia . Tadalafil was the most prescribed PDE5I ( 69.6 % ) , versus sildenafil ( 15.4 % ) , or vardenafil ( 15.0 % ) . Patients ’ mean IIEF – Erectile Function scores improved from moderate to mild and Erection Hardness Scores ( SD ) improved from 1.8 ( 1.0 ) at baseline to 3.5 ( 0.7 ) at 6 months . At 6 months , 64.9 % of patients were treatment persistent ( tadalafil , 68.8 % , sildenafil , 65.8 % , and vardenafil , 45.9 % ) and 59.6 % were adherent . Factors significantly predictive ( p < 0.05 ) of persistence at 6 months included age , employment status , and ED severity . Factors significantly predictive of adherence were age , employment status , and duration of ED . Interpretation of differences between drugs was limited by substantial differences in prescription rates between countries . Conclusions : At 6 months , 64.9 % of men were treatment persistent . In this study , age , employment status , ED severity , and duration of ED were associated with persistence and /or adherence",
"Initiation of ED treatment with a particular PDE5I may influence treatment-adherence and other outcomes . In this multicenter , open-label study , men with ED , naïve to PDE5I , were r and omized to tadalafil 5 mg once-a-day ( OaD ; N=257 ) , 10 mg on dem and ( PRN ; N=252 ) or sildenafil-citrate ( sildenafil ) 50 mg PRN ( N=261 ) for 8 weeks ( dose adjustments allowed ) , followed by 16 weeks of pragmatic treatment ( switching between PDE5I allowed ) . Primary outcomes ( treatment-adherence ) were reported previously . Here , we report effects on : Psychological and Interpersonal Relationship Scales , Self-Esteem and Relationship ( SEAR ) question naire , ED Inventory of Treatment Satisfaction ( EDITS ) , International Index of Erectile Function ( IIEF ) , Sexual Encounter Profile ( SEP ) and Global Assessment Questions ( GAQ ) . Mixed-model for repeated measures and analysis of covariance were used to analyze changes from baseline ; GAQ-responses were evaluated by logistic regression . Analyses were adjusted for treatment , country , ED-severity , baseline and baseline-by-treatment interaction . Patients r and omized to tadalafil OaD or PRN reported greater improvement ( least-square mean ( s.e . ) change ) in Sexual Self-Confidence ( OaD + 0.90 ( 0.048 ) , PRN + 0.93 ( 0.050 ) , vs + 0.73 ( 0.049 ) ; P=0.006 and P=0.001 ) and Spontaneity ( OaD + 0.11 ( 0.035 ) , PRN + 0.13 ( 0.035 ) , vs + 0.02 ( 0.035 ) ; P=0.044 and P=0.010 ) compared with sildenafil . Improvements in GAQ and SEP responses , IIEF-EF , orgasmic function , sexual desire , overall satisfaction domains , SEAR and EDITS scores did not differ significantly between treatment groups",
"INTRODUCTION Phosphodiesterase type 5 ( PDE-5 ) inhibitor treatment for erectile dysfunction ( ED ) is frequently discontinued ; adherence may vary depending on the initial regimen . AIM To evaluate the effects of initiating treatment with tadalafil once a day ( OaD ) , tadalafil on dem and ( pro re nata [ PRN ] ) , or sildenafil PRN on treatment adherence . METHODS In this multicenter , open-label study , men ( ≥ 18 years ) with ED , naïve to PDE-5 inhibitors , were r and omized ( 1:1:1 ) to tadalafil 5 mg OaD , tadalafil 10 mg PRN , or sildenafil 50 mg PRN . An 8-week r and omized treatment ( RT ) period ( dose adjustment possible ) was succeeded by 16 weeks of pragmatic treatment ( switches between PDE-5 inhibitors allowed ) . MAIN OUTCOME MEASURES Treatment adherence was measured as time to discontinuation of RT ( any cause ) , estimated by Kaplan-Meier product-limit method . Treatment-group differences were estimated as hazard ratio ( HR ; Cox proportional hazards ) . RESULTS Seven hundred seventy patients ( mean age 53 years ) were r and omized to tadalafil OaD ( N = 257 ) , tadalafil PRN ( N = 252 ) , and sildenafil PRN ( N = 261 ) . Kaplan-Meier estimates for patients discontinuing RT were 52.2 , 42.0 , and 66.7 % , respectively . Median time to discontinuation of RT was significantly longer for tadalafil OaD and PRN ( 130 and > 168 days ) compared with sildenafil ( 67 days ) ( HR [ 97.5 % confidence interval ] : 0.66 [ 0.51 , 0.85 ] and 0.49 [ 0.37 , 0.65 ] ; P with significant differences between groups ( P included \" lack of efficacy ( duration of erection ) \" ( sildenafil 9.2 % vs. tadalafil OaD 4.3 % , PRN 2.8 % ) , \" time constraints due to short window of action \" ( sildenafil 4.2 % vs. tadalafil OaD 0 % , PRN 0.4 % ) , and \" feel medication controls my sexual life \" ( sildenafil 2.7 % vs. tadalafil OaD 0 % ) . No between-group differences were found in International Index of Erectile Function-Erectile Function domain change from baseline to end of RT ( least squares mean : 9.4 - 10.0 , P = 0.359 ) or discontinuations due to adverse events ( 1.2 - 1.6 % ) . The most common adverse event ( ≥ 4 % ) was headache . CONCLUSIONS ED patients assigned to tadalafil OaD or PRN adhered significantly longer to initial treatment than patients assigned to sildenafil PRN . Improvement of erectile function and safety profiles were similar in all three treatment groups",
"AIM To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day ( OaD ) vs. tadalafil 20 mg or sildenafil 100 mg as needed ( pro re nata [ PRN ] ) in patients with erectile dysfunction ( ED ) . METHODS A r and omized , open-label , crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 ( PDE5 ) inhibitor PRN . Data were analyzed with a mixed effects model for crossover design . MAIN OUTCOME MEASURES The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales ( PAIRS ) between tadalafil OaD and sildenafil PRN . SECONDARY OUTCOMES INCLUDED : Time Concerns and Spontaneity domains of PAIRS , and the Self-Esteem and Relationship ( SEAR ) scale . RESULTS Men naive to tadalafil OaD were enrolled ( N = 378 ) , with 61 - 69 % prior PDE5 inhibitor use . There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN ( P ) . The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD , 0.5 ± 0.72 for tadalafil PRN , and 0.39 ± 0.67 for sildenafil PRN . The difference in least-squares mean was 0.12 ± 0.04 ( confidence interval [ CI ] = 0.04 , 0.19 ; P = 0.001 ) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 ( CI = -0.06 , 0.08 ; P = 0.872 ) between tadalafil OaD and tadalafil PRN . The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN ( P no differences in SEAR scores between treatments . CONCLUSIONS Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence , Time Concerns , and Spontaneity . There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN . Changes in SEAR , the erectile function domain of the International Index of Erectile Function , and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar",
"BACKGROUND Three inhibitors of phosphodiesterase 5 ( PDE5 ) are now available for the treatment of erectile dysfunction ( ED ) : sildenafil citrate , vardenafil , and tadalafil . Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made by the physician and patient . Therefore , clinical research is needed to investigate whether individual properties of the PDE5 inhibitors play a role in shaping patient preference . OBJECTIVES The goal of this study was to determine what proportion of ED patients currently taking sildenafil would , after a period of treatment with tadalafil , elect to resume treatment with sildenafil at the customary dose and what proportion would elect a switch to tadalafil 20 mg for a longer period . The tolerability of both treatments was also investigated . METHODS This was a short-term , multicenter , open-label , 1-way crossover trial conducted in Sweden and Italy . Eligible patients included men aged > or=18 years with a minimum 3-month history of ED who had been taking sildenafil at stable fixed doses of 25 , 50 , or 100 mg as needed for at least 6 weeks and up to 24 weeks . The study consisted of 6 phases : a 1-week screening phase , a 3-week sildenafil assessment phase , a 1-week washout phase , a 6-week tadalafil initiation phase , a 3-week tadalafil assessment phase , and a 6-month extension phase , during which patients received their treatment of choice free of charge . The primary outcome measure was the proportion of patients electing to take sildenafil or tadalafil during the extension phase . RESULTS Of 155 men enrolled , 147 ( 97.8 % ) completed the assessment phases of the trial . Of these 147 men , 133 ( 90.5 % ) elected to receive tadalafil in the 6-month extension phase and 14 ( 9.5 % ) elected to receive sildenafil ( P proportions preferring tadalafil to sildenafil were similar irrespective of age group ( > or=50 years , 92 % ; severity of ED ( mild , 95 % ; moderate , 88 % ; severe , 96 % ) , etiology of ED ( psychogenic , 94 % ; organic , 91 % ; mixed , 87 % ) , and sildenafil dose at study entry ( 50 mg , 90 % ; 100 mg , 89 % ) . Both medications were well tolerated . The most common treatment-emergent adverse events occurring in > or=2 % of patients during the tadalafil assessment phase included headache ( 4.8 % ) , nasal congestion ( 4.1 % ) , dyspepsia ( 3.4 % ) , flushing ( 2.7 % ) , back pain ( 2.0 % ) , diarrhea ( 2.0 % ) , and nausea ( 2.0 % ) ; the most common treatment-emergent adverse events during the sildenafil assessment phase were flusing ( 7.1 % ) , nasal congestion ( 6.5 % ) , headache ( 4.5 % ) , and nasopharyngitis ( 3.2 % ) . CONCLUSIONS In this short-term , open-label study , patients who were currently taking sildenafil for ED and then received tadalafil preferred to continue oral therapy with tadalafil over sildenafil by a ratio of approximately 9:1 . Although the study sought to mimic the experience of actual patients receiving treatment for ED , the results are subject to potential limitations due to the design of the study , which included differences in dosing instructions and dosages for sildenafil and tadalafil . Both sildenafil and tadalafil were well tolerated",
"INTRODUCTION We conducted a prospect i ve , r and omized , open-label , fixed-dose preference study , with a crossover design , using sildenafil , vardenafil , and tadalafil . AIM To assess patient preference for sildenafil ( 100 mg ) , vardenafil ( 20 mg ) , and tadalafil ( 20 mg ) for the treatment of erectile dysfunction . Secondary objectives included finding out whether patients would follow treatment with a second or third option , in the event that the preferred drug was not available , and to assess side effects . MAIN OUTCOME MEASURES Patient preference for any treatment , and evaluation of the elements that patients would assess when choosing one of these drugs . MATERIAL AND METHODS Sildenafil ( 100 mg ) , vardenafil ( 20 mg ) , and tadalafil ( 20 mg ) were taken at least six times over a period of 45 - 60 days with a washout period of 7 days . A total of 132 patients were enrolled to achieve a valid sample of 90 cases ( 15 per r and omized group , total of six groups ) . Enrolled patients had mild to moderate erectile function . RESULTS The International Index of Erectile Function ( IIEF ) score improved from baseline and was statistically significant in all cases ( P IIEF scores , we found a statistically significant difference between tadalafil and vardenafil ( P = 0.0002 ) favoring the former ; similar results were obtained with the Erectile Dysfunction Inventory for Treatment Satisfaction ( EDITS ) Question naire ( P = 0.000075 ) . We also found a significant difference ( P = 0.012 ) between tadalafil and sildenafil , again in favor of the former . In assessing drug preference , 25 patients ( 27.77 % ) chose sildenafil , 18 ( 20 % ) vardenafil , and 47 ( 52.22 % ) tadalafil . A total of 94 % of patients would be willing to take another drug if the preferred choice was not available . All drugs were well tolerated . CONCLUSIONS Although this is a preference study based on subjective elements , statistically significant differences comparing the IIEF score and the EDITS Question naire lead us to believe that beyond patients ' subjective preference per se , said preference is probably also based on a genuinely superior response to one drug over another"
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4116d6ac-06ff-11f0-808a-c43d1ab1c353
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Introduction : The role of antibiotic prophylaxis for routine flexible cystoscopy ( FC ) is not clear due to the varying practice s of individual clinicians . There are no formal guidelines , and this may be due to a lack of formal summary of the data . Methods : A systematic review was conducted in April 2014 including all r and omised control trials on prophylactic antibiotic use for FC . The main outcome measures were confirmed bacteriuria on mid-stream urine ( MSU ) , asymptomatic bacteriuria and symptomatic bacteriuria . A meta- analysis was conducted with difference between groups expressed as an odds ratio ( OR ) and control group risk . Results : 5,107 patients were included , 2,173 in placebo and 2,934 in the antibiotic group . The OR for all three outcomes favoured the antibiotic group ; the risk of developing symptomatic bacteriuria was 0.06 times more likely in the control group ( OR 0.34 ) , 0.054 ( OR 0.40 ) for developing asymptomatic bacteriuria and 0.109 for confirming bacteriuria on MSU ( OR 0.36 ) . The number needed to treat ( NNT ) was 15 ( 13 - 19 ) for MSU positive bacteriuria ; 32 ( 27 - 42 ) for symptomatic bacteriuria and 26 ( 23 - 33 ) for asymptomatic bacteriuria . Conclusions : Antibiotic prophylaxis did confer a reduction in cases of symptomatic and asymptomatic bacteriuria but the NNT were high . Therefore , the authors can not advocate the use of antibiotic prophylaxis for routine FC procedures
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"PURPOSE Intradetrusor botulinum toxin-A injection is a promising emerging therapy for neurogenic and idiopathic overactive bladder that is refractory to current antimuscarinic agents . We evaluated a sedation-free procedure using flexible endoscopy to perform intradetrusor botulinum toxin-A injection using a vali date d pain score to assess the tolerability of this technique . MATERIAL S AND METHODS Five men and 22 women with idiopathic overactive bladder refractory to antimuscarinics were prospect ively evaluated and r and omized to 100 U ( 14 ) or 150 U botulinum toxin-A ( 13 ) . Subjects underwent BTA injection with intravesical lidocaine using a 14Fr Olympus flexible cystoscope , which accommo date s a 27 gauge flexible Olympus injection needle . Patients were evaluated with the visual analog scale to evaluate discomfort during and 15 minutes after the procedure . Procedure time was recorded . RESULTS In 22 female patients the mean pain score was 3.1 ( range 0 to 10 ) during the procedure and 0.7 ( range 0 to 7 ) 15 minutes after the procedure . In 5 male patients the mean pain score was 1.6 ( range 0 to 3.5 ) during the procedure and 0.0 with all reporting no pain 15 minutes after the procedure . Mean procedure time was 4.5 minutes ( range 4 to 6 ) . Only 1 of the 27 patients requested sedation before any subsequent injections . CONCLUSIONS Sedation-free intradetrusor botulinum toxin-A injection using intravesical lidocaine and flexible endoscopy is a well tolerated and safe procedure to perform in an office setting",
"PURPOSE To examine the incidence of urinary tract infection ( UTI ) after flexible cystoscopy ( FC ) and determine whether prophylactic norfloxacin reduces this incidence compared with placebo . PATIENTS AND METHODS A double-blind trial was performed , r and omizing 234 patients to either 400 mg of norfloxacin or placebo prior to FC . All patients provided a midstream urine specimen ( MSU ) before the procedure , as well as at day 3 and day 7 after FC . In addition , a telephone question naire was performed to correlate the nature and severity of any symptoms associated with UTI . RESULTS Interim analysis was performed because of the low recruitment rate , and a significantly lower infection rate than expected meant that the trial was discontinued . There was one symptomatic UTI in the placebo group ( 0.82 % ) and one in the norfloxacin group ( 0.89 % ) . The UTI in the placebo group was de novo , while the infection in the norfloxacin group was secondary to pre-FC bacteriuria . There was no difference in the infection rates in the two groups . The overall infection rate ( de novo and secondary to existing bacteruria ) after FC was 0.85 % . CONCLUSION Infection after flexible cystoscopy is rare and not associated with significant morbidity . A much larger study would be required to determine whether antibiotic prophylaxis significantly reduces the rate of postprocedure UTI",
"OBJECTIVE To determine the efficacy of prophylactic nitrofurantoin in preventing bacteriuria after urodynamics and cystourethroscopy . METHODS We assumed that nitrofurantoin prophylaxis would decrease the rate of infection after urodynamics and cystourethroscopy from 19 % to 5 % . All women presenting for urodynamics and cystourethroscopy during a 27-month period were offered enrollment , and 142 were r and omly assigned to receive two doses of long-acting nitrofurantoin 100 mg ( n = 74 ) , or two doses of placebo ( n = 68 ) . Nitrofurantoin and placebo capsules were identical , and subjects and physicians were masked to group assignment . Differences were assessed using Student t test for continuous data and chi2 analysis for dichotomous data . RESULTS There were no statistical differences in demographic characteristics or final diagnoses between groups . Seven women ( 5 % ) who had bacteriuria on initial urine culture were not included in the final analysis . The frequency of bacteriuria in the postinstrumentation urine cultures was 6 % overall , 7 % in the treatment group , and 5 % in the controls , a nonsignificant difference ( [ relative risk ] 1.49 , [ confidence interval ] 0.37 , 5.95 ) . The power of the study was 33 % to detect a significant difference . CONCLUSION Bacteriuria after combined urodynamics and cystourethroscopy was not improved by a 1-day course of nitrofurantoin",
"Objective To establish the efficacy of antibiotic prophylaxis prior to cystoscopy in out patients in decreasing the incidence of post-procedure urinary tract infection . Study design and setting A r and omized clinical trial in patients ( men and women ) older than 18 who underwent cystoscopy for any non-urgent indication . The intervention was Levofloxacin 500 mg single dose , and the control was placebo 500 mg single dose made with similar characteristics . The primary outcome was urinary tract infection ( UTI ) measured 3–10 days after the procedure . It was performed as per protocol analysis . Results Hundred and thirty-eight patients in each study arm completed the trial . The incidence of UTI in the intervention group was 0.7 % and in the placebo group was 3 % ( p = 0.17 ) , and no significant differences were found . The incidence of asymptomatic bacteriuria in the intervention group was 5.8 % and in the control group was 14.5 % ( p = 0.01 ) . Conclusions No significant differences were found in the use of prophylactic antibiotic compared to placebo to reduce the incidence of UTI in patients who undergo cystoscopy as an outpatient procedure with sterile urine demonstrated by urine culture",
"OBJECTIVES One of the main drawbacks of flexible urethrocystoscopy is the risk of urinary tract infection ( UTI ) . In order to reduce this risk , antimicrobial prophylaxis has been considered , however there is not a unanimous view regarding indications , dosage , type of antibiotic , and so on . To clarify this uncertainty , we practice d a pilot and experimental study aim ed at assessing the effectiveness of chemoprophylaxis with 3 grams of fosfomycin trometamol in the prevention of UTI after urethrocystoscopy . METHODS Sixty patients were entered into a pilot r and omized clinical trial between March and August 2011 . Thirty patients were assigned to a control group without receiving any antibiotic dose , and the intervention group ( 30 patients ) received 3 g fosfomycin trometamol . Ten days later urine culture and sediment analysis were performed in all patients . Significant bacteriuria was considered from > 105 CFU /ml . One month later a telephone survey was developed to assess urinary symptoms , and assistance to the family doctor . We estimated the cumulative incidence of bacteriuria , pyuria and microhematuria in both groups , and we compared the results using a strategy of analysis per protocol and intention to treat . RESULTS The incidence of bacteriuria , pyuria and microhematuria in the control group was 10 % , 23.3 % and 26.7 % respectively and in the intervention groups the values differed depending on the type of analysis . Considering only the 27 patients ( per protocol analysis ) , the incidence would be 11.1 % , 37.0 % and 29.6 % respectively . If we include the three patients who did not completed the study ( per intention to treat analysis ) and considering their results as negative , the results were 10 % , 33.3 % and 26.7 % respectively . Finally , in the case the three cultures not performed in this group had produced a positive result , the impact would have been 20.0 % , 43.3 % and 36.7 % . In any of the three cases , the differences with the control group were not statistically significant . CONCLUSIONS In a selected population and with appropriate aseptic measures , antibiotic chemoprophylaxis does not appear to show a clinical ly relevant reduction in the incidence of UTI in patients undergoing flexible urethrocystoscopy",
"OBJECTIVES To investigate the incidence of symptomatic and asymptomatic bacteriuria and to assess patient satisfaction after flexible cystoscopy ( FC ) and urodynamic ( UD ) evaluation in a prospect i ve survey . The incidence of urinary tract infection after FC and UD studies and the use of prophylactic antibiotics are issues of debate . The tolerability and acceptance of FC and UD studies by patients have not been thoroughly documented . It would be helpful to be able to give such information to patients before performing these procedures . METHODS A total of 215 nonconsecutive patients seen as out patients for FC and UD studies to evaluate various indications were studied . A midstream urine sample was taken before and 48 hours after the procedures . Patients were given a question naire that inquired about the presence of lower urinary tract symptoms before and 48 hours after the procedures . The self-administered question naire included questions to assess patients ' tolerance of the procedures and how it compared with their expectations . RESULTS Of the 201 patients analyzed ( FC 103 , UD studies 98 ) , 9 patients ( 4 . 5 % ) developed significant bacteriuria within 48 hours of FC and UD studies . Only 2 patients with significant bacteriuria reported newly developed symptoms within 48 hours . In a subgroup of 25 patients who were given prophylactic antibiotics for various reasons , 6 ( 24 % ) reported new symptoms , although none developed significant bacteriuria . The association between patients who had preprocedure pyuria ( n = 7 ) and the development of significant growth after the procedure ( n = 6 ) was significant ( P safe , well-tolerated procedures . The addition of prophylactic antibiotics in these procedures is unnecessary , unless specific indications are present",
"To report a large prospect i ve , pragmatic , double‐blind r and omized controlled trial to determine whether oral prophylactic antibiotics reduce the risk of bacteriuria after flexible cystoscopy ( FC ) , as up to 10 % of patients develop urinary infection afterwards , with significant morbidity and costs for health services",
"Instrumentation of lower urinary tract is a predisposing factor for the development of urinary infection . Incidence of infective complications following urethrocystoscopy has been evaluated in a multicenter , prospect i ve , comparative and r and omized study in 2,284 patients , who had a previous negative urine culture . Patients were r and omized into two groups : one to be used as control and the other one to received antimicrobial prophylaxis prior to instrumentation ( ceftriazone , 1 gr intramuscular ) . Clinical and microbiological responses were evaluated at 48 - 72 hours and 4 weeks after cystoscopy . Symptomatic bacteriuria was observed in 10.2 % of patients in the control group and in 2.5 % in the prophylaxis group ( p asymptomatic bacteriuria in 3.02 % and 1.52 % ( p > 0.05 ) and irritative syndrome with sterile urine in 2.93 % and 2.60 % ( p > 0.05 ) , respectively . Thus , the use of prophylaxis reduced the incidence of infective complications in these patients",
"Objective : The aim of this study was to determine whether single – dose parenteral antibacterial therapy significantly alters the rate of infection in patients undergoing flexible cystourethroscopy . Patients and Methods : 162 patients were studied prospect ively having either received parenteral antibacterial chemoprophylaxis prior to flexible cystourethroscopy or not . Pre– and postprocedure mid stream sample s of urine ( MSSU ) were obtained to objective ly evaluate the presence of infection . Results : Gentamicin prophylaxis reduced the rate of post – cystoscopy – positive MSSUs from 21 to 5 % . Conclusion : The surprisingly high rate of infection after flexible cystoscopy was significantly reduced by a single dose of gentamicin"
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4116d6e8-06ff-11f0-808a-c43d1ab1c353
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The purpose of this study was to compare the operative outcome between mini and st and ard incisions in total hip arthroplasty ( THA ) . We identified 12 r and omised or quasi-r and omised control trials ( RCT or q RCT ) published between 1996 and 2008 . Subgroup and sensitivity analyses were performed to evaluate the differences in results for surgical approach , trial quality , and follow-up duration . Operative time and blood loss were significantly reduced in the mini-incision group for studies with the posterior or posterolateral approach . Concerning postoperative complications , there were no significant differences between the two groups with no significant heterogeneity . No differences were observed between the two groups for Harris hip score and radiographic results except for cup anterversion . Although mini-incision appeared to have similar outcomes compared to st and ard incision , the follow-up is short-term according to current st and ards in THA . High- quality studies are required to compare the outcomes of these two procedures .ResuméLe but de cette étude est de comparer le devenir opératoire des patients ayant bénéficié d'une prothèse totale de hanche par voie mini-invasive ou par incision st and ard . Nous avons identifié 12 publications d'essais r and omisés ou quasi r and omisés ( RCT ou q RCT ) publiées entre 1996 et 2008 . Des sous-groupes ont été réalisés de façon à évaluer la différence des résultats selon l'approche chirurgicale , la qualité des essais et la durée du suivi . Le temps opératoire et les pertes sanguines étaient significativement moins importants dans le groupe mini-incision réalisé par voie postérieure ou postéro-latérale . Il n'y a pas de différence significative dans les complications postopératoires entre les deux groupes de même en ce qui concerne le score de Harris , les résultats radiologiques exceptés pour l'antéversion de la cupule . Cependant , la mini incision semble avoir un devenir comparable à l'incision st and ard , mais avec des suites plus rapides . Des études ultérieures de gr and e qualité seront nécessaires pour comparer le devenir de ces deux procédés
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"Implant malposition and poor fixation are potential risks of compromising long-term results after total hip arthroplasty performed with a minimally invasive technique . Between September 2000 and February 2002 , 120 cemented primary total hip arthroplasties were performed at the authors ' institutions in patients with primary osteoarthritis of the hip and with BMI lower than 35 . In 60 of these cases selected at r and om , a posterolateral incision no longer than 10 cm was used . The other 60 THA 's were performed through a st and ard posterolateral approach . The inclination and anteversion of the cup and the position of the femoral stem were assessed on radiographs and statistically evaluated . In the miniinvasive group , the average inclination angle of the cup was 42.3 degrees ( range : 36 to 52 degrees ) and the anteversion angle 13.6 degrees ( range : 6 to 29 degrees ) . The coronal alignment of the femoral component was within 3 degrees of neutral in 54 cases ( 90.0 % ) . Following conventional implantation in the other group , the average cup inclination angle was 42.4 degrees ( range : 35 to 50 degrees ) and the anteversion angle 13.6 degrees ( range : 8 to 24 degrees . A total of 53 stems ( 88.3 % ) were implanted optimally . Statistical analysis found no significant difference between the two groups regarding components position . These findings suggest that using a smaller posterolateral incision as was done in this study does not introduce a potential risk of compromising long-term results",
"BACKGROUND AIMS Evaluation of : 1 . early clinical and radiographic results of total hip arthroplasty ( THA ) through a st and ard lateral direct approach , 2 . early clinical and radiographic results of THA through a minimal lateral approach , 3 . comparison of the results of THA in these two groups . MATERIAL AND METHODS 120 THAs ( 60 cementless and 60 cemented ) done in 120 patients due to degenerative changes were evaluated prospect ively . 60 THAs were done through a minimal lateral approach and constituted a study group . 60 THAs were done through a direct lateral approach and constituted a control group . The mean age of the 120 patients ( 98 women and 22 men ) was 45 y.o . ( range : 32 - 67 y.o . ) . The duration of follow-up in the study group was from 6 to 12 months ( mean : 8.5 months ) . The duration of follow-up in the control group was from 10 to 16 months ( mean : 10.5 months ) . Mean preoperative functional status of the study group was 44.5 points according to the Harris hip score . Radiographic evaluation of the results was done according to the criteria of the Joint Committee of the Hip Society , AAOS and SICOT . RESULTS 6 months after THA , clinical results were 92 pts in the study group and 88 pts in the control group . Radiographic outcomes were very good in all 120 patients from both arms : there were no differences between the control and study group . The incidence of complications was similar in both groups . CONCLUSIONS Minimally invasive THA demonstrated its value in the treatment of degenerative changes of the hip joint with regard to short-term outcomes . The clinical and radiographic outcomes were comparable between the st and ard and minimally invasive approaches . Success with THA using a minimally invasive approach depends on excellent operative technique and experience with st and ard hip approaches rather than on the use of special instruments",
"Minimally invasive total hip arthroplasty using a short skin incision is a subject of much debate in the literature . The present study estimates the possible minimal length of the exposure in an unselected patient cohort and compares the lateral mini-incision technique and traditional total hip arthroplasty ( THA ) . One hundred and two patients were divided into three groups according to the type of surgery and length of incision : mini-incision ( less than 10 cm ) was performed in 38 patients ; midi-incision ( 10–14 cm ) in 43 ; and st and ard-incision ( longer than 14 cm ) in 21 patients . No statistical difference was found with regard to intraoperative and total blood loss , the rate of complications , and postoperative recovery . Significantly decreased body mass index ( BMI ) , shorter operative time , and higher number of hips with malpositioning of the acetabular cup were found in the mini-incision group . These patients , however , experienced less pain in the early postoperative period and were highly satisfied with the cosmetic results . The length of incision was shortened and optimized ( less than 14 cm ) in 82 % of patients , and mini-incision was performed in 38 patients of this unselected cohort . Because of the underst and able dem and of the patients for less invasive intervention , the surgeon should use a smaller but not necessarily mini-incision with minimal soft tissue trauma that still allows him to perform the procedure well , without compromising the type of implants and the otherwise excellent long-term results . R and omized prospect i ve studies are needed to explore the real value of the minimally invasive total hip arthroplasty . RésuméLa chirurgie arthroplastie de la hanche par voie mini invasive est un sujet de débat et de controverse dans la littérature . Cette étude a pour but d’estimer la longueur minimale de la voie d’abord sur une suite de patients non sélectionnés et de comparer la technique de mini incision avec la technique d’incision traditionnelle antérolatérale . Cent deux patients ont été divisés en trois groupes , en fonction du type de chirurgie et en fonction de la longueur d’incision . Premier groupe : mini incision moins de 10 cm chez 38 patients , deuxième groupe : incision moyenne 10 à 14 cm chez 43 patients et troisième groupe : incision st and ard , supérieure à 14 cm chez 21 patients . Aucune différence statistique n’a été trouvée pour la perte sanguine et sur le taux des complications post-opératoires . Dans le groupe des mini incisions peu de sujets avaient une surcharge pondérale , par contre , il existait un gr and nombre de hanches avec une mal position de la cupule . Ces patients ont cependant présenté moins de douleur dans la période post-opératoire et ont été très satisfaits du résultat cosmétique . La longueur de l’incision dans la chirurgie prothétique de la hanche peut être raccourcie et la longueur optimum peut être de moins de 14 cm chez 82 % des patients . Une mini incision a été réalisé dans cette série , chez 38 patients du fait de la dem and e des patients pour une chirurgie mini invasive , les chirurgiens ont utilisé une petite incision avec un minimum de traumatisme des tissus mous . Cette mini incision doit donc permettre au chirurgien de réaliser son intervention correctement sans compromission sur le type d ’ implants , ni sur la qualité des résultats à long terme . Il n’y a pas besoin pour cela nécessairement d’une mini incision néanmoins des études prospect ives r and omisées doivent être réalisées pour explorer le vrai résultat de la chirurgie arthroplastie par voie mini invasive",
"CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion",
"OBJECTIVE To report the clinical outcome of minimally invasive total hip arthroplasty with anterior incision . METHODS One hundred and twenty cases were r and omly divided into two groups . Sixty cases ( group 1 ) who had undergone a mini-invasive THA were compared with 60 cases ( group 2 ) who had undergone THA with st and ard posterolateral incision . The operation time , length of incision , blood loss , anteversion angle of acetabulum cup , Harris score and complications were observed . RESULT The average operation time was almost the same ; The average length of incision for group 1 was 7.9 cm ( 7.4 - 9.0 cm ) and 16.3 cm ( 14 - 22 cm ) for group 2 ( P average blood loss for group 1 was 350 ml ( 250 - 530 ml ) and 650 ml ( 400 - 1200 ml ) for group 2 , there was significant difference between two groups ( P mean anteversion angles of cup were 24 degrees ( 19 degrees - 27 degrees ) for group 1 and 19 degrees ( 15 degrees - 22 degrees ) for group 2 . The average length of post-operative hospital stay was 7 days ( 5 - 8 days ) in group 1 and 13.5 days ( 12 - 16 days ) in group 2 ( P Harris score of group 1 was 91.4 ( 67 - 94 ) and 78.5 ( 67 - 91 ) for group 2 at the 3 month follow-up ( P 0.05 ) , but the average ROM of group 1 were definitely more greater than that of group 2 ( 110.0 degrees + /- 3.2 degrees vs. 90.0 degrees + /- 2.9 degrees P cup reinsertion in group 1 because of large anteversion angle ; 2 cases of symptomatic DVT and 1 case of lethargy because of cerebral infa rct ion happened in group 2 . CONCLUSIONS Minimally invasive total hip arthroplasty using anterior approach is a safe and effective technique with the advantages of less soft tissue damage and less blood loss",
"Scar cosmesis is one of the proposed benefits of mini-incision total hip replacement as opposed to st and ard-incision procedures ; however , there has been no scientific proof of this clinical outcome . The cosmetic appearances of healed incisions of 34 primary total hip replacement procedures done by one surgeon using either a mini-incision ( 20 procedures ) or a st and ard-length incision ( 14 procedures ) were compared at an average of 2 years postoperatively . Each scar ’s appearance was grade d independently by two plastic surgeons using a st and ardized rating system . Patients answered a question naire regarding their subjective assessment of their scar . The blinded observers found that more mini-scars ( six of 20 ) were rated poor than st and ard scars ( one of 14 ) and that more st and ard-incision patients had scars that were rated good . More mini-incision patients ( two of 20 versus zero of 14 ) had wound-healing problems . All the patients thought that their hip scar was acceptable in appearance , but 30 of 31 patients rated the relief of pain and total hip replacement longevity as higher priorities than scar cosmesis . The cosmesis of mini-incision total hip replacement scars may be inferior to st and ard-incision scars because of skin and soft tissue damage produced by high retractor pressures needed for exposure using a limited skin incision . Level of Evidence : Therapeutic study , Level II-2 ( prospect i ve comparative study ) . See the Guidelines for Authors for a complete description of levels of evidence",
"To assess the potential recovery rate of a minimally invasive total hip replacement technique with minimal soft tissue disruption , an accelerated rehabilitation protocol was implemented with weightbearing as tolerated on the day of surgery . One hundred consecutive patients were enrolled in this prospect i ve study . Ninety-seven patients ( 97 % ) met all the inpatient physical therapy goals required for discharge to home on the day of surgery ; 100 % of patients achieved these goals within 23 hours of surgery . Outpatient therapy was initiated in 9 % of patients immediately , 62 % of patients by 1 week , and all patients by 2 weeks . The mean time to discontinued use of crutches , discontinued use of narcotic pain medications , and resumed driving was 6 days postoperatively . The mean time to return to work was 8 days , discontinued use of any assistive device was 9 days , and resumption of all activities of daily living was 10 days . The mean time to walk ½ mile was 16 days . Furthermore , there were no readmissions , no dislocations , and no reoperations . Therefore , a rapid rehabilitation protocol is safe and fulfills the potential benefits of a rapid recovery with minimally invasive total hip arthroplasty",
"Minimally invasive surgery has become a trend over the last few years in all aspects of orthopaedic surgery , including total hip arthroplasty . So-called mini-incision techniques involve limiting the length of the skin incision to 10 cm with use of either an anterior , lateral or posterior approach . Between March 2004 and December 2005 one hundred consecutive unilateral total hip replacements were performed by the same senior surgeon in our institute . All patients were r and omly assigned to study group ( group A ) or control group ( group B ) . In group A ( 50 patients ) the skin incision was 8 cm ; in group B ( 50 patients ) the skin incision was st and ard ( about 12 - 14 cm ) . Patient demographic data , including sex , age , height , weight , BMI , diagnosis and preoperative Harris hip score were recorded . Other criteria evaluated included the perioperative and postoperative complications , the surgical time , the blood loss , the length of the incision , the acetabular and stem positions , the length of hospital stay , Harris Hip Score ( HHS ) and the WOMAC osteoarthritis index at six months . No significant differences were found between the groups with respect to the average surgical time , the acetabular and stem position , the length of hospital stay and the Harris Hip Score ( HHS ) and the WOMAC osteoarthritis index at six months . A significant lower blood loss was found in the mini-incision group . A higher percentage of peri-operative complications was recorded in Group A ( two stupor of sciatic nerve and one fracture of the greater trochanter ) . On the basis of our experience we could speculate that minimally invasive surgery should be directed to the new surgical approach with muscle sparing , instead of a shorter skin incision using st and ard approaches",
"The interest in minimally invasive approaches for total hip replacement ( THR ) has not waned in any way . We carried out a prospect i ve and comparative study in order to analyse the interest of the anterolateral minimal invasive ( ALMI ) approach in comparison with a minimally invasive posterior ( MIP ) approach . A group of 35 primary THRs with a large head using the ALMI approach was compared with a group of 43 THR performed through a MIP approach . The groups were not significantly different with respect to age , sex , bony mass index , ASA score , Charnley class , diagnoses and preoperative Womac index and PMA score . The preoperative Harris Hip Score was significantly lower in the ALMI group . The duration of surgical procedure was longer and the calculated blood loss more substantial in the ALMI group . The perioperative complications were significantly more frequent in this group , with four greater trochanter fractures , three false routes , one calcar fracture , and two metal back bascules versus one femoral fracture in MIP group . Other postoperative data ( implant positioning , morphine consumption , length of hospital stay , type of discharge ) are comparable , such as the early functional results . No other complication has been noted during the first 6 months . The ALMI approach uses the intermuscular interval between the tensor fascia lata and the gluteus medius . It leaves intact the abductor muscles , the posterior capsule and the short external rotators . The early clinical results are excellent , despite the initial complications related to the initial learning curve for this approach and the use of a large head . The stability and the absence of muscular damage should permit acceleration of the postoperative rehabilitation in parallel with less perioperative complications after the initial learning curve . RésuméNous rapportons une étude prospect i ve et comparative de l’abord antéro-latéral mini invasif de la hanche ( AMLI ) pour 35 arthroplasties totales primaires avec tête de gr and diamètre avec l’abord mini invasif postérieur ( MIP ) pour 43 arthroplasties . Les deux groupes n’étaient pas différents selon l’âge , le sexe , l’indice de masse osseuse , le score ASA , la classe de Charnley , le diagnostic , l’index WOMAC et le score de Merle d’Aubigné et Postel . Le score de Harris était plus faible dans le groupe AMLI . La durée opératoire et la perte sanguine calculée étaient plus importantes dans le groupe AMLI . Dans ce même groupe les complications per-opératoires étaient plus fréquentes , avec quatre fractures du gr and trochanter , trois fausses routes , une fracture du calcar , et deux bascules du composant acétabulaire alors qu’il n’y avait qu’une fracture fémorale dans le groupe MIP . Les autres données post-opératoires étaient identiques notamment le résultat fonctionnel précoce . Il n’y avait pas d’autre complication pendant les 6 premiers mois . L’abord antéro-latéral utilise l’intervalle entre le tenseur et le gluteus medius laissant intact les abducteurs , la capsule postérieure et les pelvi-trochantériens . Les résultats cliniques précoces étaient excellents en dépit des complications initiales liées à la courbe d’apprentissage et l’utilisation d’une tête de gr and diamètre . La stabilité et l’absence de dommage musculaire permettaient une récupération post-opératoire plus précoce",
" A group of 42 primary total hip arthroplasties performed through an abridged surgical incision ( group 1 ) was prospect ively compared to a cohort of 42 primary total hip arthroplasties performed through a st and ard surgical incision ( group 2 ) . The length of the incision was 8.8 + /- 1.5 cm for group 1 and 23.0 + /- 2.1 cm for group 2 . The groups were not significantly different with respect to age , height , preoperative Harris Hip scores ( HHS ) , estimated blood loss , or length of hospital stay ( P>.05 ) . Group 1 patients had a lower body mass index than group 2 patients ( P Length of surgery was slightly less for group I ( P = .02 ) . A 0 % incidence was found of infection , nerve palsy , component malposition , and aseptic loosening in both groups . No dislocations occurred in group 1 , and one dislocation occurred in group 2 . Patients in group 1 have expressed considerable enthusiasm regarding the cosmetic appearance of the surgical incisions , and their postoperative HHS are slightly higher than those of group 2 ( P = .042 ) . Total hip arthroplasty can be performed safely and effectively through an abridged surgical incision , but this investigation confirms no dramatic clinical benefit other than cosmetic appeal",
"PURPOSE OF THE STUDY The aim of this prospect i ve r and omized study was to compare , by means of biochemical markers , the operative invasiveness of the st and ard total hip replacement with that of the minimally invasive anterolateral ( MIS-AL ) approach . MATERIAL Twenty-six r and omly assigned patients with st and ard and 22 patients with MIS-AL total hip replacement were included in the study . Patients with elevated pre-operative levels of the markers evaluated or patients taking medication that might affect marker levels were not included . METHODS Creatine phosphokinase ( CPK ) and C-reactive protein ( CRP ) were chosen as markers of muscle damage and post-operative inflammatory changes , respectively . Blood sample s were drawn before surgery ( less than 24 hours ) and after surgery at 24 , 48 and 96 hours , which respected biological half-lives of the markers and permitted us to study their dynamics . The results were evaluated and statistically analyzed at the department of biochemistry , using the two sample t-test . RESULTS Statistically significant differences between the two groups of patients were found for both markers . The average CRP values differed significantly ( p and ard than MIS-AL total hip replacement by 28 % and 44 % , respectively . The average CPK values showed the most marked difference at 48 hours after surgery , when the level was higher by 62.5 % in the st and ard than MIS-AL total hip replacement ( p muscle tissue damage and post-operative inflammatory changes . The study was focused on the invasiveness of surgery only and neither subjective nor objective outcomes of implantation were evaluated . The use of the muscle sparing approach MIS-AL results in minimal damage to muscle tissue and , consequently , a lower degree of post-operative inflammation than is recorded in traditional hip replacement surgery . CONCLUSIONS In the patients undergoing MIS-AL total hip replacement , post-operative levels of CPK and CRP were significantly lower than in the patients with st and ard total hip replacement . The MIS-AL technique evidently provides a more sparing approach to soft tissues",
"This prospect i ve study compares a mini-incision technique and traditional posterior approach for total hip arthroplasty ( THA ) . Thirty-three patients who had undergone a mini-incision THA were matched by diagnosis , gender , average age , and preoperative Harris Hip Score ( HHS ) to 33 patients who had undergone THA using the traditional posterior approach . The average length of the incision for group 1 was 11.7 cm ( range , 7.3 - 13.0 ) and for group 2 was 20.2 cm ( range , 14.8 - 26.0 ) . At the 3-month follow-up , patients in the mini-incision group had significant improvement in limp ( P ability to climb stairs ( P mini-incision group was significantly better in terms of limp ( P distance walked ( P stairs ( P pain , function , or range of motion at the 1-year follow-up examination",
"The purpose of this prospect i ve r and omized study was to compare the early results of primary total hip arthroplasties performed with a minimally invasive technique or a st and ard technique . A consecutive series of 70 patients who underwent primary bilateral simultaneous total hip arthroplasties was studied . All procedures were performed through a posterolateral approach . Operative times and duration of hemovac drains were significantly shorter in the group with a minimally invasive technique ( P risk of infection when using this technique . There were no any late transfusions in any of our patients postdischarge . This minimally invasive technique did not offer any advantages because the results were not different , and in our h and s , it increased our infection rate",
"Patients without prior hip surgery and body mass index lower than 30 undergoing primary total hip arthroplasty were eligible to participate in a r and omized prospect i ve study comparing a minimally invasive with a st and ard approach . The patients were r and omized to receive incisions of 8 cm ( group A , n = 28 ) or 15 cm ( group B , n = 32 ) . The groups were similar demographically . Patients in group A had significantly less intraoperative blood loss ( P total blood loss ( P Operative time , transfusion requirements , narcotic usage , length of hospital stay , achievement of rehabilitation milestones , cane usage , and complications were similar in both groups . There was no difference between the groups at 1- and 2-year follow-up . Compared with a st and ard incision , patients who underwent a minimally invasive total hip arthroplasty demonstrated decreased blood loss and limped less at 6-week follow-up",
"BACKGROUND Few prospect i ve r and omized studies have demonstrated benefits of minimally invasive total hip arthroplasty when compared with conventional total hip arthroplasty . We hypothesized that patients treated with a posterior mini-incision would have better results than those treated with a posterior long incision with regard to the achievement of established goals for pain relief and functional recovery permitting hospital discharge by the second postoperative day . METHODS Sixty of 231 eligible patients were r and omized ( with thirty in each group ) to have a total hip arthroplasty performed through either a posterior mini-incision ( 10 + /- 2 cm ) or a traditional long incision ( 20 + /- 2 cm ) . After completion of the total hip arthroplasty , the mini-incision group underwent extension of the skin incision to 20 cm . Patients were evaluated on the basis of self-determined pain scores , requirements for pain medicine , need for assistive gait devices , and time until discharge . Gait analysis provided objective functional assessment . RESULTS The average hospital stay was 63.2 + /- 13.3 hours in the mini-incision group and 73.6 + /- 23.5 hours in the long-incision group ( p = 0.04 ) . More patients with a mini-incision were discharged by the second postoperative day ( p = 0.003 ) and more were using just a single assistive device at the time of discharge ( p = 0.005 ) . As scored on a verbal analog scale of 0 to 10 points , patients with a mini-incision had less pain on each postoperative day and the pain score remained significantly lower at the time of discharge ( mean , 2.2 + /- 1.0 points compared with 3.1 + /- 0.9 points in the long-incision group ; p = 0.002 ) . After hospital discharge , there were no clinical differences in pain or function between the two groups of patients . CONCLUSIONS Compared with conventional total hip arthroplasty performed through a posterior incision , posterior minimally invasive total hip arthroplasty result ed in better early pain control , earlier discharge to home , and less use of assistive devices . Subsequent evaluations at six weeks and three months showed equivalency between the clinical results in the two groups . LEVEL OF EVIDENCE Therapeutic Level",
" Twenty patients who underwent total hip arthroplasty were r and omly allocated to have surgery through a mini incision of or = 8 cm ( mini-incision surgery [ MIS ] group , n = 10 ) or a st and ard incision of 14 cm ( st and ard group , n = 10 ) . A laser Doppler flowmeter was used to measure the intraoperative blood flow of the skin . The measurements were performed at 2 regions , specifically , anterior and posterior regions across the middle points of skin incision . The measurements were taken before making the incision and after implantation . As a control , the skin blood flow over the anterior superior iliac spine was measured . After implantation , mean skin blood flows at both regions in the MIS group were significantly decreased by 32 % and 33 % . However , the corresponding flows in st and ard group and control regions were constant during operation"
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ABSTRACT Data about harms or benefits associated with the consumption of aspartame , a nonnutritive sweetener worldwide consumed , are still controversial . This systematic review and meta- analysis of r and omized controlled clinical trials aim ed to assess the effect of aspartame consumption on metabolic parameters related to diabetes and obesity . The search was performed on Cochrane , LILACS , PubMed , SCOPUS , Web of Science data bases , and on a gray literature using Open Grey , Google Scholar , and ProQuest Dissertations & Theses Global . Search es across all data bases were conducted from the earliest available date up to April 13 , 2016 , without date and language restrictions . Pooled mean differences were calculated using a r and om or fixed-effects model for heterogeneous and homogenous studies , respectively . Twenty-nine articles were included in qualitative synthesis and twelve , presenting numeric results , were used in meta- analysis . Fasting blood glucose ( mmol/L ) , insulin levels ( μU/mL ) , total cholesterol ( mmol/L ) , triglycerides concentrations ( mmol/L ) , high-density lipoprotein cholesterol ( mmol/L ) , body weight ( kg ) , and energy intake ( MJ ) were considered as the main outcomes in subjects that consumed aspartame , and results were presented as mean difference ; % confidence interval , range . Aspartame consumption was not associated with alterations on blood glucose levels compared to control ( −0.03 mmol/L ; 95 % CI , −0.21 to 0.14 ) or to sucrose ( 0.31 mmol/L ; 95 % CI , −0.05 to 0.67 ) and on insulin levels compared to control ( 0.13 μU/mL ; 95 % CI , −0.69 to 0.95 ) or to sucrose ( 2.54 μU/mL ; 95 % CI , −6.29 to 11.37 ) . Total cholesterol was not affected by aspartame consumption compared to control ( −0.02 mmol/L ; 95 % CI , −0.31 to 0.27 ) or to sucrose ( −0.24 mmol/L ; 95 % CI , −0.89 to 0.42 ) . Triglycerides concentrations were not affected by aspartame consumption compared to control ( 0.00 mmol/L ; 95 % CI , −0.04 to 0.05 ) or to sucrose ( 0.00 mmol/L ; 95 % CI , −0.09 to 0.09 ) . High-density lipoprotein cholesterol serum levels were higher on aspartame compared to control ( −0.03 mmol/L ; 95 % CI , −0.06 to −0.01 ) and lower on aspartame compared to sucrose ( 0.05 mmol/L ; 95 % CI , 0.02 to 0.09 ) . Body weight did not change after aspartame consumption compared to control ( 5.00 kg ; 95 % CI , −1.56 to 11.56 ) or to sucrose ( 3.78 kg ; 95 % CI , −2.18 to 9.74 ) . Energy intake was not altered by aspartame consumption compared to control ( −0.49 MJ ; 95 % CI , −1.21 to 0.22 ) or to sucrose ( −0.17 MJ ; 95 % CI , −2.03 to 1.69 ) . Data concerning effects of aspartame on main metabolic variables associated to diabetes and obesity do not support a beneficial related to its consumption
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"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",
"To assess whether acute hyperglycemia affects fibrinolytic balance in elderly subjects with normal glucose tolerance ( NGT ) or impaired glucose tolerance ( IGT ) , 40 non-obese elderly subjects ( 20 NGT , age 68 ± 8 years ; and 20 IGT , age 69 ± 11 years ) were studied . On two experimental days , r and omly allocated and spaced 1 week apart , plasma concentrations of glucose , insulin , fibrinogen , tissue plasminogen activator , plasminogen activator inhibitor type 1 and von Willebr and factor ( vWF ) were measured in each subject at baseline ( 0 ) and 30 , 60 , 90 , 120 min after the ingestion of 75 g glucose or a similarly sweet dose of aspartame ( 250 mg ) ( control test ) . In both NGT and IGT elderly subjects , tissue plasminogen activator , plasminogen activator inhibitor type 1 and fibrinogen plasma levels did not significantly change after both oral aspartame and glucose load . In IGT subjects , vWF plasmatic levels decreased after glucose ( not aspartame ) oral load , reaching the minimum level at 90 min after load ( 82.7 ± 7.8 versus 93.7 ± 10.2 , P that acute hyperglycemia does not modify plasma fibrinolysis in elderly subjects . The decrease of plasma concentration of vWF in IGT elderly subjects requires cautious interpretation and further extensive investigations",
"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 Evidence exists that beverages do not trigger appropriate anticipatory physiologic responses , such as cephalic phase insulin release . Therefore , it is of interest to eluci date the food properties necessary for triggering adaptive responses . Previously , we found a prolonged dose-dependent decrease in the hypothalamic functional magnetic resonance imaging signal after ingestion of a glucose solution . OBJECTIVES The aims of the present study were to measure the effects of sweet taste and energy content on the hypothalamic response to glucose ingestion and to measure the concomitant changes in blood glucose and insulin concentrations . DESIGN Five healthy , normal-weight men participated in a r and omized crossover design trial . The subjects were scanned 4 times for 37 min on separate days with functional magnetic resonance imaging . After 7 min , they ingested 1 of the following 4 stimuli ( 300 mL of each ) : water ( control ) , a glucose solution , an aspartame ( sweet taste ) solution , or a maltodextrin ( nonsweet carbohydrate ) solution . RESULTS Glucose ingestion result ed in a prolonged and significant signal decrease in the upper hypothalamus ( P maltodextrin ingestions result ed in similar increases in blood glucose and insulin concentrations . However , only glucose triggered an early rise in insulin concentrations . Aspartame did not trigger any insulin response . CONCLUSIONS Our findings suggest that both sweet taste and energy content are required for a hypothalamic response . The combination of sweet taste and energy content could be crucial in triggering adaptive responses to sweetened beverages",
"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",
"Background Aspartame is a commonly used intense artificial sweetener , being approximately 200 times sweeter than sucrose . There have been concerns over aspartame since approval in the 1980s including a large anecdotal data base reporting severe symptoms . The objective of this study was to compare the acute symptom effects of aspartame to a control preparation . Methods This was a double-blind r and omized cross over study conducted in a clinical research unit in United Kingdom . Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals . They were given aspartame (100mg)-containing or control snack bars r and omly at least 7 days apart . The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms , biochemistry and metabonomics . Results Aspartame sensitive and non-sensitive participants differed psychologically at baseline in h and ling feelings and perceived stress . Sensitive participants had higher triglycerides ( 2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L ; p value 0.008 ) and lower HDL-C ( 1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L ; p value 0.04 ) , reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups . Urine metabonomic studies showed no significant differences . None of the rated symptoms differed between aspartame and control bars , or between sensitive and control participants . However , aspartame sensitive participants rated more symptoms particularly in the first test session , whether this was placebo or control . Aspartame and control bars affected GLP-1 , GIP , tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects . Conclusion Using a comprehensive battery of psychological tests , biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame . This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of aspartame does not have any detectable psychological or metabolic effects in humans . Trial Registration IS RCT N Registry IS RCT",
"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",
"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",
"Ten healthy volunteers with no history of aspartame intolerance ( 6 men and 4 women , aged 21 - 36 years ) received a single dose of aspartame ( 15 mg/kg body weight in capsules ) or matching placebo in a r and omized , double-blind crossover study . Eleven blood sample s collected over 24 hours were analyzed for plasma glucose and amino acid concentrations . The following variables were evaluated at 1 , 2 , 4 , 8 , and 24 hours post-dosage : changes in mood measured on visual analog scales , cognitive function determined by digit-symbol substitution test ( DSST ) and arithmetic test scores , and reaction time measured with a brake-pedal reaction timer . Memory was tested at 2 and 24 hours after dosage based on recall of st and ardized 16-item word lists . No significant differences between aspartame and placebo were found in measures of sedation , hunger , headache , reaction-time , cognition , or memory at any time during the study . Plasma phenylalanine levels were significantly higher following aspartame ( P less than .01 ) than with placebo between 1 and 6 hours postdosage , reaching a maximum difference of + 3.36 mumols/dl at 2 hours . Plasma glucose concentrations were not significantly different between aspartame and placebo . The results of this study suggest that following a single 15 mg/kg dose of aspartame , no detectable effects are observed in a group of healthy volunteers with no history of aspartame intolerance , despite significant increases in plasma phenylalanine concentrations",
"Background / objective : Artificial sweeteners were thought to be metabolically inactive , but after demonstrating that the gustatory mechanism was also localized in the small intestine , suspicions about the metabolic effects of artificial sweeteners have emerged . The objective of this study was to determine the effect of artificial sweeteners ( aspartame and sucralose ) on blood glucose , insulin , c-peptide and glucagon-like peptide-1 ( GLP-1 ) levels . Subjects/ methods : Eight newly diagnosed drug-naive type 2 diabetic patients ( mean age 51.5±9.2 years ; F/M : 4/4 ) and eight healthy subjects ( mean age 45.0±4.1 years ; F/M : 4/4 ) underwent 75 g oral glucose tolerance test ( OGTT ) . During OGTT , glucose , insulin , c-peptide and GLP-1 were measured at 15- min intervals for 120 min . The OGTTs were performed at three setting s on different days , where subjects were given 72 mg of aspartame and 24 mg of sucralose in 200 ml of water or 200 ml of water alone 15 min before OGTT in a single-blinded r and omized order . Results : In healthy subjects , the total area under the curve ( AUC ) of glucose was statistically significantly lower in the sucralose setting than in the water setting ( P=0.002 ) . There was no difference between the aspartame setting and the water setting ( P=0.53 ) . Total AUC of insulin and c-peptide was similar in aspartame , sucralose and water setting s. Total AUC of GLP-1 was significantly higher in the sucralose setting than in the water setting ( P=0.04 ) . Total AUC values of glucose , insulin , c-peptide and GLP-1 were not statistically different in three setting s in type 2 diabetic patients . Conclusions : Sucralose enhances GLP-1 release and lowers blood glucose in the presence of carbohydrate in healthy subjects but not in newly diagnosed type 2 diabetic patients",
"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 ",
"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",
"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",
"OBJECTIVE High concentrations of fructose enhance postpr and ial lipemia following lipid loading whereas glucose exerts a negative or minimal effect . This study evaluated the effect of lower sweetener concentrations and the contribution of their sweetness level and palatability . METHODS At each of four test sessions , twelve male and ten female healthy adults ingested one of four milkshakes containing 108 g dairy cream alone or supplemented with 30 g fructose , 17.5 g glucose or 1 g aspartame . Blood sample s were collected at baseline , two , four , six and eight hours after ingestion . Sensory discrimination tests were conducted after the last two sessions . RESULTS Fructose and glucose led to 37 % ( p = 0.03 ) and 59 % ( p = 0.08 ) rises in triacylglycerol area under the curve ( TG AUC ) when compared to the plain milkshake , respectively . Although the sweetened shakes were equisweet and were more palatable than the plain shake , the TG rise after the aspartame milkshake did not differ from the plain milkshake . CONCLUSIONS These data indicate that low levels of glucose and fructose consumed with lipid enhance postpr and ial lipemia . Sweetness and palatability did not account for the effect",
" 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",
"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",
"This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence",
"BACKGROUND Increased energy intake is consistently observed in individuals consuming sugar-sweetened beverages ( SSBs ) , likely mainly because of an inadequate satiety response to liquid calories . However , SSBs have a high content of fructose , the consumption of which acutely fails to trigger responses in key signals involved in energy homeostasis . It is unclear whether the fructose content of SSBs contributes to the increased energy intake in individuals drinking SSBs . OBJECTIVE We investigated whether the relative amounts of fructose and glucose in SSBs modifies ad libitum energy intake over 8 d in healthy adults without fructose malabsorption . DESIGN We conducted 2 r and omized , controlled , double-blind crossover studies to compare the effects of consuming 4 servings/d of a fructose- , glucose- , or aspartame-sweetened beverage ( study A ; n = 9 ) or a fructose- , glucose- , or high-fructose corn syrup (HFCS)-sweetened beverage ( study B ; n = 24 ) for 8 d on overall energy intake . SSBs were provided at 25 % of estimated energy requirement , or an equivalent volume of the aspartame-sweetened beverage , and consumption was m and atory . All solid foods were provided at 125 % of estimated energy requirements and were consumed ad libitum . RESULTS In study A , ad libitum energy intake was 120 % ± 10 % , 117 % ± 12 % , and 102 % ± 15 % of estimated energy requirements when subjects consumed the fructose- , glucose- , and aspartame-sweetened beverages . Energy intake was significantly higher in the fructose and glucose phases than in the aspartame phase ( P , total energy intake during the fructose , HFCS , and glucose phases was 116 % ± 14 % , 116 % ± 16 % , and 116 % ± 16 % of the subject 's estimated total energy requirements ( P = 0.880 ) . CONCLUSIONS In healthy adults , total 8-d ad libitum energy intake was increased in individuals consuming SSBs compared with aspartame-sweetened beverages . The energy overconsumption observed in individuals consuming SSBs occurred independently of the relative amounts of fructose and glucose in the beverages . These trials were registered at clinical trials.gov as NCT00475475 and NCT01424306",
"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"
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Introduction : The purpose of this systematic review was to examine literature on workplace factors associated with neck pain or symptoms in computer users performing clerical functions . Methods : A systematic search of the Cochrane , Medline , CINAHL , and EMBASE data bases was conducted for observational and experimental studies published since 2000 . This review applied the case definition of The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders . Results : Seven hundred twenty‐nine studies were identified . Seven hundred and two studies were excluded . Twenty‐seven studies fulfilled inclusion criteria and were assessed for risk of bias . Cross‐sectional studies were commonly at risk from nonresponse bias and lack of adequate case definitions . Experimental studies were mostly at risk of bias due to confounding and participant recruitment methods . Conclusions : Neck pain was not significantly associated with high job dem and s , low skill discretion , low decision authority , or low peer support . However , when these variables were combined with increased duration of computing tasks , or ergonomic dem and s , they reached significance . Supervisor support was found to be the only significant buffer capable of preventing these variables reaching significance in female office workers
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"STUDY DESIGN Systematic review and best evidence synthesis . OBJECTIVES To describe the prevalence and incidence of neck pain and disability in workers ; to identify risk factors for neck pain in workers ; to propose an etiological diagram ; and to make recommendations for future research . SUMMARY OF BACKGROUND DATA Previous review s of the etiology of neck pain in workers relied on cross-sectional evidence . Recently published cohorts and r and omized trials warrant a re- analysis of this body of research . METHODS We systematic ally search ed Medline for literature published from 1980 - 2006 . Retrieved articles were review ed for relevance . Relevant articles were critically appraised . Articles judged to have adequate internal validity were included in our best evidence synthesis . RESULTS One hundred and nine papers on the burden and determinants of neck pain in workers were scientifically admissible . The annual prevalence of neck pain varied from 27.1 % in Norway to 47.8 % in Québec , Canada . Each year , between 11 % and 14.1 % of workers were limited in their activities because of neck pain . Risk factors associated with neck pain in workers include age , previous musculoskeletal pain , high quantitative job dem and s , low social support at work , job insecurity , low physical capacity , poor computer workstation design and work posture , sedentary work position , repetitive work and precision work . We found preliminary evidence that gender , occupation , headaches , emotional problems , smoking , poor job satisfaction , awkward work postures , poor physical work environment , and workers ' ethnicity may be associated with neck pain . There is evidence that interventions aim ed at modifying workstations and worker posture are not effective in reducing the incidence of neck pain in workers . CONCLUSION Neck disorders are a significant source of pain and activity limitations in workers . Most neck pain results from complex relationships between individual and workplace risk factors . No prevention strategies have been shown to reduce the incidence of neck pain in workers",
"Neck pain is more prevalent in office workers than in the general community . To date , findings from prospect i ve studies that investigated causal relationships between putative risk factors and the onset of neck pain in this population have been limited by high loss to follow-up . The aim of this research was to prospect ively evaluate a range of risk factors for neck pain in office workers , using vali date d and reliable objective measures as well as attain an estimate of 1-year incidence . We assembled a cohort of 53 office workers without neck pain and measured individual , physical , workplace and psychological factors at baseline . We followed participants for 1 year to measure the incidence of neck pain . We achieved 100 % participant follow-up . Cox regression analysis was applied to examine the relationship between the putative risk factors and the cumulative incidence of neck pain . The 1-year incidence proportion of neck pain in Australian office workers was estimated in this study to be 0.49 ( 95 % CI 0.36–0.62 ) . Predictors of neck pain with moderate to large effect sizes were female gender ( HR : 3.07 ; 95 % CI : 1.18–7.99 ) and high psychological stress ( HR : 1.64 ; 95 % CI : 0.66–4.07 ) . Protective factors included increased mobility of the cervical spine ( HR : 0.44 ; 95 % CI : 0.19–1.05 ) and frequent exercise ( HR : 0.64 ; 95 % CI : 0.27–1.51 ) . These results reveal that neck pain is common in Australian office workers and that there are risk factors that are potentially modifiable",
"Objectives Complaints of the arms , neck , and shoulders in general and computer-related disorders in particular affect many office workers in economically developed countries . However , with the increased use of computer systems in developing countries , the associated musculoskeletal symptoms and risk factors are yet to be investigated . The study investigates the relationship between work-related physical and psychosocial characteristics and symptoms of the arms , neck , and shoulders in an African economically developed worksite . Methods A prospect i ve cohort study with 1-year follow-up was conducted . Data were used from 250 computer office workers in Khartoum , Sudan . Data were collected using the Arabic version of the Maastricht Upper Extremity Question naire . Prevalence rates for symptoms were calculated and the categories of risk factors being evaluated consisted of physical , psychological , and individual risk factors . Multivariable logistic regression analysis was used to identify risk factors associated with complaints that were expressed as odds ratios ( ORs ) with 95 % confidence intervals ( CIs ) . Results The 1-year follow-up prevalence rate was 0.63 ( 95 % CI : 0.58 - 0.70 ) for neck symptoms , 0.56 ( 95 % CI : 0.45 - 0.66 ) for shoulder symptoms , and 0.46 ( 95 % CI : 0.42 - 0.59 ) for symptoms of the forearms/h and s. Three main risk factors were significantly associated with the presence of symptoms : ( 1 ) time pressure [ OR : 1.31 ( 1.00 to 1.90 ) P=0.05 ] , ( 2 ) task difficulty [ OR : 1.85 ( 1.73 to 1.99 ) P=0.03 ] , and ( 3 ) previous history of symptoms [ OR : 4.62 ( 2.20 to 9.35 ) P=0.01 ] . Conclusions The targeted office workers in Sudan are reporting symptoms in the neck , shoulders , and forearms . Work-related psychological factors predicted more significantly the presence of symptoms in the targeted population",
"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",
"The aim of this study is to investigate if there is a change in oxygen saturation and blood flow in the different parts of the trapezius muscle in office workers with and without trapezius myalgia during a st and ardized computer task . Twenty right-h and ed office workers participated ; ten were recruited based on pain in the trapezius and ten as matching controls . Subjects performed a combination of typing and mousing tasks for 60 min at a st and ardized workstation . Muscle tissue oxygenation and blood flow data were collected from the upper trapezius ( UT ) , the middle trapezius ( MT ) and the lower trapezius ( LT ) , both on the left and right side at seven moments ( at baseline and every tenth minute during the 1-h typing task ) by use of the oxygen to see device . In all three parts of the trapezius muscle , the oxygen saturation and blood flow decreased significantly over time in a similar pattern ( p Oxygenation of the left and right UT was significantly higher compared to the other muscle parts ( p Oxygen saturation for the MT was significantly lower in the cases compared to the control group ( p = 0.027 ) . Blood flow of the UT on the right side was significantly lower than the blood flow on the left side ( p = 0.026 ) . The main finding of this study was that 1 h of combined workstation tasks result ed in decreased oxygen saturation and blood flow in all three parts of the trapezius muscle . Future research should focus on the influence of intervention strategies on these parameters",
"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",
"OBJECTIVE In the course of performing systematic review s on the prevalence of low back and neck pain , we required a tool to assess the risk of study bias . Our objectives were to ( 1 ) modify an existing checklist and ( 2 ) test the final tool for interrater agreement . STUDY DESIGN AND SETTING The final tool consists of 10 items addressing four domains of bias plus a summary risk of bias assessment . Two research ers tested the interrater agreement of the tool by independently assessing 54 r and omly selected studies . Interrater agreement overall and for each individual item was assessed using the proportion of agreement and Kappa statistic . RESULTS Raters found the tool easy to use , and there was high interrater agreement : overall agreement was 91 % and the Kappa statistic was 0.82 ( 95 % confidence interval : 0.76 , 0.86 ) . Agreement was almost perfect for the individual items on the tool and moderate for the summary assessment . CONCLUSION We have addressed a research gap by modifying and testing a tool to assess risk of study bias . Further research may be useful for assessing the applicability of the tool across different conditions",
"Physical and psychosocial stressors in the workplace have been independently associated with the development of neck pain , yet interactions among these risk factors remain unclear . The purpose of this study was to compare the effects of mentally challenging computer work performed with and without exposure to a psychosocial stressor on cervical muscle activity and posture . Changes in cervical posture and electromyography of upper trapezius , cervical extensor , and sternocleidomastoid muscles were compared between a resting seated posture at baseline , a low stress condition with mental concentration , and a high stress condition with mental concentration and psychosocial stress in sixty healthy office workers . Forward head posture significantly increased with mental concentration compared to baseline , but did not change with further introduction of the stressor . Muscle activity significantly increased from the low stress to high stress condition for both the dominant and non-dominant upper trapezius , with no corresponding change in activity of the cervical extensors or flexors between stress conditions . These findings suggest that upper trapezius muscles are selectively activated by psychosocial stress independent of changes in concentration or posture , which may have implication s for the prevention of stress-related trapezius myalgia in the workplace",
"QUESTIONS Do symptomatic female office workers perform computing tasks with higher cervical postural muscle loads ( in terms of higher amplitudes and less muscular rest ) and more discomfort compared with asymptomatic individuals ? Are these differences in postural muscle loads consistent across bilateral ( typing ) and unilateral ( mousing ) conditions ? DESIGN an experimental case-control study . PARTICIPANTS 18 symptomatic female office workers and 21 asymptomatic female office workers . INTERVENTION Three conditions ( typing , mousing , and type- and -mouse ) were performed in r and om order . OUTCOME MEASURES Muscle load was measured as median amplitude and gap frequency using surface EMG of bilateral cervical erector spinae and upper trapezius . Discomfort was measured using a numerical rating scale . RESULTS The case group demonstrated 4.3 % ( 95 % CI 0.1 to 8.4 ) higher amplitude during typing and 3.5 % ( 95 % CI 0.1 to 6.9 ) higher amplitude during type- and -mouse in the right cervical erector spinae compared with the control group . There was a similar difference between groups in the left cervical erector spinae which also demonstrated a 1.2 gaps/min ( 95 % CI -2.3 to 0.0 ) lower frequency during typing . The case group had significantly higher discomfort during all conditions compared with the control group . The case group demonstrated higher median amplitudes and lower gap frequencies than the control group during bilateral conditions ( typing and type- and -mouse ) compared with unilateral conditions ( mousing ) for both muscle groups . CONCLUSION There was increased amplitude and decreased muscular rest in the cervical erector spinae of office workers performing typing and mousing tasks . These findings may represent a mechanism underlying computer-related musculoskeletal disorders",
"The present study investigated the effect of chronic neck muscle pain ( defined as trapezius myalgia ) on neck/shoulder muscle function during concentric , eccentric and static contraction . Forty-two female office workers with trapezius myalgia ( MYA ) and 20 healthy matched controls ( CON ) participated . Isokinetic ( -60 , 60 and 180 degrees s(-1 ) ) and static maximal voluntary shoulder abductions were performed in a Biodex dynamometer , and electromyography ( EMG ) obtained in the trapezius and deltoideus muscles . Muscle thickness in the trapezius was measured with ultrasound . Pain and perceived exertion were registered before and after the dynamometer test . The main findings were that shoulder abduction torque ( at -60 and 60 degrees s(-1 ) ) and trapezius EMG amplitude ( at -60 , 0 and 60 degrees s(-1 ) ) were significantly lower in MYA compared with CON ( p Deltoideus EMG and trapezius muscle thickness were not significantly different between the groups . While perceived exertion increased in both groups in response to the test ( p pain increased in MYA only ( p strength capacity and lowered activity of the painful trapezius muscle . The most consistent differences-in terms of both torque and EMG-were found during slow concentric and eccentric contractions . Activity of the synergistic pain free deltoideus muscle was not significantly lower , indicating specific inhibitory feedback of the painful trapezius muscle only . Parallel increase in pain and perceived exertion among MYA were observed in response to the maximal contractions , emphasizing that heavy physical exertion provokes pain increase only in conditions of myalgia"
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PURPOSE To up date the 2006 American Society of Clinical Oncology guideline on the use of hematopoietic colony-stimulating factors ( CSFs ) . METHODS The American Society of Clinical Oncology convened an Up date Committee and conducted a systematic review of r and omized clinical trials , meta-analyses , and systematic review s from October 2005 through September 2014 . Guideline recommendations were based on the review of the evidence by the Up date Committee . RESULTS Changes to previous recommendations include the addition of tbo-filgrastim and filgrastim-sndz , moderation of the recommendation regarding routine use of CSFs in older patients with diffuse aggressive lymphoma , and addition of recommendations against routine dose-dense chemotherapy in lymphoma and in favor of high-dose-intensity chemotherapy in urothelial cancer . The Up date Committee did not address recommendations regarding use of CSFs in acute myeloid leukemia or myelodysplastic syndromes in adults . RECOMMENDATIONS Prophylactic use of CSFs to reduce the risk of febrile neutropenia is warranted when the risk of febrile neutropenia is approximately 20 % or higher and no other equally effective and safe regimen that does not require CSFs is available . Primary prophylaxis is recommended for the prevention of febrile neutropenia in patients who are at high risk on the basis of age , medical history , disease characteristics , and myelotoxicity of the chemotherapy regimen . Dose-dense regimens that require CSFs should only be used within an appropriately design ed clinical trial or if supported by convincing efficacy data . Current recommendations for the management of patients exposed to lethal doses of total-body radiotherapy , but not doses high enough to lead to certain death as a result of injury to other organs , include the prompt administration of CSFs
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"PURPOSE Guidelines advise primary granulocyte colony-stimulating factor ( G-CSF ) prophylaxis during chemotherapy if risk of febrile neutropenia ( FN ) is more than 20 % , but this comes with considerable costs . We investigated the incremental costs and effects between two treatment strategies of primary pegfilgrastim prophylaxis . METHODS Our economic evaluation used a health care perspective and was based on a r and omized study in patients with breast cancer with increased risk of FN , comparing primary G-CSF prophylaxis throughout all chemotherapy cycles ( G-CSF 1 - 6 cycles ) with prophylaxis during the first two cycles only ( G-CSF 1 - 2 cycles ) . Primary outcome was cost effectiveness expressed as costs per patient with episodes of FN prevented . RESULTS The incidence of FN increased from 10 % in the G-CSF 1 to 6 cycles study arm ( eight of 84 patients ) to 36 % in the G-CSF 1 to 2 cycles study arm ( 30 of 83 patients ) , whereas the mean total costs decreased from € 20,658 ( 95 % CI , € 20,049 to € 21,247 ) to € 17,168 ( 95 % CI € 16,239 to € 18,029 ) per patient , respectively . Chemotherapy and G-CSF determined 80 % of the total costs . As expected , FN-related costs were higher in the G-CSF 1 to 2 cycles arm . The incremental cost effectiveness ratio for the G-CSF 1 to 6 cycles arm compared with the G-CSF 1 to 2 cycles arm was € 13,112 per patient with episodes of FN prevented . CONCLUSION We conclude that G-CSF prophylaxis throughout all chemotherapy cycles is more effective , but more costly , compared with prophylaxis limited to the first two cycles . Whether G-CSF prophylaxis throughout all chemotherapy cycles is considered cost effective depends on the willingness to pay per patient with episodes of FN prevented",
"BACKGROUND This study was design ed to determine whether delivering neo-adjuvant chemotherapy at a higher dose in a shorter period of time improves outcome of breast cancer patients . PATIENTS AND METHODS Women with newly diagnosed breast cancer were r and omly assigned to neoadjuvant chemotherapy of four cycles of doxorubicin and cyclophosphamide followed by four cycles of docetaxel ( AC 60/600 - T 100 mg/m(2 ) ) or six cycles of TAC ( 75/50/500 mg/m(2 ) ) every 3 weeks . The primary endpoint was the pathologic complete response ( pCR ) rate , defined as no invasive tumour present in the breast . RESULTS In total , 201 patients were included . Baseline characteristics were well balanced . AC-T result ed in pCR in 21 % and TAC in 16 % of patients ( odds ratio 1.44 ( 95 % confidence interval ( CI ) 0.67 - 3.10 ) . AC-T without primary granulocyte-colony stimulating factor ( G-CSF ) prophylaxis was associated with more febrile neutropenia compared to TAC with primary G-CSF prophylaxis ( 23 % versus 9 % ) , and with more grade 3/4 sensory neuropathy ( 5 % versus 0 % ) . CONCLUSIONS With a higher cumulative dose for the concurrent arm , no differences were observed between the two treatment arms with respect to pCR rate . The differential toxicity profile could partly be explained by different use of primary G-CSF prophylaxis",
"PURPOSE We report on the effects of granulocyte colony-stimulating factor ( G-CSF ) on hemoglobin ( Hb ) value in early breast cancer patients receiving high-dose epirubicin and cyclophosphamide ( EC ) adjuvant treatment . METHODS Five hundred and six stage I or stage II female breast cancer patients were treated with E 120 mg/m2 and C 600 mg/m2 with or without G-CSF and r and omly assigned to receive in a factorial 2 x 2 design : EC ; EC + lonidamine ; EC + G-CSF ; EC + lonidamine + G-CSF . Five consecutive G-CSF schedules tested 100 r and omly assigned patients each : ( 1 ) 480 microg subcutaneously on days 8 to 14 ; ( 2 ) 480 microg on days 8 , 10 , 12 , 14 ; ( 3 ) 300 microg on days 8 to 14 ; ( 4 ) 300 microg on days 8 , 10 , 12 , and 14 ; and ( 5 ) 300 microg on days 8 and 12 . The mean Hb level of 246 patients receiving EC plus G-CSF was compared with that of 240 patients receiving EC alone . The data presented are derived from an exploratory hypothesis-generating analysis . RESULTS The EC dose intensity did not statistically differ between the G-CSF and the control arm . From the third cycle onward , the mean Hb value result ed significantly lower in G-CSF arm compared with control at each time point of each cycle ( P mean Hb level was observed between schedule 5 and control . Of interest , from the second course onward , the mean Hb level tended to be lower in patients receiving seven or four G-CSF injections compared with those patients who received only two injections . CONCLUSION Our data suggest that a G-CSF dose-related effect may play a role in worsening anemia in patients receiving adjuvant EC",
"Background Recombinant granulocyte colony-stimulating factors ( G-CSFs ) such as Filgrastim are used to treat chemotherapy-induced neutropenia . We investigated a new G-CSF , XM02 , and compared it to Neupogen ™ after myelotoxic chemotherapy in breast cancer ( BC ) patients . Methods A total of 348 patients with BC receiving docetaxel/doxorubicin chemotherapy were r and omised to treatment with daily injections ( subcutaneous 5 μg/kg/day ) for at least 5 days and a maximum of 14 days in each cycle of XM02 ( n = 140 ) , Neupogen ™ ( n = 136 ) or placebo ( n = 72 ) . The primary endpoint was the duration of severe neutropenia ( DSN ) in cycle 1 . Results The mean DSN in cycle 1 was 1.1 , 1.1 , and 3.9 days in the XM02 , Neupogen ™ , and placebo group , respectively . Superiority of XM02 over placebo and equivalence of XM02 with Neupogen ™ could be demonstrated . Toxicities were similar between XM02 and Neupogen ™ . Conclusion XM02 was superior to placebo and equivalent to Neupogen ™ in reducing DSN after myelotoxic chemotherapy . Trial Registration Current Controlled Trials IS RCT",
"PURPOSE We evaluated the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia associated with docetaxel in breast cancer patients . PATIENTS AND METHODS Patients were r and omly assigned to either placebo or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day chemotherapy cycle of 100 mg/m(2 ) docetaxel . The primary end point was the percentage of patients developing febrile neutropenia ( defined as body temperature > /= 38.2 degrees C and neutrophil count incidence of hospitalizations associated with a diagnosis of febrile neutropenia , intravenous ( IV ) anti-infectives required for febrile neutropenia , and the ability to maintain planned chemotherapy dose on time . Patients with febrile neutropenia were converted to open-label pegfilgrastim in subsequent cycles . RESULTS Nine hundred twenty-eight patients received placebo ( n = 465 ) or pegfilgrastim ( n = 463 ) . Patients receiving pegfilgrastim , compared with patients receiving placebo , had a lower incidence of febrile neutropenia ( 1 % v 17 % , respectively ; P febrile neutropenia-related hospitalization ( 1 % v 14 % , respectively ; P use of IV anti-infectives ( 2 % v 10 % , respectively ; P percentage of patients receiving the planned dose on time was similar between patients receiving pegfilgrastim and patients who initially received placebo ( 80 % and 78 % , respectively ) , as would be expected of the study design . Pegfilgrastim was generally well tolerated and safe , and the adverse events reported were typical of this patient population . CONCLUSION First and subsequent cycle use of pegfilgrastim with a moderately myelosuppressive chemotherapy regimen markedly reduced febrile neutropenia , febrile neutropenia-related hospitalizations , and IV anti-infective use",
"PURPOSE Patients with inflammatory breast cancer ( IBC ) or locally advanced breast cancer ( LABC ) were r and omly assigned to 21-day doxorubicin and cyclophosphamide administered for five cycles ( st and ard arm ) versus weekly doxorubicin and daily oral cyclophosphamide administered with granulocyte colony-stimulating factor support for 15 weeks ( continuous arm ) . All patients had subsequent weekly paclitaxel for 12 weeks before surgery . PATIENTS AND METHODS Patients ( n = 372 ) were r and omly assigned to the st and ard arm ( n = 186 ) or the continuous arm ( n = 186 ) stratified by disease type ( LABC , n = 256 ; IBC , n = 116 ) . The primary outcome was microscopic pathologic complete response ( pCR ) at surgery . Secondary outcomes included disease-free survival , overall survival , and toxicity . RESULTS More patients in the st and ard arm had grade 3 to 4 leukopenia and neutropenia , but there were more instances of stomatitis/pharyngitis and h and -foot skin reaction in the continuous arm . Assessed among 356 eligible patients , pCR was not different between the treatment groups stratified by disease type ( P = .42 ) . In subset analysis , higher pCR rates were observed in the continuous arm versus the st and ard arm only for stage IIIB disease ( P = .0057 ) and in IBC ( P = .06 ) . Comparison of overall survival and disease-free survival showed no difference between treatment groups ( P = .37 and P = .87 , respectively ) . CONCLUSION No significant clinical benefit was seen for the investigational arm in this trial overall",
"This phase 3 , multicenter , r and omized ( 1:1 ) , double-blind , placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor ( G-CSF ) in mobilizing hematopoietic stem cells in patients with multiple myeloma . Patients received G-CSF ( 10 microg/kg ) subcutaneously daily for up to 8 days . Beginning on day 4 and continuing daily for up to 4 days , patients received either plerixafor ( 240 microg/kg ) or placebo subcutaneously . Starting on day 5 , patients began daily apheresis for up to 4 days or until more than or equal to 6 x 10(6 ) CD34(+ ) cells/kg were collected . The primary endpoint was the percentage of patients who collected more than or equal to 6 x 10(6 ) CD34(+ ) cells/kg in less than or equal to 2 aphereses . A total of 106 of 148 ( 71.6 % ) patients in the plerixafor group and 53 of 154 ( 34.4 % ) patients in the placebo group met the primary endpoint ( P plerixafor-treated patients reached target after one apheresis , whereas 56 % of the placebo-treated patients required 4 aphereses to reach target . The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions . Plerixafor and G-CSF were well tolerated , and significantly more patients collected the optimal CD34(+ ) cell/kg target for transplantation earlier compared with G-CSF alone . This study is registered at www . clinical trials.gov as # NCT00103662",
"Nonr and omized trials suggest that pegfilgrastim , a pegylated granulocyte colony-stimulating factor , could be used in lieu of filgrastim after autologus peripheral blood stem cell transplantation . This phase III , r and omized , double-blinded , placebo-controlled trial compared the efficacy , costs , and safety of single-dose pegfilgrastim ( single 6 mg dose ) versus daily filgrastim ( 5 microg/kg/day ) for this indication . Seventy-eight patients , matched for age , sex , underlying disease , stage , and CD34/kg transplant dose were enrolled . Cytokines were started on day + 1 posttransplant and continued to an absolute neutrophil count ( ANC ) of 5x10(9)/L for 3 days or 10x10(9)/L for 1 day . The median time to neutrophil engraftment ( ANC > 1.5x10(9)/L for 3 days or 5x10(9)/L for 1 day ) was the same in both groups ( 12 days ) . No differences in platelet engraftment ( 11 versus 13 days ) , number of platelet transfusions ( 5 versus 4 ) , percent with positive cultures for bacterial pathogens ( 23 % versus 15 % ) , days of fever ( 1 versus 2 ) , deaths prior to engraftment ( 1 versus 1 ) , or duration of hospital stay ( 19 versus 19 days ) were seen between the pegfilgrastim and filgrastim groups , respectively . Using the average wholesale price for doses used in this trial , there was a per-patient savings of $ 961 for the pegfilgrastim group ( P time to neutrophil engraftment or any clinical sequelae between pegfilgrastim and filgrastim when given post-APBSCT , with pegfilgrastim achieving a cost savings over filgrastim",
"PURPOSE Patients with primary breast cancer who have extensive axillary lymph node involvement have a poor prognosis after conventional adjuvant therapy . We compared intense dose-dense ( IDD ) adjuvant chemotherapy with conventionally scheduled adjuvant chemotherapy in patients with high-risk primary breast cancer . PATIENTS AND METHODS In this r and omized , phase III trial , a total of 1,284 eligible patients with four or more involved axillary lymph nodes were r and omly assigned to receive IDD sequential epirubicin , paclitaxel , and cyclophosphamide ( IDD-ETC ) every 2 weeks or conventionally scheduled epirubicin/cyclophosphamide followed by paclitaxel every three weeks . The primary end point was event-free survival ( EFS ) . RESULTS At a median follow-up of 62 months , 5-year event-free survival rates were 62 % in the conventional arm and 70 % in the IDD-ETC arm , representing a 28 % reduction of the relative risk of relapse ( P 5-year overall survival rates were 77 % versus 82 % , representing a 24 % reduction of the relative risk of death ( P = .0285 ) . IDD therapy was associated with significantly more nonhematologic and hematologic toxicities , but no treatment-related death occurred . Four occurrences of acute myeloid leukemia or myelodysplastic syndrome ( MDS ) were observed in the IDD-ETC arm . No severe congestive heart failure was reported . CONCLUSION IDD-ETC was less well tolerated compared with conventional chemotherapy but significantly improved event-free and overall survivals in patients with high-risk primary breast cancer who had four or more positive axillary lymph nodes",
"PURPOSE To assess the non-inferiority of pegfilgrastim versus filgrastim in speeding the recovery of polymorphonuclear cells ( PMN ) in pediatric patients who underwent autologous peripheral blood stem cell transplant ( PBSCT ) . METHODS The sample size of this r and omized , multicenter , phase III study , was calculated assuming that a single dose of pegfilgrastim of 100 ug/kg was not inferior to 9 doses of filgrastim of 5 ug/kg/day . R and omization was performed by a computer-generated list and stored by sequentially numbered sealed envelopes . RESULTS Sixty-one patients , with a median age of 11.5 years , were recruited : 29 in the filgrastim arm and 32 in the pegfilgrastim arm . Twenty percent were affected by lymphoma/leukaemia and eighty percent by solid tumors . The mean time to PMN engraftment was 10.48 days ( st and ard deviation [ SD ] 1.57 ) and 10.44 days ( SD 2.44 ) in the filgrastim and pegfilgrastim arms , respectively . Having fixed a non-inferiority margin Delta of 3 , the primary endpoint of non-inferiority was reached . No differences were observed for other secondary endpoints : platelet engraftment , mean time to platelet recovery ( 28 days vs. 33 days ) , fever of unknown origin ( 79 % vs. 78 % ) , proven infection ( 34 % vs. 28 % ) , mucositis ( 76 % vs. 59 % ) . After a median follow-up of 2.3 years ( 95 % C.I. : 1.5 , 3.3 ) , 20 deaths were observed due to disease progression . CONCLUSIONS We conclude that pegfilgrastim was not inferior to daily filgrastim in pediatric patients who underwent PBSCT . EU CLINICAL TRIAL REGISTER NUMBER : 2007 - 001430 - 14",
"PURPOSE In advanced urothelial cancer , treatment with dose-dense methotrexate , vinblastine , doxorubicin , and cisplatin ( ddMVAC ) results in a high response rate , less toxicity , and few dosing delays . We explored the efficacy and safety of neoadjuvant ddMVAC with pegfilgrastim support in muscle-invasive urothelial cancer ( MIUC ) . PATIENTS AND METHODS Patients with cT2-cT4 , N0 - 1 , M0 MIUC were enrolled . Four cycles of ddMVAC were administered , followed by radical cystectomy . The primary end point was pathologic response ( PaR ) defined by pathologic downstaging to ≤ pT1N0M0 . The study used Simon 's optimal two-stage design to evaluate None and alternative hypotheses of PaR rate of 35 % versus 55 % . Secondary end points included toxicity , disease-free survival ( DFS ) , radiologic response ( RaR ) , and biomarker correlates , including ERCC1 . RESULTS Between December 2008 and April 2012 , 39 patients ( cT2N0 , 33 % ; cT3N0 , 18 % ; cT4N0 , 3 % ; cT2 - 4N1 , 43 % ; unspecified , 3 % ) were enrolled . Median follow-up was 2 years . Overall , 49 % ( 80 % CI , 38 to 61 ) achieved PaR of ≤ pT1N0M0 , and we concluded this regimen was effective . High- grade ( grade ≥ 3 ) toxicities were observed in 10 % of patients , with no neutropenic fevers or treatment-related death . One-year DFS was 89 % versus 67 % for patients who achieved PaR compared with those who did not ( hazard ratio [ HR ] , 2.6 ; 95 % CI , 0.8 to 8.1 ; P = .08 ) and 86 % versus 62 % for patients who achieved RaR compared with those who did not ( HR , 4.1 ; 95 % CI , 1.3 to 12.5 ; P = .009 ) . We found no association between serum tumor markers or ERCC1 expression with response or survival . CONCLUSION In patients with MIUC , neoadjuvant ddMVAC was well tolerated and result ed in significant pathologic and radiologic downstaging",
"BACKGROUND Previous r and omized controlled trials that used the two-drug chemotherapy regimen of cisplatin and doxorubicin as the conventional arm showed no evidence of benefit from an increase in the number of agents or the length of treatment . It was then proposed that survival could be improved by increasing the planned dose intensity of cisplatin and doxorubicin . METHODS Previously untreated patients with nonmetastatic , high- grade , central osteosarcoma of an extremity were r and omly assigned to Regimen-C ( conventional treatment with six 3-week cycles of cisplatin [ 100 mg/m2 by 24-hour infusion ] and doxorubicin [ 25 mg/m2/day by 4-hour infusion for 3 days ] ) or to Regimen-DI ( intensified treatment with identical total doses of cisplatin and doxorubicin , planned as six 2-week cycles supported by granulocyte colony stimulating factor ( G-CSF ) . Surgery was scheduled for week 6 in both arms . Primary and secondary outcome measures were overall and progression-free survival , respectively . Intention-to-treat analyses were performed using st and ard survival analysis methods . L and mark analyses were performed in patients with known surgical details and central ly review ed histologic response . All statistical tests were two-sided . RESULTS Between May 1993 and September 2002 , treatment was r and omly allocated to 497 eligible patients . Six cycles of chemotherapy were completed by 78 % of patients in Regimen-C and 80 % of patients in Regimen-DI . The delivered preoperative median dose intensity of cisplatin was 86 % in Regimen-C and 111 % in Regimen-DI ( as the percentage of that planned for the conventional regimen ) . Postoperative median dose intensity of cisplatin was 82 % in Regimen-C and 110 % in Regimen-DI ( the corresponding figures for doxorubicin dose intensity were similar ) . Regimen-DI was associated with lower risks of severe leucopenia and neutropenia and higher risks of thrombocytopenia and mucositis . Good histologic response ( > 90 % tumor necrosis ) was observed in 36 % of Regimen-C patients and 50 % of Regimen-DI patients ( P = .003 , chi2 test ) . There was no evidence of a difference in overall survival ( hazard ratio [ HR ] = 0.94 , 95 % CI = 0.71 to 1.24 ; P = .64 ) or progression-free survival ( HR = 0.98 , 95 % CI = 0.77 to 1.24 ; P = .83 ) . L and mark analyses showed similar results . CONCLUSIONS Planned intensification of chemotherapy with cisplatin and doxorubicin increased received dose intensity and result ed in a statistically significant increase in favorable histologic response rate , but not in increased progression-free or overall survival . Our results call into question the use of histologic response as a surrogate outcome measure in trials of this disease",
"PURPOSE To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer . PATIENTS AND METHODS A 2 × 2 factorial design was used to test two hypotheses : ( 1 ) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and ( 2 ) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer . With 3,250 patients , a disease-free survival ( DFS ) hazard ratio of 0.82 for each r and omization could be detected with 90 % power with two-sided α = .05 . Overall survival ( OS ) was a secondary outcome . RESULTS Interim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens . After a median follow-up of 6 years , a significant interaction developed between the two r and omization factors ( DFS P = .024 ; OS P = .010 ) in the 2,716 patients r and omly assigned in the original design , which precluded interpretation of the two factors separately . Comparing all four arms showed a significant difference in OS ( P = .040 ) but not in DFS ( P = .11 ) , with all treatments given once every 2 weeks associated with the highest OS . This difference in OS seemed confined to patients with hormone receptor-negative/human epidermal growth factor receptor 2 ( HER2 ) -negative tumors ( P = .067 ) , with no differences seen with hormone receptor-positive/HER2-negative ( P = .90 ) or HER2-positive tumors ( P = .40 ) . CONCLUSION Patients achieved a similar DFS with any of these regimens . Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor-negative/HER2-negative tumors ",
"Purpose : To compare the effectiveness , tolerance , and pharmacokinetics of a single dose of pegfilgrastim to daily filgrastim in children and young adults with sarcomas treated with dose-intensive combination chemotherapy . Experimental Design : Patients were r and omized to receive a single dose of 100 mcg/kg of pegfilgrastim s.c . or 5 mcg/kg/day of filgrastim s.c . , daily until neutrophil recovery after two treatment cycles with vincristine , doxorubicin , and cyclophosphamide ( VDC ) and two cycles of etoposide and ifosfamide ( IE ) . The duration of severe neutropenia ( absolute neutrophil count , ≤500/mcL ) during cycles 1 to 4 and cycle duration for all cycles were compared . Pharmacokinetics of pegfilgrastim and filgrastim and CD34 + stem cell mobilization were studied on cycle 1 . Growth factor – related toxicity , transfusions , and episodes of fever and neutropenia and infections were collected for cycles 1 to 4 . Results : Thirty-four patients ( median age , 20 years ; range 3.8 - 25.8 ) were enrolled , and 32 completed cycles 1 to 4 . The median ( range ) duration of absolute neutrophil count of was 5.5 ( 3 - 8 ) days for pegfilgrastim and 6 ( 0 - 9 ) days for filgrastim ( P = 0.76 ) after VDC , and 1.5 ( 0 - 4 ) days for pegfilgrastim and 3.75 ( 0 - 6.5 ) days for filgrastim ( P = 0.11 ) after IE . More episodes of febrile neutropenia and documented infections occurred on the filgrastim arm . Serum pegfilgrastim concentrations were highly variable . Pegfilgrastim apparent clearance ( 11 mL/h/kg ) was similar to that reported in adults . Conclusion : A single dose per cycle of pegfilgrastim was well tolerated and may be as effective as daily filgrastim based on the duration of severe neutropenia and number of episodes of febrile neutropenia and documented infections after dose-intensive treatment with VDC and IE . ( Clin Cancer Res 2009;15(23):7361–7",
"Neutropenic complications remain an important dose‐limiting toxicity of cancer chemotherapy‐associated with considerable morbidity , mortality , and cost . Risk of the initial neutropenic event is greatest during the first cycle . The purpose of this study was to better underst and timing of neutropenic events in relation to delivered chemotherapy dose intensity and utilization of supportive care during cancer treatment . A prospect i ve cohort study of adult patients with solid tumors or lymphoma initiating chemotherapy was conducted at 115 r and omly selected US practice sites between 2002 and 2006 . Chemotherapy‐associated toxicities were captured in up to four treatment cycles including severe neutropenia , febrile neutropenia , and infection . Documented interventions included colony‐stimulating factor ( CSF ) , antibiotics use , and reductions in chemotherapy relative dose intensity ( RDI ) . A total of 3638 patients with breast ( 39.7 % ) , lung ( 23.7 % ) , colorectal ( 13.6 % ) , ovarian ( 8.3 % ) cancers , or lymphoma ( 14.7 % ) were eligible for this analysis . The majority of neutropenic and infection events occurred in the first cycle . A significant inverse relationship was observed between reductions in neutropenic and infectious events and increased utilization of measures to reduce these complications in subsequent cycles . More than 60 % of patients with stage IV solid tumors underwent reductions in RDI . Patients with lymphoma and stage I – III solid tumors had less dose reductions while receiving more prophylactic CSFs . Approximately , 15 % of patients received prophylactic antibiotics . While the risk of neutropenic complications remains greatest during the initial cycle of chemotherapy , subsequently instituted clinical measures in efforts to reduce the risk of these events vary with cancer type and stage",
"BACKGROUND Dose intensification with a combination of cyclophosphamide , doxorubicin , vincristine , and prednisolone ( CHOP ) every 2 weeks improves outcomes in patients older than 60 years with diffuse large B-cell lymphoma compared with CHOP every 3 weeks . We investigated whether this survival benefit from dose intensification persists in the presence of rituximab ( R-CHOP ) in all age groups . METHODS Patients ( aged ≥18 years ) with previously untreated bulky stage IA to stage IV diffuse large B-cell lymphoma in 119 centres in the UK were r and omly assigned central ly in a one-to-one ratio , using minimisation , to receive six cycles of R-CHOP every 14 days plus two cycles of rituximab ( R-CHOP-14 ) or eight cycles of R-CHOP every 21 days ( R-CHOP-21 ) . R-CHOP-21 was intravenous cyclophosphamide 750 mg/m(2 ) , doxorubicin 50 mg/m(2 ) , vincristine 1·4 mg/m(2 ) ( maximum dose 2 mg ) , and rituximab 375 mg/m(2 ) on day 1 , and oral prednisolone 40 mg/m(2 ) on days 1 - 5 , administered every 21 days for a total of eight cycles . R-CHOP-14 was intravenous cyclophosphamide 750 mg/m(2 ) , doxorubicin 50 mg/m(2 ) , vincristine 2 mg , rituximab 375 mg/m(2 ) on day 1 , and oral prednisolone 100 mg on days 1 - 5 , administered every 14 days for six cycles , followed by two further infusions of rituximab 375 mg/m(2 ) on day 1 every 14 days . The trial was not masked . The primary outcome was overall survival ( OS ) . This study is registered , number IS RCT N 16017947 . FINDINGS 1080 patients were assigned to R-CHOP-21 ( n=540 ) and R-CHOP-14 ( n=540 ) . With a median follow-up of 46 months ( IQR 35 - 57 ) , 2-year OS was 82·7 % ( 79·5 - 85·9 ) in the R-CHOP-14 group and 80·8 % ( 77·5 - 84·2 ) in the R-CHOP-21 ( st and ard ) group ( hazard ratio 0·90 , 95 % CI 0·70 - 1·15 ; p=0·3763 ) . No significant improvement was noted in 2-year progression-free survival ( R-CHOP-14 75·4 % , 71·8 - 79·1 , and R-CHOP-21 74·8 % , 71·0 - 78·4 ; 0·94 , 0·76 - 1·17 ; p=0·5907 ) . High international prognostic index , poor-prognosis molecular characteristics , and cell of origin were not predictive for benefit from either schedule . Grade 3 or 4 neutropenia was higher in the R-CHOP-21 group ( 318 [ 60 % ] of 534 vs 167 [ 31 % ] of 534 ) , with no prophylactic use of recombinant human granulocyte-colony stimulating factor m and ated in this group , whereas grade 3 or 4 thrombocytopenia was higher with R-CHOP-14 ( 50 [ 9 % ] vs 28 [ 5 % ] ) ; other frequent grade 3 or 4 adverse events were febrile neutropenia ( 58 [ 11 % ] vs 28 [ 5 % ] ) and infection ( 125 [ 23 % ] vs 96 [ 18 % ] ) . Frequencies of non-haematological adverse events were similar in the R-CHOP-21 and R-CHOP-14 groups . INTERPRETATION R-CHOP-14 is not superior to R-CHOP-21 chemotherapy for previously untreated diffuse large B-cell lymphoma ; therefore , R-CHOP-21 remains the st and ard first-line treatment in patients with this haematological malignancy . No molecular or clinical subgroup benefited from dose intensification in this study . FUNDING Chugai Pharmaceutical , Cancer Research UK , National Institute for Health Research Biomedical Research Centres scheme at both University College London and the Royal Marsden NHS Foundation Trust , and Institute of Cancer Research",
"BACKGROUND To study the effects of deferring pegfilgrastim until day 4 on the reduction of chemotherapy-induced leukocytopenia . PATIENTS AND METHODS Patients of age 61 - 80 years with aggressive lymphoma were r and omly assigned to receive 6 mg pegfilgrastim on day 2 or 4 of a 2-week chemotherapy regimen ( R-CHOP-14 ) . RESULTS Two hundred and ninety-two and 313 chemotherapy cycles were evaluable in 103 patients . Post-nadir pegfilgrastim serum levels were higher after day 4 than after day 2 application . This was associated with an attenuated leukocyte nadir after day 4 pegfilgrastim and there were fewer days with leukocytes Grade 3 and 4 leukocytopenias ( 70 % versus 43.3 % ; P and grade 4-only leukocytopenias ( 47 % versus 20.5 % ; P pegfilgrastim . There were more chemotherapy cycles with grade 3 and 4 infections after day 2 than day 4 pegfilgrastim ( 9.4 % versus 6.0 % ; P = 0.118 ) . Interventional antibiotics were given more often after day 2 than after day 4 pegfilgrastim ( 30.7 % versus 21.9 % of cycles ; P = 0.008 ) . There were five deaths during leukocytopenia after day 2 and none after day 4 pegfilgrastim ( P = 0.027 ) . CONCLUSIONS Administration of pegfilgrastim on day 4 was more effective in reducing severe leukocytopenias and result ed in fewer deaths during leukocytopenia . Pegfilgrastim should be given on day 4 to better exploit its myeloprotective potential",
"Children with acute myelogenous leukemia ( AML ) have a high risk of infectious complications that might be reduced by prophylactic granulocyte colony-stimulating factor ( G-CSF ) . However , G-CSF could induce AML blast proliferation . The prospect i ve r and omized trial AML-BFM 98 investigated the impact of G-CSF on hematopoetic recovery and infectious complications ( primary endpoints ) and on outcome ( secondary endpoint ) in children ( aged 0 - 18 years ) with de novo AML . Patients with more than 5 % blasts in day-15 bone marrow or with FAB M3 were not included . Between 1998 and 2003 , 161 children with AML were r and omized to receive G-CSF after inductions 1 and 2 , whereas 156 patients were assigned to the control group . Time of neutropenia after inductions 1 and 2 was significantly shorter in the G-CSF group ( 23 vs 18 days and 16 vs 11 days ; P=.02 and = .001 , respectively ) . G-CSF did not decrease the incidence of febrile neutropenia ( 72 and 36 patients vs 78 and 37 patients , respectively ) , microbiologically documented infections ( 27 and 25 patients vs 36 and 19 patients , respectively ) and infection-associated mortality ( 5 vs 2 patients ) . Both groups had similar 5-year event-free survival ( EFS ; 59%+/-4 % vs 58%+/-4 % ) . Since G-CSF does not influence the risk of infectious complications or outcome in children undergoing therapy for AML , one can not advocate the routine use of G-CSF in this patient group",
"BACKGROUND American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy ( HDC ) and peripheral blood stem cell ( PBSC ) support . This r and omized trial aims to demonstrate the noninferiority of pegfilgrastim ( PEG ) compared with filgrastim ( FIL ) after HDC . PATIENTS AND METHODS Eighty patients were assigned to FIL at a daily dose of 5 mug/kg or a single fixed dose of PEG ( 6 mg ) 1 day after PBSC . The primary end point was the duration of neutropenia both in terms of absolute neutrophil count ( ANC ) reach an ANC > 0.5 x 10(9)/l . RESULTS The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC > 0.5 x 10(9)/l was 11.5 and 10.8 in the FIL and PEG group , respectively . No differences were observed in the mean time to reach an ANC > 1.0 x 10(9)/l ( 12.2 versus 12.0 days ) in the incidence of fever ( 62 % versus 56 % ) and of documented infections ( 31 % versus 25 % ) . The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group , respectively . CONCLUSION PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC",
"Recombinant granulocyte colony-stimulating factors ( G-CSFs ) such as filgrastim or lenograstim are being used to treat chemotherapy-induced neutropenia . The aim of the present study was to investigate a new G-CSF , XM02 , in comparison to filgrastim in terms of safety and efficacy in the prevention of chemotherapy-induced neutropenia in non-Hodgkin-lymphoma ( NHL ) . A total of 92 patients receiving chemotherapy were r and omised in cycle 1 to treatment with daily injections ( subcutaneous 5 µg/kg/day ) of XM02 ( n = 63 ) or filgrastim ( n = 29 ) for at least 5 days and a maximum of 14 days . In subsequent cycles , all patients received XM02 . The mean duration of severe neutropenia ( DSN ) was 0.5 and 0.9 days in cycle 1 for XM02 and filgrastim , respectively ( p = 0.1055 ) . In cycle 1 , the incidence of febrile neutropenia ( FN ) was 11.1 % for XM02 and 20.7 % for filgrastim ( p = 0.1232 ) . The adverse event profile was similar between XM02 and filgrastim . XM02 demonstrated equivalent efficacy and similar safety profile as the reference medication filgrastim . Treatment with XM02 is as beneficial as filgrastim in ameliorating severe neutropenia and FN in patients with NHL receiving chemotherapy . XM02 is safe and well tolerated in the doses applied in this study",
"To explore the impact of dose intensity ( DI ) in the adjuvant setting of breast cancer , a r and omized phase III trial was conducted comparing postoperative dose-dense sequential chemotherapy with epirubicin , paclitaxel , and cyclophosphamide , methotrexate and fluorouracil (CMF)in high-risk breast cancer patients . From Oct 2000 to June 2005 , 1,121 node-positive patients were r and omized to dose-dense sequential epirubicin 110 mg/m2 and paclitaxel ( Taxol ® , Bristol Myers-Squibb , Princeton , NJ ) 250 mg/m2 ( group A ) , or concurrent epirubicin 83 mg/m2 and paclitaxel 187 mg/m2 ( group B ) , both followed by three cycles of “ intensified ” combination chemotherapy with CMF . By protocol design total cumulative dose and duration of treatment were identical in both groups . Dose intensity of epirubicin and paclitaxel was double in the dose-dense arm . Prophylactic treatment with granulocyte colony-stimulating factor was given with the dose-dense treatments . Disease-free survival ( DFS ) was the primary endpoint . At a median follow-up of 76 months , 253 patients ( 23 % ) had documented disease relapse ( 123 vs. 130 in groups A and B , respectively ) and 208 deaths ( 101 , group A and 107 , group B ) had been observed . The 5-year DFS rate of 74 and 74 % and OS rate of 86 and 85 % were observed for group A and group B , respectively . No differences were found in DFS or OS between the two treatment groups ( P = 0.78 and P = 0.45 for DFS and OS , respectively ) . Safety analysis results showing that both regimens were well tolerated and safe have been previously published ( Fountzilas et al. Ann Oncol 2008 ) . No DFS or OS benefit from the dose-dense sequential epirubicin and paclitaxel was detected when compared to the concurrent administration of the same drugs . No additional safety issues were raised with long-term follow-up",
"BACKGROUND The role of prophylactic antibacterial agents after chemotherapy remains controversial . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in patients who were receiving cyclic chemotherapy for solid tumors or lymphoma and who were at risk for temporary , severe neutropenia ( fewer than 500 neutrophils per cubic millimeter ) . Patients were r and omly assigned to receive either 500 mg of levofloxacin once daily or matching placebo for seven days during the expected neutropenic period . The primary outcome was the incidence of clinical ly documented febrile episodes ( temperature of more than 38 degrees C ) attributed to infection . Secondary outcomes included the incidence of all probable infections , severe infections , and hospitalization but did not include a systematic evaluation of antibacterial resistance . RESULTS A total of 1565 patients underwent r and omization ( 784 to placebo and 781 to levofloxacin ) . The tumors included breast cancer ( 35.4 percent ) , lung cancer ( 22.5 percent ) , testicular cancer ( 14.4 percent ) , and lymphoma ( 12.8 percent ) . During the first cycle of chemotherapy , 3.5 percent of patients in the levofloxacin group had at least one febrile episode , as compared with 7.9 percent in the placebo group ( P levofloxacin group had at least one febrile episode , as compared with 15.2 percent of patients in the placebo group ( P=0.01 ) ; the respective rates of probable infection were 34.2 percent and 41.5 percent ( P=0.004 ) . Hospitalization was required for the treatment of infection in 15.7 percent of patients in the levofloxacin group and 21.6 percent of patients in the placebo group ( P=0.004 ) . The respective rate of severe infection was 1.0 percent and 2.0 percent ( P=0.15 ) , with four infection-related deaths in each group . An organism was isolated in 9.2 percent of probable infections . CONCLUSIONS Among patients receiving chemotherapy for solid tumors or lymphoma , the prophylactic use of levofloxacin reduces the incidence of fever , probable infection , and hospitalization",
"EORTC protocol 30924 is an international r and omized trial reporting a 7.3 year up date of a 2 weekly regimen of high-dose intensity chemotherapy with M-VAC plus granulocyte colony stimulating factor ( HD-M-VAC ) compared to classic M-VAC in advanced transitional cell carcinoma ( TCC ) . Two hundred and sixty three untreated patients with bidimensionally measurable TCC were included . In an intention to treat analysis , there were 28 complete responses ( CR ) ( 21 % ) and 55 partial responses ( PR ) ( 41 % ) , for an overall response rate ( RR ) of 64 % on the HD-M-VAC arm . On M-VAC , there were 12 CR ( 9 % ) and 53 PR ( 41 % ) , for an overall RR of 50 % . The P-value for the difference in CR was 0.009 ; and for RR , was 0.06 . After a median follow-up of 7.3 years , 24.6 % are alive on the HD-M-VAC arm vs. 13.2 % on the M-VAC arm . Median progression-free survival was better with HD-MVAC ( 9.5 months ) vs. M-VAC ( 8.1 months ) . The mortality hazard ratio ( HR ) was 0.76 . The 2-year survival rate for HD-M-VAC was 36.7 % vs. 26.2 % for M-VAC . At 5 years , the survival rate was 21.8 % in the HD-M-VAC vs. 13.5 % . Median survival was 15.1 months on HD-MVAC and 14.9 months on M-VAC . There was one death from toxicity in each arm ; and more patients died to malignant disease in the M-VAC arm ( 76 % ) than in the HD-M-VAC arm ( 64.9 % ) . With longer follow-up initial results have been confirmed , and shows that HD-M-VAC produces a borderline statistically significant relative reduction in the risk of progression and death compared to M-VAC",
"PURPOSE This study evaluates the safety and efficacy of plerixafor ( AMD3100 ) , a CXCR4 antagonist , in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin 's lymphoma ( NHL ) patients . PATIENTS AND METHODS This is a phase III , multicenter , r and omized ( 1:1 ) , double-blind , placebo-controlled study . Patients with non-Hodgkin 's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible . Patients received granulocyte colony-stimulating factor ( G-CSF ; 10 microg/kg ) subcutaneously daily for up to 8 days . Beginning on evening of day 4 and continuing daily for up to 4 days , patients received either plerixafor ( 240 microg/kg ) or placebo subcutaneously . Starting on day 5 , patients began daily apheresis for up to 4 days or until > or = 5 x 10(6 ) CD34 + cells/kg were collected . The primary end point was the percentage of patients who collected > or = 5 x 10(6 ) CD34 + cells/kg in 4 or fewer apheresis days . RESULTS This report presents all data for all patients ( n = 298 ) through 12 months follow-up . Eighty-nine ( 59 % ) of 150 patients in the plerixafor group and 29 ( 20 % ) of 148 patients in the placebo group met the primary end point ( P plerixafor group and 82 patients ( 55 % ) in placebo group underwent transplantation after initial mobilization . Median time to engraftment was similar in both groups . The most common plerixafor-associated adverse events were GI disorders and injection site reactions . CONCLUSION Plerixafor and G-CSF were well tolerated and result ed in a significantly higher proportion of patients with non-Hodgkin 's lymphoma achieving the optimal CD34 + cell target for transplantation in fewer apheresis days , compared with G-CSF alone",
"Background Preliminary data suggest that pegfilgrastim given on day 4 ( P4 ) might be superior to pegfilgrastim on day 2 ( P2 ) in reducing grade 4 leucopenia . Methods Patients with node-positive primary breast cancer receiving epirubicin – paclitaxel – cyclophosphamide chemotherapy were r and omized to receive P2 versus P4 . Primary endpoint was leucopenia grade 4 , assuming a risk reduction of 50 % with P4 from 50 % in P2 to 25 % with P4 . Results Three-hundred fifty-one patients were r and omized to P2 ( n = 174 ) versus P4 ( n = 177 ) . The rate of leucopenia ( grade 4 ) was 47.1 % with P2 and 42.0 % with P4 ( p = 0.387 ) , neutropenia ( grade 3 + 4 ) was 47.9 % versus 40.8 % ( p = 0.337 ) , FN was 4.7 % versus 8.0 % ( p = 0.271 ) , and infections was 29.9 % versus 25.4 % ( p = 0.404 ) , respectively . Conclusion This study failed to demonstrate that pegfilgrastim on day 4 was more efficacious than on day 2 with respect to grade 4 leucopenia ( the primary endpoint ) , febrile neutropenia , or infections",
"We undertook a comparative study of Pegfilgrastim vs. Filgrastim after high-dose melphalan and autologous peripheral blood stem cell transplantation ( APBSCT ) in multiple myeloma ( MM ) patients . Thirty-seven consecutive patients were r and omly assigned to receive a single 6 mg dose of Pegfilgrastim on day 1 post-transplant ( n = 18 patients ) vs. daily subcutaneous injections of Filgrastim 5 microg/kg ( n = 19 patients ) starting on day 5 post-transplant . The median duration of grade 4 neutropenia in the Pegfilgrastim and Filgrastim groups was 5 and 6 d , respectively ( P = ns ) . The results for the two groups were also not significantly different for time to neutrophil and platelet recovery , but incidence of febrile neutropenia ( 61.1 % vs. 100 % , P = 0.003 ) and duration of febrile neutropenia ( 1.5 d vs. 4 d , P = 0.005 ) , were lower in the Pegfilgrastim arm . After initial haematopoietic reconstitution , we observed significantly higher value of leukocytes x 10(9 ) L on day 15 ( 6.0 vs. 2.7 , P = 0.004 ) , in the Pegfilgrastim group compared with the Filgrastim group . This study shows that a single injection Pegfilgrastim can be used with safety and efficacy similar to those provided by daily injections of Filgrastim and it is associated with a decrease incidence of infectious events after APBSCT in MM patients",
"OBJECTIVE To compare the pathologic complete response ( pCR ) rate of patients treated with 5-fluorouracil ( 5-FU ) , doxorubicin , and cyclophosphamide ( FAC ) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity , disease-free survival ( DFS ) and overall survival ( OS ) times , and toxicity between treatment arms in patients with breast cancer . METHODS Patients were r and omized to receive preoperative FAC ( 5-FU , 500 mg/m(2 ) ; doxorubicin , 50 mg/m(2 ) ; cyclophosphamide , 500 mg/m(2 ) ) every 21 days for four cycles or dose-intense FAC ( 5-FU , 600 mg/m(2 ) ; doxorubicin , 60 mg/m(2 ) ; cyclophosphamide , 1,000 mg/m(2 ) ) plus G-CSF every 18 days for four cycles . RESULTS Two hundred two patients were r and omly assigned . The median follow-up was 7.5 years . Patients r and omized to FAC plus G-CSF had a higher pCR rate as well as clinical complete response rate ; however , these differences were not statistically different from those with the FAC arm . Patients in the FAC + G-CSF arm had a higher delivered dose intensity of doxorubicin in the neoadjuvant and adjuvant setting s than those in the st and ard FAC arm . DFS and OS times were not significantly different between the two groups . However , the OS and DFS rates were significantly higher for patients who achieved a pCR than for those who did not . Thrombocytopenia , febrile neutropenia , and infection rates were higher in the FAC + G-CSF arm . CONCLUSIONS A higher delivered dose intensity of doxorubicin with the FAC + G-CSF regimen did not result in a statistically significant higher pCR rate . However , patients who achieved a pCR experienced longer DFS and OS times",
"Optimal dose and timing of CHOP ( cyclophosphamide , doxorubicin , vincristine , and prednisone ) chemotherapy for aggressive non-Hodgkin lymphoma ( NHL ) is still an unresolved issue . We assessed whether dose intensifications with cyclophosphamide and doxorubicin might improve outcome in younger patients with intermediate-risk aggressive NHL . Previously untreated patients were assigned to receive either 8 courses of st and ard CHOP ( n = 239 ) or 6 courses of intensified (I)-CHOP ( n = 238 ) . Although there was a tendency in favor of I-CHOP for overall survival ( OS ) , disease-free survival ( DFS ) , and event-free survival ( EFS ) , the differences were not significant . However , although these analyses were not planned , when the intermediate-risk group was divided into low-intermediate- and high-intermediate-risk patients according to the International Prognostic Index ( IPI ) , low-intermediate-risk patients had improved 6-year OS ( 67 % vs 52 % ; P = .05 ) , DFS ( 58 % vs 45 % ; P = .06 ) , and EFS ( 41 % vs 30 % ; P = .21 ) when they were treated with I-CHOP compared with st and ard CHOP . On the other h and , high-intermediate-risk patients seem to have no benefit from I-CHOP . Although clinical ly relevant side effects occurred more often in the I-CHOP arm , treatment-related mortality was similar . These data suggest that I-CHOP might be preferable to st and ard CHOP in younger patients with low-intermediate-risk aggressive NHL",
"BACKGROUND There is a misconception that elderly cancer patients can not tolerate st and ard doses of chemotherapy because of the frequency and severity of myelosuppressive complications . The reactive use of colony-stimulating factors ( i.e. , in response to severe neutropenia ) commonly observed in this setting contributes to the frequency and severity of these complications . This study evaluated the incidence of febrile neutropenia and related events in elderly cancer patients receiving pegfilgrastim beginning with cycle 1 ( proactive ) in comparison with pegfilgrastim initiated after cycle 1 at the physician 's discretion ( reactive ) . METHODS Patients ( > or = 65 years of age ) with either solid tumors or non-Hodgkin 's lymphoma ( NHL ) were r and omly assigned to receive pegfilgrastim either proactively or reactively . The primary endpoint was the proportion of patients experiencing febrile neutropenia . RESULTS There were 852 patients enrolled ( median age , 72 years ) . Proactive pegfilgrastim use result ed in a significantly lower incidence of febrile neutropenia for both solid tumor and NHL patients compared with reactive use . Proactive pegfilgrastim use also led to fewer hospitalizations result ing from neutropenia and febrile neutropenia by approximately 50 % . Antibiotic use was lower for solid tumor patients receiving proactive pegfilgrastim and equivalent in the two NHL groups . CONCLUSIONS This is the largest , r and omized , prospect i ve trial evaluating growth factor support in typical elderly cancer patients . Proactive pegfilgrastim use effectively produced a lower incidence of febrile neutropenia and related events in elderly patients with either solid tumors or NHL receiving an array of mild to moderately neutropenic chemotherapy regimens . Pegfilgrastim should be used proactively in elderly cancer patients to support the optimal delivery of st and ard chemotherapy",
"BACKGROUND Immunochemotherapy with rituximab and cyclophosphamide , doxorubicin , vincristine , and prednisone ( R-CHOP ) has become the st and ard of care for elderly patients with diffuse large B-cell lymphoma . We aim ed to ascertain if a dose-dense R-CHOP regimen administered every 2 weeks ( R-CHOP14 ) was superior to the st and ard 3-week schedule ( R-CHOP21 ) . METHODS We did a r and omised phase 3 trial at 83 centres in four countries . 602 patients aged 60 - 80 years with untreated diffuse large B-cell lymphoma and at least one adverse prognostic factor ( age-adjusted international prognostic index ≥ 1 ) were eligible for the study . We r and omly allocated individuals to R-CHOP-ie , rituximab ( 375 mg/m(2 ) ) , cyclophosphamide ( 750 mg/m(2 ) ) , doxorubicin ( 50 mg/m(2 ) ) , vincristine ( 1.4 mg/m(2 ) , up to 2 mg ) all on day 1 , and prednisone 40 mg/m(2 ) daily for 5 days-administered every 14 days ( n=304 ) or every 21 days ( n=298 ) for eight cycles . We did permuted-block r and omisation ( block size four , allocation ratio 1:1 ) stratified by centre and number of adverse prognostic factors . The primary endpoint was event-free survival . Our analysis was of the intention-to-treat population , and we present the final analysis . This study is registered with Clinical Trials.gov , number NCT00144755 . FINDINGS Two patients allocated R-CHOP21 were ineligible for the study and were excluded from analyses . After median follow-up of 56 months ( IQR 27 - 60 ) , 3-year event-free survival was 56 % ( 95 % CI 50 - 62 ) in the R-CHOP14 group and 60 % ( 55 - 66 ) in the R-CHOP21 group ( hazard ratio 1.04 , 95 % CI 0.82 - 1.31 ; p=0.7614 ) . Grade 3 - 4 neutropenia occurred in 224 ( 74 % ) of 304 patients allocated R-CHOP14 and 189 ( 64 % ) of 296 assigned R-CHOP21 , despite increased use of granulocyte colony-stimulating factor in the R-CHOP14 group compared with the R-CHOP21 group . 143 ( 47 % ) patients in the R-CHOP14 group received at least one red-blood-cell transfusion versus 93 ( 31 % ) in the R-CHOP21 group ( p=0.0001 ) . 35 ( 12 % ) patients allocated R-CHOP14 received at least one platelet transfusion versus 25 ( 8 % ) assigned R-CHOP21 ( p=0.2156 ) . 155 ( 51 % ) patients who were assigned R-CHOP14 had at least one serious adverse event compared with 140 ( 47 % ) who were allocated R-CHOP21 . INTERPRETATION In elderly patients with untreated diffuse large B-cell lymphoma and at least one adverse prognostic factor , a 2-week dose-dense R-CHOP regimen did not improve efficacy compared with the 3-week st and ard schedule . The frequency of toxic side-effects was similar between regimens , but R-CHOP14 was associated with increased need for red-blood-cell transfusion . FUNDING Groupe d'Etude des Lymphomes de l'Adulte ( GELA ) , Amgen",
"PURPOSE Practice guidelines do not recommend the routine use of colony-stimulating factors when there is a low risk ( neutropenia ( FN ) . We prospect ively determined whether expert peer-to-peer consultation with prescribing oncologists would improve adherence to guidelines and whether there would be any adverse events associated with that adherence . METHODS Commencing in March 2010 , we review ed requests for pegfilgrastim from 22 community oncology practice s comprising 78 physicians providing service to approximately 97,000 Medicare members . Paid cl aims data on all chemotherapy and supportive care medications were review ed from fourth quarter ( Q4 ) 2009 through third quarter ( Q3 ) 2010 . In total , 82 patients received pegfilgrastim . If the prescribed chemotherapy was associated with a low risk ( pegfilgrastim , and no denials were issued . RESULTS A total of 245 units ( 1 unit = 6 mg ) of pegfilgrastim were administered during the four quarters analyzed . Use in the low-risk category decreased from 52 units in Q4 2009 to 15 units in Q3 2010 . The per-member per-month ( PMPM ) cost of pegfilgrastim decreased across quarters , with an average cost of $ 1.07 PMPM for Q4 2009 and $ 0.57 PMPM for Q3 2010 . No studied patient was admitted for neutropenic fever . CONCLUSION Active expert peer-to-peer consultation with prescribing oncologists can promote adherence to guidelines and potentially lead to significant cost reductions without significant risk of neutropenic fever , with or without hospitalization , for patients with cancer",
"PURPOSE Rituximab with cyclophosphamide , doxorubicin , vincristine , and prednisone ( R-CHOP ) is one of the most effective front-line therapies to treat indolent B-cell lymphoma . Granulocyte colony-stimulating factor ( G-CSF ) , which potentiates antibody-dependent rituximab cytotoxicity , is used to shorten CHOP intervals . To improve progression-free survival ( PFS ) in patients treated with R-CHOP as the primary end point , we conducted a phase III study . PATIENTS AND METHODS Patients with untreated stages III to IV indolent B-cell lymphoma were r and omly assigned to six cycles of R-CHOP every 3 weeks ( R-CHOP-21 ) or every 2 weeks ( R-CHOP-14 ) with G-CSF . Maintenance rituximab was not allowed . RESULTS Three hundred patients were enrolled . At the median follow-up time of 5.2 years , there was no significant difference in PFS between arms for the 299 eligible patients ; the median was 3.7 ( R-CHOP-21 ) v 4.7 ( R-CHOP-14 ) years , 57 % v 58 % at 3 years , and 41 % v 43 % at 6 years , respectively ( hazard ratio [ HR ] , 0.92 ; 95 % CI , 0.68 to 1.25 ; one-sided P = .30 ) . The median overall survival ( OS ) time was not reached in either arm , and there was no significant difference ( 6-year OS : 87 % [ R-CHOP-21 ] v 88 % [ R-CHOP-14 ] ; HR , 1.15 ; 95 % CI , 0.57 to 2.30 ; one-sided P = .65 ) . Although grade 4 neutropenia and grade 3 infections were more frequent in the R-CHOP-21 group , R-CHOP was feasible in both arms . CONCLUSION The R-CHOP dose-dense strategy failed to improve PFS of patients with untreated indolent B-cell lymphoma . Further improvement of first-line treatment or investigations on postremission therapy following R-CHOP should be explored",
"BACKGROUND The prophylactic use of fluoroquinolones in patients with cancer and neutropenia is controversial and is not a recommended intervention . METHODS We r and omly assigned 760 consecutive adult patients with cancer in whom chemotherapy-induced neutropenia ( to receive either oral levofloxacin ( 500 mg daily ) or placebo from the start of chemotherapy until the resolution of neutropenia . Patients were stratified according to their underlying disease ( acute leukemia vs. solid tumor or lymphoma ) . RESULTS An intention-to-treat analysis showed that fever was present for the duration of neutropenia in 65 percent of patients who received levofloxacin prophylaxis , as compared with 85 percent of those receiving placebo ( 243 of 375 vs. 308 of 363 ; relative risk , 0.76 ; absolute difference in risk , -20 percent ; 95 percent confidence interval , -26 to -14 percent ; P=0.001 ) . The levofloxacin group had a lower rate of microbiologically documented infections ( absolute difference in risk , -17 percent ; 95 percent confidence interval , -24 to -10 percent ; P bacteremias ( difference in risk , -16 percent ; 95 percent confidence interval , -22 to -9 percent ; P single-agent gram-negative bacteremias ( difference in risk , -7 percent ; 95 percent confidence interval , -10 to -2 percent ; P Mortality and tolerability were similar in the two groups . The effects of prophylaxis were also similar between patients with acute leukemia and those with solid tumors or lymphoma . CONCLUSIONS Prophylactic treatment with levofloxacin is an effective and well-tolerated way of preventing febrile episodes and other relevant infection-related outcomes in patients with cancer and profound and protracted neutropenia . The long-term effect of this intervention on microbial resistance in the community is not known",
"Increasing dose intensity ( DI ) of chemotherapy for patients with aggressive non‐Hodgkin lymphoma ( NHL ) may improve outcomes at the cost of increased toxicity . This issue was addressed in a r and omized trial aim ing to double the DI of myelosuppressive drugs . Between 1994 and 1999 , 250 patients with previously untreated aggressive NHL were r and omized to treatment with six cycles of 3‐weekly st and ard ( s ) or intensive ( i ) chemotherapy : s‐CEOP – cyclophosphamide 750 , epirubicin 75 , vincristine 1.4 mg/m2 all on day 1 , and prednisolone 100 mg days 1–5 ; i‐CEOP – cyclophosphamide 1,500 , epirubicin 150 , vincristine 1.4 mg/m2 all on day 1 , and prednisolone 100 mg days 1–5 . Primary endpoint was 5‐year overall survival ( OS ) . Relative to s‐CEOP patients , i‐CEOP patients achieved a 78 % increase in the DI of cyclophosphamide and epirubicin . Despite this , there was no significant difference in any outcome : 5‐year OS ( 56.7 % i‐CEOP ; 55.1 % s‐CEOP ; P = 0.80 ) , 5‐year progression free survival ( PFS ; 41 % i‐CEOP ; 43 % s‐CEOP ; P = 0.73 ) , 5‐year time to progression ( TTP ; 44 % i‐CEOP ; 47 % s‐CEOP ; P = 0.72 ) , or complete remission ( CR ) + unconfirmed CR ( CRu ) rates ( 53 % i‐CEOP ; 59 % s‐CEOP ; P = 0.64 ) . Long‐term follow up at 10 years also showed no significant differences in OS , PFS , or TTP . The i‐CEOP arm had higher rates of febrile neutropenia ( 70 vs. 26 % ) , hospitalisations , blood product utilisation , haematological and gastrointestinal toxicities , and lower quality of life scores during treatment , although without significant differences 6‐month later . In the treatment of aggressive NHL in the prerituximab era , increasing DI did not result in improved outcomes , while at the same time lead to increased toxicity . Am . J. Hematol . 89:536–541 , 2014 . © 2014 Wiley Periodicals ,",
"Background : The combination of carboplatin and etoposide ( CE ) is one of the most effective regimens in the treatment of small-cell lung cancer ( SCLC ) . The aim of this study was to investigate whether dose-intensified CE with the supplementation of granulocyte-colony-stimulating factor ( G-CSF ) is more effective than conventional CE in terms of survival with acceptable toxicity . Methods : In a 2-arm multicentric prospect i ve open label study , adult patients with SCLC in “ extensive disease ” stage were r and omized either to conventional CE ( carboplatin AUC 5 on day 1 IV and etoposide 140 mg/m2 IV on days 1–3 , q28 days ) or to dose-intensified therapy ( carboplatin AUC 5 on day 1 IV and etoposide 190 mg/m2 days 1–3 IV with lenograstim 263 & mgr;g subcutaneously on days 4–13 , q21 days ) . Primary end point was overall survival ; secondary endpoints were toxicity , quality of life , and disease-free survival . Results : Seventy-nine patients were included . Thirty-seven received conventional CE and 42 received the dose-intensified regimen . Median survival in the conventional group and the dose-intensified group were 11.2 months [ confidence interval ( CI ) 9.1–15.2 ] and 11.7 months ( CI 8.8–14.7 ) , respectively . Progression-free survival was 6.7 ( CI 5.8–7.5 ) and 7.4 months ( CI 6.2–9.0 ) , respectively . There was no statistically significant difference between these groups . Grade 3/4 neutropenia occurred in 69.4 % in the conventional arm versus 37.5 % in the dose-intensified group ( P = 0.009 ) . Conclusion : Dose-intense CE with GM-CSF support can be administered safely but does not prolong overall or progression-free survival compared with st and ard therapy",
"A prospect i ve cohort study was undertaken to develop and vali date a risk model for neutropenic complications in cancer patients receiving chemotherapy",
"Background : Recombinant granulocyte colony-stimulating factors such as Neupogen are used to treat chemotherapy-induced neutropenia . The aim of the study was to show that a new granulocyte colony-stimulating factor , XM02 , is as safe and effective as Neupogen in the treatment of chemotherapy-induced neutropenia in patients with small cell or non-small cell lung cancer . Patients and methods : A total of 240 patients receiving platinum-based chemotherapy were r and omized in cycle 1 to treatment with daily injections ( subcutaneous 5 & mgr;g/kg/d ) of XM02 ( n = 160 ) or Filgrastim Neupogen ( n = 80 ) for at least 5 days and a maximum of 14 days . In subsequent cycles , all patients received XM02 . Results : The mean duration of severe neutropenia was 0.5 and 0.3 days in cycle 1 for XM02 and Filgrastim , respectively . In the analysis of covariance for duration of severe neutropenia in cycle 1 , the estimated treatment difference “ XM02 minus Filgrastim ” was 0.157 days , with 95 % confidence level ( −0.114 days , 0.428 days ) , which was included in the prespecified equivalence range ( −1 , 1 ) . There was no statistically significant difference of the end point incidence of febrile neutropenia in cycle 1 between XM02 and Filgrastim ( p = 0.2347 ) . The adverse event profile was similar between XM02 and Filgrastim . Conclusion : XM02 demonstrated similar efficacy and safety profile as the reference medication Filgrastim in cycle 1 . In conclusion , treatment with XM02 is beneficial in ameliorating severe neutropenia and febrile neutropenia in lung cancer patients receiving myelosuppressive chemotherapy . XM02 is safe and well tolerated in the doses applied in this study",
"High costs of molecule-targeted drugs , such as rituximab , ibritumomab , and tositumomab have given rise to an economical issue for treating patients with non-Hodgkin 's lymphoma ( NHL ) . Granulocyte colony-stimulating factors ( G-CSFs ) , which are also expensive , are widely used for treating neutropenia after chemotherapy . In Japan , lenograstim at 2 microg/kg ( about 100 microg/body ) or filgrastim at 50 microg/m(2 ) ( about 75 microg/body ) is commonly administered for patients with NHL after chemotherapy . Therefore , cost-effectiveness is an important issue in treatment for NHL . Patients with advanced-stage NHL who needed chemotherapy with cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) or a CHOP-like regimen with or without rituximab were enrolled in this r and omized cross-over trial to investigate the efficacy and safety of low-dose G-CSF . Half of the patients were administered 75 microg filgrastim in the first course after neutropenia and 50 microg lenograstim in the second course , and the other half were crossed over . Forty-seven patients were enrolled in this cross-over trial , and 24 patients completed the trial . Frequencies and duration s of grade 4 leukocytopenia and neutropenia were similar in the two groups . Severe infection was rare and was observed at similar frequency . Frequencies of antibiotics use were also similar . The total cost of G-CSF ( cost/drug x duration of administration ) was significantly lower in patients who received 50 microg lenograstim . Hence , a low dose of lenograstim might be safe , effective and pharmaco-economically beneficial in patients with advanced-stage NHL",
"PURPOSE Chemotherapy with alternating vincristine-doxorubicin-cyclophosphamide and ifosfamide-etoposide cycles and primary tumor treatment with surgery and /or radiation therapy constitute the usual approach to localized Ewing sarcoma in North America . We tested whether chemotherapy intensification through interval compression could improve outcome . PATIENTS AND METHODS This was a prospect i ve , r and omized controlled trial for patients younger than 50 years old with newly diagnosed localized extradural Ewing sarcoma . Patients assigned to st and ard and intensified treatment were to begin chemotherapy cycles every 21 and 14 days , respectively , provided an absolute neutrophil count greater than 750 × 10(6)/L and a platelet count greater than 75 × 10(9)/L. Patients received vincristine ( 2 mg/m2 ) , doxorubicin ( 75 mg/m2 ) , and cyclophosphamide ( 1.2 g/m2 ) alternating with ifosfamide ( 9 g/m2 ) and etoposide ( 500 mg/m2 ) for 14 cycles , with filgrastim ( 5 mg/kg per day ; maximum , 300 mg ) between cycles . Primary tumor treatment ( surgery , radiation , or both ) was to begin at week 13 ( after four cycles in the st and ard arm and six cycles in the intensified arm ) . The primary end point was event-free survival ( EFS ) . The study is registered at Clinical Trials.gov ( identifier : NCT00006734 ) . RESULTS Five hundred eighty-seven patients were enrolled and r and omly assigned , and 568 patients were eligible , with 284 patients in each regimen . For all cycles , the median cycle interval for st and ard treatment was 21 days ( mean , 22.45 days ) ; for intensified treatment , the median interval was 15 days ( mean , 17.29 days ) . EFS at a median of 5 years was 65 % in the st and ard arm and 73 % in the intensified arm ( P=.048 ) . The toxicity of the regimens was similar . CONCLUSION For localized Ewing sarcoma , chemotherapy administered every 2 weeks is more effective than chemotherapy administered every 3 weeks , with no increase in toxicity ",
"PURPOSE To compare data on severe ( grade 4 ) neutropenia duration and febrile neutropenia incidence in patients receiving chemotherapy with pegfilgrastim administered the same day or 24 hours after chemotherapy . PATIENTS AND METHODS These were similar , r and omized , double-blind phase II noninferiority studies of patients with lymphoma or non-small-cell lung ( NSCLC ) , breast , or ovarian cancer . Each study was analyzed separately . The primary end point in each study was cycle-1 severe neutropenia duration . Approximately 90 patients per study were to be r and omly assigned at a ratio of 1:1 to receive pegfilgrastim 6 mg once per cycle on the day of chemotherapy or the day after ( with placebo on the alternate day ) . RESULTS In four studies , 272 patients received chemotherapy and one or more doses of pegfilgrastim ( 133 same day , 139 next day ) . Three studies ( breast , lymphoma , NSCLC ) enrolled an adequate number of patients for analysis . However , in the NSCLC study , the neutropenic rate was lower than expected ( only two patients per arm experienced grade 4 neutropenia ) . In the breast cancer study , the mean cycle-1 severe neutropenia duration was 1.2 days ( 95 % confidence limit [ CL ] , 0.7 to 1.6 ) longer in the same-day compared with the next-day group ( mean , 2.6 v 1.4 days ) . In the lymphoma study , the mean cycle-1 severe neutropenia duration was 0.9 days ( 95 % CL , 0.3 to 1.4 ) longer in the same-day compared with the next-day group ( mean , 2.1 v 1.2 days ) . In the breast and lymphoma studies , the absolute neutrophil count profile for same-day patients was earlier , deeper , and longer compared with that for next-day patients , although the results indicate that same-day administration was statistically noninferior to next-day administration according to neutropenia duration . CONCLUSION For patients receiving pegfilgrastim with chemotherapy , pegfilgrastim administered 24 hours after chemotherapy completion is recommended"
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CONTEXT AND OBJECTIVE Hypertensive urgencies are defined as severe elevations in blood pressure without evidence of acute or progressive target-organ damage . The need for treatment is considered urgent but allows for slow control using oral or sublingual drugs . If the increase in blood pressure is not associated with risk to life or acute target-organ damage , blood pressure control must be implemented slowly over 24 hours . For hypertensive urgencies , it is not known which class of antihypertensive drug provides the best results and there is controversy regarding when to use antihypertensive drugs and which ones to use in these situations . The aim of this review was to assess the effectiveness and safety of oral drugs for hypertensive urgencies . METHODS This systematic review of the literature was developed at the Brazilian Cochrane Center , and in the Discipline of Emergency Medicine and Evidence -Based Medicine at the Universidade Federal de São Paulo - Escola Paulista de Medicina ( Unifesp-EPM ) , in accordance with the methodology of the Cochrane Collaboration . RESULTS Sixteen r and omized clinical trials including 769 participants were selected . They showed that angiotensin-converting enzyme inhibitors had a superior effect in treating hypertensive urgencies , evaluated among 223 participants . The commonest adverse event for calcium channel blockers were headache ( 35/206 ) , flushing ( 17/172 ) and palpitations ( 14/189 ) . For angiotensin-converting enzyme inhibitors , the principal side effect was bad taste ( 25/38 ) . CONCLUSIONS There is important evidence in favor of the use of angiotensin-converting enzyme inhibitors for treating hypertensive urgencies , compared with calcium channel blockers , considering the better effectiveness and the lower frequency of adverse effects ( like headache and flushing )
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"In a 6-month prospect i ve study , the efficacy and safety of urapidil and nifedipine in an outpatient population with hypertensive urgencies ( systolic blood pressure > 200 mm Hg ; diastolic blood pressure > 110 mm Hg ) was investigated . Response to treatment was defined as a stable reduction of systolic blood pressure below 180 mm Hg and diastolic blood pressure below 100 mm Hg 15 minutes after application of a single dose of either 25 mg urapidil intravenously ( N = 26 ) or 10 mg nifedipine sublingually ( N = 27 ) . If the blood pressure was still elevated , a second dose of 10 mg nifedipine or 12.5 mg urapidil was given , and blood pressure response was evaluated 15 minutes after application of the second dose according to the aforementioned criteria s. After the first application of nifedipine , 19 ( 70 % ) responders have been observed . Eight patients needed an additional 10 mg of nifedipine . In four of these patients , no reduction of blood pressure was observed after a second dose of nifedipine . In contrast , 24 ( 92 % ) patients responded well to the first application of 25 mg of urapidil . Two patients required a second dose of 12.5 mg of urapidil , but no nonresponder to urapidil was observed . No severe side-effects were noted in both groups . Intravenous urapidil is a highly effective drug in the treatment of hypertensive urgencies and is more effective than sublingual nifedipine , because the number of patients treated successfully was significantly higher",
"To determine whether nitroglycerin is just as effective as nifedipine in lowering the blood pressure in excessive hypertension and hypertensive crisis , two groups of 20 patients received in r and om sequence either 1.2 mg of nitroglycerin sublingually or a 10 mg nifedipine capsule , which was chewed and swallowed . The blood pressure fell after 5 min in the nitroglycerin group from 211/122 mm Hg to 171/95 mm Hg and after nifedipine from 210/118 to 185/102 mm Hg . The greater effect of nitroglycerin results from faster absorption through the oral mucosa than through the small intestinal mucosa where nifedipine is primarily absorbed . After 15 to 20 min a satisfactory reduction in blood pressure was reached in both groups : 157/91 and 158/92 mm Hg , respectively . After 30 min the heart rate in the nitroglycerin group had decreased from 83 to 80/min , but in the nifedipine group it had increased from 84 to 90/min . The reduction in blood pressure persisted up to 6 h. No significant difference in side-effects was determined . Since a hypertensive crisis is usually accompanied by left-ventricular failure , pulmonary edema or angina pectoris and infa rct ion , and nitroglycerin has been definitively shown to positively influence these conditions , preference should be given to nitroglycerin in the treatment of hypertensive crisis",
"Twenty patients with acute severe hypertension were r and omised to therapy with either nifedipine capsules ( 10 mg ) or captopril tablets ( 25 mg ) given sublingually and the blood pressure recorded for 240 minutes . Oral monotherapy with either agent followed for 3 weeks , then the agents were combined for a further 2 weeks and in the final 6 weeks of the trial a beta-blocker and diuretic were added , if needed . Thirteen patients completed the trial . The major results were : ( i ) nifedipine decreased blood pressure more rapidly than captopril 60 minutes after first ingestion but at 240 minutes equal degrees of fall in blood pressure had been obtained ; ( ii ) neither agent given as sustained monotherapy was able to reduce blood pressure adequately , although nifedipine was better than captopril ; and ( iii ) combination therapy with both agents was conspicuously successful in achieving reduction in blood pressure . It is suggested that combination nifedipine-captopril therapy be subject to a formal trial for early therapy in acute severe hypertension",
"Sublingual nifedipine is commonly used in hypertensive crisis , however , it may result in several adverse effects such as reflex tachycardia , headache , and flushing . Research is continuing to find a new drug that has the same efficiency and fewer side effects . Sublingual captopril , a new preparation of angiotensin-converting enzyme inhibitor , lowers blood pressure . It is not known whether it is effective in these emergent clinical setting s. Therefore we design ed a r and omized , double-blind study to compare the efficacy and safety of those two drugs in hypertensive crisis . Eighty patients ( 32 male and 48 female ) with hypertensive crisis were included in the study ; their mean age was 43.4 ± 7.9 years . Nifedipine 10 mg was given sublingually to 34 and captopril 25 mg to 46 patients r and omly . There was no difference between the two drugs with respect to their antihypertensive effect . Heart rate significantly dropped ( p taking captopril , but no changes were observed in the patients taking nifedipine . Twenty-three of 34 patients taking nifedipine encountered adverse effects . Adverse effects were observed in only three patients taking captopril ( p . Sublingual captopril is as effective as and has less side effects than sublingual nifedipine . Because sublingual captopril has fewer side effects , it may be safer than nifedipine in the treatment of hypertensive crisis",
"We examined the antihypertensive efficacy of : ( 1 ) sublingual-oral single doses of captopril ( 25 mg ) and nifedipine-capsules ( 10 mg ) in 9 + 9 white patients and in 9 + 8 black patients with hypertensive crisis ; and ( 2 ) a single oral dose of the slow-acting preparation of nifedipine-retard ( 20 mg ) in another 10 black patients . Blood pressure ( BP ) was assessed at 10 min intervals for 6 h after administration . After 6 h , the BP falls induced by these drugs were still significantly lower than the baseline placebo values . Hypotensive effect of nifedipine-capsules was established more rapidly than that of captopril in both white and black patients , and of nifedipine-retard in black patients . Considering the area under the curve of BP values during the 6-h treatment , the overall hypotensive effect of nifedipine-capsules was similar to captopril in white patients , but significantly more pronounced than captopril and nifedipine-retard in black patients . In white patients similar maximal drops of BP ( mean ± s.e.m . ) were obtained with nifedipine-capsules ( 71 ± 4/52 ± 4 mm Hg ) and with captopril ( 69 ± 4/50 ± 3 mm Hg ) . In black patients the maximal drop of BP of nifedipine-capsules ( 70 ± 4/52 ± 4 mm Hg ) was greater ( P captopril ( 48 ± 4/32 ± 3 mm hg ) but similar to that of nifedipine-retard ( 71 ± 4/49 ± 4 mm hg ) . however , in contrast to nifedipine-capsules and captopril , nifedipine-retard produced a slower drop in bp . the time of peak drop in bp of both nifedipine-capsules and captopril occurred within the first 2 h whereas with nifedipine-retard it occurred only between 4 and 6 h after administration . fewer patients reported side effects with nifedipine-retard as compared with the other two preparations . we conclude that single doses of captopril and nifedipine reduces bp for at least 6 h in both white and black patients with hypertensive crisis , but nifedipine is more potent than captopril in black patients . the slow release form of nifedipine-retard effectively and safely lowers bp while achieving a rapid enough effect without the critical rapid falls in bp that occur with nifedipine-capsules ",
"Fifty two patients of severe hypertension , diastolic blood pressure > or = 115 mmHg , with or without acute complications , were treated with sublingual nifedipine 10 mg or sublingual captopril 25 mg in a r and omized prospect i ve in patient study with careful clinical monitoring . Both the drugs were safe and effective in rapidly lowering blood pressure . Nifedipine appeared to be superior to captopril with earlier onset of action , greater magnitude of response and longer duration of action . No significant side effects were observed in either of the two groups",
"In order to determine the prevalence of arterial hypertension and clinical presentation of the hypertensive crisis , as well as the need and efficacy of treatment , 3626 patients who were seen at an Emergency care Unit during a period of 37 r and omly chosen days in a total time period of three months , have been studied . Two hundred and fifty one patients presented arterial hypertension , defined as a systolic arterial pressure above 160 mmHg and /or diastolic above 95 mmHG , which represents 6,92 % of medical emergencies and 1.79 % of total emergencies . Only 104 patients ( 2.86 % ) seeked help for some pathology related to hypertension , of whom 49 ( 19.5 % of hypertense patients ) presented as a hypertensive emergency , being the acute lung edema and unstable angina the most frequently encountered emergencies . Nifedipine was the most frequently used drug in both groups and managed to control pressure levels in almost 90 % of patients with a hypertensive emergency in a mean time of less than one hour",
"OBJECTIVE This study was design ed to show the effects of sublingually administered nifedipine and captopril on middle cerebral arterial blood flow during hypertensive crisis in the emergency department . METHODS AND RESULTS Transcranial Doppler ultrasonography ( TCD ) was performed on the patients fulfilling the criteria ( 15 patients given captopril , 13 patients given nifedipine , mean ( + /-SD ) age 56 + /- 11 and 54 + /- 10 years , respectively ) . Then , patients were r and omized into sublingually administered captopril or nifedipine groups and after the drug administration , TCD was repeated . Initial systolic and diastolic blood pressures were 200 + /- 21/125 + /- 21 mmHg in the captopril group and 199 + /- 17/ 123 + /- 20 mmHg in the nifedipine group . There was no significant difference between antihypertensive effects of the drugs after initiation of treatment . Before the treatment with captopril , middle cerebral artery ( MCA ) flow velocities ( Vm ) and pulsatility index ( PI ) were 76.74 + /- 6.38 cm/s and 1.18 + /- 0.09 , respectively . The values after the treatment with captopril were 78.21 + /- 5.24cm/s ( p nifedipine , Vm and PIs were 64.73 + /- 5.11 cm/s and 1.14 + /- 0.18 , respectively . After the treatment with nifedipine , Vm was 60.04 + /- 5.36 cm/s ( p PI was 1.21 + /- 0.09 ( p captopril , PIs were decreased to normal limits but in the group treated with nifedipine , PIs increased to more pathological values . These results showed that we should reconsider the use of nifedipine in the emergency departments as an antihypertensive agent in hypertensive attack treatment",
"& NA ; This study estimated the efficacy of sublingual nifedipine 10 mg vs. sublingual lacidipine 4 mg in the management of hypertensive crises . We studied 40 patients with diastolic blood pressure ≥120 mm Hg , who were divided into two groups of 20 . Blood pressure and heart rate were assessed in the recumbent position before treatment and after 30 , 120 , and 240 min . Comparison of the effectiveness of these drugs was analyzed by Student 's t test . Both drugs tested revealed a statistically significant hypotensive effect on diastolic and systolic blood pressure , and few side effects . Compared with lacidipine , nifedipine had a greater hypotensive effect on diastolic and systolic blood pressure in the first 30 min and on the diastolic blood pressure after the first 120 min . However , the hypotensive effect of lacidipine is statistically significant . After 4 h , both drugs showed a similar efficacy without significant statistical variations . We concluded that in the management of hypertensive crises the use of each of these drugs can have a particular range : nifedipine can be used when a pronounced and rapid blood pressure decrement is necessary , whereas lacidipine can be used when a more gradual effect is preferable",
"Summary To determine whether nitroglycerin is as effective as nifedipine in lowering the blood pressure in severe hypertension and hypertensive crisis , two goups of 20 patients received in r and om sequence either 1.2 mg nitroglycerin sublingually or a 10-mg nifedipine capsule , which was chewed and swallowed . The blood pressure fell after 5 min in the nitroglycerin group from 211/122 mmHg to 171/95 mmHG and after nifedipine from 210/118 to 185/102 mmHg . The greater effect of nitroglycerine may result from faster absorption through the oral mucosa than through the small intestinal mucosa where nifedipine is primarily absorbed . After 15–20 min a satisfactory reduction in blood pressure was reached in both groups : 157/91 and 158/92 mmHg , respectively . After 30 min the heart rate in the nitroglycerin group had decreased from 83 to 80/min , but in the nifedipine group it had increased from 84 to 90/min . The reduction in blood pressure persisted up to 6 h. No significant differences in side effects were determined . Since a hypertensive crisis is usually accompanied by left ventricular failure , pulmonary edema , angina pectoris , or infa rct ion , nitroglycerin has been definitively shown positively to influence these conditions , and preference should be given to nitroglycerin in the treatment of hypertensive crises",
"To determine whether a dose of 5 mg of nifedipine would be useful in the treatment of hypertensive emergencies , we compared the acute hypotensive effects of two different doses of nifedipine , 5 mg and 10 mg , in patients with severe hypertension . In this prospect i ve , r and omized , double-blind study , 30 consecutive black patients with diastolic blood pressure that was equal to or greater than 115 mm Hg received either a 5 mg or 10 mg nifedipine capsule and a placebo capsule , which matched that of the alternative strength . Patients were asked to bite the capsules and swallow the contents . Blood pressure response over 4 hours and adverse effects were monitored . Mean systolic blood pressure was reduced from 191.7 mm Hg ( 95 % confidence interval 170.8 to 212.7 mm Hg ) to 157.9 mm Hg ( 137.0 to 178.9 mm Hg ) and 206.1 mm Hg ( 185.1 to 227.0 mm Hg ) to 153.7 mm Hg ( 132.8 to 174.7 mm Hg ) in patients who were given 5 mg and 10 mg doses of nifedipine , respectively . Mean diastolic blood pressure in the group of patients that received 5 mg doses of nifedipine decreased from 128.2 mm Hg ( 115.6 to 140.7 mm Hg ) to 105.2 mm Hg ( 92.7 to 117.7 mm Hg ) ; the corresponding values in the group that received 10 mg doses of nifedipine were 129.9 mm Hg ( 117.4 to 142.5 mm Hg ) and 97.5 mm Hg ( 85.0 to 110.1 mm Hg ) , respectively . The minimum mean systolic blood pressures occurred 20 and 25 minutes after administration of the 5 mg and 10 mg capsules , respectively ; the minimum diastolic blood pressures were reached after 20 and 30 minutes , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The prehospital management of severe hypertension is limited by a paucity of pharmacologic agents suitable for field use . This prospect i ve study was design ed to test the safety and efficacy of intraoral nifedipine therapy in 50 patients with severe hypertension being transported by an urban emergency medical service system . Ten milligrams of nifedipine were administered . Serial blood pressure determinations were obtained at 3 , 5 , 10 , and 15 minutes and patients were observed for possible side effects . A marked effect on systolic blood pressure ( SP ) , diastolic blood pressure ( DP ) , and mean arterial pressure ( MAP ) was evident and was statistically significant in all three categories by 3 minutes . MAP decreased from 169 to 129 mm Hg ( delta MAP of 40 mm Hg ) at 15 minutes with parallel changes in the SP ( 55 mm Hg ) and delta DP ( 32 mm Hg ) . These changes were highly significant ( P less than .01 ) when compared with those of 50 historical controls . No evidence of severe adverse effects were noted . Nifedipine appears to be a promising agent for the prehospital treatment of severe hypertension , but its proper role is not yet defined",
"In order to investigate the efficacy of isradipine in the treatment of hypertensive crisis , we treated three groups of patients who had diastolic blood pressure ( DBP ) greater than 120 mm Hg , and who were without signs of acute target-organ damage . Isradipine was given sublingually in doses of 1.25 mg ( group 1 ; n = 10 ) , 2.5 mg ( group 2 ; n = 10 ) , and 5 mg ( group 3 ; n = 7 ) . Mean arterial pressure ( MAP ) was reduced in all patients [ from 153.4 + /- 4.3 to 124.0 + /- 2.3 mm Hg at 60 min , and to 118.0 + /- 2.1 mm Hg at 2 h after administration ( p less than 0.001 ) ] . The heart rate ( HR ) did not change significantly ( from 82.4 + /- 3.7 to 84.0 + /- 6 beats/min ; NS ) . No significant differences were noted in the overall responses of the three groups ; however , blood pressure reduction was more rapid in the group receiving 5 mg compared with the other two dosages . These results show that isradipine given sublingually is effective in reducing the elevated blood pressure of a hypertensive crisis and is not accompanied by limiting side effects . Isradipine 's onset of action is early ( approximately 30 min after dosing ) and reaches its maximum blood pressure response within 2 h of administration . No dose-dependent reductions in blood pressure were observed with the dosage range employed in this study",
"Thirty-seven patients with severe hypertension were r and omly assigned to receive 20 mg of ketanserin sublingually , 10 mg of ketanserin intravenously , or 20 mg of nifedipine sublingually . Systolic and diastolic blood pressures fell significantly after the three treatments . The maximum effects were reached 25 minutes after sublingual ketanserin ( with decreases of 7.7 % in systolic and 7.1 % in diastolic blood pressure ) , six minutes after intravenous ketanserin ( decreases of 9.4 % and 9.6 % , respectively ) , and 25 minutes after sublingual nifedipine ( decreases of 16.9 % and 15.9 % , respectively ) . Blood pressure returned to pretreatment levels 20 minutes after intravenous ketanserin . Heart rate increased significantly in the group receiving nifedipine . No changes in plasma aldosterone , sodium , or potassium levels or in erythrocyte sodium and potassium levels were found after ketanserin . It is concluded that even intravenous ketanserin is inferior to sublingual nifedipine in the control of blood pressure",
"Nitrendipine is a new calcium antagonist of the 1,4-dihydropyridine group with strong vasodilating properties . In a r and omized trial involving 45 patients , whose mean blood pressure was 236 + /- 24/129 + /- 21 mm Hg , 5 mg nitrendipine ( given sublingually via a phiole ) was compared with 20 mg nifedipine ( given sublingually via two pierced 10-mg capsules ) and 0.15 mg clonidine ( given intravenously ) . Blood pressure and heart rate were assessed for 8 h after intake of the antihypertensive agents . Within 60 min , nitrendipine reduced blood pressure by an average of 78 + /- 17 mm Hg for the systolic and 42 + /- 12 mm Hg for the diastolic . Heart rate fell significantly from 106 + /- 17 to 87 + /- 11 beats/min . Nifedipine produced equivalent falls in systolic ( -72 + /- 15 mm Hg ) and diastolic ( -41 + /- 11 mm Hg ) blood pressure , but increased heart rate from 89 + /- 13 to 103 + /- 14 beats/min within 1 h. Intravenous administration of clonidine lowers systolic ( -84 + /- 13 mm Hg ) and diastolic ( -35 + /- 10 mm Hg ) blood pressure within 60 min . Heart rate decreased from 96 + /- 15 to 84 + /- 9 beats/min . The antihypertensive effect of each drug was maintained until 8 h after medication . Main side effects were observed in the nifedipine group ( flush and reflex tachycardia ) and in the clonidine group ( dry mouth and drowsiness ) . In conclusion , nitrendipine , nifedipine , and clonidine show similar efficacy in the treatment of hypertensive urgencies and emergencies . However , sublingual application of the calcium antagonists is simple and safe ; moreover , nitrendipine is better tolerated than nifedipine and clonidine",
"We compared antihypertensive efficacy and safety of a single administration of equipotent doses of lacidipine versus nifedipine in the hypertensive urgencies . Twenty-nine asymptomatic essential hypertensive patients ( nine men , 20 women ) with a mean age of 55.03+/-11.19 years and baseline diastolic blood pressure ( DBP ) of > or = 120 mm Hg after resting 30 min , not taking antihypertensive drugs for the last 24 h , were r and omized in a single-blind fashion to receive lacidipine , 4 mg ( LCD , 15 patients ) or short-acting nifedipine , 20 mg ( NFD , 14 patients ) in a single dose . Blood pressure ( BP ) and heart rate ( HR ) were taken every 30 min during the first 8 h and every 2 h until 24 h of follow-up . Baseline BP values were similar in the two groups ( LCD , 222.5+/-32.8/124.6+/-8.4 mm Hg vs. NFD , 215.9+/-20.6/128+/-7.7 mm Hg ; p = NS ) . Both drugs promoted a significant reduction of systolic blood pressure ( SBP ; 169.6+/-27.8 vs. 170.6+/-25.3 mm Hg ) and diastolic blood pressure ( DBP ; 104.1+/-16 vs. 102.9+/-12.4 mm Hg ) after 8 h. However , either SBP ( 165+/-27.3 vs. 190.6+/-18.2 mm Hg ; p = 0.008 ) and DBP ( 99.9+/-12.3 vs. 117.2+/-11.4 mm Hg ; p = 0.001 ) were significantly higher in the NFD group after 24-h dosing . Eleven patients in the LCD group had a decrease in BP > 25 % of the baseline value both 8 and 24 h after the dose . Although 10 patients showed the same response in the NFD group 8 h after the dose , only four patients maintained these values at 24 h. One patient treated with NFD had a transient cerebrovascular ischemic attack . No adverse effects were observed in the LCD group . We conclude that the long-acting calcium antagonist lacidipine was more effective than the short-acting nifedipine in both controlling BP and maintaining this BP reduction over 8 h in essential hypertensive patients with acute asymptomatic BP increase",
"In a r and omized parallel-group placebo-controlled study , we compared the short-term hypotensive efficacy and the safety of a single administration of nifedipine-retard ( 20-mg tablets ) with that of two administrations 6 h apart of nifedipine capsules ( 10 mg ) in 10 and 11 black patients , respectively , with acute severe hypertension . Both groups had similar pretreatment blood-pressure ( BP ) values . Blood pressure was recorded at 10-min intervals for 12 h by using an automated device . In the first 3 h of treatment , nifedipine capsules induced a faster and greater hypotensive effect than nifedipine retard , which was associated with an increase in heart rate . At 2 h after treatment , nifedipine capsules decreased BP to levels ( 159 + /- 5/105 + /- 3 mm Hg ) that were significantly lower than those reached by nifedipine-retard ( 175 + /- 4/118 + /- 4 mm Hg ; p maximal BP decrease of approximately 30 % of the placebo values , but the peak decrease of BP occurred significantly later with nifedipine-retard ( 283 + /- 31 min after administration ) than with nifedipine capsules ( 100 + /- 14 min ; p hypotensive effect of nifedipine capsules was blunted , and a second administration was necessary , whereas nifedipine-retard reduced BP slowly and continuously for Flush and headache were more frequently found with nifedipine capsules . We conclude that in black patients with hypertensive crisis , nifedipine capsules produce an abrupt decrease in BP that may be potentially harmful . Thus for patients suitable for treatment with nifedipine , nifedipine-retard is preferable because it effectively reduces BP for > or = 12 h while achieving a rapid enough effect without critical short-term decreases in BP",
"The purpose of this study was to evaluate the antihypertensive efficacy of captopril ( C ) and its correlation with body mass index ( BMI ) , age and initial blood pressure ( BP ) in hypertensive crises . The time of the beginning of the antihypertensive effect of C and its side effects were evaluated . Twenty patients , aged between 22 and 59 years , were included in this investigation . BP was measured after 15 min of rest ; age , weight and height were recorded and BMI was calculated using the st and ard formula ( Kg/m2 ) . Patients were not taking antihypertensive medications . After the placebo was given to the patients , BP was measured at 30 and 60 min . Sublingual captopril 25 mg was administered and BP was again measured at 5 , 10 , 15 , 30 , 60 , 120 y 240 min . There was not statistically significant difference between the values of BP before and after placebo . A significant decrease was observed post C , from 182.6/123.6 to 174.6/117.3 ( p : SN/p decrease in diastolic BP > or = 5 mmHg , 10 min . post C. No correlation was found between decrease in BP and age , nor with BMI . Pearson r correlation index between the decrease in systolic BP and initial systolic BP was 0.63 ( p decrease in diastolic BP and initial diastolic BP , 0.59 ( p effects were mild and well tolerated . In conclusion , C effectively reduced BP in hypertensive crises . Because the efficacy of C , its rapid onset of action and minimal side effects , sublingual Captopril should be considered a first line drug for hypertensive crises",
"This study was a prospect i ve , r and omized , double-blind , placebo-controlled clinical trial design ed to evaluate the safety and efficacy of oral nicardipine for the treatment of urgent hypertension in the emergency department . Of 57 patients with urgent hypertension 53 patients were enrolled : 36 men and 17 women , 43 black and 10 white , age range 48 + /- 11 years , and diastolic blood pressure 128 + /- 7 mm Hg . Patients were r and omly assigned to receive 30 mg nicardipine or placebo in blind fashion followed by 30 mg open-label nicardipine in nonresponders . Responders to one or two doses of nicardipine received 30 or 40 mg nicardipine three times a day for 1 week after discharge from the emergency department . Adequate blood pressure reduction , defined as a reduction of diastolic blood pressure to less than 100 mm Hg or by at least 20 mm Hg , was achieved in 65 % and 22 % of patients who received 30 mg nicardipine or placebo ( p = 0.002 ) . Adequate blood pressure reduction after administration of open-label nicardipine occurred in 76 % of the nonresponders to placebo . Blood pressure reductions were maintained at 1 week after discharge . The drug was well tolerated , and no significant adverse events occurred . We conclude that oral nicardipine is a safe and effective drug for the initial treatment of urgent hypertension",
"We r and omized patients with severe hypertension in the Medical Intensive Care Unit to a treatment regimen of oral nifedipine or intravenous nitroprusside . Patients treated with nifedipine achieved a sustained reduction in diastolic blood pressure to less than or equal to 120 mm Hg in an average of less than five hours . Patients treated with nitroprusside achieved a similar reduction in 14 hours ( p less than 0.05 ) . Treatment with nifedipine was less expensive and required less time in the ICU than treatment with nitroprusside and was accompanied by no associated increase in morbidity or mortality . Oral nifedipine can be used as an alternative to intravenous nitroprusside in severe uncomplicated hypertension",
"The use of sublingual captopril has been recently suggested in hypertensive crisis on the assumption of a faster absorption and thus a more rapid effect on blood pressure than with the oral route . To verify this hypothesis we have compared the hypotensive effect of oral and sublingual captopril in 40 essential hypertensives who were r and omly allocated to either route of administration . Captopril was administered orally dissolved in water or allowed to dissolve under the tongue . After 5 , 10 , 20 , 30 , 40 , 60 and 90 minutes blood pressure , Plasma Renin Activity ( PRA ) and Angiotensin Converting Enzyme ( ACE ) were measured . No significant differences were found between the two groups in the time course of blood pressure decrease , PRA increase and ACE inhibition . The changes of the parameters studied was superimposable irrespective of the route of administration thus not supporting the hypothesis that sublingual captopril might be absorbed more rapidly",
"We have compared the efficacy and safety of slow release nifedipine and atenolol given orally as initial treatment for malignant hypertension . Twenty consecutive black patients with untreated malignant hypertension , whose diastolic pressure remained greater than 120 mm Hg after 3 h bed rest , were r and omized to receive either slow release nifedipine 40 mg at 1 and 12 h , or atenolol 100 mg at 0 h only . Patients remained supine throughout the study . Blood pressure was measured using a semi-automatic recorder ( Omega 1000 ) at 15 min intervals from -3 to 24 h. Baseline blood pressure was similar in the nifedipine ( 233/142 mm Hg ) and atenolol ( 226/141 mm Hg ) groups . The rate of fall of pressure was greater after nifedipine whose maximum hypotensive effect occurred 4 - 5 h after each dose . Blood pressure decreased more slowly and more enduringly after atenolol , although the extent of fall was the same ( delta BP 5 h after first dose nifedipine = 67/41 mm Hg ; delta BP 16 h after atenolol = 64/40 mm Hg ) . There were no precipitous falls in pressure . No patient developed focal neurological signs , nor was heart failure precipitated by either form of treatment . These results support recommendations that most patients with malignant hypertension can be managed without recourse to parenteral therapy",
"Sixty-five patients with unclomplicated hypertenive urgencies were treated in the emergency and cardiology departments with 20 mg nifedipine , 20 mg nicardipine , or 25 mg captopril in a r and omized study . The study population consisted of 65 patients ranging in age from forty-one to seventy-one . Blood pressure and heart rate were assessed for six hours after intake of the antihyper tensive agents . Within sixty minutes nifedipine reduced blood pressure by an average of 74.7 mmHg for the systolic and 35.4 mmHg for the diastolic . Average heart rate increased significantly by 11.6 beats/min at within thirty minutes . Nicardipine and captopril produced equivalent falls in systolic ( -81.6 and -79.4 mmHg ) and diastolic ( -37.3 and -33 mmHg ) blood pressure respectively , but did not increase heart rate significantly . The antihypertensive effect of each drug was maintained until six hours after medication . In conclusion , nifedipine , nicardipine , and captopril show similar efficacy in the treatment of hypertensive urgencies . The authors believe that these drugs can be used as first-line therapy in the treatment of hypertensive urgencies safely and effectively",
"Therapy in hypertensive urgencies is debated and complicated by the side effects of available agents . In a prospect i ve , r and omized , open labeled study , the use of oral labetalol , an alpha- and beta-adrenergic blocker , with oral nifedipine in hypertensive urgencies in the emergency department was compared . Patients with diastolic blood pressures ( DBP ) of more than 120 mm Hg without criteria for a hypertensive emergency were eligible . The drugs were given in a loading manner with doses and timing based on their respective pharmacokinetics until a DBP of 110 mm Hg or lower was obtained or 4 hours had passed . Either an initial labetalol dose of 200 mg and a repeat dose of 100 to 200 mg at 2 hours , depending on the DBP or nifedipine , 10-mg bite and swallow every hour up to a total dose of 20 mg were given . Ten patients were enrolled into each study group . A 100 % response rate was defined as a DBP of 110 mm Hg or less was observed for nifedipine and an 80 % response rate for labetalol ( P > .2 ) was observed . The mean time to control was 67.5 minutes for labetalol and 60.0 minutes for nifedipine ( P > .2 ) . The pretreatment pressure for labetalol was 195/127 mm Hg and for nifedipine was 198/128 mm Hg ( P > .2 ) , which decreased to a posttreatment pressure for labetalol of 154/100 mm Hg and for nifedipine of 163/100 mm Hg ( P > .2 ) . The mean decrease in systolic (SBP)/DBP was 42.6/26.5 mm Hg with labetalol and 34.9/28.4 mm Hg for nifedipine ( P > .2 ) . No significant side effects occurred with either drug . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In 48 patients ( p ) with hypertensive crisis ( HC ) the effect of nifedipine ( N ) sublingual 10 - 20 mg alone ( group I , n = 19 , mean control AH + /- SD 232 + /- 15.3/132.5 + /- 4.9 mmHg ) or associated with furosemide and clonidine ( group II , n = 29 , AT 249 + /- 21/131.8 + /- 13.6 mmHg ) . In both groups the AT fell significantly starting five minutes after the administration of N ( except diastolic AT in group II ) ; the values measured at 45 min . being 177 + /- 32/105.4 + /- 13 mmHg in group I and 164.6 + /- 44.4/100.1 + /- 16.3 mmHg in group II ( the mean proportional difference at 45 min . for systolic AT was 24.6 + /- 11.4 % in group I and 28.7 + /- 12.2 % in group II ; for diastolic AT 20.5 + /- 9.4 % in group I , and 27 + /- 12.2 % for group II ) . The good clinical results consisted of lowering of the AT values below critical levels and clinical improvement in 42 p ( 87.5 % ) . Tolerance to N was good , in a single case was hypotension associated with fainting , both being promptly treated by simple means . CONCLUSIONS . 1 . N administered sublingual , 10 - 20 mg , alone or associated with furosemide has in most patients a rapid hypotensive effect , lowering AT below critical limits within 45 min ; 2 . the drug is readily administered and without the risk of side effects and can be used in the field in the emergency treatment of hypertension"
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BACKGROUND Benign prostatic hyperplasia ( BPH ) , a nonmalignant enlargement of the prostate , can lead to obstructive and irritative lower urinary tract symptoms ( LUTS ) . The pharmacologic use of plants and herbs ( phytotherapy ) for the treatment of LUTS associated with BPH is common . The extract of the berry of the American saw palmetto , or dwarf palm plant , Serenoa repens ( also known by its botanical name of Sabal serrulatum ) , is one of several phytotherapeutic agents available for the treatment of BPH . OBJECTIVES This systematic review aim ed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH . SEARCH STRATEGY Trials were search ed in computerized general and specialized data bases ( MEDLINE , EMBASE , and The Cochrane Library ) , by checking bibliographies , and by h and search ing the relevant literature . SELECTION CRITERIA Trials were eligible if they ( 1 ) r and omized men with symptomatic BPH to receive preparations of Serenoa repens ( alone or in combination ) for at least four weeks in comparison with placebo or other interventions , and ( 2 ) included clinical outcomes such as urologic symptom scales , symptoms , and urodynamic measurements . Eligibility was assessed by at least two independent observers . DATA COLLECTION AND ANALYSIS Information on patients , interventions , and outcomes was extracted by at least two independent review ers using a st and ard form . The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other interventions was the change in urologic symptom-scale scores . Secondary outcomes included changes in nocturia and urodynamic measures . The main outcome measure for side effects or adverse events was the number of men reporting side effects . MAIN RESULTS In this up date 9 new trials involving 2053 additional men ( a 64.8 % increase ) have been included . For the main comparison - Serenoa repens versus placebo - 3 trials were added with 419 subjects and 3 endpoints ( IPSS , peak urine flow , prostate size ) . Overall , 5222 subjects from 30 r and omized trials lasting from 4 to 60 weeks were assessed . Twenty-six trials were double blinded and treatment allocation concealment was adequate in eighteen studies .Serenoa repens was not superior to placebo in improving IPSS urinary symptom scores , ( WMD ( weighted mean difference ) -0.77 points , 95 % CI -2.88 to 1.34 , P > 0.05 ; 2 trials ) , finasteride ( MD ( mean difference ) 0.40 points , 95 % CI -0.57 to 1.37 , P > 0.05 ; 1 trial ) , or tamsulosin ( WMD -0.52 points , 95 % CI -1.91 to 0.88 , P > 0.05 ; 2 trials).For nocturia , Serenoa repens was significantly better than placebo ( WMD -0.78 nocturnal visits , 95 % CI -1.34 to -0.22 , P /= 40 subjects ) , demonstrated no significant difference ( WMD -0.31 nocturnal visits , 95 % CI -0.70 to 0.08 , P > 0.05 ; 5 trials ) ( I(2 ) = 11 % ) . Serenoa repens was not superior to finasteride ( MD -0.05 nocturnal visits , 95 % CI -0.49 to 0.39 , P > 0.05 ; 1 trial ) , or to tamsulosin ( per cent improvement ) ( RR ) ( risk ratio ) 0.91 , 95 % CI 0.66 to 1.27 , P > 0.05 ; 1 trial).Comparing peak urine flow , Serenoa repens was not superior to placebo at trial endpoint ( WMD 1.02 mL/s , 95 % CI -0.14 to 2.19 , P > 0.05 ; 10 trials ) , or by comparing mean change ( WMD 0.31 mL/s , 95 % CI -0.56 to 1.17 , P > 0.05 ; 2 trials).Comparing prostate size at endpoint , there was no significant difference between Serenoa repens and placebo ( MD -1.05 cc , 95 % CI -8.84 to 6.75 , P > 0.05 ; 2 trials ) , or by comparing mean change ( MD -1.22 cc , 95 % CI -3.91 to 1.47 , P > 0.05 ; 1 trial ) . AUTHORS ' CONCLUSIONS Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH
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"Objective To test the hypothesis that in patients with benign prostatic hyperplasia ( BPH ) , the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL , using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy",
"OBJECTIVES To assess the effects of saw palmetto on urinary symptoms , sexual function , and urinary flow rate in men with lower urinary tract symptoms using a double-blind , r and omized , placebo-controlled trial . METHODS The eligible patients were 45 years of age or older and had an International Prostate Symptom Score of 8 or greater . After a 1-month placebo run-in period , 85 men were r and omized to receive saw palmetto or placebo for 6 months . Patients were evaluated using the International Prostate Symptom Score , a sexual function question naire , and by measurement of the urinary flow rate . RESULTS The mean symptom score decreased from 16.7 to 12.3 in the saw palmetto group compared with 15.8 to 13.6 in the placebo group ( P = 0.038 ) . The quality -of-life score improved to a greater degree in the saw palmetto group , but this difference was not statistically significant . No change occurred in the sexual function question naire results in either group . The peak flow rate increased by 1.0 mL/s and 1.4 mL/s in the saw palmetto and placebo groups , respectively ( P = 0.73 ) . CONCLUSIONS Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo . Saw palmetto had no measurable effect on the urinary flow rates . The mechanism by which saw palmetto improves urinary symptoms remains unknown",
"PURPOSE We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia ( BPH ) via a r and omized , placebo controlled trial . MATERIAL S AND METHODS We r and omized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo . End points included routine clinical measures ( symptom score , uroflowmetry and post-void residual urine volume ) , blood chemistry studies ( prostate specific antigen , sex hormones and multiphasic analysis ) , prostate volumetrics by magnetic resonance imaging , and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies . RESULTS Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group ( not statistically significant ) . Neither prostate specific antigen nor prostate volume changed from baseline . Prostate epithelial contraction was noted , especially in the transition zone , where percent epithelium decreased from 17.8 % at baseline to 10.7 % after 6 months of saw palmetto herbal blend ( p percent of atrophic gl and s increased from 25 . 2 % to 40.9 % after treatment with saw palmetto herbal blend ( p apoptosis , cellular proliferation , angiogenesis , growth factors or and rogen receptor expression . We noted no adverse effects of saw palmetto herbal blend . When the study was no longer blinded , 41 men elected to continue therapy in an open label extension . CONCLUSIONS Saw palmetto herbal blend appears to be a safe , highly desirable option for men with moderately symptomatic BPH . The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo ( not statistically significant ) . However , saw palmetto herbal blend therapy was associated with epithelial contraction , especially in the transition zone ( p < 0.01 ) , indicating a possible mechanism of action underlying the clinical significance detected in other studies",
"In a r and omised , double-blind study , the preparation Curbicin , obtained from pumpkin seeds and dwarf palm plants ( Cucurbita pepo L. and Sabal serrulata ) , was compared with a placebo in the treatment of symptoms caused by prostatic hyperplasia ; 53 patients took part in the study , which was carried out over a 3-month period . Urinary flow , micturition time , residual urine , frequency of micturition and a subjective assessment of the effect of treatment were all significantly improved in the treatment group . No untoward side effects were noted",
"OBJECTIVES To present the results of a pooled analysis of three double-blind , placebo-controlled studies of doxazosin in benign prostatic hyperplasia ( BPH ) . Heterogeneous symptom and bother score data collected using different symptom indices were transformed to enable a comparison of the data and to conduct a pooled , in-depth analysis . METHODS Urinary flow rates , and symptom and bother score data were shown by analysis of covariance methods to give consistent estimates of the efficacy of doxazosin across different studies , thus confirming the validity of pooling the results . Prior to analysis , symptom and bother score data were transformed so that all scales started from zero ( least symptoms or bother ) and were expressed as a percentage of the maximum score . RESULTS Doxazosin produced a significantly greater improvement than placebo in peak urinary flow rate ( P = 0.0017 ) , symptom severity ( P bother caused by symptoms ( P doxazosin treatment by those with more severe symptoms at baseline ( P = 0.0001 ) . Stratification by age showed that age did not affect the capacity to benefit from treatment . Analysis of the pooled peak flow-rate data showed that doxazosin produced a consistently greater increase in flow compared with placebo . Doxazosin was well tolerated , with 10 % of patients having withdrawn due to adverse events versus 4 % with placebo ( P Doxazosin is well tolerated and effective in the treatment of BPH . Pooling of data has enabled more extensive and robust conclusions to be drawn than was possible for each one of the individual three studies",
"BACKGROUND Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration . METHODS In this double-blind trial , we r and omly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract ( 160 mg twice a day ) or placebo . The primary outcome measures were changes in the scores on the American Urological Association Symptom Index ( AUASI ) and the maximal urinary flow rate . Secondary outcome measures included changes in prostate size , residual urinary volume after voiding , quality of life , laboratory values , and the rate of reported adverse effects . RESULTS There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores ( mean difference , 0.04 point ; 95 percent confidence interval , -0.93 to 1.01 ) , maximal urinary flow rate ( mean difference , 0.43 ml per minute ; 95 percent confidence interval , -0.52 to 1.38 ) , prostate size , residual volume after voiding , quality of life , or serum prostate-specific antigen levels during the one-year study . The incidence of side effects was similar in the two groups . CONCLUSIONS In this study , saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00037154 . )",
"Because benign prostatic hyperplasia ( BPH ) is relatively common , it is important to discover safe and effective means to treat this often debilitating perturbation . Accordingly , we examined the effectiveness of a combination of natural products ( cernitin , saw palmetto , B-sitosterol , vitamin E ) in treating symptoms of BPH . We undertook a r and omized , placebo-controlled , double-blind study . Patients were enrolled from 3 urological practice s in the USA . 144 subjects were r and omized for study . 17 subjects eventually withdrew , leaving 70 patients in the test group and 57 in the placebo group to complete the study . Inclusion criteria consisted of a diagnosis of BPH , no evidence of cancer , and a maximal urinary flow rate between 5 and 15 ml/second . Patients received either placebo or the combined natural products for 3 months . Evaluations were performed via the American Urological Association ( AUA ) Symptom Index score , urinary flow rate , PSA measurement , and residual bladder volume . Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo ( p Daytime frequency was also lessened significantly ( p individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study , the difference proved highly significant ( p PSA measurements , maximal and average urinary flow rates , and residual volumes showed no statistically significant differences . When taken for 3 months , a combination of natural products ( cernitin , saw palmetto , B-sitosterol , vitamin E ) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score . The combination of natural products caused no significant adverse side effects",
"The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule ( PRO 160/120 ) was investigated in elderly , male patients suffering from lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia in a prospect i ve multicenter trial . A total of 257 patients ( 129 and 128 , respectively ) were r and omized to treatment with PRO 160/120 or placebo ( 127 and 126 were evaluable for efficacy ) . Following a single-blind placebo run-in phase of 2 weeks , the patients received 2 × 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks . Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120 . Outcome measures for treatment efficacy included the assessment of the patients ’ LUTS by means of the I-PSS self-rating question naire and a quality of life index as well as uroflow and sonographic parameters . Using the International Prostate Symptom Score ( I-PSS ) , patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group ( 6 points vs 4 points ; P=0.003 , one tailed ) with a tendency in the same direction after 16 weeks . This applied to obstructive as well as to irritative symptoms , and to patients with moderate or severe symptoms at baseline . Patients r and omized to placebo showed a marked improvement in LUTS ( as measured by the I-PSS ) after being switched to PRO 160/120 during the control period ( P=0.01 , one tailed , in comparison to those who had been treated with PRO 160/120 in the double-blind phase ) . The tolerability of PRO 160/120 was comparable to the placebo . In conclusion , PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS . PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms . The tolerability of the herbal extract was excellent",
"To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH )",
"PURPOSE Permixon is a lipidosterolic extract of Serenoa repens ( SR ) widely used to treat men with benign prostatic hyperplasia ( BPH ) . We tested the effect of this drug on molecular mechanisms associated with apoptosis , such as the Bax-to-Bcl-2 expression ratio and caspase-3 activity , in prostatic tissue from men with symptomatic BPH treated for 3 months before surgery . MATERIAL S AND METHODS An open , multicenter pilot study of 2 parallel groups of patients with BPH was done . They were r and omized to be followed for 3 weeks without any treatment before surgery ( control group ) or to receive 160 mg SR orally twice daily for a 3-month period preceding the same surgery . Surgery was ultimately performed in 17 controls and 12 patients by transurethral prostate resection or retropubic adenomectomy . Bax and Bcl-2 expression , and caspase-3 activity were determined by Western blot in 15 controls and 10 patients , and reported in blinded fashion . RESULTS The Bax-to-Bcl-2 ratio , which is used as an apoptotic index , was significantly increased in the prostatic tissue of treated patients . The level of the intact 116 kDa poly ( adenosine diphosphate-ribose ) polymerase form , an enzyme involved in the cell death apoptotic pathway , was also found to be decreased in prostatic tissue from SR treated patients , suggesting increased caspase 3 activity in the prostate . CONCLUSIONS Permixon increased molecular markers involved in the apoptotic process , ie the Bax-to-Bcl-2 expression ratio and caspase-3 activity . This could have clinical relevance due to the improvement in symptoms produced by treatment with this drug",
"Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH",
"A double-blind placebo-controlled study was performed in 35 benign prostatic hypertrophy ( BPH ) patients never treated before . The patients were r and omized into two groups , the 1st ( 18 cases ) receiving Serenoa repens extract ( 160 mg t.d . ) for 3 months up to the day before the operation of transvesical adenomectomy and the 2nd ( 17 cases ) receiving placebo . Steroid receptors were evaluated in the nuclear ( n ) and cytosolic ( c ) fraction using the saturation analysis technique ( Scatchard analysis or single saturating-dose assay ) for and rogen ( AR ) and estrogen ( ER ) receptors and the enzyme immunoassay ( EIA ) for ER and progesterone receptors ( PgR ) . Scatchard analysis of ERc and ERn revealed the presence of two classes of binding sites , one with high-affinity low-capacity binding and the other with low-affinity high-capacity binding . In the untreated BPH group , ER were higher in the n than in the c fraction : ERn were positive in 14 cases and ERc in 12 of 17 cases . In the BPH group treated with S. repens extract on the contrary , ERn were negative for both binding classes in 17 cases and ERc in 6 of 18 cases . Using EIA , ERn and ERc were detected in all 15 sample s examined , but in the treated group , ERn were significantly ( p less than 0.01 ) lower than in the untreated group , whilst ERc remained almost unchanged . Similar results were obtained measuring PgR : the n fraction of the treated group prostatic sample s was significantly ( p less than 0.01 ) lower than that of the untreated group . ( ABSTRACT TRUNCATED AT 250 WORDS",
"PURPOSE We determined the effect of Prostataplex in men with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 92 Chinese men between 49 and 75 years old with lower urinary tract symptoms were r and omly assigned in this double-blind , placebo controlled trial . The 46 patients in the intervention group were given 2 Prostataplex soft gels daily for 12 weeks , while the 46 in the control group were given 2 placebo soft gels for the same time . RESULTS The treated and control groups appeared to have more than a 95 % compliance rate , as judged by counting the remaining pills in the bottle collected at the end of trial months 1 to 3 . After 12 weeks of intervention the mean + /- SD maximum urinary flow rate was significantly higher in the treatment group than in the control group ( 14.07 + /- 2.56 vs 11.74 + /- 1.23 ml per second , p relative urinary resistance was significantly lower in the treatment group than in the control group ( 2.35 + /- 0.83 vs 3.02 + /- 1.18 , p = 0.002 ) . While there was no significant difference in mean prostate volume or International Prostate Symptom Score between the 2 groups , 18 of 46 patients ( 39.1 % ) in the treatment group showed an International Prostate Symptom Score improvement ( decrease of 3 or greater ) after intervention , whereas only 1 of 46 ( 2.2 % ) in the control group showed an International Prostate Symptom Score improvement ( chi-square test p Prostataplex may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia",
"This prospect i ve , controlled study was undertaken to evaluate the early urodynamic and symptomatic impact of the lipido-sterolic extract of Serenoa repens ( Permixon ® ) in the treatment of patients with benign prostatic hyperplasia ( BPH ) . A total of 75 patients , aged 52–78 y with lower urinary tract symptoms due to mild/moderate BPH ( mean International Prostate Symptom Score ( I-PSS ) 8.2 ) were included in the study , of which 57 received Permixon ® 160 mg twice daily for 9 weeks . Urodynamic evaluation , including maximum urinary flow rate ( Qmax ) and detrusor pressure ( DP ) , was performed at baseline and endpoint . Prostate volume and post-void residual urine volume were assessed by transrectal and transabdominal ultrasound respectively . In addition , the I-PSS and its associated quality of life ( QoL ) score were determined and adverse events were recorded . Baseline parameters were comparable between the active treatment and control groups . After 9 weeks of Permixon ® treatment Qmax increased ( 6.0 % , P in DP at maximum flow ( 12.8 % , P opening DP ( 12.6 % , P and residual urine volume ( 12.6 % , P the I-PSS and QoL score both decreased significantly from baseline in the active treatment group ( 26.8 % and 18.2 % respectively , P improvements in prostate volume ( 2.7 % ) and maximum DP ( 5.2 % ) in the Permixon ® group which did not reach significance . Three patients receiving Permixon ® experienced gastrointestinal disturbances but these did not lead to withdrawal or require additional therapy . In patients with mild/moderate BPH , Permixon ® treatment reduced infravesical obstruction and produced a rapid improvement in urodynamic parameters and symptoms . The drug was well tolerated . These data support the use of Permixon ® as first-line therapy in patients with uncomplicated symptomatic BPH",
"A total of 32 healthy male volunteers ( age range 20 - 30 years ) were enrolled in a 1-week open , r and omized , placebo-controlled study comparing finasteride ( Proscar ) , a 5 alpha-reductase inhibitor , with Permixon , the plant extract of Serenoa repens . The objective of the study was to evaluate the effect of single and multiple doses of the drugs on the inhibition of 5 alpha-reductase as assessed by serum dihydrotestosterone level determination . Following baseline measurements on day 1 , the subjects were r and omized to finasteride 5 mg once a day ( n = 10 ) , Permixon 80 mg x 2 twice a day ( n = 11 ) , or to placebo once a day ( n = 11 ) for 7 days . Serum testosterone and dihydrotestosterone levels , were determined on day 1 ( baseline and 12 h ) and on days 2 ( 24 h ) , 3 ( 48 h ) , 4 ( 72 h ) , 6 ( 120 h ) , and 8 ( 168 h ) . After 12 h , a single dose of finasteride 5 mg reduced the serum dihydrotestosterone level by 65 % ( p serum dihydrotestosterone level . No significant difference was detected between finasteride and Permixon or between finasteride and placebo with respect to serum testosterone , except on days 3 and 6 , respectively ( p serum testosterone levels remained within the normal ranges . These data confirm the efficacy of finasteride as inhibitor of 5 alpha-reductase . ( ABSTRACT TRUNCATED AT 250 WORDS",
"AIM Aim of the study is to evaluate the efficacy of a pretreatment with lipidic-sterolic extract of Serenoa repens ( Permixon ) to reduce bleeding during transurethral resection of prostate ( TURP ) in patients with benign prostatic hyperplasia . METHODS This is a monocentric , r and omised versus control group study . We enrolled 108 patients , r and omised either in the experimental group or in the control one . Patients in the experimental group received a pretreatment with Serenoa repens ( 320 mg/die of Permixon ) for at least 8 weeks before the TURP procedure . In the control group patients did not receive any medical treatment before the intervention . RESULTS Out of 108 enrolled patients , 88 were evaluated per protocol . In the pretreated group the perioperative bleeding was significantly lower than in the control one ( respectively 124 vs 287 ml ) and the need of transfusion decreased remarkably . Moreover , in the pretreated group , the duration of postoperative catheterization ( respectively 3 vs 5 days ) and the evaluated hematological parameters ( red cells 4.5 vs 4 million , hemoglobin 13.4 vs 11.9 g , hematocrit 40 % vs 35 % ) were significantly lower than in the control group . CONCLUSION The pretreatment with Serenoa repens , before TURP procedure , improves the efficacy of the procedure itself and reduces the risk of complications , in particular perioperative bleeding and duration of postoperative catheterization",
"BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P doxazosin ( P risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P finasteride ( P doxazosin . Doxazosin ( P finasteride ( P=0.001 ) , and combination therapy ( P scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy",
"OBJECTIVES Sixty-three patients suffering from benign prostatic hyperplasia ( BPH ) entered a double-blind , comparative , parallel-groups study lasting 3 weeks , carried out to compare the efficacy and safety of alfuzosin 2.5 mg tid ( n = 32 ) vs serenoa repens 160 mg bid ( n = 31 ) in BPH . METHODS Efficacy was assessed both on clinical symptoms ( Boyarsky 's scale , visual analogue scale , clinical global impression ) , urinary flow rates ( uroflowmetry ) and residual urinary volume ( transabdominal ultrasound ) . Events and reported signs were recorded throughout the entire study . RESULTS Statistically significant and clinical ly relevant differences were found between the two treatments in favour of alfuzosin for Boyarsky 's total score ( decrease from 9.6 + /- 3.0 to 5.9 + /- 3.0 , 38.8 % for alfuzosin and from 9.3 + /- 2.5 to 6.8 + /- 2.8 , 26.9 % for serenoa repens ) and obstructive score ( decrease from 4.9 + /- 2.1 to 3.0 + /- 1.9 , 37.8 % for alfuzosin ; from 4.4 + /- 1.7 to 3.4 + /- 1.8 , 23.1 % for Serenoa repens ; p = 0.01 for both ) . Clinical ly relevant differences were found between the two treatments for visual analogue scale and overall clinical impression at the end of the study . Furthermore , the increase in quality of micturition was better with alfuzosin . The proportion of responders ( increase on day 21 in peak flow rate of at least 25 % relative to the baseline values ) was in favour of alfuzosin ( 71.8 % and 48.4 % for alfuzosin and Serenoa repens , respectively ; p = 0.057 ) . Both treatments were well tolerated . No patient treated with alfuzosin complained of any adverse event at any time during the study . One patient in the Serenoa group complained of mild pruritus which cleared spontaneously . Systolic , diastolic blood pressure and heart rate did not show any clinical ly relevant change during treatment with alfuzosin . CONCLUSIONS The findings confirm the efficacy and safety of alfuzosin in symptomatic BPH and indicate the superiority of alfuzosin over Serenoa repens in the treatment of urinary signs and symptoms of BPH",
"BACKGROUND Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia ( BPH ) . METHODS This was a 6-month double-blind r and omized equivalence study that compared the effects of a plant extract ( 320 mg Permixon ) with those of a 5 alpha-reductase inhibitor ( 5 mg finasteride ) in 1,098 men with moderate BPH using the International Prostate Symptom Score ( IPSS ) as the primary end-point . RESULTS Both Permixon and finasteride decreased the IPSS ( -37 % and -39 % , respectively ) , improved quality of life ( by 38 and 41 % ) , and increased peak urinary flow rate ( + 25 % and + 30 % , P = 0.035 ) , with no statistical difference in the percent of responders with a 3 ml/sec improvement . Finasteride markedly decreased prostate volume ( -18 % ) and serum PSA levels ( -41 % ) ; Permixon improved symptoms with little effect on volume ( -6 % ) and no change in PSA levels . Permixon fared better than finasteride in a sexual function question naire and gave rise to less complaints of decreased libido and impotence . CONCLUSIONS Both treatments relieve the symptoms of BPH in about two-thirds of patients but , unlike finasteride , Permixon has little effect on so-called and rogen-dependent parameters . This suggests that other pathways might also be involved in the symptomatology of BPH",
"OBJECTIVE To compare the efficacy of the lipido-sterolic extract of Serenoa repens , Permixon , to that of the alpha-blocker , tamsulosin , in the treatment of severe low urinary tract symptoms ( LUTS ) of benign prostatic hyperplasia ( BPH ) . METHODS In a 12-month , double-blind , r and omized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ( \" PERMAL study \") , 685 BPH patients with IPSS > or = 10 had been analyzed for efficacy . Of these , the 124 patients with severe LUTS ( IPSS > 19 ) at r and omization were retained for this subset analysis . After a 4-week run-in period , 59 and 65 patients had been r and omized to tamsulosin and Permixon groups , respectively . Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores , LUTS-related QoL , prostate volume , Q(max ) and MSF-4 ( sexual activity question naire ) at different time points over 1 year . An analysis of variance of changes from baseline to end point was performed for all the parameters . The over-time evolutions of total , irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements . RESULTS At 12 months , total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin ( p=0.051 ) ; the irritative symptoms improved significantly more ( p=0.049 ) with Permixon ( -2.9 versus -1.9 with tamsulosin ) . The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 ( p=0.03 ) . CONCLUSION Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment",
"INTRODUCTION The role of infiltrating cells ( I.C. ) , commonly observed in the adenoma interstitial tissue , is unknown . We tested the hypothesis that I.C. are related with BPH progression by : phenotypically characterising these cells ; quantifying the expression of lymphokines and growth factors ; investigating the response to Permixon ( P ) in a clinical study . Permixon is a lipido sterolic extract of Serenoa repens possessing pharmacological activities and widely used in the treatment of men with BPH . MATERIAL AND METHODS A multicenter open pilot study of two parallel groups on BPH patients was carried out . They were r and omized to receive either oral Permixon ( P ) 160 mg bid for three months or to be followed for 3 weeks without any treatment before surgery ( control group C ) . Strict inclusion and exclusion criteria were applied to conform homogeneous groups , avoiding interferences of inflammatory drugs or others . Baseline clinical profile was almost identical in both groups in terms of age ( 65.7+/-5.1 vs. 67.1+/-5.8 years ) , IPSS ( 19.8+/-6.1 vs. 19.0+/-5.8 ) , prostate volume ( 64.8+/-18.9 vs. 71.5+/-29.3cc ) , Q(max ) ( 9.6+/-3.2 vs. 10.6+/-2.6 ml/s ) , and Q(L ) ( 4.0+/-1.1 vs. 3.5+/-0.7 ) . Surgery was ultimately performed on 29 patients ( 17C , 12P ) by TURP or retropubic adenomectomy . Adenoma sample s were routinely stained with HE and later prepared for immunohistochemical studies using CD3 , CD20 and CD68 antibodies . Counting of positives cells , lymphoid aggregates and foci were done using EnVision technique and the Tech Mate processor . Cytokines , growth factors and eicosanoids were determined by Elisa kits following the manufactured recommendation . RESULTS HISTOLOGICAL : A difference was observed in the number of lymphocytes B between C ( 91.4+/-44.1 ) and P treated ( 58.2+/-53.7 ) groups ( p=0.097 ) . BIOLOGICAL MARKERS : TNFalpha and IL-1beta were dramatically lower in the Permixon treated group . Other parameters did not show significant changes . CLINICAL : IPSS in the Permixon treated group was significantly reduced ( p humans . Our pilot study shows a significant reduction of some inflammatory parameters in prostatic tissues of patients treated with Permixon . These biological findings justify a pharmacological effect of this drug on the inflammatory status of the adenoma . A correlation with clinical improvement was observed",
"OBJECTIVES To assess the effects of saw palmetto on voiding symptoms and urodynamic parameters in men with lower urinary tract symptoms ( LUTS ) presumed secondary to benign prostatic hyperplasia ( BPH ) . METHODS Fifty men with previously untreated LUTS and a minimum International Prostate Symptom Score ( IPSS ) of 10 or greater were treated with a commercially available form of saw palmetto ( 160 mg twice per day ) for 6 months . The initial evaluation included measurement of peak urinary flow rate , postvoid residual urine volume , pressure-flow study , and serum prostate-specific antigen ( PSA ) level . Patients completed an IPSS , serum PSA was determined , and flow rate was measured every 2 months during the course of the study . A urodynamic evaluation was repeated at the completion of the 6-month trial . RESULTS The mean IPSS ( + /-SD ) improved from 19.5+/-5.5 to 12.5+/-7.0 ( P 46 men who completed the study . Significant improvement in the symptom score was noted after treatment with saw palmetto for 2 months . An improvement in symptom score of 50 % or greater after treatment with saw palmetto for 2 , 4 , and 6 months was noted in 21 % ( 10 of 48 ) , 30 % ( 14 of 47 ) , and 46 % ( 21 of 46 ) of patients , respectively . There was no significant change in peak urinary flow rate , postvoid residual urine volume , or detrusor pressure at peak flow among patients completing the study . No significant change in mean serum PSA level was noted . CONCLUSIONS Saw palmetto is a well-tolerated agent that may significantly improve lower urinary tract symptoms in men with BPH . However , we were unable to demonstrate any significant improvement in objective measures of bladder outlet obstruction . Placebo-controlled trials of saw palmetto are needed to evaluate the true effectiveness of this compound",
"OBJECTIVE The mechanism of action of plant extracts used for the medical treatment of human benign prostatic hyperplasia ( BPH ) is still unknown . In this prospect i ve , r and omized , double-blind trial , we investigated the possible influence of the Sabal serrulata extract IDS 89 ( Strogen ) on epithelial and stromal enzyme activities of BPH tissue . METHODS 18 patients with BPH were r and omly assigned to receive 3 x 2 capsules Strogen uno ( 320 mg/capsule ) ( n = 8) or placebo ( n = 10 ) daily for 3 months . The activity ( Vmax and Km ) of 5 alpha-reductase . 3 alpha-HSORred , 3 beta-HSORred , and creatine kinase was determined in mechanically separated epithelium and stroma of human BPH . RESULTS The multivariate correlation analysis revealed a positive correlation between therapy and the following enzyme alterations : ( 1 ) In epithelium , the substrate affinity of the 5 alpha-reductase decreased slightly ( increase of Km value ) . ( 2 ) In stroma , the Vmax value of the 3 alpha-HSORred increased statistically distinctly , leading to a moderate increase of Vmax/Km . ( 3 ) In stroma , the Vmax value of the 3 beta-HSORred increased moderately , but not statistically significant . ( 4 ) In stroma , the Vmax value of creatine kinase increased significantly , leading to a statistically distinct increase of Vmax/Km . CONCLUSION This double-blind , placebo-controlled clinical trial with the S. serrulata extract IDS 89 revealed significant biochemical changes at the cellular level of BPH tissue . However , the alterations are merely moderate , their biochemical causes and consequences regarding the pathophysiology of BPH rather uncertain . Therefore , more studies are needed before plant extracts like IDS 89 become valid c and i date s likewise synthetic substances already used for medical treatment of human BPH",
"This 3-month double-blind , r and omized , parallel-group study compared the efficacy and tolerability of two regimens of the lipido-sterolic extract of Serenoa repens ( Permixon ) ( two 160-mg capsules once daily [ OD ] and one 160-mg capsule twice daily [ BID ] ) in 100 out patients with symptomatic benign prostatic hyperplasia ( BPH ) . Both regimens significantly ( P International Prostate Symptom Score ( I-PSS ) mean total score from baseline ; improvements achieved statistical significance after the first month and were maintained for the duration of the study . Significant ( P I-PSS quality -of-life ( QoL ) scores , maximum and mean urinary flow rates , and residual urine volume ; this benefit was further increased at month 3 for I-PSS total score and QoL and residual volume , and was maintained for maximum and mean flow rates . A highly significant decrease ( P residual urine was observed in both groups . No significant differences were noted between regimens . Clinical adverse events occurred at a similar incidence in both groups ( BID , 24 % ; OD , 22 % ) and were deemed unrelated or unlikely to be related to Permixon",
"This 6-month double-blind , r and omized , parallel-group study compared two dose regimens of Libeprosta ® , the lipidosterolic extract ofSerenoa repens in 100 male out patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH ) . The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily . Baseline evaluations included maximum and mean urinary flow rates , postvoid residual urine volume , and International Prostate Symptom Score ( I-PSS ) total and quality -of-life scores . Both regimens significantly reduced the I-PSS mean total score from baseline values ( P in quality -of-life scores , maximum and mean urinary flow rates , and residual urine volume ( P decrease in residual urine with both regimens was highly significant ( P clinical adverse events occurred . In this clinical study , the lipidosterolic extract ofSerenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH",
"BACKGROUND Men with benign prostatic hyperplasia can be treated with alpha 1-adrenergic-antagonist drugs that relax prostatic smooth muscle or with drugs that inhibit 5 alpha-reductase and therefore reduce tissue and rogen concentrations . However , the effects of the two types of drugs have not been compared . METHODS We compared the safety and efficacy of placebo , terazosin ( 10 mg daily ) , finasteride ( 5 mg daily ) , and the combination of both drugs in 1229 men with benign prostatic hyperplasia . American Urological Association symptom scores and peak urinary-flow rates were determined at base line and periodically for one year . RESULTS The mean changes from base line in the symptom scores in the placebo , finasteride , terazosin , and combination-therapy groups at one year were decreases of 2.6 , 3.2 , 6.1 , and 6.2 points , respectively ( P placebo ) . The mean changes at one year in the peak urinary-flow rates were increases of 1.4 , 1.6 , 2.7 , and 3.2 ml per second , respectively ( P terazosin and combination therapy with finasteride and with placebo ) . Finasteride had no more effect on either measure than placebo . In the placebo group , 1.6 percent of the men discontinued the study because of adverse effects , as did 4.8 to 7.8 percent of the men in the other three groups . CONCLUSIONS In men with benign prostatic hyperplasia , terazosin was effective therapy , whereas finasteride was not , and the combination of terazosin and finasteride was no more effective than terazosin alone",
"OBJECTIVES To examine the nuclear chromatin characteristics of epithelial cells , looking for an SPHB-mediated effect on nuclear DNA structure and organization . Saw palmetto herbal blend ( SPHB ) causes contraction of prostate epithelial cells and suppression of tissue dihydrotestosterone levels in men with symptomatic benign prostatic hyperplasia , but a fundamental mechanism remains unknown . METHODS A 6-month r and omized trial , comparing prostatic tissue of men treated with SPHB ( n = 20 ) or placebo ( n = 20 ) , was performed . At baseline , the two groups were similar in age ( 65 versus 64 years ) , symptoms ( International Prostate Symptom Score 18 versus 17 ) , uroflow ( maximal urinary flow rate 10 versus 11 mL/s ) , prostate volume ( 59 versus 58 cm(3 ) ) , prostate-specific antigen ( 4.2 versus 2.7 ng/mL ) , and percentage of epithelium ( 17 % versus 16 % ) . Prostatic tissue was obtained by sextant biopsy before and after treatment . Five-micron sections were Feulgen stained and quantitatively analyzed using the AutoCyte QUIC-DNA imaging system . Images were captured from 200 r and omly selected epithelial cell nuclei , and 60 nuclear morphometric descriptors ( NMDs ) ( eg , size , shape , DNA content , and textural features ) were determined for each nucleus . Logistic regression analysis was used to assess the differences in the variances of the NMDs between the treated and untreated prostate epithelial cells . RESULTS At baseline , the SPHB and placebo groups had similar NMD values . After 6 months of placebo , no significant change from baseline was found in the NMDs . However , after 6 months of SPHB , 25 of the 60 NMDs were significantly different compared with baseline , and a multivariate model for predicting treatment effect using 4 of the 25 was created ( P area under the receiver operating characteristic curve of 94 % and an accuracy of 85 % . CONCLUSIONS Six months of SPHB treatment appears to alter the DNA chromatin structure and organization in prostate epithelial cells . Thus , a possible molecular basis for tissue changes and therapeutic effect of the compound is suggested",
"A double-blind trial comparing the effect of Permixon ( 160 mg bd ) against placebo in the treatment of benign prostatic hypertrophy is described . In both groups a significant improvement in flow rate and subjective assessment of symptoms was seen . There was no significant difference between the results of treatment in either group",
"CONTEXT Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia ( BPH ) ; however , recent clinical trials have question ed their efficacy , at least at st and ard doses ( 320 mg/d ) . OBJECTIVE To determine the effect of saw palmetto extract ( Serenoa repens , from saw palmetto berries ) at up to 3 times the st and ard dose on lower urinary tract symptoms attributed to BPH . DESIGN , SETTING , AND PARTICIPANTS A double-blind , multicenter , placebo-controlled r and omized trial at 11 North American clinical sites conducted between June 5 , 2008 , and October 10 , 2010 , of 369 men aged 45 years or older , with a peak urinary flow rate of at least 4 mL/s , an American Urological Association Symptom Index ( AUASI ) score of between 8 and 24 at 2 screening visits , and no exclusions . INTERVENTIONS One , 2 , and then 3 doses ( 320 mg/d ) of saw palmetto extract or placebo , with dose increases at 24 and 48 weeks . MAIN OUTCOME MEASURES Difference in AUASI score between baseline and 72 weeks . Secondary outcomes included measures of urinary bother , nocturia , peak uroflow , postvoid residual volume , prostate-specific antigen level , participants ' global assessment s , and indices of sexual function , continence , sleep quality , and prostatitis symptoms . RESULTS Between baseline and 72 weeks , mean AUASI scores decreased from 14.42 to 12.22 points ( -2.20 points ; 95 % CI , -3.04 to -1.36 ) [corrected]with saw palmetto extract and from 14.69 to 11.70 points ( -2.99 points ; 95 % CI , -3.81 to -2.17 ) with placebo . The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo ( upper bound of the 1-sided 95 % CI most favorable to saw palmetto extract was 1.77 points , 1-sided P = .91 ) . Saw palmetto extract was no more effective than placebo for any secondary outcome . No clearly attributable adverse effects were identified . CONCLUSION Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00603304"
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BACKGROUND Generic preference-based measures of health like the EQ-5D and SF-6D ( ® ) are increasingly being used in economic evaluation and outcome assessment . However , there are concerns as to whether or not these generic measures are appropriate for use in people with mental health problems . OBJECTIVES The EQ-5D and SF-36 ( ® ) ( including its derivatives the SF-12 ( ® ) and SF-6D ) were assessed using the psychometric criteria of validity and responsiveness using quantitative and qualitative methods . Another aim was to estimate mapping functions between the EQ-5D and SF-6D and condition-specific measures , where appropriate . DESIGN Four studies were undertaken to examine the appropriateness of the measures : ( 1 ) a systematic review of quantitative evidence on validity and responsiveness ; ( 2 ) a further quantitative assessment of these criteria using existing data sets ; ( 3 ) a review of qualitative research on the quality of life of people with mental health problems ; and ( 4 ) qualitative semistructured interviews of people with a full range of problems . A fifth study estimated mapping functions between mental health-specific measures and the EQ-5D and SF-6D . SETTING A choice of venue was offered for the interviews including the participant 's own home , a room at the university or a centre frequently used by mental health services . PARTICIPANTS The interviews were undertaken with 19 people with a broad range of mental health problems at varying levels of severity . MAIN OUTCOME MEASURES The review s included the EQ-5D and SF-36 ( and the SF-12 and SF-6D ) . The psychometric analysis included the Hospital Anxiety and Depression Scale ( HADS ) , Clinical Outcomes in Routine Evaluation - Outcome Measure ( CORE-OM ) , Generalised Anxiety Disorder Assessment ( GAD-7 ) , General Health Question naire ( GHQ-12 ) and Patient Health Question naire ( PHQ-9 ) . RESULTS ( 1 ) and ( 2 ) The EQ-5D and SF-36 achieved an adequate level of performance in depression , and to some extent in anxiety and personality disorder . Results from the psychometric analyses in schizophrenia and bipolar disorder have been more mixed . ( 3 ) A framework analysis of 13 studies identified six major themes . ( 4 ) The interview data fitted the themes from the review well and result ed in minor modifications to the themes . The final set of themes comprised : well-being and ill-being ; control , autonomy and choice ; self-perception ; belonging ; activity ; hope and hopelessness ; and physical health . CONCLUSIONS The EQ-5D and SF-36 achieved mixed results in the quantitative testing against psychometric criteria . The qualitative analysis suggests this is because they provide a very limited coverage of themes identified by people with mental health problems . Recommendations for future work include the development of new preference-based measures in mental health that are based on , or substantially revise , an existing measure . FUNDING The Medical Research Council
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"A total of 480 patients were treated in a large , multicenter r and omized trial of a brief form of cognitive therapy , manual-assisted cognitive behavior therapy ( MACT ) versus treatment as usual ( TAU ) for recurrent deliberate self-harm . Each patient was r and omized after a self-harm episode assessed at an accident and emergency center and followed up over 1 year . The main hypothesis tested was that those allocated to MACT would have a lower proportion of self-harm episodes in the succeeding year . A total of 60 % of those allocated to MACT had face-to-face treatment and 430 ( 90 % ) of all patients had self-harm data recorded after 1 year . Although the results showed no significant difference between those repeating self-harm in the MACT group ( 39 % ) compared with the TAU group ( 46 % ) ( P = 0.20 ) , the treatment was cost effective ( 10 % cheaper than TAU ) and the frequency of self-harm episodes was fewer ( 50 % ) in the MACT group . A total of nine of 10 patients had some personality disturbance ( 42 % of these with disorder ) , and for those where information on parasuicide events was collected , the proportion having a repeat episode ranged from 33 % to 63 % for different personality disorders . Those with BPD were most likely to repeat episodes quickly ( mean 89 days for 25 % to repeat ) with dissocial personality disorder ( equivalent mean 384 days ) the slowest to repeat . Total costs were significantly greater in those with personality disorder and were reduced in those allocated to MACT ; this saving was reversed in those with borderline disorder . On average , MACT appeared to increase the cost of those patients with BPD ( BPD ) and reduce the cost of those with other personality disorders . It is concluded that MACT has value in preventing self-harm cost effectively but this appears to be confined mainly to those who do not have BPD",
"BACKGROUND Health-related quality of life ( HRQoL ) data in depression are limited . We studied the impact of antidepressant ( AD ) treatment on HRQoL outcomes in depressed patients and investigated factors associated with these outcomes in routine practice setting s. METHODS The Factors Influencing Depression Endpoints Research ( FINDER ) study was a 6-month , European , prospect i ve , observational study , design ed to estimate HRQoL in 3468 adult patients with a clinical ly diagnosed episode of depression at baseline and at 3 and 6-months after commencing AD treatment . HRQoL was assessed by the Medical Outcome Short-Form ( 36 ) Health Survey ( SF-36 ) and European Quality of Life-5 Dimensions ( EQ-5D ) . Regression analysis identified baseline and treatment variables independently and significantly associated with HRQoL outcomes . RESULTS Most HRQoL improvement occurred within 3 months of starting treatment . Better HRQoL outcomes were strongly associated with fewer somatic symptoms at baseline , AD treatment taken and not switching within AD groups . Education and occupational status were also important . Depression variables ( number of previous depressions and current episode duration ) were consistently associated with worse HRQoL outcomes . Self-rated depression severity was associated with poorer outcomes on the SF-36 mental component only . LIMITATIONS As this was an observational study , the important finding that between and within AD group switching impacted HRQoL will need to be investigated in more controlled setting s. CONCLUSIONS Receiving an AD treatment was associated with large improvements in HRQoL , but switching within AD groups was consistently associated with poorer outcomes . Somatic symptoms , including painful symptoms , are often present in depressed patients and appear to negatively impact HRQoL outcomes ",
"OBJECTIVES Schizophrenia causes significant impairments of quality of life . As treatment approaches have advanced , more attention has been given to re-integrating patients into their psychosocial environments , rather than simply monitoring psychotic symptoms . The development of the second-generation antipsychotics raised hope that these medications would provide better quality of life improvement than conventional antipsychotics . This improvement is particularly relevant early in the course of schizophrenia . METHODS To address these considerations , improvements in measures of general health and social function ( determined using the SF-36 ) were assessed in 195 patients with first-episode schizophrenia for up to one year following r and omization to either olanzapine or haloperidol in a double blind clinical trial . We hypothesized that olanzapine would demonstrate better improvement on these measures than haloperidol . In order to test this hypothesis , we used a repeated measure model with SF-36 scores as the outcome , and treatment group , time , time2 , time-by-treatment group interaction , and time2-by-treatment group interaction as fixed effects . RESULTS Both treatments demonstrated similar changes on the SF-36 . Independent of treatment , patients demonstrated significant improvements in most of the SF-36 subscales , which approached normative scores by the end of one year of treatment . Forty-six of 100 olanzapine-treated patients and 37 of 95 haloperidol-treated patients completed the one year of this study ( p patients with new onset schizophrenic disorders , namely that they can expect to recover significant quality of life and social function at least initially in treatment",
"Various preference-based measures of health are available for use as an outcome measure in cost-utility analysis . The aim of this study is to compare two such measures EQ-5D and SF-6D in mental health patients . Baseline data from a Dutch multi-centre r and omised trial of 616 patients with mood and /or anxiety disorders were used . Mean and median EQ-5D and SF-6D utilities were compared , both in the total sample and between severity subgroups based on quartiles of SCL-90 scores . Utilities were expected to decline with increased severity . Both EQ-5D and SF-6D utilities differed significantly between patients of adjacent severity groups . Mean utilities increased from 0.51 at baseline to 0.68 at 1.5 years follow-up for EQ-5D and from 0.58 to 0.70 for SF-6D . For all severity subgroups , the mean change in EQ-5D utilities as well as in SF-6D utilities was statistically significant . St and ardised response means were higher for SF-6D utilities . We concluded that both EQ-5D and SF-6D discriminated between severity subgroups and captured improvements in health over time . However , the use of EQ-5D result ed in larger health gains and consequent lower cost-utility ratios , especially for the subgroup with the highest severity of mental health problems",
"OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered \" mildly ill \" according to the CGI approximately corresponded to a PANSS total score of 58 , \" moderately ill \" to a PANSS of 75 , \" markedly ill \" to a PANSS of 95 and severely ill to a PANSS of 116 . To be \" minimally improved \" according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating \" much improved \" were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate",
"BACKGROUND Deliberate self-harm can be costly , in terms of treatment and subsequent suicide . Any intervention that reduces episodes of self-harm might therefore have a major impact on the costs incurred by service providers and the productivity losses due to illness or premature death . METHOD Four hundred and eighty patients with a history of recurrent deliberate self-harm were r and omized to manual-assisted cognitive behaviour therapy ( MACT ) or treatment as usual . Economic data were collected from patients at baseline , 6 and 12 months , and these data were complete for 397 patients . Incremental cost-effectiveness was explored using the primary outcome measure , proportion of patients having a repeat episode of deliberate self-harm , and quality of life . The uncertainty surrounding costs and effects was represented using cost-effectiveness acceptability curves . RESULTS Differences in total cost per patient were statistically significant at 6 months in favour of MACT ( pounds sterling -897 , 95 % CI -1747 to -48 , P=0.04 ) , but these differences did not remain significant at 12 months ( pounds sterling -838 , 95 % CI -2142 to 466 , P=0.21 ) . Nevertheless , exploration of the uncertainty surrounding these estimates suggests there is > 90 % probability that MACT is a more cost-effective strategy for reducing the recurrence of deliberate self-harm in this population over 1 year than treatment as usual . The results for quality of life were not conclusive . CONCLUSION Cost-effectiveness acceptability curves demonstrate that , based on the evidence currently available , to reject MACT on traditional grounds of statistical significance and to continue funding current practice has < 10 % chance of being the correct decision in terms of cost-effectiveness",
"The purpose of this study was to evaluate the psychometric properties of selected health-related quality of life ( HRQL ) self-report measures in 62 euthymic and depressed patients diagnosed with bipolar disorder . Patients completed the Quality of Life in Depression Scale ( QLDS ) , Mental Health Index-17 ( MHI-17 ) , Cognitive Function Scale , and Medical Outcomes Study Short Form-36 ( SF-36 ) at baseline and 8 weeks following treatment . Hamilton and Young Rating Scales were used to assess clinical status and vali date the HRQL measures . The MHI-17 , Cognitive Function Scale , QLDS , and SF-36 social function , vitality , role limitations -emotional , and mental health scales have good reliability and validity , and are responsive to changes in clinical status in patients with bipolar disorder . Although the small sample size limits generalizablity , euthymic and depressed out patients with bipolar disorder appear to contribute reliable self reports on selected aspects of their quality of life",
"Background : No previous studies have compared the effectiveness of different modalities of psychotherapeutic treatment , as defined by different setting s and duration s , for patients with cluster C personality disorders . The aim of this multicentre study was to compare the effectiveness of 5 treatment modalities for patients with cluster C personality disorders in terms of psychiatric symptoms , psychosocial functioning , and quality of life . The following treatment modalities were compared : long-term outpatient ( more than 6 months ) , short-term day hospital ( up to 6 months ) , long-term day hospital , short-term inpatient , and long-term inpatient psychotherapy . Methods : The study was conducted between March 2003 and June 2008 in 6 mental health care centres in the Netherl and s , with a sample of 371 patients with a DSM-IV-TR axis-II cluster C diagnosis . Patients were assigned to 5 different modalities of psychotherapeutic treatment , and effectiveness was assessed at 12 months after baseline . An intention-to-treat analysis was conducted for psychiatric symptoms ( Brief Symptom Inventory ) , psychosocial functioning ( Outcome Question naire-45 ) , and quality of life ( EQ-5D ) , using multilevel statistical modelling . As the study was non-r and omised , the propensity score method was used to control for initial differences . Results : Patients in all treatment groups had improved on all outcomes 12 months after baseline . Patients receiving short-term inpatient treatment showed more improvement than patients receiving other treatment modalities . Conclusions : Psychotherapeutic treatment , especially in the short-term inpatient modality , is an effective treatment for patients with cluster C personality disorders",
"For people at risk of depressive relapse , mindfulness-based cognitive therapy ( MBCT ) has an additive benefit to usual care ( H. F. Coelho , P. H. Canter , & E. Ernst , 2007 ) . This study asked if , among patients with recurrent depression who are treated with antidepressant medication ( ADM ) , MBCT is comparable to treatment with maintenance ADM ( m-ADM ) in ( a ) depressive relapse prevention , ( b ) key secondary outcomes , and ( c ) cost effectiveness . The study design was a parallel 2-group r and omized controlled trial comparing those on m-ADM ( N = 62 ) with those receiving MBCT plus support to taper/discontinue antidepressants ( N = 61 ) . Relapse/recurrence rates over 15-month follow-ups in MBCT were 47 % , compared with 60 % in the m-ADM group ( hazard ratio = 0.63 ; 95 % confidence interval : 0.39 to 1.04 ) . MBCT was more effective than m-ADM in reducing residual depressive symptoms and psychiatric comorbidity and in improving quality of life in the physical and psychological domains . There was no difference in average annual cost between the 2 groups . Rates of ADM usage in the MBCT group was significantly reduced , and 46 patients ( 75 % ) completely discontinued their ADM . For patients treated with ADM , MBCT may provide an alternative approach for relapse prevention",
"BACKGROUND We carried out a large r and omized trial of a brief form of cognitive therapy , manual-assisted cognitive behaviour therapy ( MACT ) versus treatment as usual ( TAU ) for deliberate self-harm . METHOD Patients presenting with recurrent deliberate self-harm in five centres were r and omized to either MACT or ( TAU ) and followed up over 1 year . MACT patients received a booklet based on cognitive behaviour therapy ( CBT ) principles and were offered up to five plus two booster sessions of CBT from a therapist in the first 3 months of the study . Ratings of parasuicide risk , anxiety , depression , social functioning and global function , positive and negative thinking , and quality of life were measured at baseline and after 6 and 12 months . RESULTS Four hundred and eighty patients were r and omized . Sixty per cent of the MACT group had both the booklet and CBT sessions . There were seven suicides , five in the TAU group . The main outcome measure , the proportion of those repeating deliberate self-harm in the 12 months of the study , showed no significant difference between those treated with MACT ( 39 % ) and treatment as usual ( 46 % ) ( OR 0.78 , 95 % CI 0.53 to 1.14 , P=0.20 ) . CONCLUSION Brief cognitive behaviour therapy is of limited efficacy in reducing self-harm repetition , but the findings taken in conjunctin with the economic evaluation ( Byford et al. 2003 ) indicate superiority of MACT over TAU in terms of cost and effectiveness combined",
"Systematic Review Series Series Editors : Cynthia Mulrow , MD , MSc Deborah Cook , MD , MSc The last article in this series outlined methods with which to search the literature for studies on the clinical question that generates a systematic review [ 1 ] . Herein , we discuss the subsequent steps of selecting and appraising studies for a review . Both of these steps involve important judgments that can influence the results of a review . In selecting studies , review ers judge the relevance of the studies to the review question . In appraising studies , review ers judge numerous features of design and analysis . Some of these judgments are easy to make ; others are more difficult and prone to error . To be confident in their decisions , review ers should use methods that are reliable ( the results do not change if the procedure is repeated ) , impartial ( not influenced by the study results ) , and explicit ( unambiguous ) [ 2 ] . These strategies for selection and appraisal are sensible , and they distinguish most systematic review s from most narrative review s. However , evidence to support the importance of some of the methods we suggest is either scant or conflicting ; readers are referred to the original research on these approaches for more details . Selecting Studies for Systematic Review s If review ers perform a comprehensive search of the literature using the methods described previously in this series [ 1 ] , they will probably have assembled a large sample of articles . This sample will include most ( ideally , all ) studies that are relevant to the review question ( that is , the sensitivity of the search will be high ) . Inevitably , because such a wide net is cast , articles not pertinent to the clinical question will be retrieved ( that is , the specificity of the search will be modest ) . Thus , the review ers ' next task is to sort through all of the potentially relevant articles and select those that will be included in the review . To do so , review ers adopt several of the tactics listed in Table 1 and Table 2 for planning and executing the selection process ( in effect , improving the specificity of the search ) ; these tactics are described below . Table 1 . Planning Study Selection Table 2 . Strategies for Selecting and Appraising Studies Begin with a Well-Built Clinical Question Review ers should ensure that the question for review includes the four elements of a well-built clinical question [ 3 , 4 ] : the patients of interest , the main interventions under investigation , the comparison interventions , and the clinical outcomes of interest . By including these four elements , review ers can better focus the selection process . Choose Selection Criteria That Fit the Clinical Question Consider a systematic review of the effectiveness of a drug treatment ( for example , a proton-pump inhibitor ) for patients with a particular disorder ( such as esophageal reflux ) . Review ers need to decide whether to include studies of patients with any symptoms of reflux , only those with classic symptoms , or only those in whom definitive diagnostic tests have confirmed the presence of reflux . In addition , review ers might choose to include studies of patients with different comorbid conditions ; patients from different demographic or geographic or cultural background s ; or patients from different health systems , such as inpatient or community population s. Similarly , review ers should use selection criteria that reflect the main and comparison interventions of interest . In our esophageal reflux example , review ers would need to decide whether to include studies of a particular drug or studies of all agents in that drug 's class and whether to include studies of any dose and regimen or only studies with a specific regimen . For the comparison interventions , the review ers would decide whether to include studies that compare the experimental drug with alternate treatments ( such as antacids or histamine-2-receptor antagonists ) , with placebo , or with both . For the clinical outcomes , review ers have analogous tasks of defining the outcomes and translating them into criteria . In our example , the review ers would start by listing each clinical outcome ( for example , whether the outcome was endoscopic or clinical and whether it focused on cure or persistence ) and then decide whether to include studies that reported any outcome or only those with certain clinical ly important outcomes ( such as improvement in symptoms at 1 year ) . After thoroughly considering each element of the review question , review ers compile a set of explicit selection criteria . When these criteria are not explicit , the results of the review are more prone to error [ 5 , 6 ] . Reporting the selection criteria used in a review is extremely important to readers because the criteria indicate the relevance of the review to the readers ' clinical practice . Specify the Types of Study Design To Be Included After creating selection criteria that appropriately reflect the review question , review ers should consider which study design s to include . Ideally , review ers choose study design s that are most likely to produce valid results . For example , to answer questions about therapy or harm , review ers may want to include r and omized trials [ 7 ] because they provide more accurate estimates of benefit or harm than do cohort studies , casecontrol studies , and case series [ 8 ] . In reality , however , r and omized trials may not be conducted to address questions of harm [ 9 ] . Therefore , review ers need to consider which study design s are likely to be available to answer their question ; this information may necessitate modification of originally conceptualized selection criteria to incorporate observational ( nonexperimental ) studies . Specify Criteria Related to Type and Form of Publication Review ers also need to consider issues related to type and form of publication . Ideally , all of the relevant studies would be published as peer- review ed journal articles . However , some completed studies may be published only as abstract s , in non-peer- review ed form , or not at all . Review ers decide whether to include these incompletely reported studies when planning their literature search . By including all articles in various stages of publication and subjecting them to rigorous critical appraisal , review ers minimize the threat of publication bias ( the preferential reporting of studies with positive results ) [ 10 - 12 ] , which could generate misleading review s. Other studies may be reported more than once . To avoid over-representing duplicate studies in the review , investigators should plan to look for and exclude duplicate publications [ 13 ] . Finally , because studies may be published in different language s and because excluding studies published in different language s may bias the results of review s [ 14 , 15 ] , articles should be included , as appropriate , regardless of the language of publication ( translating as necessary ) . Limited time and re sources , however , may preclude such an approach . Construct and Pretest Selection Forms After deciding on selection criteria , review ers can prepare customized forms that contain checklists of the selection criteria ( Figure 1 ) . Using these forms can simplify the selection process , increase reliability , and provide a record of the judgments made about each study . After drafting form prototypes , review ers pretest these forms for clarity , ease of application , and reliability . To pretest the forms , two or more independent review ers typically apply them to a r and om sample of studies identified by the literature search . Review ers compare their results to identify sources of ambiguity and then revise the forms accordingly . If the revisions are substantial , this process may need to be repeated before the forms can be used . Figure 1 . Example of a form that might be developed for the selection of studies for a systematic review evaluating the efficacy of -blockers for secondary prevention of variceal bleeding . Write a Detailed Protocol Having a selection protocol as part of a larger protocol for the entire review helps review ers in two ways . First , it provides a document that explicitly states the review question and the selection criteria , making the process accountable . Review ers can later return to the protocol for guidance in resolving disagreements about article selection . Second , the selection protocol identifies what work will be done , by whom , in what manner , when , and for what reason ; thus , it provides a mode of communication within the review team . When review ers have a very large sample of studies from which to select , they can simplify this task by review ing all of the titles , then the abstract s , and then the full articles , excluding studies that do not meet one or more selection criteria at each step . In doing so , review ers should record ( on the selection forms ) the reasons for exclusion . After review ers have selected studies for the systematic review , they will move to the next task of critical appraisal . This procedure also requires careful planning . Appraising Studies for Systematic Review s Review ers appraise the studies selected for review with three objectives in mind : 1 ) to underst and the validity of the studies , 2 ) to uncover reasons for differences among study results other than chance , and 3 ) to provide readers with sufficient information with which to judge for themselves the applicability of the systematic review to their clinical practice . To achieve these goals , review ers use the strategies outlined in Table 2 and Table 3 to carefully reexamine many important features of the primary studies . Table 3 . Planning Study Appraisal Examine Important Clinical Features Although the selection criteria for a systematic review define the population , interventions , and outcomes of interest , the appraisal process involves a detailed assessment of the patients ( for example , high , medium , or low risk ) , the study interventions ( for example , frequency , degree , and duration ) , and the outcome measurements ( for example , definitions and degree of surveillance ) ",
"Background Factors Influencing Depression Endpoints Research ( FINDER ) is a 6-month , prospect i ve , observational study carried out in 12 European countries aim ed at investigating health-related quality of life ( HRQoL ) in out patients receiving treatment for a first or new depressive episode . The Italian HRQoL data at 6 months is described in this report , and the factors associated with HRQoL changes were determined . Methods Data were collected at baseline , 3 and 6 months of treatment . HRQoL was measured using components of the 36-item Short Form Health Survey ( SF-36 ; mental component summary ( MCS ) , physical component summary ( PCS ) ) and the European Quality of Life-5 Dimensions ( EQ-5D ; visual analogue scale ( VAS ) and health status index ( HSI ) ) . The Hospital Anxiety and Depression Scale ( HADS ) was adopted to evaluate depressive symptoms , while somatic and painful physical symptoms were assessed by using the 28-item Somatic Symptom Inventory ( SSI-28 ) and a VAS . Results Of the initial 513 patients , 472 completed the 3-month observation and 466 the 6-month observation . The SF-36 and EQ-5D mean ( ± SD ) scores showed HRQoL improvements at 3 months and a further smaller improvement at 6 months , with the most positive effects for SF-36 MCS ( baseline 22.0 ± 9.2 , 3 months 34.6 ± 10.0 ; 6 months 39.3 ± 9.5 ) and EQ-5D HSI ( baseline 0.4 ± 0.3 ; 3 months 0.7 ± 0.3 ; 6 months 0.7 ± 0.2 ) . Depression and anxiety symptoms ( HADS-D mean at baseline 13.3 ± 4.2 ; HADS-A mean at baseline 12.2 ± 3.9 ) consistently decreased during the first 3 months ( 8.7 ± 4.3 ; 7.5 ± 3.6 ) and showed a further positive change at 6 months ( 6.9 ± 4.3 ; 5.8 ± 3.4 ) . Somatic and painful symptoms ( SSI and VAS ) significantly decreased , with the most positive changes in the SSI-28 somatic item ( mean at baseline 2.4 ± 0.7 ; mean change at 3 months : -0.5 ; 95 % CI -0.6 to -0.5 ; mean change at 6 months : -0.7 ; 95 % CI -0.8 to -0.7 ) ; in ' interference of overall pain with daily activities ' ( mean at baseline 45.2 ± 30.7 ; mean change at 3 months -17.4 ; 95 % CI -20.0 to -14.8 ; mean change at 6 months -24.4 ; 95 % CI -27.3 to -21.6 ) and in ' having pain while awake ' ( mean at baseline 41.1 ± 29.0 ; mean change at 3 months -13.7 ; 95 % CI -15.9 to -11.5 ; mean change at 6 months -20.2 ; 95 % CI -22.8 to -17.5 ) domains . The results from linear regression analyses showed that the antidepressant switch within classes was consistently associated with a worsening in SF-36 MCS , EQ-5D VAS and HSI compared to non-switching treatment . Furthermore , between-group antidepressants ( AD ) switch was associated with a worse SF-36 MCS and EQ-5D HSI . MCS ( P = 0.028 ) , PCS ( P = 0.036 ) and HSI ( P = 0.002 ) were inversely related to the number of each previous additional depressive episode . PCS ( P = 0.009 ) and HSI ( P = 0.005 ) were also less improved in patients suffering from a chronic medical condition . Moreover , PCS ( P = 0.044 ) and EQ-5D VAS ( P point on the SSI-somatic score and on the overall pain VAS score at baseline , HSI score were on average 0.062 ( P starting AD treatment , HRQoL improvements at 3 and 6 months were observed . However , several factors can negatively influence HRQoL , such as the presence of somatic and painful symptoms , the presence of any chronic medical condition or previous psychiatric illness",
"Background Multi-attribute utility measures are preference-based health-related quality of life measures that have been developed to inform economic evaluations of health care interventions . The objective of this study was to compare the empirical validity of two multi-attribute utility measures ( EQ-5D and SF-6D ) based on hypothetical preferences in a large maternity population in Engl and . Methods Women who participated in a r and omised controlled trial of additional postnatal support provided by trained community support workers represented the study population for this investigation . The women were asked to complete the EQ-5D descriptive system ( which defines health-related quality of life in terms of five dimensions : mobility , self care , usual activities , pain/discomfort and anxiety/depression ) and the SF-36 ( which defines health-related quality of life , using 36 items , across eight dimensions : physical functioning , role limitations ( physical ) , social functioning , bodily pain , general health , mental health , vitality and role limitations ( emotional ) ) at six months postpartum . Their responses were converted into utility scores using the York A1 tariff set and the SF-6D utility algorithm , respectively . One-way analysis of variance was used to test the hypothetically-constructed preference rule that each set of utility scores differs significantly by self-reported health status ( categorised as excellent , very good , good , fair or poor ) . The degree to which EQ-5D and SF-6D utility scores reflected alternative dichotomous configurations of self-reported health status and the Edinburgh Postnatal Depression Scale score was tested using the relative efficiency statistic and receiver operating characteristic ( ROC ) curves . Results The mean utility score for the EQ-5D was 0.861 ( 95 % CI : 0.844 , 0.877 ) , whilst the mean utility score for the SF-6D was 0.809 ( 95 % CI : 0.796 , 0.822 ) , representing a mean difference in utility score of 0.052 ( 95 % CI : 0.040 , 0.064 ; p health status as excellent , very good , good , fair or poor ( p health status , and between 129.8 % and 161.7 % more efficient at detecting differences in the Edinburgh Postnatal Depression Scale score . In addition , the SF-6D generated higher area under the curve ( AUC ) scores generated by the ROC curves than the EQ-5D , indicating greater discriminatory power , although in all but one analysis the differences in AUC scores between the measures were not statistically significant . Conclusion This study provides evidence that the SF-6D is an empirically valid and efficient alternative multi-attribute utility measure to the EQ-5D , and is capable of discriminating between external indicators of maternal health",
"Background Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment . Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined . The MATISSE study aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia . Method / Design The MATISSE study is a three-arm , parallel group , pragmatic , r and omised , controlled trial of referral to group Art Therapy plus st and ard care , referral to an attention control ' activity ' group plus st and ard care , or st and ard care alone . Study participants were recruited from inpatient and community-based mental health and social care services at four centres in Engl and and Northern Irel and . Participants were aged over 18 years with a clinical diagnosis of schizophrenia , confirmed by an examination of case notes using operationalised criteria . Participants were then r and omised via an independent and remote telephone r and omisation service using permuted stacked blocks , stratified by site . Art Therapy and activity groups were made available to participants once a week for up to 12 months . Outcome measures were assessed by research ers masked to allocation status at 12 and 24 months after r and omisation . Participants and care givers were aware which arm of the trial participants were allocated to . The primary outcomes for the study are global functioning ( measured using the Global Assessment of Functioning scale ) and mental health symptoms ( measured using the Positive and Negative Syndrome Scale ) assessed at 24 months . Secondary outcomes were assessed at 12 and 24 months and comprise levels of group attendance , social function , satisfaction with care , mental wellbeing , and costs . Discussion We believe that this is the first large scale pragmatic trial of Art Therapy for people with schizophrenia . Trial registration Current Controlled Trials IS RCT",
"BACKGROUND Improving patients ' health-related quality of life ( HRQOL ) could be a treatment goal for bipolar depression . OBJECTIVES The objectives of these secondary analyses of a previous report were to determine the benefits of olanzapine alone and olanzapine-fluoxetine combination ( OFC ) for improving HRQOL in patients with bipolar depression using both a generic and a depression-specific HRQOL instrument , and to examine the association between the 2 HRQOL instruments and the construct validity of the depression-specific HRQOL instrument . METHODS This was a double-blind , placebo-controlled , 83-site , international , r and omized trial . Adults with bipolar I disorder , most recent episode depressed ( according to the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ) , were r and omly assigned to receive olanzapine ( 6 - 20 mg/d ) , OFC ( 6/25 , 12/25 , or 12/50 mg/d ) , or placebo for 8 weeks . HRQOL improvement was calculated as last-observation-carried-forward changes in dimension and component summary scores on Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and total score on the Quality of Life in Depression Scale ( QLDS ) . RESULTS Patients were assigned to receive olanzapine ( n = 370 ) , [ corrected ] OFC ( n = 86 ) , or placebo ( n = 377 ) [ corrected ] for 8 weeks . Of 833 enrolled patients , 454 discontinued ( olanzapine , 191/370 [ 51.6 % ] [corrected]OFC , 31/86 [ 36.0 % ] ; and placebo , 232/377 [ 61.6 % ] ) [ corrected ] Compared with placebo , olanzapine-treated patients exhibited greater improvements on SF-36 mental component summary ( MCS ) score ( P=0.002 ) and 3 of 8 SF-36 dimension scores ( mental health [ P=0.015 ] , role-emotional [ P=0.046 ] , and social functioning [ P=0.006 ) . OFC-treated patients exhibited greater improvements on MCS score ( P placebo and olanzapine ) , 5 SF-36 dimension scores ( general health perception ( P olanzapinel , mental health [ P=0.001 ] vs both placebo and olanzapine ] , role-emotional [ P social functioning [ P=0.001 ] vs placebo ; [ P=0.032 ] vs olanzapine ] , and vitality [ P=0.002 ] vs placebo ; [ P=0.011 ] vs olanzapine ] ) , and QLDS total score ( P SF-36 scores of mental health , social functioning , role-emotional , and vitality were highly correlated to changes in the QLDS total score ( all p patients with bipolar depression receiving olanzapine or OFC for 8 weeks had greater improvement in HRQOL than those receiving placebo . OFC treatment was associated with greater improvement in HRQOL than olanzapine alone . The correlation results support the construct validity of the QLDS",
"BACKGROUND Individuals with anxiety disorders often do not receive an accurate diagnosis or adequate treatment in primary care . AIMS To analyse the cost-effectiveness of an optimised care model for people with anxiety disorders in primary care . METHOD In a cluster r and omised controlled trial , 46 primary care practice s with 389 individuals positively screened with anxiety were r and omised to intervention ( 23 practice s , 201 participants ) or usual care ( 23 practice s , 188 participants ) . Physicians in the intervention group received training on diagnosis and treatment of anxiety disorders combined with the offer of a psychiatric consultation-liaison service for 6 months . Anxiety , depression , quality of life , service utilisation and costs were assessed at baseline , 6-month and 9-month follow-up . RESULTS No significant differences were observed between intervention and control group on the Beck Anxiety Inventory , Beck Depression Inventory and EQ-5D during follow-up . Total costs were higher in the intervention group ( euro4911 v. euro3453 , P = 0.09 ) . The probability of an incremental cost-effectiveness ratio optimised care model did not prove to be cost-effective",
"Background Most tools for estimating utilities use clinical trial data from general health status models , such as the 36-Item Short-Form Health Survey ( SF-36 ) . A disease-specific model may be more appropriate . The objective of this study was to apply a disease-specific utility mapping function for schizophrenia to data from a large , 1-year , open-label study of long-acting risperidone and to compare its performance with an SF-36-based utility mapping function . Methods Patients with schizophrenia or schizoaffective disorder by DSM-IV criteria received 25 , 50 , or 75 mg long-acting risperidone every 2 weeks for 12 months . The Positive and Negative Syndrome Scale ( PANSS ) and SF-36 were used to assess efficacy and health-related quality of life . Movement disorder severity was measured using the Extrapyramidal Symptom Rating Scale ( ESRS ) ; data concerning other common adverse effects ( orthostatic hypotension , weight gain ) were collected . Transforms were applied to estimate utilities . Results A total of 474 patients completed the study . Long-acting risperidone treatment was associated with a utility gain of 0.051 using the disease-specific function . The estimated gain using an SF-36-based mapping function was smaller : 0.0285 . Estimates of gains were only weakly correlated ( r = 0.2 ) . Because of differences in scaling and variance , the requisite sample size for a r and omized trial to confirm observed effects is much smaller for the disease-specific mapping function ( 156 versus 672 total subjects ) . Conclusion Application of a disease-specific mapping function was feasible . Differences in scaling and precision suggest the clinical ly based mapping function has greater power than the SF-36-based measure to detect differences in utility",
"INTRODUCTION The objectives of this study were to determine the economic , clinical , and quality -of-life outcomes associated with olanzapine treatment in patients diagnosed with mania . METHODS Patients with a diagnosis of bipolar I disorder with manic or mixed episodes were enrolled in a r and omized controlled trial . The study design comprised a 3-week acute phase followed by a 49-week open label extension . In the open label extension , the use of lithium and fluoxetine was permitted for patients who experienced breakthrough symptoms . Clinical , economic , and quality -of-life outcomes of treatment were assessed . RESULTS During the acute phase , olanzapine patients experienced a statistically significant greater mean improvement from baseline on the Y-MRS total score compared to the placebo patients . In the open label extension , patients experienced a statistically significant mean change of 11.8 units on the Y-MRS from the end of the acute phase . When compared to costs incurred in the previous 12 months of therapy , patients experienced savings of almost $ 900 per month during the 49 weeks of olanzapine therapy . These cost savings were largely driven by reductions in in-patient costs during the open label extension . Health-related quality of life improvements measured by the SF-36 were seen on several dimensions both in the 3-week acute phase as well as in the 49-week open label extension . CONCLUSION From a clinical , economic , and quality -of-life outcomes st and point , olanzapine had a significant impact in the treatment of mania , and could be considered a cost-effective treatment option for use in this population if these findings are extrapolated to non- clinical trial population",
"Background . The Clinical Outcomes in Routine Evaluation– Outcome Measure ( CORE-OM ) is used to evaluate the effectiveness of psychological therapies in people with common mental disorders . The objective of this study was to estimate a preference-based index for this population using CORE-6D , a health state classification system derived from the CORE-OM consisting of a 5-item emotional component and a physical item , and to demonstrate a novel method for generating states that are not orthogonal . Methods . Rasch analysis was used to identify 11 emotional health states from CORE-6D that were frequently observed in the study population and are , thus , plausible ( in contrast , conventional statistical design might generate implausible states ) . Combined with the 3 response levels of the physical item of CORE-6D , they generate 33 plausible health states , 18 of which were selected for valuation . A valuation survey of 220 members of the public in South Yorkshire , United Kingdom , was undertaken using the time tradeoff ( TTO ) method . Regression analysis was subsequently used to predict values for all possible states described by CORE-6D . Results . A number of multivariate regression models were built to predict values for the 33 health states of CORE-6D , using the Rasch logit value of the emotional state and the response level of the physical item as independent variables . A cubic model with high predictive value ( adjusted R2 = 0.990 ) was selected to predict TTO values for all 729 CORE-6D health states . Conclusion . The CORE-6D preference-based index will enable the assessment of cost-effectiveness of interventions for people with common mental disorders using existing and prospect i ve CORE-OM data sets . The new method for generating states may be useful for other instruments with highly correlated dimensions",
"BACKGROUND There is equivocal evidence of the effectiveness of adherence therapy in improving treatment adherence and clinical outcomes for people with schizophrenia . AIMS To evaluate the effectiveness of adherence therapy in improving quality of life for people with schizophrenia . METHOD A 52-week , single-blind , multicentre r and omised controlled trial of the effectiveness of adherence therapy . Participants were individually r and omised to receive eight sessions of adherence therapy or health education . Assessment s were undertaken at baseline and at 52-week follow-up . RESULTS Adherence therapy was no more effective than health education in improving quality of life . CONCLUSIONS This effectiveness trial provides evidence for the lack of effect of adherence therapy in people with schizophrenia with recent clinical instability , treated in ordinary clinical setting",
"BACKGROUND The cost-effectiveness of tricyclic antidepressants ( TCAs ) and selective serotonin reuptake inhibitors ( SSRIs ) has not been compared in a prospect i ve study in primary care . AIMS To determine the relative cost-effectiveness of TCAs , SSRIs and lofepramine in UK primary care . METHOD An open-label , three-arm r and omised trial with a preference arm . Practitioners referred 327 patients with incident depression . RESULTS No significant differences were found in effectiveness or cost-effectiveness . The numbers of depression-free weeks over 12 months ( on the Hospital Anxiety and Depression Scale ) were 25.3 ( 95 % CI 21.3 - 29.0 ) for TCAs , 28.3 ( 95 % CI 24.3 - 32.2 ) for SSRIs and 24.6 ( 95 % CI 20.6 - 28.9 ) for lofepramine . Mean health service costs per patient were pound 762 ( 95 % CI 553 - 1059 ) for TCAs , pound 875 ( 95 % CI 675 - 1355 ) for SSRIs and pound 867 ( 95 % CI 634 - 1521 ) for lofepramine . Cost-effectiveness acceptability curves suggested SSRIs were most cost-effective ( with a probability of up to 0.6 ) . CONCLUSIONS The findings support a policy of recommending SSRIs as first-choice antidepressants in primary care",
"OBJECTIVE Repetitive transcranial magnetic stimulation ( rTMS ) has been reported to be as effective as electroconvulsive therapy ( ECT ) for major depression . The authors conducted a multicenter r and omized , controlled trial to test the equivalence of rTMS with ECT . METHOD Forty-six patients with major depression referred for ECT were r and omly assigned to either a 15-day course of rTMS of the left dorsolateral prefrontal cortex ( N=24 ) or a st and ard course of ECT ( N=22 ) . The primary outcome measures were the score on the 17-item Hamilton Depression Rating Scale ( HAM-D ) and the proportion of patients with remissions ( Hamilton score , mood self-ratings on the Beck Depression Inventory-II and visual analogue mood scales , Brief Psychiatric Rating Scale ( BPRS ) score , and both self-reported and observer-rated cognitive changes . The patients were followed up after 6 months . RESULTS HAM-D scores at the end of treatment were significantly lower for ECT , with 13 patients ( 59.1 % ) achieving remission in the ECT group and four ( 16.7 % ) in the rTMS group . However , at 6 months the HAM-D scores did not differ between groups . Beck scale , visual analogue mood scale , and BPRS scores were lower for ECT at the end of treatment and remained lower after 6 months . Self- and observer-rated cognitive measures were similar in the two groups . CONCLUSIONS rTMS was not as effective as ECT , and ECT was substantially more effective for the short-term treatment of depression",
"Objective To evaluate benefits for postnatal women of two psychologically informed interventions by health visitors . Design Prospect i ve cluster trial r and omised by general practice , with 18 month follow-up . Setting 101 general practice s in Trent , Engl and . Participants 2749 women allocated to intervention , 1335 to control . Intervention Health visitors ( n=89 63 clusters ) were trained to identify depressive symptoms at six to eight weeks postnatally using the Edinburgh postnatal depression scale ( EPDS ) and clinical assessment and also trained in providing psychologically informed sessions based on cognitive behavioural or person centred principles for an hour a week for eight weeks . Health visitors in the control group ( n=49 38 clusters ) provided usual care . Main outcome measures Score ≥12 on the Edinburgh postnatal depression scale at six months . Secondary outcomes were mean Edinburgh postnatal depression scale , clinical outcomes in routine evaluation- outcome measure ( CORE-OM ) , state-trait anxiety inventory ( STAI ) , SF-12 , and parenting stress index short form ( PSI-SF ) scores at six , 12 , 18 months . Results 4084 eligible women consented and 595 women had a six week EPDS score ≥12 . Of these , 418 had EPDS scores available at six weeks and six months . At six months , 34 % women ( 93/271 ) in the intervention group and 46 % ( 67/147 ) in the control group had an EPDS score ≥12 . The odds ratio for score ≥12 at six months was 0.62 ( 95 % confidence interval 0.40 to 0.97 , P=0.036 ) for women in the intervention group compared with women in the control group . After adjustment for covariates , the odds ratio was 0.60 ( 0.38 to 0.95 , P=0.028 ) . At six months , 12.4 % ( 234/1880 ) of all women in the intervention group and 16.7 % ( 166/995 ) of all women in the control group had scores ≥12 ( 0.67 , 0.51 to 0.87 , P=0.003 ) . Benefit for women in the intervention group with a six week EPDS score ≥12 and for all women was maintained at 12 months postnatally . There was no differential benefit for either psychological approach over the other . Conclusion Training health visitors to assess women , identify symptoms of postnatal depression , and deliver psychologically informed sessions was clinical ly effective at six and 12 months postnatally compared with usual care . Trial registration IS RCT N92195776",
"BACKGROUND Limited information is available on the outcome of bipolar disorder in developing countries . OBJECTIVE To describe the symptomatic and functional outcome of bipolar disorder . METHODS The psychoses and affective disorder modules of the CIDI were used to screen 68,378 individuals by a door-to-door survey of a defined district in Ethiopia . In addition , key informants were used to identify individuals with probable major mental illnesses . SCAN interviews were completed at the second stage to confirm the diagnosis . A total of 315 cases of bipolar disorder were identified , of which 264 ( 69 recent-onset and 195 prevalent cases ) were prospect ively followed for a mean of 2.5 ( range 1 - 4 ) years by baseline and annual clinical assessment s using symptom rating scales . Functional dimensions of the SF-36 scale were used to describe functional outcome . R and om coefficient analyses were used to evaluate potential correlates of outcome . RESULTS The magnitudes of mania and depression symptoms were elevated at baseline but improved with follow-up , although the improvement was less marked for depression . Sociodemographic or clinical variables were not associated with the improvements in symptomatic outcome . Between 35 % and 47 % of the recent-onset cases had functional role restrictions , while 42 - 52 % of long-st and ing cases had such restrictions during the follow-up years . Similarly , social and physical functioning deficits were also present in 52 - 86 % and 35 - 47 % of recent-onset and long-st and ing cases , respectively . The magnitude of depression and mania symptoms was associated with poor functional outcome , while male sex , rural residence and being married were associated with better functional outcome . CONCLUSION Although there were improvements in function with follow-up , between one-third and one-half of cases continued to have functional deficits",
"INTRODUCTION Borderline Personality Disorder ( BPD ) is a severe psychiatric disorder and is associated with significant impairment in quality of life . The aim of the present study is to assess the internal and external responsiveness of the EuroQoL-5D ( EQ-5D ) in BPD patients . PATIENTS AND METHODS Data from 49 patients included in a multi-center Dutch r and omized trial were used . We used both the EQ-5D utility score and the Visual Analogue Scale of the EuroQoL , and the Borderline Personality Disorder Severity Index-IV ( BPDSI-IV ) . To determine internal responsiveness , we calculated the st and ardized response mean ( SRM ) . To determine external responsiveness , we calculated Spearman correlations for the change scores , and compared EQ-5D scores for clinical ly improved vs. non- clinical ly improved patients as measured with the BPDSI-IV . RESULTS Patient scores improved on all instruments during the three years . SRMs for BPDSI-IV were significantly higher than EQ-5D utility . Three-year Spearman correlation between change scores of BPDSI-IV and EQ-5D utility was 0.487 , between BPDSI-IV and EQ-VAS it was 0.404 , both statistically significant . EQ-5D utility scores for patients who clinical ly improved were significantly higher than for patients who did not . DISCUSSION We conclude that the EQ-5D is fairly responsive in BPD , and , therefore , especially because of its brevity and user-friendliness , can serve as a useful tool in economic evaluations in patients with BPD",
"Background : For patients with cluster B personality disorders there is no consensus regarding the optimal treatment setting . The aim of this study was to compare the effectiveness of different psychotherapeutic setting s for patients with cluster B personality disorders , i.e. outpatient , day hospital , and inpatient treatment . Methods : The study was conducted between March 2003 and June 2008 in 6 mental health care centres in the Netherl and s , with a sample of 207 patients with a DSM-IV-TR axis II cluster B diagnosis . Patients were assigned to 3 different setting s of psychotherapeutic treatment and effectiveness was assessed at 18 months after baseline . An intention-to-treat analysis was conducted for psychiatric symptoms ( Brief Symptom Inventory ) , psychosocial functioning ( Outcome Question naire-45 ) , and quality of life ( EQ-5D ) , using multilevel statistical modelling . As the study was non-r and omised , the propensity score method was used to control for initial differences . Results : Patients in all 3 setting s improved significantly in terms of psychiatric symptoms , social and interpersonal functioning , and quality of life 18 months after baseline . The inpatient group showed the largest improvements . The comparison of outpatient and inpatient treatment regarding psychiatric symptoms showed a marginally significant result ( p = 0.057 ) in favour of inpatient treatment . Conclusions : Patients with cluster B personality disorders improved in all investigated treatment setting s , with a trend towards larger improvements of psychiatric symptoms in the inpatient setting compared to the outpatient setting . Specialised inpatient treatment should be considered as a valuable treatment option for cluster B personality disorders , both in research and in clinical practice",
"Background : While psychopharmacological studies are common in patients with cluster A personality disorders , the effects of psychotherapy have received little attention . The aim of this study is to explore whether psychotherapeutic treatment yields health gains for these patients . Methods : The study was conducted between March 2003 and June 2008 in 6 mental health care centres in the Netherl and s , with a sample of 57 patients with a DSM-IV-TR axis II cluster A diagnosis . Patients were assigned to 3 setting s of psychotherapeutic treatment ( outpatient , day hospital , inpatient ) , and effectiveness was assessed at 18 months after baseline . An intention-to-treat analysis was conducted for psychiatric symptoms ( Brief Symptom Inventory ) , psychosocial functioning ( Outcome Question naire-45 ) and quality of life ( EQ-5D ) , using multilevel statistical modelling . As the study was non-r and omised , the propensity score method was used to control for initial differences . Results : Patients in the day hospital and inpatient group improved substantially in terms of psychiatric symptoms , social and interpersonal functioning , and quality of life . Patients in the outpatient group showed less improvement . Direct comparison of the improvement of psychiatric symptoms showed significant results in favour of day hospital ( p = 0.046 ) and inpatient ( p = 0.01 ) treatment , as compared to outpatient treatment . However , due to substantial baseline differences , this direct comparison should be judged carefully . Conclusions : Cluster A psychopathology is not a contraindication to benefit from psychotherapy . This is especially true for more intensive forms like inpatient and day hospital treatment . Future research should focus more on psychotherapeutic treatment to gain further insight into effective treatment options for this patient group",
"BACKGROUND We investigated the impact of treatment with long-acting , injectable risperidone versus placebo on health-related quality of life ( HRQoL ) in patients with schizophrenia . Results are discussed in the context of HRQoL in the general U.S. population . METHOD Patients with DSM-IV schizophrenia entered a r and omized , double-blind , placebo-controlled trial . After screening , previous antipsychotics were discontinued , and oral risperidone was titrated up to a dose of 4 mg/day over 1 week . Patients were then r and omly assigned to receive placebo [ N = 92 ] or long-acting risperidone ( 25 [ N = 93 ] , 50 [ N = 97 ] , or 75 mg [ N = 87 ] every 2 weeks ) for 12 weeks . HRQoL was measured using the Medical Outcomes Study Short-Form 36-item question naire ( SF-36 ) . RESULTS At week 12 , patients receiving long-acting risperidone had improved significantly ( p domains of the SF-36 ( bodily pain , general health , social functioning , role-emotional , and mental health ) compared with patients receiving placebo . The effect was greatest for the 25-mg group , with significant improvement versus placebo in 6 domains ( p SF-36 domain scores except bodily pain were significantly lower ( p placebo , scores in all 8 domains remained below normal values after 12 weeks , while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels , with clinical ly meaningful improvements in all mental-health domains . In the 25-mg group , scores in 7 domains were not statistically different from normal values after 12 weeks . CONCLUSIONS Long-acting , injectable risperidone improved HRQoL toward normal levels . After 12 weeks , HRQoL of patients receiving 25 mg was not significantly different from normal",
"Background Generic health preference measures that capture quality of life improvements in depression are important for economic analysis of new technologies . Aim To compare two widely used preference measures , the EQ-5D and SF-6D , in terms of their dimensions and health utility values . Method EQ-5D and SF-6D data collected from 114 patients with depression , who participated in a cluster , r and omised controlled trial to evaluate a collaborative care intervention in UK , primary care practice s. Utilities were examined across the whole sample and by level of depression severity using the PHQ-9 . Results Depression was associated with disutility at baseline . At 3 month follow-up mean utility increased 0.147 for EQ-5D and 0.082 for SF-6D . Health gains were observed in patients in remission from depression and those with the mildest level of depression severity . Conclusions Both generic preference measures were sensitive to health gains in depression within a relatively short follow-up period ; larger health gain was observed for the EQ-5D",
"Background : Little information is available on the impact of the atypical antipsychotic olanzapine on quality of life ( QOL ) . A 6-week , double-blind r and omized multicenter trial , with a long-term extension , was conducted to evaluate the clinical efficacy and QOL of olanzapine and haloperidol in treating schizophrenia and other psychotic disorders . Methods : A total of 828 out patients provided QOL data . Study patients were aged greater than 18 years with a DSM-III-R diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder and baseline BPRS ( items scored on 0–6 scale ) total scores , ≥18 were r and omized to 6 weeks of treatment with olanzapine 5 to 20 mg/day or haloperidol 5 to 20 mg/day . Patients entered a 46-week double-blind extension if they demonstrated minimal clinical response and were tolerant to study medication . The Quality of Life Scale ( QLS ) and SF-36 Health Survey were used to evaluate QOL . Results : During the 6-week acute phase , olanzapine treatment significantly improved BPRS total ( p = 0.004 ) , PANSS total scores ( p = 0.043 ) , QLS total ( p = 0.005 ) , intrapsychic foundations ( p ) and interpersonal relations scores ( p = 0.036 ) , and SF-36 mental component summary scores ( p compared with haloperidol . During the extension phase , olanzapine treatment significantly improved PANSS negative scores ( p = 0.035 ) and improved QLS total ( p = 0.001 ) , intrapsychic foundations ( p , and instrumental role category scores ( p = 0.015 ) versus haloperidol treatment . Significantly more haloperidol patients discontinued treatment due to adverse events during the acute and extension phases ( p = 0.041 and p = 0.014 , respectively ) . Changes in QLS total and MCS scores were associated with changes in clinical symptoms , depression scores and extrapyramidal symptoms . Conclusions : Olanzapine was more effective than haloperidol in reducing severity of psychopathology and in improving QOL in patients with schizophrenia and other psychotic disorders . The QOL benefits of olanzapine , although modest , may be important for long-term treatment",
"BACKGROUND The aim of this study was to compare the scorings of anxiety and depression assessed by the Hospital Anxiety and Depression Scale ( HADS-A [ Anxiety ] and HADS-D [ Depression ] ) with the scorings on the eight subscales of Short Form 36 ( SF-36 ) and the Physical ( PCS ) and Mental Component Summary ( MCS ) assessed by the same patients . METHOD In a cross-sectional study 736 long-term survivors after treatment for testicular cancer ( TC ) completed HADS and SF-36 . Pearson 's correlation coefficients were calculated on item and scale level to assess the associations between the HADS and the SF-36 scales and , in particular , between HADS and PCS and MCS , respectively . Independent predictors for PCS and MCS were identified by linear regression analysis . RESULTS HADS-A and HADS-D were significantly associated with the SF-36 summary scales . HADS-A explained 5 % of the variance of PCS and 49 % of the variance of MCS . The comparable figures for HADS-D were 10 % and 45 % , respectively . In the multivariate analysis the HADS-D scoring independently predicted the level of PCS together with the patients ' educational level , long-lasting working disability and age ( variance : 30 % ) . Both HADS-D and HADS-A remained independent parameters for MCS ( variance : 58 % ) together with the patient 's civil status . HADS-D item D4 ( \" slowed down \" ) was similarly associated with both PCS and MCS . CONCLUSION In univariate analyses HADS-D and HADS-A were statistically associated with PCS and MCS . The highest r values were observed for the associations between HADS and MCS , in particular between HADS-A and MCS . In the multivariate analyses HADS-D , but not HADS-A , contributed to PCS , whereas both HADS-A and HADS-D were associated with MCS . This pattern of different predictions of the summary scales of SF-36 supports a clinical practice that anxiety and depression should be assessed separately . Additional use of a self-rating instrument for depression and anxiety , such as HADS , is recommended when SF-36 is used for quality of life ( QL ) assessment",
"Background : The first set of aims of the present study was to determine the prevalence of personality disorders ( PDs ) in a nation , and gender differences in the types and numbers of PDs endorsed . The second set of aims was to establish the relationship of PD to other , non-PD disorders , physical conditions , and disability . Method : Data were obtained from the Australian National Survey of Mental Health and Wellbeing , conducted between May and August 1997 . A stratified r and om sample of households was generated , from which all those aged 18 or over were considered potential interviewees . There were 10,641 respondents to the survey , and this represented a response rate of 78 % . Each interviewee was asked 59 questions indexing specific ICD-10 PD criteria . Results : Of the total survey sample , 704 persons had at least one PD . Using weighted replicate weights , it was estimated that approximately 6.5 % of the adult population of Australia have one or more PDs ( lifetime prevalence ) . Persons with PD were more likely to be younger , male , and not married , and to have an anxiety disorder , an affective disorder , a substance use disorder , or a physical condition . They were also more likely to have greater disability than those without PD . Conclusion : The study is the first nation-wide survey of mental disorders conducted within Australia . It provides an estimate of the prevalence of the various types of PD . The survey has considerable limitations , however , and these are discussed",
"It has often been postulated that simple , short question naires are unable to reflect complex changes in well-being of individuals with chronic psychiatric disorders . To investigate these assumptions we included two recently developed instruments to measure quality of life ( the WHOQoL-Bref and the EuroQoL EQ-5D ) in a r and omised control trial ( RCT ) in which two treatment conditions were compared . Aims of the study were to assess the sensitivity and validity of these quality of life (QoL)-instruments , to establish their relationship and to examine the predictors of changes in QoL. Subjective changes in QoL were measured on three assessment s waves in a period of 18 months and compared to objective changes in psychopathology and social functioning in a sample of 76 chronic schizophrenic patients who participated in the RCT . Results indicated that both WHOQoL-Bref and EuroQoL EQ-5D are capable of detecting changes in QoL over time in physical and psychological well-being . The instruments partly measure the same aspects of QoL , indicated by 50 % common variance on total scores . Reduction of positive psychotic symptoms appeared to be the most important factor in improving QoL. The weighted TTO-score of EuroQoL-5D , which is often used as an index in economic evaluations of health care , did however not correspond with these changes , which indicates that it is less sensitive to changes in social and psychological well-being . It ’s use as the core measure in ( economic ) health evaluation in the field of psychiatry therefore seems less appropriate",
"OBJECTIVE To examine treatment-specific changes in health-related quality of life ( QOL ) among patients with schizophrenia and to assess the association between clinical and QOL improvement . METHOD This post hoc analysis used the findings of a 28-week , r and omized , multicenter trial of patients with schizophrenia ( DSM-IV ) treated with olanzapine ( 10 - 20 mg/day ) or ziprasidone ( 80 - 160 mg/day ) . Data were collected from August 2001 to December 2002 . Efficacy was measured using the Positive and Negative Syndrome Scale ( PANSS ) . Quality of life was assessed with the generic health self-administered Medical Outcomes Study Short-Form 36-Item Health Survey ( SF-36 ) and the disease-specific expert-administered Heinrichs-Carpenter Quality of Life Scale ( QLS ) . Mixed-effects-repeated- measures and last-observation-carried-forward approaches were used to assess the effects of treatment on QOL and the association of clinical outcomes to QOL outcomes . RESULTS Olanzapine- and ziprasidone-treated patients demonstrated similar improvement from baseline to endpoint on the SF-36 and QLS . All correlations between changes in PANSS scores and the SF-36 were significant ( p changes in PANSS scores and the QLS were significant ( p the 2 QOL measures were generally significant but small to moderate in magnitude . CONCLUSIONS The results of this study indicate that , in patients with schizophrenia , olanzapine and ziprasidone treatment are associated with significant QOL and clinical improvements . Further , the significant correlation between change scores on the PANSS and QOL measures suggests that treatment-related clinical improvements are associated with improved health-related and disease-specific QOL . CLINICAL TRIALS REGISTRATION Clinical Study Results .org identifier 2347",
"We developed a self-administered instrument to assess health-related quality of life ( HRQL ) among people with schizophrenia . The S-QoL , based on Calman 's approach to the subject 's point of view , is a multidimensional instrument that is sensitive to change . The scale is a 41-item question naire with eight subscales ( psychological well-being , self-esteem , family relationships , relationships with friends , resilience , physical well-being , autonomy and sentimental life ) and a total score . In-depth interviews with patients determined the pertinent issues for item development . The validation study , performed with 207 patients , showed high internal consistency reliability , reproducibility and responsiveness . Construct validity was confirmed using established clinical and HRQL measures . S-QoL covers domains that differ from areas tapped in other measures , with greater responsiveness . The S-QoL is an efficient instrument for the measurement of the impact of schizophrenia on individuals ' lives",
"CONTEXT Collaborative care interventions for depression in primary care setting s are clinical ly beneficial and cost-effective . Most prior studies were conducted in urban setting s. OBJECTIVE To examine the cost-effectiveness of a rural telemedicine-based collaborative care depression intervention . DESIGN R and omized controlled trial of intervention vs usual care . SETTING Seven small ( serving 1000 to 5000 veterans ) Veterans Health Administration community-based outpatient clinics serving rural catchment areas in 3 mid-South states . Each site had interactive televideo dedicated to mental health but no psychiatrist or psychologist on site . Patients Among 18 306 primary care patients who were screened , 1260 ( 6.9 % ) screened positive for depression ; 395 met eligibility criteria and were enrolled from April 2003 to September 2004 . Of those enrolled , 360 ( 91.1 % ) completed a 6-month follow-up and 335 ( 84.8 % ) completed a 12-month follow-up . Intervention A stepped-care model for depression treatment was used by an off-site depression care team to make treatment recommendations via electronic medical record . The team included a nurse depression care manager , clinical pharmacist , and psychiatrist . The depression care manager communicated with patients via telephone and was supported by computerized decision support software . MAIN OUTCOME MEASURES The base case cost analysis included outpatient , pharmacy , and intervention expenditures . The effectiveness outcomes were depression-free days and quality -adjusted life years ( QALYs ) calculated using the 12-Item Short Form Health Survey st and ard gamble conversion formula . RESULTS The incremental depression-free days outcome was not significant ( P = .10 ) ; therefore , further cost-effectiveness analyses were not done . The incremental QALY outcome was significant ( P = .04 ) and the mean base case incremental cost-effectiveness ratio was $ 85 634/QALY . Results adding inpatient costs were $ 111 999/QALY to $ 132 175/QALY . CONCLUSIONS In rural setting s , a telemedicine-based collaborative care intervention for depression is effective and expensive . The mean base case result was $ 85 634/QALY , which is greater than cost per QALY ratios reported for other , mostly urban , depression collaborative care interventions",
"OBJECTIVE The main objective of the study was to estimate a preference-based Short Form (SF)-6D index from the SF-36 for Japan and compare it with the UK results . STUDY DESIGN AND SETTING The SF-6D was translated into Japanese . Two hundred and forty-nine health states defined by this version of the SF-6D were then valued by a representative sample of 600 members of the Japanese general population using st and ard gamble ( SG ) . These health-state values were modeled using classical parametric r and om-effect methods with individual-level data and ordinary least squares ( OLS ) on mean health-state values , together with a new nonparametric approach using Bayesian methods of estimation . RESULTS All parametric models estimated on Japanese data were found to perform less well than their UK counterparts in terms of poorer goodness of fit , more inconsistencies , larger prediction errors and bias , and evidence of systematic bias in the predictions . Nonparametric models produce a substantial improvement in out-of- sample predictions . The physical , role , and social dimensions have relatively larger decrements than pain and mental health compared with those in the United Kingdom . CONCLUSION The differences between Japanese and UK valuations of the SF-6D make it important to use the Japanese valuation data set estimated using the nonparametric Bayesian technique presented in this article",
"BACKGROUND Electroconvulsive therapy ( ECT ) has a long history of use in treating depression . Repetitive transcranial magnetic stimulation ( rTMS ) has been introduced more recently to the treatment spectrum . Its cost-effectiveness has not been explored . METHOD Forty-six right-h and ed people with severe depressive episodes referred for ECT were r and omised to receive either ECT twice weekly or rTMS on consecutive weekdays . Health and other service use were recorded for retrospective periods of 3 months prior to initiation of treatment and during the 6 months following the end of allocated treatment . Costs were calculated for the treatment period and the subsequent 6 months , and comparisons made between groups after adjustment for any baseline differences . Cost-effectiveness analysis was conducted with incremental change on the 17-item Hamilton Rating Scale for Depression ( HRSD ) as the primary outcome measure , and quality -adjusted life years ( based on SF6D-generated utility scores with societal weights ) as secondary outcome , cost-effectiveness acceptability curves plotted . RESULTS Based on the HRSD scores and other outcome measures , rTMS was not as effective as ECT . The cost of a single session of rTMS was lower than the cost of a session of ECT , but overall there were no treatment cost differences . In the treatment and 6-month follow-up periods combined , health and other service costs were not significantly different between the two groups . Informal care costs were higher for the rTMS group . Total treatment , service and informal care costs were also higher for the rTMS group . The cost-effectiveness acceptability curves indicated a very small probability that decision-makers would view rTMS as more cost-effective than ECT . LIMITATIONS Small sample size , some sample attrition and a relatively short follow-up period of 6 months for a chronic illness . Productivity losses could not be calculated . CONCLUSIONS ECT is more cost-effective than rTMS in the treatment of severe depression",
"BACKGROUND Recent data indicate high prevalence of both anxiety and substance comorbidity in bipolar disorder . However , few studies have utilized public sector sample s , and only one has attempted to separate contributions of each type of comorbidity . METHODS 328 inpatient veterans with bipolar disorder across 11 sites were assessed using selected Structured Clinical Interview for DSM-IV modules and self-reports . RESULTS Comorbidity was common ( current : 57.3 % ; lifetime : 78.4 % ) , with multiple current comorbidities in 29.8 % . Substance comorbidity rate was comparable to rates typically reported in non-veteran inpatient sample s ( 33.8 % current , 72.3 % lifetime ) . Selected anxiety comorbidity rates exceeded those in other inpatient sample s and appeared more chronic than episodic/recurrent ( 38.3 % current , 43.3 % lifetime ) . 49 % of PTSD was due to non-combat stressors . Major correlates of current substance comorbidity alone were younger age , worse marital status , and higher current employability . Correlates of current anxiety comorbidity alone were early age of onset , greater number of prior-year depressive episodes , higher rates of disability pension receipt , and lower self-reported mental and physical function . Combined comorbidity resembled anxiety comorbidity . LIMITATIONS This is a cross-sectional analysis of acutely hospitalized veterans . CONCLUSIONS Distinct patterns of substance and anxiety comorbidity are striking , and may be subserved by distinct neurobiologic mechanisms . The prevalence , chronicity and functional impact of anxiety disorders indicate the need for improved recognition and treatment of this other dual diagnosis group is warranted . Clinical and research interventions should recognize these divergent comorbidity patterns and provide individualized treatment built \" from the patient out .",
"OBJECTIVE To determine the relative cost-effectiveness of three classes of antidepressants : tricyclic antidepressants ( TCAs ) , selective serotonin reuptake inhibitors ( SSRIs ) , and the modified TCA lofepramine , as first choice treatments for depression in primary care . DESIGN Open , pragmatic , controlled trial with three r and omised arms and one preference arm . Patients were followed up for 12 months . SETTING UK primary care : 73 practice s in urban and rural areas in Engl and . PARTICIPANTS Patients with a new episode of depressive illness according to GP diagnosis . INTERVENTIONS Patients were r and omised to receive a TCA ( amitriptyline , dothiepin or imipramine ) , an SSRI ( fluoxetine , sertraline or paroxetine ) or lofepramine . Patients or GPs were able to choose an alternative treatment if preferred . MAIN OUTCOME MEASURES At baseline the Clinical Interview Schedule , Revised ( CIS-R PROQSY computerised version ) was administered to establish symptom profiles . Outcome measures over the 12-month follow-up included the Hospital Anxiety and Depression Scale self-rating of depression ( HAD-D ) , CIS-R , EuroQol ( EQ-5D ) for quality of life , Short Form ( SF-36 ) for generic health status , and patient and practice records of use of health and social services . The primary effectiveness outcome was the number of depression-free weeks ( HAD-D less than 8 , with interpolation of intervening values ) and the primary cost outcome total direct NHS costs . Quality -adjusted life-years ( QALYs ) were used as the outcome measure in a secondary analysis . Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were computed . Estimates were bootstrapped with 5000 replications . RESULTS In total , 327 patients were r and omised . Follow-up rates were 68 % at 3 months and 52 % at 1 year . Linear regression analysis revealed no significant differences between groups in number of depression-free weeks when adjusted for baseline HAD-D. A higher proportion of patients r and omised to TCAs entered the preference arm than those allocated to the other choices . Switching to another class of antidepressant in the first few weeks of treatment occurred significantly more often in the lofepramine arm and less in the preference arm . There were no significant differences between arms in mean cost per depression-free week . For values placed on an additional QALY of over 5000 pounds , treatment with SSRIs was likely to be the most cost-effective strategy . TCAs were the least likely to be cost-effective as first choice of antidepressant for most values of a depression-free week or QALY respectively , but these differences were relatively modest . CONCLUSIONS When comparing the different treatment options , no significant differences were found in outcomes or costs within the sample , but when outcomes and costs were analysed together , the result ing cost-effectiveness acceptability curves suggested that SSRIs were likely to be the most cost-effective option , although the probability of this did not rise above 0.6 . Choosing lofepramine is likely to lead to a greater proportion of patients switching treatment in the first few weeks . Further research is still needed on the management of depressive illness in primary care . This should address areas such as the optimum severity threshold at which medication should be used ; the feasibility and effectiveness of adopting structured depression management programmes in the UK context ; the importance of factors such as physical co-morbidity and recent life events in GPs ' prescribing decisions ; alternative ways of collecting data ; and the factors that give rise to many patients being reluctant to accept medication and discontinue treatment early",
"BACKGROUND Prospect i ve outcome studies based on a community sample of mostly neuroleptic naive cases of schizophrenia are uncommon . OBJECTIVES To describe short-term symptomatic and functional outcomes of schizophrenia , and potential predictors of outcome . METHODS After a baseline assessment , 63 incident and 208 prevalent cases of schizophrenia were followed by a yearly clinical assessment for an average of 2.5 ( range 1 - 4 ) years . Scores of negative symptoms and positive symptoms were used as indicators of symptomatic outcomes . SF-36 scores of physical and social functioning , and role limitation due to mental health problems were used as indicators of functional outcomes . Several variables were evaluated as potential predictors of outcome in r and om coefficient models . RESULTS Functioning and other measures of health related quality of life were significantly diminished in cases as compared to the general population of the area at baseline and follow up . Of the socio-demographic and clinical factors evaluated , only lower negative and positive symptom scores were significantly associated with improvements in functioning . The level of functioning observed in cases from Butajira was lower than that reported for cases from developed countries . CONCLUSIONS Our findings are not in accord with other outcome studies that have reported better functional outcome for cases of schizophrenia from developing countries ",
"OBJECTIVE Time to all-cause treatment discontinuation is considered a composite proxy measure of treatment efficacy , safety , and tolerability . Longer time to discontinuation of antipsychotic medication for any cause has been shown to be associated with greater symptom improvements in the treatment of schizophrenia . This study examines whether longer time to all-cause medication discontinuation is also linked to better functional outcomes . METHOD Using pooled data from 4 r and omized , double-blind antipsychotic trials of 24- to 28-weeks ' duration , this study examined the association between time to all-cause treatment discontinuation and functional outcomes , as assessed by a disease-specific , clinician-rated measure ( Quality of Life Scale [ QLS ] ) and a generic , patient-reported measure ( Medical Outcomes Study Short Form 36 [ SF-36 ] ) . Patients in these trials had a DSM-IV diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder . This post hoc analysis used Pearson partial correlations to assess relationships between time to treatment discontinuation and changes in functional scores , adjusting for baseline scores . Repeated measures analyses were also conducted to compare post-baseline functional outcome change over time between completers and noncompleters . RESULTS Longer time to all-cause treatment discontinuation was found to be significantly associated with greater improvements in all assessed functional domains ( p Patients who completed their respective trials ( 46.8 % , 761/1627 ) experienced significantly greater improvement in functional outcome measures ( in 4 QLS domains and SF-36 mental health component summary score ; all , p greater symptom improvement was significantly associated with greater functional improvements in assessed domains . CONCLUSIONS Findings from this post hoc analysis illustrate the importance of longer treatment duration with antipsychotics for improving functional outcomes in the treatment of patients with schizophrenia",
"OBJECTIVE To examine the relationship between changes in mood symptoms and changes in functioning or disability in people treated for bipolar disorder . METHOD This study was a secondary analysis of data from 441 patients enrolled in a r and omized trial of a care management and psychoeducational intervention for bipolar disorder ( diagnosed according to DSM-IV ) . Study participants were enrolled between August 1999 and October 2000 , and follow-up data were collected until October 2001 . Five in-person assessment s spaced 3 months apart included structured assessment of current mood symptoms ( using the Structured Clinical Interview for DSM-IV ) , the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) functional status question naire , and questions regarding days of disability during the past 3 months . Repeated- measures analyses examined the associations between each outcome measure and severity of mood symptoms . Additional analyses separated variability in mood symptoms into between-person variation ( average symptom severity , or trait effects ) and within-person variation ( change from average symptom severity , or state effects ) . RESULTS Severity of depression symptoms showed a strong and consistent association with all 4 measures of impairment and disability ( SF-36 Role-Emotional score , SF-36 Social Function score , days unable to perform household responsibilities , days disabled from other activities ; p of mania/ hypomania symptoms also showed significant association with all disability measures ( p depression ( p score , p = .004 for SF-36 Social Function score , p = .069 for days unable to perform household activities , p = .049 for days disabled from other activities ) . In analyses focused on within-person variation , change in depression was again strongly related to all measures of impairment and disability ( p impairment or disability ( p = .02 for SF-36 Role-Emotional score ; p > .40 for all other comparisons ) . CONCLUSIONS Among people treated for bipolar disorder , modest changes in severity of depression are associated with statistically and clinical ly significant changes in functional impairment and disability . In contrast , changes in severity of mania or hypomania are not consistently associated with differences in functioning . Conventional measures of functioning , however , may not be sensitive to the effects of mania symptoms",
"OBJECTIVE To determine the impact of acute depression on quality of life ( QOL ) in patients with bipolar I disorder and to compare these results with published data on QOL in patients with unipolar depression . METHODS Quality of life was assessed using the SF-36 in bipolar patients ( n = 958 ) who had recently experienced an episode of acute bipolar depression and participated in a large r and omized , double-blind , safety and efficacy trial . Seven studies that included SF-36 data from patients with unipolar depression were identified in the published literature and descriptive comparisons of SF-36 scores were made between the unipolar depression trials and this bipolar depression trial . RESULTS There were 920 patients who completed the SF-36 . Mean transformed scores , which could range from 0 to 100 , were very low in bipolar depressed patients for the role-physical ( 36.7 ) , vitality ( 22.4 ) , social functioning ( 29.9 ) , role-emotion ( 11.4 ) , and mental health ( 31.0 ) subscales . Mean SF-36 scores for all subscales were significantly and inversely correlated ( p QOL . Further , the mean SF-36 scores for the bipolar sample were consistently lower compared with published data on QOL in unipolar depression on four of the eight subscales : general health ; social functioning ; role-physical , and role-emotional . CONCLUSIONS While both unipolar and bipolar depression have serious detrimental effects on patient QOL , our results suggest that some aspects of QOL may be worse in bipolar depression",
"UNLABELLED Schizophrenia leads to impairments in mental , social , and physical functioning , which should be included in evaluations of treatment . OBJECTIVES This study was design ed to determine the reliability and validity of the Medical Outcomes Study Short Form Health Survey ( SF-36 ) for schizophrenic patients , to characterize perceived functioning and well being and to compare short-term change in SF-36 scores for patients treated with olanzapine or haloperidol . RESEARCH DESIGN Data were obtained from a r and omized , double-blind trial comparing these agents for safety , efficacy , and cost effectiveness . A 6-week acute treatment portion preceded a 46-week \" responder extension \" phase . SUBJECTS A sub sample ( n = 1,155 ) completing a pre-treatment SF-36 provided data for this study . MEASURES Psychometric analyses were conducted , and perceived level of functioning was compared with that for the US adult population . Change from baseline to 6 weeks was examined by treatment group . RESULTS Clear evidence was obtained for the instrument 's reliability and validity for these patients . There were marked deficits in General health , Vitality , Mental health , Social functioning , and in Role limitations result ing from both physical and emotional problems . Olanzapine-treated patients improved in 5 of 8 domains to a significantly greater degree than did haloperidol patients . CONCLUSIONS The SF-36 can be a reliable and valid measure of perceived functioning and well being for schizophrenic patients . The perceptions of functioning can be valuable indices of disease burden and can help to demonstrate the effectiveness of newer antipsychotic medications such as olanzapine",
"Abstract Aim : To assess the relative cost effectiveness of escitalopram compared with venlafaxine XR in patients with major depressive disorder ( MDD ) . Methods : An economic evaluation was conducted alongside a double-blind , multinational , r and omised clinical trial and examined the costs and quality of life of 251 patients taking escitalopram versus venlafaxine . Out patients fulfilling criteria for MDD were r and omised to receive oral escitalopram 10–20 mg/day or venlafaxine 75–150 mg/day for 8 weeks . Patient-reported outcomes ( EuroQOL question naire , Quality of Life Depression Scale ) , use of medical services and absence from work ( relating to the previous 3 months ) were recorded at baseline , with repeated measurements at week 8 . Unit costs in year values were applied to the re source utilisation data . A cost-effectiveness analysis was performed using the EuroQOL score as the effectiveness measure . The perspective was that of the healthcare payer , with a societal perspective considered in a sensitivity analysis . Results : Statistically significant improvements in patient-reported outcomes ( vs baseline ) were observed in both groups after 8 weeks ’ treatment . Patients treated with escitalopram tended to report fewer problems on the EuroQOL dimensions than venlafaxine recipients . Mean per-patient costs in euros ( € , year 2003 values ) for the escitalopram group , compared with the venlafaxine group , were 32 % lower ( € 110 vs € 161 ) from a healthcare perspective , although this was not a statistically significant difference . Differences were related to lower drug acquisition costs and fewer hospitalisations for escitalopram than venlafaxine recipients . A multivariate model adjusting for baseline characteristics showed that escitalopram reduced direct costs compared with venlafaxine ( p = 0.007 ) . Bootstrapped distributions of the incremental cost-effectiveness ratios also showed similar effectiveness but lower costs for escitalopram compared with venlafaxine . Inclusion of indirect costs led to similar results . Conclusion : This prospect i ve economic analysis suggests that escitalopram has similar effectiveness to venlafaxine in the treatment of MDD , but may be associated with lower healthcare costs . These findings are consistent with previously published economic evaluations",
"Background . The Health Utilities Index Mark 3 ( HUI3 ) is a generic multiattribute preference‐based measure of health status and health‐related quality of life that is widely used as an outcome measure in clinical studies , in population health surveys , in the estimation of quality ‐adjusted life years , and in economic evaluations . HUI3 consists of eight attributes ( or dimensions ) of health status : vision , hearing , speech , ambulation , dexterity , emotion , cognition , and pain with 5 or 6 levels per attribute , varying from highly impaired to normal . Objectives . The objectives are to present a multiattribute utility function and eight single‐attribute utility functions for the HUI3 system based on community preferences . Study Design . Two preference surveys were conducted . One , the modeling survey , collected preference scores for the estimation of the utility functions . The other , the direct survey , provided independent scores to assess the predictive validity of the utility functions . Measures . Preference measures included value scores obtained on the Feeling Thermometer and st and ard gamble utility scores obtained using the Chance Board . Respondents . A r and om sample of the general population ( ≥16 years of age ) in Hamilton , Ontario , Canada . Results . Estimates were obtained for eight single‐attribute utility functions and an overall multiattribute utility function . The intraclass correlation coefficient between directly measured utility scores and scores generated by the multiattribute function for 73 health states was 0.88 . Conclusions . The HUI3 scoring function has strong theoretical and empirical foundations . It performs well in predicting directly measured scores . The HUI3 system provides a practical way to obtain utility scores based on community preferences",
"We aim ed to compare clinical outcomes , health-related quality of life ( HRQOL ) and work status associated with olanzapine and haloperidol treatment in patients with bipolar disorder . This double-blind , r and omized controlled trial , comparing flexible dosing of olanzapine ( 5–20 mg/day , n = 234 ) to haloperidol ( 3–15 mg/day , n = 219 ) , consisted of a 6-week acute phase , followed by a 6-week continuation phase . Symptomatic remission rates were similar for olanzapine- and haloperidol-treated patients at weeks 6 and 12 . At week 6 , significant changes in five dimensions of the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) [ general health ( P = 0.010 ) , physical functioning ( P 0.001 ) , role limitations due to physical problems ( P , social functioning ( P and vitality ( P ] and the SF-36 physical components summary score were found in favour of olanzapine compared to haloperidol . At week 12 , olanzapine treatment maintained the significantly favourable HRQOL changes . At the end of week 12 , patients on olanzapine showed significantly greater improvement than haloperidol in work activities impairment and household activities impairment scores on the Streamlined Longitudinal Interview Clinical Evaluation from the Longitudinal Interval Follow-up Evaluation ( SLICE/LIFE ) activities impairment scores . Subgroup analyses revealed that olanzapine treatment significantly increased a proportion of employed patients and their weekly paid working hours . In conclusion , compared to haloperidol , olanzapine treatment was comparably effective in the remission of bipolar mania and significantly improved HRQOL and work status in patients with bipolar I disorder"
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BACKGROUND / AIMS Fragment reattachment is a procedure that offers advantages , such as preservation of tooth structure and maintenance of color , shape , and translucency of the original tooth . The aim of this study was to analyze the reattachment techniques used to restore anterior teeth fractured by trauma . MATERIAL S AND METHODS The PubMed , LILACS , Web of Science , Cochrane , and Scopus data bases were search ed in October 2016 , and the search was up date d in February 2017 . A search of the gray literature was performed in Google Scholar and OpenGrey . Reference lists of eligible studies were evaluated to identify additional studies . Two authors assessed studies for inclusion and extracted the data . In vitro studies that evaluated permanent human teeth fractured by trauma were included . RESULTS Twenty-one studies remained after screening . The bond strength between the fragment and the crown was evaluated in 119 experimental groups . Ten different techniques were evaluated as follows : no preparation , chamfer , bevel , anchors , overcontour , internal groove , no preparation associated with chamfer after reattachment , fragment dentin removal associated with chamfer after reattachment , bevel associated with overcontour , and groove associated with shoulder . Five different material s were used to reattach the fragment : bonding system , luting composite resin , flowable composite , microhybrid composite , and nanocomposite . CONCLUSION Fragment reattachment using a technique with no preparation and an adhesive system associated with an intermediate composite with good mechanical properties can restore part of the resistance of the fractured tooth
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"Statement of Problem : Reattachment of the fractured tooth fragment should be considered as a conservative treatment and valid alternative to a composite restoration . Purpose : This in vitro study was to evaluate the influence of different adhesives and composite resins on fracture resistance of dental fragment reattached to the sectioned incisal edges . Material s and Method : 120 sound human maxillary central incisors were selected under st and ard conditions and r and omly divided into 3 groups , 12 sound teeth were used as a control group and the remaining teeth were assigned to 3 groups ( n=36 ) and each group into three subgroups ( n=12 ) . The incisal third of the sample s was sectioned using a diamond disk and the respective fragments were then reattached utilizing different intermediate restorative material s , namely : i ) adhesive material s alone ( OptiBond S or OptiBond XTR or OptiBond All-in-One ; ii ) Premise flowable composite and iii ) Point 4 composite in the one of the mentioned adhesive interface . After storage for two weeks at 37 ° C and 100 % humidity and then thermocycling ; shear bond strength ( SBS ) was recorded in kilogram force ( kgf ) by applying a load in the middle incisal third with a Zwick Universal Testing Machine at a cross-head speed of 1 mm/min . Data was analyzed with one-way ANOVA and Tukey HSD ( p higher SBS than other groups ( p= 0.001 ) ; the highest SBS values were obtained using the Premise flowable composite and OptiBond S adhesive ( 112.44±30.46 MPa ) ; and the lowest with OptiBond All-in-One alone ( 33.97± 15.63 MPa ) . Conclusion : Although , none of the tested material s provided fracture resistance similar to that found with the intact maxillary central incisors ; utilizing the Premise flowable composite and OptiBond S adhesive improved the SBS of the reattached fragment than other material",
"Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers",
"OBJECTIVES Fractured coronal fragments of incisors can be adhered to the remaining tooth with resin composite , but are prone to failure . This study explores whether mini fibre-reinforced composite ( FRC ) anchors increase fracture resistance of reattached fragments . METHODS Forty-five extracted incisors were r and omly divided into three groups . In Groups A and B coronal fragments were reattached to the remaining tooth , with additionally two anchors placed in Group B. In Group C resin composite buildups were made . Specimens were statically loaded until failure occurred . Failure modes were characterized as intact remaining tooth substrate ( adhesive or cohesive failure of coronal fragment ) or fractured remaining tooth substrate ( fracture limited to enamel or extending into dentin ) . RESULTS Mean fracture loads were 255N ( SD=108N ) for Group A , 599N ( SD=465N ) for Group B and 786N ( SD=197N ) for Group C ( values significantly different , all p values adhesive failures , while Groups B and C showed 73 and 53 % fractures of remaining tooth substrate ( p Mini FRC anchors increase fracture resistance of reattached coronal fragments , but induce more remaining tooth substrate fractures",
"OBJECTIVES When coronal fracture occurs in anterior teeth , fragment reattachment can be a valid alternative to a direct restoration . The aim of this study was to evaluate the influence of the material and the technique used to reattach the fragment . MATERIAL S AND METHODS Eighty sound maxillary and m and ibular incisors were selected and r and omly divided into eight groups ( n = 10 ) . The incisal third of each tooth was removed using a saw machine . The fragments in groups 1 - 4 were reattached using resin-based material s : group 1 adhesive , group 2 flow , group 3 composite , group 4 cement ; in groups 5 - 8 , the same material s mentioned before were used but a bevel was also performed on both labial and lingual surfaces . Shear bond strength ( SBS ) was calculated by applying a load incisal to the reattachment line . A two-way Anova was used to evaluate the influence of material s and techniques on the SBS . RESULTS The technique used was statistically significant ( P SBS , whereas a bevel performed on the labial and lingual surfaces can significantly improve the SBS of the reattached fragment",
"Fracture of anterior teeth by trauma is a common problem in children and teenagers . Complex metal-ceramic crowns with considerable loss of remaining sound structure are no longer necessary due to adhesive techniques , such as composite restorations and re-attachment techniques . This study compared the fracture strength of sound and restored anterior teeth using a resin composite and four re-attachment techniques . A \" one bottle \" adhesive system ( One-Step , BISCO ) and a dual cure resin cement ( Duo-Link , BISCO ) were applied . Thirty-five sound permanent lower central incisors were fractured by an axial load applied to the buccal area and r and omly divided into five groups . The teeth were restored as follows : 1 ) bonded only = just bonding the fragment ; 2 ) chamfer-group = after bonding , a chamfer was prepared on the enamel at the bonding line and filled with composite ; 3 ) overcontour group = after bonding , a thin composite overcontour was applied on the buccal surface around the fracture line ; 4 ) internal dentinal groove = before bonding , an internal groove was made and filled with a resin composite ; 5 ) resin composite group = after a bevel preparation on the enamel edge , the adhesive system was applied and the fractured part of the teeth rebuilt by resin composite . Restored teeth were subjected to the same loading in the same buccal area . Fracture strength after restorative procedure was expressed as a percentage of the original fracture strength and the results analyzed by Kruskal-Wallis statistical analysis . The mean percentages of fracture strength were : Group 1 : 37.09 % , Group 2 : 60.62 % , Group 3 : 97.2 % , Group 4 : 90.54 % and Group 5 : 95.8 % . It was concluded that the re-attachment techniques used in Groups 3 and 4 , as well as the composite restored group ( Group 5 ) , were statistically similar and reached the highest fracture resistance , similar to the fracture resistance of sound teeth",
"This study investigated the shear bond strengths of sectioned human m and ibular incisor edge fragments reattached using luting cements , bonding agents or restored with composite resins . Seventy teeth were r and omly distributed among six experimental groups and a control group . Leaving half of the anatomic crowns exposed , the teeth were embedded in self-cure acrylic resins with the exposed part then sectioned . The fragments in groups 1 - 4 were bonded to their respective teeth using Clearfil Liner Bond 2V , Scotch Bond Multi Purpose Plus , Panavia-F and 3 M Opal Luting cement . The 5th and 6th groups were restored with composite resins ( Silux 3 M and Clearfil AP-X ) using their bonding agents ( Single Bond and Clearfil SE Bond ) . The results indicated that reattachment of fractured incisal fragments by using new generation bonding agents was effective against shear stresses , comparable with the intact teeth . Instead of restoration with composite resins therefore reattachment of a fractured fragment might be more preferable in cases of dental trauma",
"AIM To evaluate and compare the fracture resistance of reattached teeth using four different material s. MATERIAL S AND METHODS 150 extracted human permanent maxillary incisors were r and omly divided into five groups of 30 teeth each of one control and four experimental groups . Teeth in experimental groups were sectioned 2.5 mm from incisal edge and reattached using four different material s. The reattached teeth were subjected to evaluate fracture resistance . RESULTS The mean fracture resistance of reattached teeth using resin modified glass ionomer cement , compomer , composite resin and dual curing resin cement was 8.10 ± 2.34 , 11.15 ± 3.36 , 17.11 ± 3.99 and 14.13 ± 3.71 kg respectively . Results showed highly significant difference between the groups ( P CONCLUSION Fracture resistance of reattached teeth in the different groups varied from 24 - 51 % of that for an intact tooth . Reattachment with composite resin provides highest fracture resistance ( P with resin-modified glass ionomer cement was the weakest ( P < 0.05 )",
"This study evaluated the effect of fractured or sectioned fragments on the fracture strength recovery of four techniques used for reattachment and resin composite buildups . Ninety-one sound , permanent lower central incisors were used . Half the teeth were fractured in the incisal-proximal edge ; the other half had the incisal-proximal edge sectioned by a diamond saw . Teeth from each half were r and omly divided into five techniques : 1 ) bonded only ; 2 ) chamfer ; 3 ) over-contour ; 4 ) internal dentinal groove and 5 ) resin composite buildup . An adhesive system and dual cure resin cement were employed for the reattachment . Restored teeth were subjected to load in a specific point on the buccal surface . Based on the fracture strength of sound teeth , a fracture strength recovery was calculated for each tooth . A one-way ANOVA and Tukey 's test ( alpha=0.05 ) were used to evaluate differences between the techniques for each method of obtaining fragments . The fracture strength recovery of similar techniques was evaluated by a Student t-test ( alpha=0.05 ) . No differences could be detected among reattachment techniques when fragments were obtained by sectioning . In groups where the fragments were fractured , Techniques 3 and 4 showed the highest fracture strength recovery . The resin composite buildup provided fracture strength recovery similar to intact teeth regardless the way fragments were obtained",
"The purpose of this study was to evaluate and compare the bond strengths of experimentally fractured human tooth fragments reattached with different adhesive material s and retentive techniques in vitro . Uncomplicated crown fractures were obtained on intact human m and ibular permanent incisors by applying perpendicular load to the buccal aspect of tooth crowns . Fractured teeth were r and omly assigned into one of three reattachment protocol s : ( i ) Simple reattachment , ( ii ) Overcontour preparation , and ( iii ) Internal dentin groove . The first and second groups were divided into 10 subgroups , and the third group into five subgroups ( n = 10 per group ) with respect to five different adhesive systems ( Prime&Bond NT , Adper Single Bond II , Adper Prompt L-Pop , Clearfil S(3 ) Bond , G Bond ) used with or without a hybrid resin composite ( Z250 ) . Restored teeth were subjected to thermal cycling , and subsequently to the same loading protocol used for fracturing intact teeth . Fracture strength after reattachment procedures was recorded as a percentage of the original fracture strength . Both type of adhesive material and placement of an intermediate layer of resin composite affected the fracture resistance ( P fracture strength recovery was obtained using the internal dentin groove technique ( 54 + /- 0.58 % , P microcracks along the adhesive interface , which might contribute to postadhesive failure",
"BACKGROUND / AIMS The tooth fragment bonding technique , frequently used to restore traumatized teeth , may be affected by dehydration/rehydration periods . The aim of this study was to evaluate the effects of different dry and wet storage intervals on multimode adhesive bonding between reattached fragments and teeth . MATERIAL S AND METHODS Eighty-four bovine incisors were fractured and r and omized into groups ( n=12 ) . After teeth fracturing , each specimen was assigned to one of the following groups : G0 : control group ( sound tooth ) ; GA1 and GA2 : 1-h dehydration and a 15-min or 24-hours rewetting period , respectively ; GB1 and GB2 : 24-hours dehydration and a 15-minutes or 24-hours rewetting period , respectively ; and GC : 1-hour ( GC1 ) or 24-hours ( GC2 ) dehydration period only . Tooth fragments were then reattached using a multimode adhesive in a self-mode technique with a flowable resin composite . The fracture resistance was evaluated in a universal testing machine under a compressive load ( 1 mm/min-1 ) . Data were su bmi tted to two-way analysis of variance and post hoc Tukey test ( 5 % ) . RESULTS No significant interaction between dehydration and rehydration intervals was observed ( P>.05 ) . Only the step of rehydration significantly affected the reattachment strength when compared to the groups su bmi tted only to dehydration , regardless of the interval ( 15 minutes or 24 hours ) . CONCLUSION Rehydrating a tooth fragment for 15 minutes before bonding with a multimode adhesive maintained sufficient moisture to increase reattachment strength"
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BACKGROUND It is commonly assumed that patients with chronic low back pain are less active than healthy individuals . There has been a recent increase in the number of studies published comparing the physical activity levels of patients with chronic low back pain and healthy individuals . OBJECTIVES The aim of this systematic review was to determine , based on the current body of evidence , if patients with chronic low back pain have a lower level and /or altered pattern of physical activity compared with asymptomatic , healthy individuals . DATA SOURCES The electronic data bases Embase , Medline , ISI Web of Knowledge , Cinahl , Sport Discus and Nursing and Allied Health were search ed from the beginning of each data base until the end of December 2009 . REVIEW METHODS Studies which compared the level and /or pattern of physical activity of patients with chronic low back pain and healthy controls were included . The quality of the included studies was assessed using an assessment tool based on the Newcastle-Ottawa Scale . The scale was modified for the purpose s of this study . RESULTS Seven studies were included in the final review . Four studies recruited adult patients ( 18 - 65 years ) , two studies examined older adults ( ≥65 years ) and one study recruited adolescents ( Pooled data revealed no significant difference in the overall activity level of adults or adolescents with CLBP , however there is evidence that older adults with chronic low back pain are less active than controls . The results suggest that patients exhibit an altered pattern of physical activity over the course of a day compared to controls . Major method ological limitations were identified and are discussed . CONCLUSION There is no conclusive evidence that patients with chronic low back pain are less active than healthy individuals . Based on a limited number of studies , there is some evidence that the distribution of activities over the course of a day is different between patients with chronic low back pain and controls
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"INTRODUCTION During the last 20 years a great number of studies have emphasized the potential role of psychological factors as relevant predictors for the first onset of back pain as well as for the development of chronic pain . The formulation of a biopsychosocial perspective of the etiology and chronicity of back pain was a natural consequence . Actual questions concern the relative impact of psychological risk factors in the process of chronicity of back pain compared to biomedical , social and occupational factors . METHODS Whereas several review articles regarding the role of psychological risk factors are available up to now , a recently published review conducted by Steven Linton was the first systematic analysis of well controlled prospect i ve studies published since 1967 . Using a grading system similar to that recommended for guidelines the author defined a level A evidence when at least two good- quality prospect i ve studies supported the prospect i ve power of a variable . Level B evidence had support from one prospect i ve study . Level C represented inconclusive data and level D indicated that no studies met the criteria . Based on a literature search of more than 900 studies , 37 good- quality prospect i ve studies were analysed in detail . RESULTS The results indicated level A evidence for the following interrelations : ( 1 ) Psychosocial variables , especially chronic distress in daily life , depression and work dissatisfaction were clearly associated with the onset of back and neck pain ( 2 ) . Psychological variables , especially chronic stress in daily life , work dissatisfaction , depression and pain-related cognitions and coping behaviour were clearly linked to the transition from acute to chronic pain and disability ( 3 ) . Psychological variables generally had more prospect i ve power than biomedical , social or objective occupational variables . Among the pain-related cognitions , catastrophizing and fear-avoidance-beliefs yielded the most empirical support . Among coping behaviour passive coping stretegies such as avoiding behaviour was most important . At least level B evidence has been shown for the counterpart of an extreme suppressive coping behaviour . Patients who tended to suppress or ignore pain in order to finish all activities they started , who were unable to integrate phases of passive relaxation into the daily routine displayed a high risk of chronicity of pain 6 months after an acute phase of pain . One international and two German good- quality prospect i ve studies have shown the predictive power of a maladaptive suppressive behaviour pattern . Based on the avoidance-endurance-model of pain chronification , both extreme and one-sided passive pain coping as well as one-sided suppressive coping modes were conceptualized as maladaptive due to the process of chronicity . We assume that extreme passive behaviour will lead to immobility and muscular atrophy . Neurophysiological processes of sensitization will further lead to the development of chronic pain . On the other h and , extreme suppressive behaviour will lead to an overuse of muscles and joints with a repetitive combination of muscular hyperactivity and pain . These repetitive pain experiences will also elicit neurophysiological processes of sensitization . ( 4 ) Psychosocial variables displayed more predictive power than biomedical or biomechanical factors . ( 5 ) Psychosocial factors may be used as predictors of the risk for developing long-term pain and disability . Mixed empirical evidence has been shown for the role of personality factors ( level C evidence ) and no support has been found for the idea of a \" pain prone \" personality disorder or for the role of sexual and physical abuse . DISCUSSION 20 years of research , several qualitative review s and a recently published systematic review of 37 good- quality prospect i ve studies regarding the role of psychological , biomedical , social and objective occupational factors in the process of chronicity of back pain revealed that psychological factors are significantly related to the onset of back pain as well as to the development of chronic pain . Furthermore , the psychological factors displayed more predictive power than biomedical or biomechanical variables . As a consequence for clinical practice , these psychological risk factors have to be considered as \" yellow flags \" if a back pain problem wo n't respond to medical treatment for more than four weeks . As a further consequence , special risk factor - based psychosocial interventions should be offered in addition to the medical treatment to patients with high psychological risk factors for the development of chronic pain . The efficacy of such an interdisciplinary care in the very early phases of back pain in order to prevent chronicity of pain and disability has been published recently by our group",
"Objective Research studies focussing on the fear-avoidance beliefs model ( FABM ) have exp and ed considerably during the last years , however , there has been very little research directed at the elderly . The objective of the present study was to investigate the validity of the FABM in older patients with chronic low back pain ( CLBP ) . Method In a cross-sectional study , a group of elderly patients with CLBP ( N=103 ) was compared with an age-matched group of pain-free individuals ( N=59 ) to test the constructs inherent in the FABM . Constructs include fear avoidance beliefs ( FABs ) , disability , disuse , and physical activity . In addition , the relationship of these constructs was also investigated in the patient group . CLBP- patients had an average age of 71.41 years ( SD=5.2 ) and pain-free individuals of 71.19 years ( SD=4.73 ) . Individuals participated in a photographed series of physical activities adapted to the age group ( Photograph Series of Daily Activities-German version for the elderly ) for the assessment of FAB , in the Hannover Disability Question naire , in the Freiburg Physical Activity Question naire , and in an ultrasound measurement to evaluate lumbar flexion . In addition , they completed an activity diary for 1 week . Before computation , the physical activity measurements were converted into metabolic units that characterize energy expenditure . Results In the patient group , FAB , pain intensity , and age predicted functional capacity , but not physical activity . Lumbar flexion was predicted by FAB and age . Patients were more fear-avoidant , reported more disability , and displayed less lumbar flexion than the pain-free individuals . No differences between the groups could be detected in regard to energy expenditure measured either by the question naire or by diary data . Conclusions The findings are consistent with results reported in the literature for younger age groups and confirm the assumption that the FABM is also valid for the elderly"
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Objective : International differences are thought to exist in dosages used by clinicians treating mood disorders . This study examined international dosage differences in antidepressant clinical trials , using a data base formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine . Methods : This systematic review included 132 studies . A detailed set of method ological features and results were abstract ed from the original publications and entered into an electronic data base . Mean and maximum fluoxetine dosages were compared across countries . To evaluate the dosages of comparison medications , a defined daily dosage ( DDD ) ratio was calculated as the trial mean dosage divided by the DDD for that drug . Results : Both the maximum and mean dosages for fluoxetine and comparison medications were higher in trials conducted in the US ( fluoxetine weighted mean dosage 49.18 mg ; 95%CI , 41.30 to 57.05 ) , compared with trials conducted in Europe ( fluoxetine weighted mean dosage 29.98 mg ; 95%CI , 25.28 to 34.68 ) . Since most clinical trials were conducted in Europe or the US , we could not determine whether different dosages tended to be used in other regions . Conclusions : International differences in prescriber behaviour may influence , and in turn be influenced by , the conduct of clinical trials . It is difficult to reconcile such differences with the principles of evidence -based medicine
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"The efficacy and safety of fluoxetine and desipramine were compared in a 6-week double-blind , parallel group study of patients with major depression . Twenty-five were studied while hospitalized for treatment , and 33 were studied as out patients . Improvement on the Hamilton Rating Scale for Depression was significant for both treatments from week 1 through the end of the study and did not differ between the two treatments at any week . Overall , 64 % of fluoxetine-treated patients and 68 % of desipramine-treated patients had at least a 50 % reduction in Hamilton Depression score . We assessed whether improvement relatively early in treatment was predictive of categorical response at 6 weeks . Among fluoxetine-treated patients , but not desipramine-treated patients , the week 3 change in the Hamilton Depression mood item was significantly predictive of the response at 6 weeks . Patients treated with fluoxetine had significantly fewer side effects than those treated with desipramine . Desipramine , but not fluoxetine , caused a persistent increase in heart rate . The results suggest that early signs of response to fluoxetine are not dependent on achieving steady-state levels of the drug",
"& NA ; This was a 6‐week , double‐blind , r and omized trial of the efficacy and tolerability of venlafaxine and fluoxetine in 109 patients with major depression and melancholia . Hospitalized and day care patients with DSM‐IV major depression and melancholia and a baseline Montgomery‐Asberg Depression Rating Scale ( MADRS ) score of ≥ 25 were eligible . The doses were venlafaxine 75 mg/day or fluoxetine 20 mg/day from days 1‐4 , venlafaxine 150 mg/day or fluoxetine 40 mg/day from days 5‐10 , and venlafaxine 225 mg/day or fluoxetine 60 mg/day from days 11‐42 . The intention‐to‐treat analyses included 55 patients on venlafaxine and 54 on fluoxetine . At the final evaluation , 70 % of patients with venlafaxine and 66 % with fluoxetine had ≥ 50 % reduction in the MADRS score , and 70 % with venlafaxine and 62 % with fluoxetine had a Clinical Global Impression ( CGI ) score of 1 or 2.A CGI improvement score of 1 was observed in 51 % of patients with venlafaxine and 32 % with fluoxetine ( P = 0.018 ) . A final Hamilton Depression Rating Scale ( HAM‐D ) score for adverse events . Nausea was reported in 5.5 % of venlafaxinetreated patients and 14.8 % of fluoxetine‐treated patients . Venlafaxine was effective and well tolerated for treating in patients with major depression and melancholia . Based on remission criteria ( HAM‐D superior to fluoxetine",
"The clinical efficacy and safety of fluoxetine and imipramine were compared in a double-blind , 5-week , parallel study in 40 depressed out patients . Mean scores for most depression scales improved more in patients taking fluoxetine than in those receiving imipramine ( p less than .05 ) . Nine of 16 ( 56 % ) fluoxetine patients who completed the study and 1 of 19 ( 5 % ) imipramine patients were not at all depressed at the end of the study ( p less than .001 ) . Seven fluoxetine patients and 14 imipramine patients reported one or more adverse effects during treatment ; no fluoxetine patient terminated the study early for drug-related reasons . It was concluded that fluoxetine provides effective antidepressant activity with fewer and less troublesome side effects than imipramine",
"In a six-week double-blind r and omized trial , preceded by a one-week single-blind placebo treatment , the efficacy and the side-effects of fluoxetine ( 40 - 80 mg/d ) ( n = 30 ) and maprotiline ( 50 - 150 mg/d ) ( n = 35 ) were compared in hospitalized patients with DSM-III Major Depression without psychotic features . Efficacy was measured by means of the Hamilton Depression Rating Scale , the Raskin Depression Scale , the Covi Anxiety Scale , and a Clinical Global Impression . Side-effects were evaluated by an Adverse Events Scale . A statistically significant improvement was achieved in both treatment groups but success rates were modest . No differences in efficacy were found between the two groups . In addition , no statistically significant differences were found between the two groups either in frequency or in severity of adverse events . In fact , the only statistically significant difference found was in weight change : weight loss in the fluoxetine group and weight gain in the maprotiline group",
"Pramipexole , a dopamine D2 receptor agonist , was tested in 174 patients with major depression , with or without melancholia and without psychotic features . Three daily dose levels ( 0.375 mg , 1.0 mg , and 5.0 mg ) were compared to fluoxetine ( Prozac ) at 20 mg and placebo in a r and omized , double-blind , parallel-group study . After a 1 week placebo run-in period , patients were treated for 8 weeks , had a post- study follow-up ( week 9 ) , and were evaluated primarily with the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Clinician 's Global Impressions-Severity of Illness scale ( CGI-SI ) . All patients who received one dose of study medication were included in the observed-case analysis ( no missing data were replaced ) . Results indicated that by endpoint ( week 8) , patients receiving pramipexole at the 1.0 mg per day dose had significant improvement over baseline compared to the placebo group by measure of the HAM-D , MADRS , and CGI-SI . Significant improvement in this dose group was seen at other timepoints as well . The most obvious improvement was seen in the pramipexole 5.0 mg group , although a substantial dropout rate for this group precluded statistical tests vs. placebo late in the study . Patients taking fluoxetine also showed significant improvements at endpoint on the MADRS and earlier in the study on the HAM-D. No new or unusual safety concerns were generated during this study . Pramipexole helped safely alleviate the symptoms of depression at 1.0 mg per day and especially in those patients who could tolerate the escalation to 5 mg per day",
"Using data from a larger 12-week clinical trial , the authors evaluated the comparative efficacy and safety of sertraline ( n=42 ) and fluoxetine ( n=33 ) in patients over age 70 with a diagnosis of major depressive disorder . Similar improvement on measures of depression , including remission of depressive symptoms , was evident , although significantly more sertraline-treated patients achieved a criterion clinical response . Significantly greater improvement for the sertraline group was apparent on the Digit Symbol Substitution Test , but not on two other measures of cognitive functioning . Although there was no difference in the rate of adverse events experienced , fluoxetine-treated patients lost significantly more body weight over the 12-week trial than did sertraline-treated patients , whereas the latter group exhibited significantly more \" shaking .",
"Fluoxetine , a selective serotonin reuptake inhibitor , was compared with mianserin and placebo in a double‐blind study . In total , 81 depressed patients were included . Patients were rated weekly on the Hamilton Depression Rating Scale ( HDRS ) and the Montgomery & Asberg Depression Rating Scale ( MADRS ) . The duration was 6 weeks , and 52 patients completed the study . Significantly more patients on fluoxetine improved than patients on placebo . For mianserin no significant differences were found with either fluoxetine or placebo . Mean HDRS at the end of the study was also statistically significantly lower for fluoxetine , but not for mianserin , than placebo . Subscores of the MADRS showed improved sleep on mianserin at weeks 2 and 3 . Suicidal feelings were reduced to a greater degree on fluoxetine than on mianserin and placebo at weeks 6 and 7 . Fluoxetine induced weight loss , while patients on mianserin gained weight . Side effects were present in most patients on the two active drugs ; those on fluoxetine experienced nausea and vomiting , and those on mianserin drowsiness",
"The present study was carried out to investigate the routine use of second-generation antipsychotic drugs in the Italian psychiatric care system . Seven outpatient psychiatric services enrolled a consecutive case series of patients who were being treated , or had started treatment , with clozapine , olanzapine , risperidone , or quetiapine . Information on sociodemographic and clinical variables , current psychotropic drug use , side-effects and past use of typical drugs was collected . In addition , patient symptoms and functional status were evaluated by the Health of the Nation Outcome Scale . Patients receiving off-label prescribing of second-generation antipsychotics were identified . A total of 209 patients were collected . In comparison with patients receiving other second-generation antipsychotics , living in residential facilities , unemployment , long psychiatric histories , and problems with activities of daily living and living conditions were more common in clozapine-treated patients . Nearly 80 % of patients receiving clozapine had schizophrenia compared to less than 50 % of those receiving other second-generation antipsychotics . Overall , 109 patients ( 52 % ) received off-label prescriptions of second-generation antipsychotic drugs . This survey indicates that clozapine was mostly reserved for severe cases and poor responders ; the high rate of off-label prescriptions highlights the gap existing between recommendations derived from r and omised clinical trials and the current use of drugs",
"BACKGROUND Depression is treated by a great variety of antidepressant treatments . SSRIs ( such as fluoxetine ) are well known : it is , however , sure that further progress is needed and the search for antidepressants with other mechanisms of action ( such as tianeptine ) or different efficacy is still of interest . METHODS A multinational study compared tianeptine with fluoxetine in 387 patients with Depressive Episode , or Recurrent Depressive Disorder , or Bipolar Affective Disorder ( ICD-10 ) , in a double-blind parallel group design . They were treated for six weeks . RESULTS At inclusion , no significant difference between groups was shown . Final MADRS scores were 15.7 and 15.8 with tianeptine and fluoxetine , respectively ( ITT population ) ( p = 0.944 ) . MADRS responders were 58 % and 56 % with tianeptine and fluoxetine , respectively ( p = 0.710 ) . No statistical difference was observed for the other efficacy parameters . Thirty-six withdrawals occurred in each group , without any difference for the reasons of discontinuation . There was no major difference between groups for the other safety parameters . CONCLUSIONS In this study , both tianeptine and fluoxetine exhibited a good efficacy and safety",
"BACKGROUND We compared the efficacy and tolerability of venlafaxine XR with that of fluoxetine in a multicenter , r and omized , double-blind , placebo-controlled study in depressed out patients . METHODS Out patients , 18 years and older , who met DSM-IV criteria for major depressive disorder were included ( n = 301 r and omized ; 232 completed ) . Patients were r and omly assigned to eight weeks of treatment with either venlafaxine XR 75 - 225 mg/day ( n = 100 ) , fluoxetine 20 - 60 mg/day ( n = 103 ) , or placebo ( n = 98 ) . The primary efficacy outcome measures were the final ratings on the Hamilton Rating Scale for Depression ( HAM-D21 ) total score , HAM-D21 depressed mood item , Montgomery-Asberg Depression Rating Scale total score , and Clinical Global Impressions Scale . RESULTS Withdrawal from the study due to adverse events occurred in 6 % of the patients in the venlafaxine XR group and 9 % of the patients in the fluoxetine group . Patients treated with venlafaxine XR , but only rarely those treated with fluoxetine , had statistically significant improvements in their depression ratings compared with placebo at the end of the study . The percentages of patients who achieved full remission of their depression ( HAM-D21 total score venlafaxine XR , fluoxetine and placebo groups , respectively . The differences in remission rates between venlafaxine XR and the other groups were statistically significant ( p remission outcome observed with venlafaxine XR treatment needs to be replicated in additional studies . CONCLUSION Venlafaxine XR is a well-tolerated and efficacious treatment for depression . The results of this study suggest that venlafaxine XR is as well-tolerated as fluoxetine but may have some efficacy advantages over fluoxetine",
"BACKGROUND Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors . In a 12-week r and omized , multicenter , double-blind trial , the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in patients with moderate to severe depression . METHODS A total of 203 patients were r and omized to fixed doses ( 20 mg/day ) of paroxetine or fluoxetine for the first six weeks of therapy . From week 7 - 12 , dosing could be adjusted biweekly , as required ( paroxetine 20 - 50 mg/day , and fluoxetine 20 - 80 mg/day ) . The mean prescribed doses were paroxetine 25.5 mg/day ( range 20.0 - 40.2 mg/day ) , and fluoxetine 27.5 mg/day ( range 20.0 - 59.5 mg/day ) . Emergence of motor nervousness or restlessness was assessed using the ESRS scale for akathisia . RESULTS Both active treatments demonstrated comparable antidepressant efficacy ( HAM-D , CGI ) . Anxiolytic activity of the two drugs ( COVI , STAI , HAM-D ) was also comparable . However , paroxetine was found to be superior to fluoxetine on two subscore measures at week 1 of therapy ( HAM-D Agitation item , p incidence of adverse effects was comparable in the two treatment groups . Constipation , dyspepsia , tremor , sweating and abnormal ejaculation were more common in paroxetine-treated subjects , whereas nausea and nervousness were more frequent in fluoxetine-treated patients . Weight loss was more common in the fluoxetine versus paroxetine group ( 11.88 % versus 2.94 % , respectively ) . ESRS scores for akathisia were low throughout the study and showed little change . LIMITATIONS Differences observed between the two drugs in antianxiety effects were limited to two measures of anxiety among several others . DISCUSSION The data indicate that paroxetine and fluoxetine have comparable antidepressant and anxiolytic efficacy . Paroxetine appears to produce an earlier improvement in agitation and psychic anxiety symptoms compared with fluoxetine",
"Accumulating evidence suggests that noradrenergic and serotonergic drugs are equally effective in ameliorating the depressive symptoms of major depression . Major depression is associated also with memory impairments , but the comparative effects of the antidepressant drugs on memory are not clear . We previously found that serotonergic neurotransmission is of particular importance for some aspects of episodic memory . We set out to test whether treatment with the selective serotonergic drug Fluoxetine ( Prozac ) would be advantageous in this respect over treatment with the selective noradrenergic tricyclic antidepressant drug Desipramine ( Deprexan ) . Seventeen patients with major depressive episode , r and omly assigned for treatment with either Fluoxetine ( n = 8) or Desipramine ( n = 9 ) , were assessed for their clinical situation and for memory performance at the beginning of treatment , after 3 weeks , and after 6 weeks of pharmacological treatment . We found that although clinical ly both drugs were equally effective , the improvement of memory performance in the Fluoxetine-treated patients was significantly greater compared with that of the Desipramine-treated patients . The results support the role of serotonin in memory . More studies in larger sample s of patients are required , but it may be that in cases where memory impairment is a major symptom , it would be beneficial to consider serotonergic antidepressant drugs for treatment . Furthermore , in cases where , for various reasons , the treatment of choice is noradrenergic , it may be worthwhile to consider a supplementary serotonergic drug to improve memory deficits",
"The aim of this double-blind study was to compare the efficacy and safety of venlafaxine vs. fluoxetine in the treatment of patients with depression and anxiety . A total of 146 moderately depressed patients with associated anxiety were r and omized to receive 75 mg/d venlafaxine or 20 mg/d fluoxetine for 12 wk . Dose increases were permitted after 2 wk of treatment , to 150 mg/d venlafaxine and 40 mg/d fluoxetine , to optimize response . At the final visit , a statistically significantly greater efficacy of venlafaxine over fluoxetine was observed on depressive symptoms and concomitant anxiety , and 75.0 and 50.7 % of patients administered venlafaxine and fluoxetine , respectively , showed an overall response . A sustained response ( for at least 2 wk ) , present at the end of the study was achieved in 57.8 and 43.3 % of patients in the venlafaxine and fluoxetine groups , respectively , and at the final visit , 59.4 and 40.3 % of patients , respectively , were in remission ( virtually asymptomatic ) . Dose increases were required by a greater percentage of patients in the fluoxetine group ( 52.9 % ) , than in the venlafaxine group ( 37.1 % ) , and in those patients whose dose was increased , a higher efficacy was again observed with venlafaxine . Venlafaxine and fluoxetine were well tolerated , with the most frequently experienced adverse events being nausea and headache . Fewer patients in the venlafaxine group than in the fluoxetine group reported at least one adverse event ( 55.7 and 67.1 % patients , respectively ) . Venlafaxine therefore proved to be significantly more effective than fluoxetine in improving depressive symptoms and concomitant anxiety",
"Two dimensions of compliance ( drop-outs and adherence ) were investigated in patients treated with antidepressant drugs . Efficacy , compliance and its determinants were investigated in 66 patients suffering from major depressive disorder and treated in a double-blind manner with fluoxetine 20 mg/day or amitriptyline 150 mg/day for 9 weeks . Overall effectiveness [ 50 % decrease in the initial Hamilton Rating Scale for Depression ( HAM-D ) ] was similar in both groups ( 62.8 % for fluoxetine , 58.1 % for amitriptyline ) . The dropout rate due to side effects was 35.5 % for amitriptyline and 5.7 % for fluoxetine . A logistic regression analysis revealed that the initial HAM-D score was not predictive for dropping out , but this outcome was instead determined by sex ( increased risk for males ) , age ( increased risk for being younger ) and occurrence of severe side effects . Adherence was estimated using electronic Medication Event Monitoring System and defined as the percentage of days when the correct dose was taken out of the medication container . Of the patients studied 37 % had an adherence of less than 70 % . There was no relationship between adherence and efficacy and adherence was similar in patients on fluoxetine or amitriptyline . Side effects were not predictive of being adherent or not , but a higher initial HAM-D score predicted a higher adherence to the medication regimen . The demographic variables bad no significant effect . The present study suggests that the link between efficacy , side effects and compliance or adherence is more complex than is generally believed and that early termination and non-adherence seem to be determined by different factors",
"In a r and omised double-blind comparative trial , the antidepressant efficacy of a daily dose of 800 mg of the St. John 's wort extract LoHyp-57 ( dry extract of St. John 's wort , drug extrakt ratio 5 - 7:1 , solvent , ethanol 60 % [ w/w ] ) was shown to be equivalent to that of 20 mg fluoxetine ( CAS 54910 - 89 - 3 ) in elderly patients with mild or moderate depressive episodes according to ICD 10 ( International Statistical Classification of Diseases and Related Health Problems ) . Treatment was given for six weeks . 149 out- patients ( 129 females and 20 males ) were included in the intention-to-treat analysis . 72 of these patients were assigned to the ICD 10 diagnostic criterion F32.0 ( mild depressive episode ) , while 77 patients were suffering from moderate depressive episodes , corresponding to F32.1 . The principal target criterion was the patient 's global score on the HAMILTON Depression Scale ( items 1 - 17 ) . During the six-week course of treatment with LoHyp-57 , the HAMILTON global score fell from 16.60 points at entry to 7.91 points , and in the fluoxetine sample it fell from 17.18 to 8.11 points . In the group of patients with mild depressive episodes , the score showed a mean fall from 14.21 to 6.21 points on LoHyp-57 , and from 15.21 to 7.46 points on fluoxetine . In patients with moderate depressive episodes , the score showed a mean fall from 18.73 to 9.43 points on LoHyp-57 and from 19.10 to 8.75 points on fluoxetine . The efficacy of both medications was found to be equivalent both in mild and moderate depressive episodes . Both treatment groups showed adverse drug reactions ( ADRs ) . Twelve ADRs with a possible relationship to the study medication were reported during treatment with LoHyp-57 . Six patients were prematurely withdrawn from treatment with the study medication for this reason . On fluoxetine 17 ADRs occurred with a possible relationship to the study medication . These led to ab and onment of treatment and therefore premature withdrawal from the study in 8 cases",
"Seventy in patients with a DSM-III-R major depression were included in a double-blind , r and omized , clinical trial to compare the efficacy and tolerability of moclobemide versus fluoxetine . After a 3-day placebo run-in phase , treatments were administered for 4 weeks in daily doses of between 300 and 600 mg of moclobemide or 20 to 40 mg of fluoxetine . Efficacy was measured by the Hamilton Rating Scale for Depression ( HAM-D ) , Clinical Global Impression , and subjective mood ratings ( 45-item self-rating scale ) . Fifty-three patients ( mean age , 40 years ; 22 men , 31 women ) completed the 4-week treatment . Changes between end of treatment and baseline did not differ between both study drugs . The HAM-D responder rate ( 50 % improvement from baseline ) was 59 % in the moclobemide group and 58 % in the fluoxetine group after 4 weeks . Moclobemide , however , acted therapeutically faster than fluoxetine . After 1 week of treatment , the HAM-D scores were significantly lower in patients on moclobemide than in those on fluoxetine ( p earlier efficacy of moclobemide after 1 week was also detected by the patients ' subjective mood ratings ( p moclobemide and fluoxetine regarding tolerability ratings . These data suggest that both agents have a similar efficacy and tolerability but that moclobemide has an earlier onset of antidepressive action",
"The clinical profile of reboxetine , a selective noradrenaline reuptake inhibitor , was compared with that of the selective serotonin reuptake inhibitor fluoxetine and placebo in a double-blind , multicenter , parallel-group clinical trial of patients with major depression . Among the 381 patients treated with reboxetine 8 to 10 mg/day , fluoxetine 20 to 40 mg/day , or placebo for up to 8 weeks , a statistically significant greater reduction in the mean Hamilton Rating Scale for Depression ( 21-item HAM-D ) total score ( the primary efficacy variable ) was seen for both active treatment groups compared with placebo ( p reboxetine or fluoxetine also achieved a response ( ≥50 % reduction in HAM-D ) or remission ( HAM-D ≤10 points ) than those who received placebo ( p population of severely ill patients , with statistically significantly greater decreases in the mean HAM-D total score between both active treatment groups compared with placebo ( p ( Montgomery-Åsberg Depression Rating Scale , Clinical Global Impression ) reflected the primary efficacy analysis , with both active treatments offering comparable efficacy that was superior to that of placebo . Reboxetine and fluoxetine are more effective than placebo in the treatment of major depression . Futhermore , both antidepressants are well tolerated but possess different adverse event profiles",
"Fluoxetine , a specific serotonin reuptake inhibitor , was compared to amitriptyline in the treatment of 51 out patients with primary major depressive disorder . After a 1-week placebo washout , patients were r and omly assigned to 5 weeks of treatment with fluoxetine or amitriptyline . Fluoxetine was found to have a therapeutic effect comparable to that of amitriptyline ; however , the fluoxetine treatment group had a better Efficacy Index-Side Effects rating and a lower incidence of anticholinergic autonomic side effects . Four amitriptyline-treated patients had to discontinue the study because of serious side effects , while in the fluoxetine treatment group there were no terminations due to side effects . The amitriptyline-treated patients gained significantly more weight than the fluoxetine-treated patients",
"The effectiveness of fluoxetine as an antidepressant was contrasted with trazodone in a 6-week double-blind trial in 40 patients . The total score on the Hamilton Rating Scale for Depression and the global improvement score on the Clinical Global Impressions scale favored trazodone at the end of 3 weeks of treatment . However , that difference was no longer apparent during the remainder of the study . The authors hypothesize that fluoxetine 20 mg/day may be an ineffective dosage of the drug or that fluoxetine has a slower onset of antidepressant action than does trazodone",
"Fluoxetine ( 20 mg ) was compared to dothiepin ( 150 mg ) in a multicentre , prospect i ve , double blind , r and omised clinical trial involving 125 patients with major depression treated for an initial phase of 6 weeks and then followed up for a further 6 months . There was no difference in the efficacy of the two drugs based on the results of established rating scales ( MADRS , HAM‐D , BPRS ) . The impact of both drugs on sleep measured using the Leeds Sleep Evaluation Question naire showed no significant differences between treatments , however drowsiness and disturbed sleep were reported more frequently as side effects with dothiepin . Symptoms of anxiety responded equally well to both treatments . The short term and long term tolerability of dothiepin was inferior to that of fluoxetine . The place of dothiepin in treatment should be reassessed in the light of its anticholinergic adverse event profile , particularly in the elderly . Copyright © 2000 John Wiley & Sons ,",
"In a double-blind , placebo-controlled study the authors found that fluoxetine , a potent and selective inhibitor of serotonin reuptake , was an effective antidepressant in moderately depressed , ambulatory out patients . Typical adverse effects reported by patients treated with fluoxetine included agitation , nausea , fatigue , and insomnia . Compared to imipramine , fluoxetine was associated with fewer complaints of dry mouth , constipation , and dizziness",
"This was a 6-week , double-blind comparison of fluoxetine , imipramine , and placebo in 89 patients with bipolar depression . Using the criteria of greater than or equal to 50 % improvement in the HAMD-total score after at least 3 weeks on study drug , endpoint analysis showed 86 % of the fluoxetine-treated patients improved compared with 57 % of the imipramine-treated and 38 % of the placebo-treated patients . Significantly fewer fluoxetine-treated patients discontinued due to adverse events than did imipramine-treated patients ( 7 % vs. 30 % , respectively )",
"Fluoxetine ( 60 mg ) , a selective inhibitor of the reuptake of 5-HT , was compared in a double-blind trial to amitriptyline ( 150 mg ) in a sample of 34 patients fitting the Research Diagnostic Criteria for a major depressive disorder . Patients were studied after a drug washout period of 10 days and an active treatment period of 42 days . Sleep polygraphic recordings were performed before and at the end of the study . As indicated by the significant decrease in the Hamilton Depression scale and the Montgomery Asberg Depression scale , fluoxetine showed similar antidepressant effects to amitriptyline with significantly fewer adverse effects . Fluoxetine and amitriptyline decreased the amount of REM sleep , a well known effect of classical antidepressants . Fluoxetine showed some specific effects on sleep continuity ( potentially dose related ) as indicated by the significant increase in the number of awakenings and in stage shifts , without interfering with the therapeutic response",
"A sample of 120 patients , all of whom met DSM-III criteria for major unipolar depressive disorder , were r and omly allocated to two treatment groups . Sixty patients were treated with fluoxetine and 60 with clomipramine during a 6-week period . No significant difference was found in antidepressant efficacy , with improvement occurring on both drugs . Important differences were found in the side-effects profile of each group , their incidence being significantly lower and tending to disappear during the course of treatment in the group of patients treated with fluoxetine",
"BACKGROUND A large proportion of the elderly population complains of depressive symptoms . The ideal antidepressant for these patients , who often suffer from numerous concomitant diseases , should not worsen their cognitive functions and should be free of contraindications . METHOD To assess the effects of 2 selective serotonin reuptake inhibitors on cognitive functions in elderly depressed patients ( ICD-10 criteria ) , we conducted a double-blind , r and omized , parallel-group , multicenter study comparing paroxetine ( 20 - 40 mg daily ) and fluoxetine ( 20 - 60 mg daily ) treatment for 1 year . Cognitive performance was evaluated by means of the Buschke Selective Reminding Test , the Blessed Information and Memory Test , the Clifton Assessment Schedule , the Cancellation Task Test , and the Wechsler Paired Word Test ; the Hamilton Rating Scale for Depression ( HAM-D ) and the Clinical Anxiety Scale were administered to assess the course of depressive and anxiety symptoms , respectively . RESULTS 242 patients were enrolled ( mean + /- SD age = 75.4 + /- 6.6 years ) . During the study , no deterioration of cognition was observed ; on the contrary , most of the tested cognitive functions improved . Good antidepressant efficacy was maintained for over 1 year with both drugs , based on the percentage of responders to treatment ( patients achieving a HAM-D total score tolerability and safety profile . CONCLUSION The 2 antidepressants proved to be suitable for the long-term treatment of depression in the elderly and to be devoid of detrimental effects on the tested cognitive functions",
"This study assessed whether fluoxetine , sertraline , and paroxetine differ in efficacy and tolerability in depressed patients and the impact of baseline insomnia on outcomes . Patients ( N = 284 ) with DSM-IV major depressive disorder were r and omly assigned in a double-blind fashion to fluoxetine , paroxetine , or sertraline for 10 to 16 weeks of treatment . Using the Hamilton Rating Scale for Depression ( HAM-D ) sleep disturbance factor score , patients were categorized into low ( high ( ≥4 ) baseline insomnia subgroups . Changes in depression and insomnia were assessed . Safety assessment s included treatment-emergent adverse events ( AEs ) , reasons for discontinuation , and AEs leading to discontinuation . In addition , AEs were evaluated within insomnia subgroups to determine emergence of activation or sedation . Depression improvement , assessed with the HAM-D-17 total score , was similar among treatments in all patients ( p = 0.365 ) and the high ( p = 0.853 ) and low insomnia ( p = 0.415 ) subgroups . Insomnia improvement , assessed with the HAM-D sleep disturbance factor score , was similar among treatments in all patients ( p = 0.868 ) and in the high ( p = 0.852 ) and low insomnia ( p = 0.982 ) subgroups . Analyses revealed no significant differences between treatments in the percentages of patients with substantial worsening , any worsening , worsening at endpoint , or improvement at endpoint in the HAM-D sleep disturbance factor in either insomnia subgroup . Treatments were well tolerated in most patients . No significant differences between treatments in the incidence of AEs suggestive of activation or sedation were seen in the insomnia subgroups . These data show no significant differences in acute treatment efficacy and tolerability across fluoxetine , sertraline , and paroxetine in major depressive disorder patients . Improvement in overall depression and in associated insomnia was achieved by most patients regardless of baseline insomnia",
"Depression in the elderly appears to be frequently poorly understood and underdiagnosed . The frequency of depressed illness in subjects over the age of 65 years is an important problem of health care . General practitioners are often in the first line of care . The objective of this trial was to compare the efficacy and safety of fluoxetine 20 mg/day to tianeptine 37.5 mg/day in elderly patients suffering from major depressive episode defined according to DSM III-R criteria , Newcastle Depression Scale , each patient had to be treated for 12 weeks and was review ed 5 times during the trial . Patients had signed an informed consent . This trial was in favor of the superiority of fluoxetine compared to tianeptine . The main criterium , defined as the difference of the Montgomery and Asberg Depression Rating scale ( MADRS ) score between day 0 and day 84 , was significantly different in favour of the fluoxetine group ( intent to treat and per protocol analysis ) ( p = 0.019 ) . The success rate at the end of the treatment ( MADRS fluoxetine group ( fluoxetine group : 48.4 % vs tianeptine group : 28.1 % ) ( p = 0.005 ) . These results were confirmed by analysis of the other assessment criteria Geriatric Depression Scale ( GDS ) and Clinical Global Impression ( CGI ) . During the study , the safety of the two treatments was comparable",
"Eighteen out patients with major depression ( diagnosis was made according to DSM-III criteria ) were treated in a 5-week double-blind parallel group comparison of the new antidepressant fluoxetine with imipramine . From these results it can be shown that the drugs were comparable in efficacy , although because of the small sample size a moderate clinical difference between treatments may not have been detected . Imipramine and fluoxetine have already been compared in other studies , but never at such a low dosage ( 20 mg ) for fluoxetine . At this dosage the fluoxetine safety profile seems to be very different from previous scheduled studies with higher dosages . In fact clinical efficacy seems to remain comparable while side-effects are significantly less frequent",
"Fluoxetine and imipramine were compared in a six-week , double-blind , r and omized trial in 118 men and women , ages 18 to 70 years , hospitalized for major depressive disorder . Treatment groups were comparable at baseline . Median maintenance doses were : fluoxetine , 80 mg/day ; imipramine , 200 mg/day . Efficacy with fluoxetine and imipramine was comparable : none of the between-treatment differences was statistically significant . Mean + /- st and ard deviation baseline HAMD21 total scores and change ( last-visit-carried-forward analysis ) , respectively , were fluoxetine , 28.0 + /- 5.3 and -8.5 + /- 9.9 ; imipramine , 27.0 + /- 5.8 and -11.9 + /- 9.0 . Response and remission rates , respectively , were fluoxetine , 54.5 and 21.2 % ; imipramine , 60.0 and 34.3 % . Discontinuations for adverse events were comparable ( fluoxetine , 21.4 % ; imipramine , 22.6 % ) . Common treatment-emergent events with fluoxetine were dry mouth ( 28.6 % ) , constipation ( 17.9 % ) , and somnolence ( 17.9 % ) ; those with imipramine were dry mouth ( 58.1 % ) , constipation ( 32.3 % ) , and headache ( 22.6 % ) . Fluoxetine was as effective as imipramine in this population of in patients",
"A study was conducted to compare the relative efficacy of fluoxetine and phenelzine in patients with mood-reactive atypical depression . Forty-two patients with atypical depression by the Columbia criteria were studied in a r and omized , double-blind treatment study . Following a single-blind placebo lead-in , patients received fluoxetine 20 - 60 mg/day or phenelzine 45 - 90 mg/day for 6 weeks . Efficacy was measured by the Hamilton Depression Rating Scale , the Clinical Global Impression ( Severity and Improvement ) scales , and the Patient Global Impression ( Improvement ) scale . Of 42 patients r and omized , 2 patients never received drugs and 2 phenelzine-treated patients dropped out prior to completion ; the remainder completed the 6 weeks of the study . The rates of treatment response did not differ between groups . With a few exceptions ( e.g. , tremor ) , phenelzine produced more frequent adverse effects than fluoxetine . It was concluded that fluoxetine is as effective as phenelzine in the treatment of atypical depression , but produces fewer adverse effects and is better tolerated",
"BACKGROUND We conducted a r and omized , double-blind , placebo-controlled study of the efficacy and safety of once-daily venlafaxine extended release ( XR ) and fluoxetine in out patients with major depression and concomitant anxiety . METHOD Patients who met DSM-IV criteria for major depressive disorder and satisfied eligibility criteria were r and omly assigned to once-daily venlafaxine XR , fluoxetine , or placebo for 12 weeks . Efficacy was assessed with the Hamilton Rating Scale for Depression ( HAM-D ) , Hamilton Rating Scale for Anxiety ( HAM-A ) , and Clinical Global Impressions scale . RESULTS Among 359 out patients , venlafaxine XR and fluoxetine were significantly superior ( p placebo on the HAM-D total score beginning at week 2 and continuing to the end of the study . Venlafaxine XR but not fluoxetine was significantly better than placebo at week 2 on the HAM-D depressed mood item . At week 12 , the HAM-D response rate was 43 % on placebo , 67 % on venlafaxine XR , and 62 % on fluoxetine ( p HAM-D remission rate was significantly higher ( p venlafaxine XR and at weeks 8 , 12 , and final evaluation with fluoxetine than with placebo . The HAM-A response rate was significantly higher ( p venlafaxine XR than with fluoxetine at week 12 . The incidence of discontinuation for adverse events was 5 % with placebo , 10 % with venlafaxine XR , and 7 % with fluoxetine . CONCLUSION Once-daily venlafaxine XR is effective and well tolerated for the treatment of major depression and concomitant anxiety and provides evidence for superiority over fluoxetine",
"BACKGROUND There has been a paucity of well- design ed studies comparing selective serotonin reuptake inhibitor ( SSRI ) medications in the treatment of depression in the elderly . This multicenter study was design ed to examine the efficacy and safety of sertraline and fluoxetine in depressed elderly out patients . A secondary objective was to examine the effects of SSRI treatment on quality of life and cognitive function . METHOD Two hundred thirty-six out patients 60 years of age and older who met DSM-III-R criteria for major depressive disorder received 1 week of single-blind placebo before being r and omly assigned to 12 weeks of double-blind , parallel-group treatment with flexible daily doses of either sertraline ( range , 50 - 100 mg ) or fluoxetine ( range , 20 - 40 mg ) . Primary efficacy measures consisted of the 24-item Hamilton Rating Scale for Depression and Clinical Global Impressions scale ratings . Secondary outcome assessment s included clinician- and patient-rated measures of depression symptoms and factors , cognitive functioning , and quality of life , as well as plasma drug concentrations , which were correlated with clinical response . RESULTS Both drugs produced a similarly positive response on the primary efficacy measures , with 12-week responder rates of 73 % for sertraline and 71 % for fluoxetine . Sertraline-treated patients showed statistically greater cognitive improvement on several measures . Both drugs were safe and well tolerated . CONCLUSION Data indicate that both drugs are effective antidepressants for the treatment of depressed elderly out patients . Differences in cognitive performance effects deserve further investigation",
"We report results from a multicenter , placebo-controlled , r and omized , double-blind comparison of the efficacy and tolerability of paroxetine and fluoxetine in out patients with major depression . Across five U.S. sites , 128 out patients ( mean age : 41.3 + /- 12.6 ; 63 men and 65 women ) with moderate to moderately severe major depression without a history of mania or hypomania were recruited between 1993 and 1994 . All 128 patients completed a 1-week placebo washout period , and were then r and omized to 12 weeks of double-blind treatment with paroxetine up to 50 mg/day ( n = 55 ) , fluoxetine up to 80 mg/day ( n = 54 ) , or placebo ( n = 19 ) . Subjects were evaluated weekly for the first 4 weeks , then at weeks 6 , 9 , and 12 with the 21-item HAMD and the Covi Anxiety Scale . There were no significant differences among the three treatment groups in baseline and endpoint depression and anxiety severity , as well as in the degree of depression and anxiety improvement . There were no statistically significant differences in rates or mean numbers of adverse events between paroxetine-treated patients and fluoxetine-treated patients . In summary , our results , although limited by the lack of a significant difference from placebo in treatment outcome , suggest that the SSRIs paroxetine and fluoxetine have comparable antidepressant and antianxiety efficacies among depressed out patients , as well as similar safety and tolerability profiles",
"Fluoxetine , a new serotonin uptake blocking antidepressant , was compared with amitriptyline in a double-blind study . Patients were diagnosed as having major depression , according to DSM-III criteria , when interviewed with the Diagnostic Interview Schedule . There was significant improvement in patient and observer ratings of depression in both groups , with no difference between groups . Recent memory improved significantly in the fluoxetine group but not in the amitriptyline group . Numbers of patients reporting side-effects were similar but the profiles of side-effects were different , with more patients on amitriptyline reporting anticholinergic and intolerable side-effects",
"In a 6-week , multicentre , r and omised , double-blind controlled study , tianeptine ( 37.5 mg/day ) and fluoxetine ( 20 mg/day ) were compared for efficacy and safety in 178 patients with major depression . No significant difference was shown between the two drugs , either in terms of efficacy ( MADRS , CGI , COVI ) or in terms of safety , except for the CGI ' severity of illness ' which was lower at the end point with tianeptine than with fluoxetine . The percentages of responders ( as defined by a 50 % decrease of the MADRS score from baseline to end point ) were 75 % with tianeptine and 67 % with fluoxetine , showing the efficacy of both drugs . In conclusion , both tianeptine and fluoxetine are effective and well-tolerated treatments for major depression",
"Although common in clinical setting s , major depressive disorder with associated anxious symptoms ( ' anxious depression ' ) has not been well studied in antidepressant clinical trials . The aim of this study was to compare the effects of fluoxetine versus amitriptyline in this group of patients . After a single-blind placebo run-in period of 2 weeks , patients were treated on a double-blind basis with fluoxetine or amitriptyline for 8 weeks . Assessment instruments included : 21-item Hamilton Rating Scale for Depression , Hamilton Rating Scale for Anxiety , Clinical Global Impressions , Raskin Depression Scale and Covi Anxiety Scale . A total of 157 patients were r and omized to either fluoxetine or amitriptyline . Fluoxetine was given at a fixed dose of 20 mg/day and amitriptyline was given in a range of 50 - 250 mg/day ( mean of 138.1 mg/day ) . Fluoxetine was comparable to amitriptyline in all efficacy measures except the HAMD sleep factor . Unwanted effects were more frequent and more severe in the amitriptyline-treated patients . Fluoxetine was comparably efficacious to amitriptyline in the treatment of major depression with associated anxiety . Since fluoxetine was far better tolerated , it is a promising alternative for this frequent and disabling condition",
"The effects of trimipramine , a tricyclic antidepressant ( TCA ) with atypical pharmacological properties , and fluoxetine , a selective serotonine reuptake inhibitor ( SSRI ) , were compared in an exploratory analysis using mood and polysomnographic parameters during a six-week double-blind trial in 19 depressed geriatric patients . In sleep EEG measures , trimipramine demonstrated clear-cut effects on sleep measures result ing in higher values for sleep efficiency , total sleep time , stage 2 sleep , and shorter wake time . Under fluoxetine treatment , the proportion of REM sleep was decreased and REM latency was lengthened , whereas no change in REM sleep parameters was observed in the trimipramine group . The present data suggest that early antidepressant effects of medication occur independently of drug-induced changes in objective measures of sleep , i.e. suppression of REM sleep",
"Fluoxetine hydrochloride ( ProzacR , Lilly ) , a new antidepressant that specifically inhibits serotonin reuptake was evaluated in an open comparative trial performed in 8 Belgian centres over a period of 9 months . Seventy-six out patients were enrolled of which 66 were evaluable . Thirty-six patients received an 8 week fluoxetine treatment and 31 patients received tricyclic antidepressants ( TCA ) . Patients from both treatment groups were evaluated for safety and the fluoxetine treated group of patients was assessed for efficacy . On the Hamilton Depression Scale , the mean score dropped from 26.4 to 7.0 after 8 weeks ( p less than 0.0001 ) . The Clinical and Patient 's Global Impression scores showed a similar evolution . Patients treated with fluoxetine tended to report fewer side-effects than the TCA treated group . Therefore fluoxetine can be regarded as an efficient antidepressant which is at least as well tolerated as TCAs",
"The efficacy of moclobemide ( 300–450 mg7sol;day ) was compared with fluoxetine ( 20–40 mg/day ) in a double‐blind , multicentre study in 209 patients with new episodes of depression selected from 612 consecutive depressed patients representative of those consulting psychiatric services in Finl and . Antidepressant efficacy was assessed with the Hamilton Depression Rating Scale ( HDRS ) , Montgomery‐Åsberg Depression Rating Scale and Clinical Global Impression ( CGI ) . The Medical Outcome Study Short‐form General Health Survey ( SF‐20 ) and 15D Measure of Quality of Life were used to measure effectiveness in terms of health‐related quality of life . Efficacy was evident with both drug treatments , with 67 % in the moclobemide group and 57 % in the fluoxetine group having a reduction in HDRS of more than 50 % . Similarly , 77 % of the patients in the moclobemide group and 67 % in the fluoxetine group were assessed on the CGI as much better or very much better after 6 weeks of treatment . The most commonly reported adverse events were nausea , other gastrointestinal symptoms , nervousness , dizziness and sleep disorders . Nausea was significantly more common in the fluoxetine group and was found especially in women . Premature terminations of treatment were 18 % in the moclobemide and 21 % in the fluoxetine group . A significant change for the better in quality of life was found in both treatment groups , even at week 2 but especially after 6 weeks of treatment . Improvement was not only seen in dimensions measuring depression or mental health but also in other dimensions",
"A double‐blind clinical trial was undertaken to evaluate the clinical efficacy and safety of fluoxetine compared with imipramine in the treatment of 59 out patients suffering from major depressive disorder . The mean scores of all depression rating scales showed that the drugs had comparable efficacy . The side effect profile of imipramine was found to be mainly anticholinergic , which was not the case for fluoxetine , where it was mainly found to be gastrointestinal , such as nausea and diarrhoea . In both groups the total number of adverse events reported were the same . Fluoxetine treatment result ed in weight loss , whereas imipramine treatment result ed in a slight but significant weight increase",
"A double blind controlled trial was carried out in 65 depressed out- patients to compare the efficacy and tolerance of mianserin with fluoxetine . The two compounds present very different pharmacological activities . Mianserin is an antagonist of the alpha 2-adrenergic receptors , while fluoxetine is an inhibitor of recapture specific to serotonin . Requirements for inclusion were : depressive episode of less than 2 months duration , meeting the criteria for one of the sub-types of depression described in DSM III , with a minimum score of 25 on the Montgomery Asberg Depressive Rating Scale ( MADRS ) . The patient 's ages ranged from 18 to 65 . The only psychotropic medication allowed in association to the treatment was prazepam ( up to 40 mg/day ) . Patients gave their written consent to the study . Assessment , using the Montgomery Asberg Depression Rating Scale ( MADRS ) , the HARD diagram , the check list for somatic symptoms and side-effects was carried out before treatment and at the end of weeks 2 , 4 , 8 . Assessment of anxiety using the Hamilton Anxiety Rating Scale ( HARS ) and of sleep disturbances using a sleep question naire was carried out before treatment and at week 4 . The 8 items of the sleep question naire covers the complaints listed in criteria for insomnia disorders ( 307.42 DSM III-R ) . Clinical Global Impression ( CGI ) , Therapeutic Index ( TI ) , Tolerance Global Impression were assessed at end-point . The 2 groups were strictly comparable in respect to the clinical status at base line ( diagnosis , history and duration of the depressive illness , MADRS and HARD diagram scores ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"An eight-week double-blind , multicentre study was performed to evaluate the efficacy and safety of sertraline vs. fluoxetine in the treatment of major depression ( DSM-III-R ) . There were 108 out- patients , from nine Italian centres , entered into the study , of whom 88 were evaluable ( 48 sertraline , 40 fluoxetine ) . The final mean daily dose of sertraline was 72 mg and for fluoxetine it was 28 mg . Both treatment groups showed a statistically significant improvement from baseline at one week , and this was maintained until the end of treatment for all of the following measures : Hamilton Rating Scales for Depression and Anxiety , the Montgomery Asberg Depression Rating Scale , Clinical Global Impressions Scale , Zung Self-Rating Scale for Anxiety and the Leeds Sleep Evaluation Question naire . Although there was a numerical advantage for sertraline on several efficacy measures , there was no statistically significant difference found between the treatment groups . The incidence of adverse events was similar for both treatments ; 40.4 % for sertraline and 39.3 % for fluoxetine . However , adverse events were generally rated by patients as of lower severity in the sertraline group . In addition , for the fluoxetine group , there was a higher incidence of agitation , anxiety and insomnia than for sertraline . Sertraline was considered to be better tolerated than fluoxetine overall , since only 9.6 % of sertraline-treated patients discontinued treatment due to therapy failure whereas in the fluoxetine-treated group this figure was 19.6 % . By contrast , 13.5 % of sertraline-treated patients discontinued prematurely because of clinical improvement , compared with 10.7 % of fluoxetine-treated patients",
"BACKGROUND This study was undertaken to compare the efficacy and safety of bupropion and fluoxetine . METHOD Moderately to severely depressed out patients who fulfilled the DSM-III-R criteria for nonpsychotic major depressive disorder and had a score of 20 or more on the Hamilton Rating Scale for Depression ( 21 item ) participated in this two-center study . Following a 1-week placebo phase , patients were r and omly assigned to receive either bupropion or fluoxetine for 6 weeks of double-blind treatment . Weekly efficacy assessment s included Hamilton Rating Scale for Depression , Hamilton Rating Scale for Anxiety , Clinical Global Impressions-Severity , and Clinical Global Impressions-Improvement . Vital signs and adverse experiences were also assessed weekly . RESULTS A total of 61 patients were r and omly assigned to receive bupropion ( 225 - 450 mg/day ) and 62 were r and omly assigned to receive fluoxetine ( 20 - 80 mg/day ) . The mean daily dose at the end of the study was 382 mg/day for the bupropion treatment group and 38 mg/day for the fluoxetine treatment group . There were no statistically significant differences between treatments on any of the efficacy variables . On the basis of a 50 % or greater reduction in the HAM-D scores , 63 % ( N = 37 ) of the bupropion-treated and 58 % ( N = 35 ) of the fluoxetine-treated patients were categorized as responders , and on the basis of CGI scores , 68 % ( N = 40 ) of the bupropion-treated and 58 % ( N = 35 ) of the fluoxetine-treated patients were rated as much or very much improved . HAM-A scores decreased by 59 % for both treatment groups . The incidence of treatment-emergent adverse events was low with no statistically significant differences between treatments . Twenty-six percent ( N = 16 ) of the bupropion-treated and 29 % ( N = 18 ) of the fluoxetine-treated patients prematurely discontinued treatment . CONCLUSION Both bupropion and fluoxetine demonstrated similar efficacy in relieving depression and accompanying symptoms of anxiety , and both exhibited a similar , favorable safety profile",
"Fluoxetine and trazodone were compared in a double-blind , r and omized , parallel , 6-week trial in 43 out patients with major depression after a 1-week single-blind placebo period . Thirty-five patients completed at least 3 weeks of active medication , while 25 patients completed all 6 weeks . Response rates , whether defined by end-of-treatment Hamilton Rating Scale for Depression ( HAM-D ) score less than 10 or by a 50 % reduction in HAM-D scores , were equivalent for the two medications . For fluoxetine , HAM-D scores were significantly lower at Weeks 1 and 2 compared with those of trazodone . Trazodone improved sleep significantly more than fluoxetine . Fluoxetine was associated more frequently with weight loss ( p = .002 ) and less frequently with dizziness ( p = .04 ) than trazodone",
"In this r and omized , open-label , 8-week comparative study , the efficacy and safety of venlafaxine and fluoxetine were assessed in out patients with major depression . One hundred forty-five patients were assigned to receive venlafaxine 37.5 mg twice daily or fluoxetine 20 mg once daily . On day 15 , if clinical ly indicated to improve patient response , the dosage could be increased at the investigator 's discretion to venlafaxine 75 mg twice daily or fluoxetine 40 mg once daily . One hundred forty-five patients were evaluated for safety and 110 , for efficacy . The mean age was 37 years , and 70 % of the patients were female . In both treatment groups , mean scores on the Hamilton Depression Rating Scale decreased significantly between baseline ( 27.8 , venlafaxine ; 29.2 , fluoxetine ) and the end of the study ( 8.7 , venlafaxine ; 8.2 , fluoxetine ) . Similarly , mean scores on the Montgomery-Asberg Depression Rating Scale decreased significantly between baseline ( 31.4 , venlafaxine ; 31.6 , fluoxetine ) and the end of the study ( 8.3 , venlafaxine ; 7.6 , fluoxetine ) . In venlafaxine patients , the most common adverse events were nausea ( 44.3 % ) , headache ( 40.0 % ) , insomnia ( 31.4 % ) , dizziness ( 30.0 % ) , and dry mouth ( 22.9 % ) ; in fluoxetine patients , they were headache ( 32.0 % ) , nausea ( 28.0 % ) , insomnia ( 24.0 % ) , anxiety ( 21.3 % ) , sleepiness ( 20.0 % ) , and generalized tremor ( 20.0 % ) . The results of this study indicate that venlafaxine is effective and well tolerated for the treatment of major depression at doses of 37.5 or 75 mg twice daily and not significantly different from fluoxetine 20 or 40 mg once daily",
"A r and omized , double‐blind , parallel‐group , 6‐week study was undertaken to compare the efficacy and tolerability of once or twice daily administration of the selective serotonin reuptake inhibitors paroxetine and fluoxetine . After a 1‐week placebo wash‐out , patients suffering from DSM‐III major depression and with a score of 18 or more on the 21‐item Hamilton Rating Scale for Depression ( HRSD ) received either paroxetine or fluoxetine . The patients were assessed for efficacy using the HRSD , Montgomery‐Åsberg Depression Rating Scale and Clinical Global Impression ; for tolerability , adverse events were elicited by the use of a non‐leading question and a side effects checklist . The groups of patients were comparable on entry to the study . One hundred patients were recruited into the study , of whom 78 were evaluable for the efficacy analysis . Paroxetine and fluoxetine showed comparable efficacy at the end of the 6‐week treatment period , but a statistically significant difference in the number of responders at week 3 in favour of paroxetine was observed . This could suggest an earlier onset of action with paroxetine . Also , associated anxiety symptoms were significantly reduced on paroxetine compared with fluoxetine at week 3 . Patients on paroxetine reported fewer adverse events than those on fluoxetine . The most commonly reported adverse events were nausea and vomiting in both groups",
"The efficacy and safety of fluoxetine were compared with those of imipramine and of placebo in a 6-week r and omized double-blind parallel study of patients with major depressive illness . Mean values for all efficacy measurements were improved over baseline with fluoxetine and imipramine treatment ( p less than .001 ) . More fluoxetine patients completed the study than did imipramine or placebo patients . Predominant adverse experiences reported by imipramine patients were dry mouth and dizziness/lightheadedness . Predominant adverse experiences reported by fluoxetine patients were drowsiness/sedation and excessive sweating . In a subsequent 48-week open-label study , the predominant adverse experience in the fluoxetine group was excessive sweating and in the imipramine group was still dry mouth . In this study , fluoxetine relieved the symptoms of major depressive illness effectively and significantly better than placebo and was better tolerated than imipramine",
"BACKGROUND Depression has emerged as a contrastive area of gender differences in psychiatry , as epidemiological data has consistently shown depression is twice as common in women as men . The pharmacodynamic effect of antidepressants may also show gender differences , as suggested by reports of better response of young women to non-tricyclic antidepressants . METHODS The antidepressive effect of an SSRI ( fluoxetine ) and a tetracyclic antidepressant with selective norepinephrine reuptake inhibitory effect ( maprotiline ) was compared in a 6-week , double-blind trial of 105 depressed patients . RESULTS No significant difference was observed in the change of HAMD17 total score from baseline to week 6 between fluoxetine- and maprotiline-treated patients . A significant difference was observed in females ( fluoxetine , -17.8 ; maprotiline , -13.9 ; P=0.017 ) between treatment groups , but not in males . Amongst females , the difference was significant in women aged ( fluoxetine , -18.4 ; maprotiline , -12.9 ; P=0.023 ) but not > or = 44 years . CONCLUSIONS Females in their reproductive period are more responsive to SSRI ( fluoxetine ) than norepinephrinergic tetracyclic antidepressant ( maprotiline ) treatment . Normal cyclical ovulation , and estrogen release may have a clinical ly relevant pharmacodynamic interaction with serotonergic antidepressants",
"The purpose of this report was to evaluate specific depressive symptoms that are most suitable for a therapy with the Ze 117 St. John 's wort extract . We examined the antidepressant efficacy and drug safety of Ze 117 and fluoxetine in a multicentric prospect i ve r and omized double-blind parallel group comparison according to generally accepted guidelines such as the Declaration of Helsinki and GCP . We treated out patients ( n = 240 ; Ze 117 : 126 ; fluoxetine : 114 ) with mild to moderate depressive episodes ( ICD-10 : F 32.0 , F 32.1 ; HAMD range : 16 - 24 ) with either two tablets St John 's wort ( Ze 117 ; 500 mg extract/day ) or fluoxetine ( 20 mg/day ) for 6 weeks . Antidepressant efficacy was evaluated with the vali date d HAMD psychometric method . A vali date d analysis of HAMD subscores was made to verify the efficacy for certain depressive symptoms . The main results were : * The HAMD responder rate was 60 % in the Ze 117 group compared to 40 % in the fluoxetine group ( p = 0.005 ) . * Particularly , there was a marked decrease of depressive agitation ( pre-post comparison : 46 % ) and anxiety symptoms ( 44 % ) during the therapy with St. John 's wort . Depressive obstruction ( 44 % ) and sleep disorders ( 43 % ) were reduced during the treatment , too . There were no statistically significant differences between the treatment groups . * Adverse events occurred in 28 patients ( 25 % ) in the fluoxetine group and in 18 ( 14 % ) of the St. John 's wort group ( p fluoxetine regarding overall depressive symptoms and main symptoms of depressive episodes . An especially interesting overall observation is that Ze 117 is particularly effective in depressive patients suffering from anxiety symptoms . St. John 's wort revealed better safety and tolerability data than fluoxetine",
"It has been suggested that serotonin reuptake inhibitors ( SSRIs ) may be less effective than tricyclic antidepressants ( TCAs ) in treatment of melancholic depression . We treated 36 depressed ambulatory patients with doxepin or fluoxetine in a double-blind , r and omized 6-week trial with placebo run-in . Seven patients treated with doxepin and 13 patients treated with fluoxetine met diagnostic criteria for melancholic depression . Average daily dose was 169.4 + /- 41.6 mg for doxepin and 36.8 + /- 18 mg for fluoxetine . We observed a 50 % response rate in both treatment groups , using as outcome criterion reduction of Hamilton Depression Scale Score to less than 10 . Regardless of how strict the definition of response , we found fluoxetine to be as effective as doxepin in our group of melancholic out patients",
"This double-blind , r and omised , multicentre study compared the antidepressant efficacy and safety of two doses of milnacipran ( 100 mg/day and 200 mg/day ) and fluoxetine ( 20 mg/day ) in 289 in patients with endogenous depression . After a placebo washout period of 4–7 days , assessment s were performed weekly during ; the first 4 weeks , and then after 6 , 8 and 12 weeks , using the 17-itein Hamilton Depression Rating Scale ( HDRS ) . the Montgomery - Åsberg Depression Rating Scale ( MADRS ) and the Clinical Global Impression ( CGI ) . HDRS total score was reduced by a mean of 14.8 in the milnacipran 100 mg/day group , 12.9 in the milnacipran 200 mg/day group and 12.1 in the fluoxetine 20 mg/day group . MADRS total score decreased by 17.4 , 15.8 and 14.6 , respectively . No significant difference could be shown between the three treatment groups for either the HDRS or MADRS total scores . However , the time-by-time change showed a trend in favour of milnacipran 100 mg/day , which was found significantly superior to fluoxetine at day 28 for several converging parameters ( MADRS , CGI-3 ) . Overall , efficacy ratings for all parameters were highest for milnacipran 100 mg/day , followed by milnacipran 200 mg/day and fluoxetinc 20 mg/day . Side-effect profiles were not significantly different between groups except for a significantly greater frequency of dose-related increase hi heart rate ≥ 100 bpm in milnacipran recipients and a significantly greater weight loss in fluoxetine recipients",
"BACKGROUND Previous small trials have suggested that nefazodone does not suppress rapid-eye-movement ( REM ) sleep or increase REM latency in depressed patients , in contrast to fluoxetine . The effects of nefazodone and fluoxetine on sleep architecture and on clinician- and patient-rated sleep measures were directly compared in this 8-week , multicenter , double-blind , r and omized , parallel-group study . METHOD Forty-four out patients with moderate to severe , nonpsychotic major depressive disorder ( DSM-III-R ) and insomnia were r and omly assigned to receive nefazodone ( Days 1 - 7 , 200 mg/day ; Days 8 - 56 , 400 mg/day ) or fluoxetine ( Days 1 - 56 , 20 mg/day ) . Sleep measures were obtained at baseline , while patients were unmedicated , and at Weeks 2 , 4 , and 8 of treatment . RESULTS In 43 evaluable patients ( 23 nefazodone , 20 fluoxetine ) , nefazodone and fluoxetine demonstrated similar antidepressant efficacy . All significant values were p sleep efficiency and REM sleep and increased number of awakenings , Stage 1 sleep , and REM latency compared with baseline . In contrast , nefazodone significantly decreased percentage of awake and movement time and did not alter sleep efficiency or number of awakenings , Stage 1 or REM sleep , or REM latency compared with baseline . Nefazodone was associated with significantly less change from baseline for sleep efficiency , number of awakenings , percentage of awake and movement time , percentage of REM and Stage 1 sleep , and REM latency compared with fluoxetine . Both fluoxetine- and nefazodone-treated patients also showed significant improvement in some clinician- and patient-rated sleep disturbance scores , but nefazodone-treated patients improved to a significantly greater extent than fluoxetine-treated patients in most measures . CONCLUSION While nefazodone and fluoxetine showed equivalent antidepressant efficacy , more objective , subjective , and clinician-rated measures of sleep disturbance were improved during treatment with nefazodone than with fluoxetine . These results suggest that antidepressant effects of medications can occur independently of drug-induced changes in objective , subjective , and clinician-rated measures of sleep . Further studies , including parallel placebo-controlled comparisons with nefazodone , are needed to further test this hypothesis",
"In a r and omized , controlled , double-blind trial , 70 patients ( mean age , 49.7 years ) suffering from mild to moderate depression received one tablet of either St. John ’s Wort ( Hypericum perforatum ) extract ( Calmigen ® ) or fluoxetine hydrochloride ( Prozac ® ) twice a day for 6 weeks . Efficacy was determined according to the 17-item Hamilton Rating Scale for Depression ( HAMD ) , the von Zerssen depression scale ( DS ) , Clinical Global Impression ( CGI ) , and patients ’ overall evaluation . Significant decreases ( P the HAMD score and of 42 % and 52 % on the DS spoke to the efficacy of both medications . TheHypericum extract achieved 83 % of the efficacy of fluoxetine on the HAMD and 78 % on the DS . Assessment s by physicians ( CGI ) and patients indicated considerable improvement with no between-treatment differences . Of the 9 dropouts ( 13 % ) , 2 in theHypericum group and 2 in the fluoxetine group were due to adverse reactions . Safety evaluations demonstrated only minor changes . TheHypericum preparation tested in this study is therapeutically equivalent to fluoxetine and is therefore a rational alternative to synthetic antidepressants",
"Fluoxetine , a selective serotonin uptake inhibitor ( mean dose 73 mg each morning ) was compared with amitriptyline ( mean dose 122 mg at night ) in a double-blind study of 64 depressed out- patients . Fifty patients completed the 6-week trial . The drugs did not differ with respect to psychiatrists ' ratings , but amitriptyline was slightly superior with respect to patients ' ratings . The amitriptyline-treated group had complaints of dry mouth and dizziness on st and ing ; the fluoxetine-treated group of sleep disturbances , nausea , and headaches",
"Fluoxetine , a selective serotonin reuptake inhibitor , was compared to amineptine , a tricyclic antidepressant agent , in the treatment of 63 out patients with major depressive disorders of mild or moderate severity . Patients were r and omly assigned to 6 weeks of treatment with either fluoxetine or amineptine . Fluoxetine was found to have a more marked therapeutic effect than that of amineptine : better efficacy , fewer side-effects , and quicker and better improvement on the self evaluation scales",
"OBJECTIVE The atypical subtype of depression appears to be both well vali date d and common . Although monoamine oxidase inhibitors are effective in treating atypical depression , their side effects and prescription-associated dietary restrictions reduce their suitability as a first-line treatment . The objective of this study was to estimate the efficacy of the selective serotonin reuptake inhibitor ( SSRI ) fluoxetine in the treatment of major depression with atypical features . METHOD One hundred fifty-four subjects with DSM-IV major depression who met the Columbia criteria for atypical depression were r and omly assigned to receive fluoxetine , imipramine , or placebo for a 10-week clinical trial . Imipramine was included because its known efficacy for treatment of atypical depression helped to calibrate the appropriateness of the study group . RESULTS In both intention-to-treat and completer groups , the effectiveness of both fluoxetine and imipramine was significantly better than that of placebo . The two medications did not differ from each other in effectiveness . Significantly more patients dropped out of treatment with imipramine than with fluoxetine . Before treatment , patients on average rated themselves as very impaired on psychological dimensions of general health and moderately impaired on physical dimensions , compared with population norms . The self-ratings of patients who responded to treatment essentially normalized on these measures . CONCLUSIONS Despite earlier data that SSRIs might be the treatment of choice , fluoxetine appeared to be no better than imipramine in the treatment of atypical depression , although fluoxetine was better tolerated than imipramine",
"The efficacy and the tolerance of milnacipran ( 100 mg/day ) , a second generation antidepressant which equipotently inhibits both noradrenaline and serotonin reuptake , was compared to fluoxetine ( 20 mg/day ) , a selective serotonin reuptake inhibitor , in two parallel groups of , respectively , 97 and 93 major depressive out patients . The duration of the study was 6 weeks , with assessment s every 2 weeks by means of the Montgomery and Asberg depression scale ( MADRS ) , the Hamilton depression scale , the clinical global impressions ( CGI ) , and a checklist of symptoms and side-effects . Results showed significant superiority of fluoxetine over milnacipran on most rating instruments : MADRS ( P=0.01 ) including five individual items , Hamilton depression scale ( P=0.002 ) including ten individual items , CGI of severity ( P=0.01 ) and therapeutical index ( P=0.002 ) . On visual analogue scales assessing the clinical profile of the compounds , fluoxetine was rated as exhibiting more psychostimulating activity than milnacipran ( P=0.0008 ) . The tolerance of the two antidepressants was very similar , with the exception of symptoms of dizziness which were more frequently reported with milnacipran ( P=0.01 ) . These differences in efficacy favoring fluoxetine could result from the selection of a dose of milnacipran below the optimal therapeutic dose for this type of psychiatric patients or to the administration of the compounds in single daily intakes , whereas milnacipran possesses a plasma elimination half-life of only 7",
"A common presentation for major depression includes psychomotor agitation . However , this subtype has been the infrequent subject of controlled investigation during depression trials . Yet , the subcategorization of agitated depression has historically been associated with the belief that older , sedating compounds have a superior risk : benefit profile . In the 8-week , double-blind , r and omized , parallel trial , 124 subjects with Research Diagnostic Criteria -compatible agitated depression were r and omized to either imipramine ( IMI ) or fluoxetine ( FLU ) . Both compounds proved to be similarly effective as measured by change in HAM-D17 , HAM-D17 response , and HAM-D17 remission rates . Similar comparability was seen in secondary measures of agitation , anxiety , suicidality , and global impressions . However , of note , a statistically significant difference in early discontinuations because of intolerable adverse events emerged . Whereas 43.5 % of IMI subjects discontinued early , only 9.7 % of FLU subjects ( p central nervous system events characterized the IMI than the FLU subgroup ( IMI , 24.2 % , vs. FLU , 6.5 % ; p = 0.006 ) . In conclusion , among subjects with major depression , subtype agitated , the risk : benefit profile favored FLU over IMI . This was driven by the superior tolerance of FLU . No evidence emerged in support of the clinical hypothesis that a “ sedating ” agent is the treatment of choice for this group . The results are important when striving to maximize compliance with pharmacotherapy in order to minimize recidivism and associated psychological and economic morbidity . ( J Clin Psychopharmacol 1994;14:385–391",
"BACKGROUND Major depression with high levels of anxiety ( anxious depression ) is a common subtype of depression associated with greater psychosocial impairment and poorer response to antidepressant treatment . It is unclear whether in this population there are differences in efficacy or tolerability across selective serotonin reuptake inhibitors . For this reason , using head-to-head acute treatment comparison , we compared efficacy and tolerability of fluoxetine , sertraline , and paroxetine among depressed patients with high levels of anxiety . METHODS Patients ( N = 108 ) with DSM-IV major depression and high levels of anxiety ( a HAM-D-Anxiety/Somatization Factor score > or = 7 ) were r and omized to fluoxetine , sertraline , or paroxetine treatment in a double-blind fashion . Changes in overall depression and anxiety were assessed . RESULTS Patients demonstrated similar baseline-to-endpoint improvement in HAM-D-17 and HAM-D-Anxiety/Somatization Factor scores . Patients also demonstrated similar change-over-time improvement in HAM-D-17 and HAM-D-Anxiety/Somatization Factor scores , except at week one where fluoxetine- and sertraline-treated patients had statistically significantly greater improvement than paroxetine-treated patients in the HAM-D-Anxiety/Somatization Factor score . There were no significant differences across treatments in percentages of patients with substantial emergence , any worsening , or improvement at endpoint in individual HAM-D Items 9 ( agitation ) , 10 ( psychic anxiety ) , and 11 ( somatic anxiety ) . Overall , all treatments were well tolerated . CONCLUSION These data showed no significant differences in efficacy and tolerability of fluoxetine , sertraline , and paroxetine in patients with high levels of baseline anxiety symptoms during the acute treatment of major depression . Each treatment was similarly effective in improving depression in this subtype of patients with anxious depression",
"BACKGROUND Sertraline and fluoxetine have pharmacokinetic and pharmacologic differences , which may be of clinical relevance . METHOD A r and omized , double-blind , parallel-group study of 6 weeks ' duration comparing the efficacy and safety of sertraline ( 50 - 100 mg/day ) with those of fluoxetine ( 20 - 40 mg/day ) was conducted in 286 psychiatric out patients with DSM-III-R major depression or bipolar disorder ( depressed ) . Primary efficacy measurements consisted of the 17-item Hamilton Rating Scale for Depression ( HAM-D ) and the Clinical Global Impressions ( CGI ) scale . Secondary measurements included the Hamilton Rating Scale for Anxiety ( HAM-A ) , the Raskin Depression Scale , the Covi Anxiety Scale , and the Leeds Sleep Question naire . Additionally , scores for two items and five factors from the HAM-D were analyzed . RESULTS Efficacy was based on 124 evaluable patients in each treatment group . As measured by HAM-D and CGI-Severity scores , there was a significant ( p CGI-Improvement responder rates were 69 % for sertraline and 67 % for fluoxetine . Results of secondary efficacy measurements followed the same trend , although from the second week of treatment there was a numerical advantage ( not statistically significant ) for sertraline over fluoxetine in improving anxiety symptoms as measured by the total HAM-A score . Headache and nausea were the most frequently reported events for both drugs . The incidence of early patient withdrawals due to treatment-emergent adverse events was 14 % for sertraline and 13 % for fluoxetine . The starting dosage ( sertraline 50 mg/day , fluoxetine 20 mg/day ) was the final dosage in 76 % of patients in both treatment groups . CONCLUSION Sertraline and fluoxetine were equally effective and well tolerated in patients with major depression and associated anxiety",
"The temporal dimension , particularly anticipation , appears to he a very important component in the underst and ing of depressed patients . In a 90-day multieentre study , the efficacy and acceptability of amineptine and fluoxetine were compared in 169 patients with major depression . Comparison of the two antidepressants was bused on double-blind methods , after r and om allocation of the treatments between two parallel groups . The two drugs did not differ over the whole course of the study , but the improvement in scores on day 4 was globally more marked in the amineptine than the fluoxetine group . Intragroup analysis showed that amineptine was significantly superior to fluoxctine on the retardation pole of the mood , anxiety , retardation , danger scale . The positive effect of amineptine on anticipation may enable the depressed patient to make plans for the future . Anticipation may be a key dimension to be more precisely explored in specific psychopharmacological protocol s with antidepressants",
" The efficacy and safety of fluoxetine , a new antidepressant agent , were assessed in a double-blind , parallel , r and omized study of 44 out patients with major depressive disorder . Following a 1-week placebo period , patients were r and omly assigned to either fluoxetine or amitriptyline for a period of 5 weeks . The mean maintenance dosages were 55 mg/day for fluoxetine and 159 mg/day for amitriptyline . Both drugs were effective in relieving the symptoms of depression . The most frequently reported side effects were nausea and nervousness for fluoxetine , and dry mouth , dizziness , and drowsiness for amitriptyline",
"The efficacy and tolerability of the selective reversible monoamine oxidase A inhibitor , moclobemide ( 300 mg/day ) and the selective serotonin uptake inhibitor , fluoxetine ( 200 mg/day ) , were compared in a six-week single-centre double-blind fixed-dose study in patients ( n = 42 ) with double depression ( DSM-III-R : dysthymia with superimposed major depressive episode ) using weekly assessment on the Hamilton depression rating scale ( HDRS-17 items ) and clinical global impression ( CGI ) scale . The primary efficacy outcome measure was a decrease > or = 50 % in end of treatment HDRS score , secondary measures were the mean total endpoint HDRS scores and percentages of CGI very good and good responses . Tolerability was measured by the frequency and severity of volunteered adverse events . There were no significant differences in secondary efficacy outcome measures , but more patients achieved a > or = 50 % decrease in HDRS score on moclobemide ( 71 % vs 38 % , p mild transient anxiety ( n = 1 ) with moclobemide . The results suggest that moclobemide and fluoxetine are equally well tolerated and at least similar in efficacy in double depression . Evidence that moclobemide may be more effective requires confirmation in a larger comparative study incorporating a placebo control group",
"The safety and efficacy of nortriptyline and fluoxetine were compared in a double-blind , r and omized , multicenter 5-week trial involving 205 out patients with acute major depression of moderate severity . Seventy-two nortriptyline and 84 fluoxetine patients completed at least 2 weeks of medication and were included in the efficacy analysis ; all patients were evaluated for side effects . Average total scores on the Hamilton Rating Scale for Depression ( HAM-D ) for both treatment groups declined from 22 - 23 at baseline to 11.5 at the conclusion of the 5-week period . At Week , 5 , 71 % of nortriptyline patients and 65 % of fluoxetine patients were much or very much improved . Fluoxetine was associated more frequently with nausea ( p less than .05 ) , while nortriptyline was associated more frequently with dry mouth ( p less than .05 ) . These results are discussed in the context of selecting between nortriptyline and fluoxetine for a particular depressed patient",
"OBJECTIVE To compare the efficacy and tolerability of mirtazapine and fluoxetine in depressed in patients and out patients . METHOD Patients with a major depressive episode ( DSM-III-R ) , a baseline score of > or=21 on the 17-item Hamilton Rating Scale for Depression ( HAM-D ) , and > or=2 on HAM-D Item 1 ( depressed mood ) were r and omly assigned to a 6-week treatment with either mirtazapine ( N=66 , 15 - 60 mg/day ) or fluoxetine ( N=67 , 20 - 40 mg/day ) . The upper limit of the mirtazapine dose range was above the dose range approved in the United States ( 15 - 45 mg/day ) . Efficacy was evaluated by the HAM-D , Clinical Global Impressions , the Visual Analogue Mood Rating Scale ( VAMRS ) , and the Quality of Life Enjoyment and Satisfaction Question naire ( QLESQ ) . The efficacy analyses were performed on the intent-to-treat group using the last-observation-carried-forward method . RESULTS Mean total 17-item HAM-D scores at baseline were 26.0 for the mirtazapine- and 26.1 for the fluoxetine-treated group . The decrease from baseline on the HAM-D was larger in the mirtazapine than in the fluoxetine group throughout the treatment period , reaching statistical significance at days 21 and 28 . At assessment s from day 21 and onward , the absolute difference between the 2 study groups favoring mirtazapine ranged from 3.7 to 4.2 points , the magnitude of difference usually seen between an efficacious antidepressant drug and placebo . Mean dosages at weeks 1 - 4 were 36.5 mg/day for mirtazapine and 19.6 mg/day for fluoxetine ; the respective dosages at weeks 5 - 6 were 56.3 mg and 35.8 mg . Similar numbers of patients dropped out due to adverse events ; tolerability profiles were comparable except for changes in body weight from baseline which were statistically significantly more pronounced in the mirtazapine group compared to the fluoxetine group . CONCLUSION We found that mirtazapine was as well tolerated as fluoxetine and significantly more effective after 3 and 4 weeks of therapy",
"In the present double-blind controlled study the efficacy and safety of fluoxetine 20 mg/day versus clomipramine 75 mg/day was evaluated during 5 weeks of treatment in 30 hospitalized patients . The sample was selected according to DSM III criteria for major depressive disorders with a score of at least 18 on the first 17 items of the Hamilton Rating Scale for Depression ( HRSD ) . Therapeutic efficacy was evaluated weekly by using HRSD , Zung Self Rating Scale for Depression , Montgomery-Asberg Scale for Depression , Clinical Global Impression for severity and improvement of depressive symptoms . Safety was monitored weekly by recording body weight , blood pressure , pulse rate , temperature , physical conditions , laboratory tests , adverse experiences and concomitant medication . The results confirm the effectiveness and good tolerability of fluoxetine in the treatment of depressive disorders ",
"A double-blind clinical trial was undertaken to evaluate clinical efficacy and safety of fluoxetine in comparison with the st and ard tricyclic antidepressant , imipramine , in the treatment of depressive illness . The opportunity was taken to compare the relationship of some st and ard measures of depressive illness , two observer based -- Hamilton Depression Rating Scale and the Montgomery-Asberg Depression Rating Scale ( Montgomery and Asberg , 1979)-- and a self-rating scale -- Levine Pilowsky Depression question naire ( Pilowsky et al. , 1969 )",
"8 general practitioners and 7 specialists in the field of psychiatry and neurology participated in this study evaluating the results of fluoxetine treatment in out patients with depression in respect to safety and efficacy . They were familiarized with the requisite instruments by video rater training . The study was design ed as a r and omised double-blind parallel study involving 139 patients , comparing the effects of a daily dosage of 20 mg fluoxetine , 40 mg fluoxetine and 50 mg clomipramine . The number of patients treated in each group was 45 , 46 , and 48 , respectively and altogether 125 completed the four-week study ( five visits ) . A comparison of overall efficacy ratings showed significant antidepressant efficacy in all three treatment groups . On day 14 of the study ( visit 4 ) , patients receiving 40 mg fluoxetine showed significantly ( p less than 0.05 ) better global improvement than patients receiving clomipramine . Treatment was well tolerated by all patients . The frequency of adverse events in response to fluoxetine was lower than under clomipramine treatment . On comparing treatment by psychiatrist and general practitioner no significant differences were found regarding age , sex , number of previous episodes and duration of the recent episode and outcome . Severe depression tended to be treated by psychiatrists ; general practitioners prescribed additional medication less frequently",
"Fluoxetine , a selective inhibitor of 5-HT uptake , was compared to dothiepin in a double-blind study of 6 weeks duration in 100 depressed patients ( male and female ) drawn from 8 general practice s. Only those who scored at least 17 on the first 17 questions of the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) were selected . Both groups improved throughout the trial , though the dothiepin treated patients tended to improve quicker . However , by the end of the trial there was no statistically significant difference between the 2 groups . Subset analyses of HAM-D scores associated with anxiety and sleep revealed no statistically significant differences between the 2 treatments though improvement in anxiety scores was marginally greater for those receiving fluoxetine by the end of the trial . Other global assessment s by patients and doctors confirmed the changes in HAM-D scores . Statistically significant weight changes occurred between visits 1 and 5 . Whereas fluoxetine-treated patients lost weight ( p less than 0.05 ) , dothiepin-treated patients gained weight ( p = 0.05 ) over this period . Adverse effects were reported in 27 patients given fluoxetine and 20 dothiepin . Of these , 14 fluoxetine and 7 dothiepin-treated patients withdrew before the end of the trial . The most common adverse effects were nausea , vomiting and diarrhoea in the fluoxetine group and tiredness , drowsiness and diarrhoea in the dothiepin group . There were no haematological or clinical chemistry changes ",
"Whether fluoxetine ( FX ) is effective in the treatment of anxious depression is still debated . In the present study , after one week of placebo ( single blind ) , 142 out patients affected by major depression with relevant anxiety and agitation were r and omly assigned ( double blind ) to either FX ( 20 mg/day ) ( n. 67 ) or amitriptyline ( AM ) ( daily dose : 115+/-39.2 mg ) ( n.75 ) for a period of 10 weeks . Between groups , the mean score of Hamilton Rating Scale for Depression ( HRSD ) was significantly different only after 3 weeks of treatment ( AM 14.7+/-5.7 vs FX 17.3+/-6.2 ( p = 0.02 ) , whereas at the end of the trial it was similar ( AM 8.15+/-6.9 ; FX 8.96+/-6.6 ) . At each visit , no significant difference between groups was found regarding the scores of the HRSD items \" psychic anxiety \" , \" somatic anxiety \" , \" agitation \" . Furthermore , the FIX treatment did not increase the scores of the items \" suicide \" , \" psychic anxiety \" , \" somatic anxiety \" , \" agitation \" and \" insomnia \" . These findings suggest that patients affected by major depression with anxiety and /or agitation were effectively and safely treated with FX without increasing risks",
"OBJECTIVE Many cl aims have been made for superior compliance with selective serotonin reuptake inhibitors ( SSRIs ) compared with tricyclic antidepressants , but to date meta-analyses have not confirmed reduced dropouts in r and omized controlled trials . The authors used a r and omized study design to evaluate differential compliance with antidepressant medications in a primary care setting . METHOD A total of 152 patients treated in 10 primary care practice s in the United Kingdom were included in a r and omized , open-label , parallel-group study of fluoxetine and dothiepin at therapeutic doses for 12 weeks . Compliance was assessed by using pill count , patient question naires , and the Medication Event Monitoring System . RESULTS The level of compliance with fluoxetine was numerically higher than the level of compliance with dothiepin on all three primary outcome measures , although the differences were not significant . In a secondary analysis using data from the Medication Event Monitoring System , both a survival analysis for length of time without a gap in medicine taking and a derived compliance index showed a significant advantage to fluoxetine . Patients in the fluoxetine group reported superior response on the health transition scale of the 36-item Short-Form Health Survey Question naire and numerically greater improvement on the Hamilton Depression Rating Scale . In both treatment arms patients with a superior compliance index were more likely to have improved in Hamilton depression scale scores by the last study visit . CONCLUSIONS This study supports recent meta-analyses of SSRIs versus tricyclic antidepressants in finding no significant differences in crude indices of compliance between fluoxetine and dothiepin , despite marked differences in side effect profile and dose regimen . However , both a survival analysis and a new measure that takes account of prolonged periods of noncompliance distinguished between the treatments and was associated with improvement in both groups",
"The antidepressant efficacy and side effect profile of a fixed dose of 20 mg/day of fluoxetine , a specific serotonin reuptake inhibitor , were compared to those of amitriptyline . Fifty-eight patients with DSM-III-R depression were r and omly assigned to receive either fluoxetine or amitriptyline . Fifty-six patients ( fluoxetine N = 23 , amitriptyline N = 23 ) completed the 6 week study . Comparable antidepressant efficacy was demonstrated for the two drugs . Patients taking fluoxetine reported less side-effects than those taking amitriptyline",
"Depression is associated with considerable morbidity and mortality . As depressive disorders carry a high risk of relapse , treatment strategies include the use of a 6-month continuation period after resolution of the acute episode . Tolerability is of major importance when determining compliance and outcome during long-term therapy . Due to the superior tolerability profile of the selective serotonin reuptake inhibitors ( SSRIs ) over the older tricyclic antidepressants ( TCAs ) , the former may be more suitable for extended therapy . Comparative studies have not shown differences between the SSRIs in terms of efficacy , but side-effect profiles may vary . A multicenter , double-blind , comparative study of sertraline and fluoxetine was carried out in out patients fulfilling DSM-III-R criteria for major depressive disorder . Patients were r and omised to receive sertraline ( 50 - 150 mg , n = 118 ) or fluoxetine ( 20 - 60 mg , n = 120 ) for 24 weeks . Assessment s for depression ( HAM-D , HAD , CGI-I , CGI-S ) , anxiety ( Covi ) , sleep ( Leeds Sleep Evaluation scale ) and quality of life ( SIP ) were made at study entry and at weeks 2 , 4 , 8 , 12 , 18 and 24 . All adverse events were recorded to allow evaluation of tolerability . In total , 88 patients in the sertraline group completed the study compared with 79 in the fluoxetine group . Side effects were responsible for the premature treatment withdrawal of seven ( 6 % ) sertraline patients and 12 ( 10 % ) fluoxetine patients . Two-hundred and thirty-four patients were included in an ITT analysis up to last visit ( 116 sertraline , 118 fluoxetine ) . At study endpoint , both treatments produced a significant improvement over baseline on all efficacy variables ( P changes in depression , anxiety , and quality of life was larger with sertraline than fluoxetine , none of the between-group differences reached statistical significance . However , significant differences in favour of sertraline were observed for individual HAM-D items including item 4 ( insomnia onset ) ( P = 0.04 ) , item 9 ( agitation ) ( P = 0.02 ) , and item 13 ( general somatic symptoms ) ( P = 0.008 ) . In addition , sertraline was associated with significantly superior performance on the Leeds Sleep Evaluation scale and on SIP items relating to sleep and rest , emotional behaviour and ambulation . Both sertraline and fluoxetine were well tolerated with no significant differences between treatments",
"BACKGROUND Duloxetine hydrochloride , a dual reuptake inhibitor of serotonin and norepinephrine , was evaluated for therapeutic efficacy and safety/tolerability in the treatment of major depression . METHOD In an 8-week multicenter , double-blind , placebo-controlled study , 173 patients ( aged 18 - 65 years ) with DSM-IV major depressive disorder were r and omly allocated to receive placebo ( N = 70 ) , duloxetine ( N = 70 ) , or fluoxetine , 20 mg q.d . ( N = 33 ) . Duloxetine dose was titrated in the first 3 weeks in a forced-titration regimen from 40 mg ( 20 mg b.i.d . ) to 120 mg/day ( 60 mg b.i.d . ) . Patients were required to have a Clinical Global Impressions (CGI)-Severity of Illness scale score of at least moderate severity ( > or = 4 ) and a 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score of at least 15 . Patients could not have had any current primary DSM-IV Axis I diagnosis other than major depressive disorder , or any anxiety disorder as a primary diagnosis within the past year , excluding specific phobias . The primary efficacy measurement was the HAM-D-17 total score , and secondary measures included the Montgomery-Asberg Depression Rating Scale , CGI-Severity of Illness and CGI-Improvement , and Patient Global Impression of Improvement . Safety was evaluated by recording the occurrence of discontinuation rates and treatment-emergent adverse events and by measurement of vital signs and laboratory analytes . RESULTS Duloxetine was superior to placebo in change on the HAM-D-17 ( p = .009 ) . Estimated probabilities of response and remission were 64 % and 56 % , respectively , for duloxetine , compared with 52 % and 30 % for fluoxetine and 48 % and 32 % for placebo . Duloxetine was numerically superior to fluoxetine on the primary and most of the secondary outcome measures . In general , duloxetine was well tolerated ; 76 % of patients achieved the maximum dose , and insomnia and asthenia were the only adverse events reported statistically significantly ( p duloxetine-treated patients compared with placebo-treated patients . CONCLUSION These data indicate that duloxetine is efficacious for the treatment of major depressive disorder and is well tolerated and safe",
"This r and omized , double-blind , parallel-group design study of 100 out patients with major depressive disorder is the first study in the United States to compare the efficacy and tolerability of fluvoxamine ( 100 - 150 mg/day ) and fluoxetine ( 20 - 80 mg/day ) . After a variable , single-blind , washout period , patients were r and omized to receive either fluvoxamine ( 51 patients ) of fluoxetine ( 49 patients ) for 7 weeks . Efficacy was assessed with the 21-item Hamilton Rating Scale for Depression ( HAM-D ) , and Clinical Global Impressions scale for severity and improvement . Eighty-four percent of each treatment group completed the study with each group having a mean score at end point of less than 10 . Both groups demonstrated a 60 % improvement in HAM-D scores over the 7-week trial . There were no statistically significant differences observed between the two groups on any efficacy parameter . The medications were well tolerated , with only two patients in each group who were terminated because of side effects . There were differences in the side-effect profiles , with fluvoxamine being associated with less nausea than fluoxetine . In summary , fluvoxamine and fluoxetine were equally effective in reducing depressive symptoms , but the two drugs displayed slightly different side-effect profiles ",
"BACKGROUND Sleep disturbances are common in major depressive disorder . In previous open-label trials , nefazodone improved sleep continuity and increased rapid eye movement ( REM ) sleep , while not affecting stage 3/4 sleep or REM latency : in contrast , fluoxetine suppressed REM sleep . This study compared the objective and subjective effects of nefazodone and fluoxetine on sleep . METHODS This paper reports combined results of three identical , multisite , r and omized , double-blind , 8-week , acute-phase trials comparing nefazodone ( n = 64 ) with fluoxetine ( n = 61 ) in out patients with nonpsychotic major depressive disorder and insomnia . Sleep electroencephalographic ( EEG ) recordings were gathered at baseline and weeks 2 , 4 , and 8 . Clinical ratings were obtained at weeks 1 - 4 , 6 , and 8 . RESULTS Nefazodone and fluoxetine were equally effective in reducing depressive symptoms ; however , nefazodone differentially and progressively increased ( while fluoxetine reduced ) sleep efficiency and reduced ( while fluoxetine increased ) the number of awakenings in a linear fashion over the 8-week trial . Fluoxetine , but not nefazodone , prolonged REM latency and suppressed REM sleep . Nefazodone significantly increased total REM sleep time . Clinical evaluations of sleep quality were significantly improved with nefazodone compared with fluoxetine . CONCLUSIONS Nefazodone and fluoxetine were equally effective antidepressants . Nefazodone was associated with normal objective , and clinician- and patient-rated assessment s of sleep when compared with fluoxetine . These differential sleep EEG effects are consistent with the notion that nefazodone and fluoxetine may have somewhat different modes and spectra of action",
"In a multicentre , double blind , parallel group study 281 patients with DSM III-R diagnosis of dysthymia or a single episode of major depression in partial remission were r and omised to 3 months of treatment with amisulpride 50 mg/day or fluoxetine 20 mg/day . The baseline Montgomery and Asberg Depression Rating Scale ( MADRS ) total score was reduced by at least 50 % in 74.1 % of patients ( 103/139 ) with amisulpride and 67.4 % ( 87/129 ) with fluoxetine ( P = 0.230 ) . No significant differences between treatment groups were found in the reductions in mean total score with the MADRS , Widlöcher psychomotor retardation scale , Sheehan disability scale , and CGI . Anxiety measured by HAM-A total mean score decreased significantly more with amisulpride ( 63 % ) than with fluoxetine ( 54 % ; P = 0.021 ) . There were 13 dropouts due to adverse events with amisulpride and ten with fluoxetine . The number of patients reporting at least one adverse event was similar in the two groups ( amisulpride 47.5 % ; fluoxetine 40.9 % ) . As expected , in the amisulpride group endocrine-like adverse events in female patients were the most common , while nausea , dyspepsia , anorexia and insomnia occurred more frequently with fluoxetine",
"The objective of the present study was to compare the safety and efficacy of moclobemide versus fluoxetine in adult patients with major depressive disorder . The design of the study was a multicenter , double-blind , comparative , and r and omized trial . A 1- to 2-week single-blind placebo washout phase was followed by 6 weeks of double-blind treatment with moclobemide or fluoxetine . A total of 150 patients were enrolled in the study . There were 128 patients eligible to be r and omized , with 66 patients receiving moclobemide and 62 patients receiving fluoxetine . At the termination of the study , patients in the moclobemide group were receiving a mean dose of 440 mg + /- 123 mg , while the mean dose in the fluoxetine group was 35 mg + /- 8 mg . No significant treatment differences were found for any of the efficacy parameters . Headache and nausea were the most frequently reported adverse events in both treatment groups . Headache and blurred vision were reported significantly more often ( P fluoxetine group , whereas significantly more dry mouth was reported ( P moclobemide group . These results provide supporting evidence of the comparable efficacy of moclobemide and fluoxetine and the better tolerability of moclobemide when used in the treatment of major depressive disorder",
" A total of 27 subjects began active treatment in this double-blind study comparing the efficacy and safety of trazodone and fluoxetine in geriatric depressed patients , but only 13 completed 6 weeks on study medication . Both agents were effective according to weekly and endpoint analyses , and there was no evidence of significant effects on blood pressure , pulse , or weight . Separate analysis of patients who had received an adequate trial of medication indicated a trend toward relatively more fluoxetine-treated patients meeting clinical criteria for resolved depression . ( J Geriatr Psychiatry Neurol 1989;2:208 - 214 .",
"BACKGROUND Few studies have compared the treatment efficacy of the 2 selective serotonin reuptake inhibitors sertraline and fluoxetine . METHOD A r and omized , single-blind , parallel-group study of 10 weeks ' duration comparing the efficacy of sertraline , 50 mg/day ; sertraline , 100 mg/day ; and fluoxetine , 20 mg/day , was conducted in 44 psychiatric out patients with DSM-IV unipolar major depressive disorder . Antidepressant dosages were doubled at 6 weeks for subjects who had not achieved remission . Primary outcome measurements included the 21-item Hamilton Rating Scale for Depression ( HAM-D ) and the Clinical Global Impressions-Improvement scale ( CGI-I ) , with scores of positive treatment response were noted , with 0 % for sertraline , 50 mg ; 46 % for sertraline , 100 mg ; and 31 % for fluoxetine , 20 mg ( p = .023 ) . At 6 weeks , positive treatment response rates were 21 % , 43 % , and 31 % for subjects taking 50 mg of sertraline , those taking 100 mg of sertraline , and those taking 20 mg of fluoxetine , respectively , with treatment groups no longer differing significantly from each other . In subjects for whom antidepressant dose was doubled at week 6 , response rates at week 10 ( 4 weeks on increased dose ) were 40 % for sertraline , 100 mg ; 43 % for sertraline , 200 mg ; and 55 % for fluoxetine , 40 mg . CONCLUSION Subjects taking sertraline , 100 mg , and fluoxetine , 20 mg , demonstrated an earlier treatment response compared with subjects taking sertraline , 50 mg . For patients without a positive response at 6 weeks , an increased antidepressant dose result ed in remission for a substantial proportion of patients when assessed 4 weeks later",
" Twenty-eight elderly in patients suffering from major depressive episodes ( diagnosed according to DSM III ) received r and omly , on a double-blind basis , amitriptyline ( 75 mg/die ) or fluoxetine ( 20 mg/die ) for five weeks . There were four drop-outs in the amitriptyline group and two drop-outs in the fluoxetine group . Both groups showed a significant amelioration at the end point for Hamilton Rating Scale of Depression scores compared to the baseline value . Anticholinergic side-effects were significantly more severe in the amitriptyline group . Weight gain was detected only in patients receiving amitriptyline ",
"The efficacy and tolerability of moclobemide ( 300 or 600 mg daily ) and fluoxetine ( 20 or 40 mg daily ) were compared in a 6-week , double-blind study of 25 in patients and 24 out patients who had major depressive episodes without psychotic features ( DSM-III-R ) . Although the clinical results of this study suggest better efficacy with moclobemide and better tolerability with fluoxetine , a statistically significant difference between treatment groups was noted only with respect to Clinical Global Impressions recorded after 10 days of therapy ; these were significantly better in the moclobemide group . A daily dosage of 300 mg of moclobemide and 20 mg of fluoxetine would thus appear to be comparable both in antidepressant efficacy and tolerability",
"The aim of this study was to compare the efficacy and tolerability of reboxetine , a uniquely selective noradrenaline reuptake inhibitor , with the selective serotonin reuptake inhibitor , fluoxetine . A double-blind , r and omized , parallel-group , multicentre design was employed . One hundred and sixty-eight patients with acute major depressive episodes were r and omized to receive oral reboxetine ( 8 - 10 mg/day ) or oral fluoxetine ( 20 - 40 mg/day ) . The treatment period was 8 weeks . Reboxetine and fluoxetine were similarly effective as assessed by the mean reduction in total Hamilton Depression Rating Scale score , the percentage of responders and patients in remission , Clinical Global Impression severity of illness and global improvement scores and Montgomery-Asberg Depression Rating Scale . A sub- analysis of patients with severe depression indicated that reboxetine had superior efficacy compared with fluoxetine . Both treatments result ed in some improvement in Social Adaptation Self-evaluation Scale total scores and this was more evident for those patients treated with reboxetine who achieved remission . Both treatments were well tolerated . The results indicate that reboxetine is an effective and well tolerated antidepressant , being more effective than fluoxetine in patients with severe depression , and more effective in terms of social functioning in those patients who achieved remission",
"Fluoxetine is the first selective serotonin reuptake inhibitor antidepressant to be marketed in the U.S. In this double-blind trial fluoxetine was compared with imipramine and placebo among 198 out patients with DSM-III major depression , of whom 145 completed at least 2 weeks of active treatment and were evaluated for efficacy . Significantly fewer patients in each active drug group terminated early due to lack of efficacy compared to placebo . Both imipramine and fluoxetine were significantly superior to placebo on most measures . There were no consistently significant differences between the two active drugs although a trend favored imipramine on a number of measures . Fluoxetine was generally well tolerated . Significantly more imipramine than placebo patients terminated early due to side-effects while the fluoxetine-placebo difference was not significant . The results support previous studies which suggest fluoxetine 's superior side-effect profile and the approximate antidepressant equivalence of fluoxetine and TCAs"
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BACKGROUND Laparoscopic adjustable gastric b and ing ( LAGB ) is currently one of the most popular surgical obesity treatments worldwide . Although dietary modification is recognised as a key factor in determining weight loss and health outcomes post surgery , existing evidence regarding changes in dietary intake after LAGB has not been systematic ally evaluated . This is essential for developing best- practice dietetic guidelines for the management of LAGB patients . The aim of this systematic review was to evaluate the current evidence base regarding changes in dietary intake after LAGB . METHODS A literature search of Medline , EMBASE , Scopus , Cinahl and the Cochrane Library from 1990 to February 2010 was conducted to identify original studies that assessed dietary intake in adults who have undergone LAGB . RESULTS Only 11 articles ( 10 separate studies ) met inclusion criteria . Although the strength of the evidence base is limited by the small number of studies , observational study design s and method ological weaknesses , the results indicate that short-term positive changes occur post surgery , including reduced caloric intake , contributed to by reductions in fat , carbohydrate and protein intake . Issues including optimal macronutrient intake , diet quality and longer-term sustainability of reduced food intake remain largely unexplored . Because no dietary intervention studies were identified , evidence -based dietary strategies that may help optimise weight loss outcomes and other health outcomes remain unknown . CONCLUSIONS There is a paucity of high- quality evidence regarding changes in dietary intake after LAGB . Further well- design ed , dietary-based intervention research will be beneficial to better establish dietetic management guidelines for optimising outcomes for individuals who have LAGB
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"Background To evaluate the metabolic effects of two weight loss diets differing in macronutrient composition on features of dyslipidemia and post-pr and ial insulin ( INS ) response to a meal challenge in overweight/obese individuals . Methods This study was a parallel-arm r and omized 4 mo weight loss trial . Adults ( n = 50 , 47 ± 7 y ) matched on BMI ( 33.6 ± 0.6 kg/m2 , P = 0.79 ) consumed energy restricted diets ( deficit ~500 kcal/d ) : PRO ( 1.6 g.kg-1.d-1 protein and or CHO ( 0.8 g.kg-1.d-1 protein and > 220 g/d carbohydrate ) for 4 mos . Meal challenges of respective diets were utilized for determination of blood lipids and post-pr and ial INS and glucose response at the beginning and end of the study . Results There was a trend for PRO to lose more weight ( -9.1 % vs. -7.3 % , P = 0.07 ) with a significant reduction in percent fat mass compared to CHO ( -8.7 % vs. -5.7 % ; P = 0.03 ) . PRO also favored reductions in triacylglycerol ( -34 % vs. -14 % ; P HDL-C ( + 5 % vs. -3 % ; P = 0.05 ) ; however , CHO favored reduction in LDL-C ( -7 % vs. + 2.5 % ; P INS responses to the meal challenge were improved in PRO compared to CHO ( P loss diet with moderate carbohydrate , moderate protein results in more favorable changes in body composition , dyslipidemia , and post-pr and ial INS response compared to a high carbohydrate , low protein diet suggesting an additional benefit beyond weight management to include augmented risk reduction for metabolic disease",
"Cl aims about the merits or risks of carbohydrate ( CHO ) vs. protein for weight loss diets are extensive , yet the ideal ratio of dietary carbohydrate to protein for adult health and weight management remains unknown . This study examined the efficacy of two weight loss diets with modified CHO/protein ratios to change body composition and blood lipids in adult women . Women ( n = 24 ; 45 to 56 y old ) with body mass indices > 26 kg/m(2 ) were assigned to either a CHO Group consuming a diet with a CHO/protein ratio of 3.5 ( 68 g protein/d ) or a Protein Group with a ratio of 1.4 ( 125 g protein/d ) . Diets were isoenergetic , providing 7100 kJ/d , and similar amounts of fat ( approximately 50 g/d ) . After consuming the diets for 10 wk , the CHO Group lost 6.96 + /- 1.36 kg body weight and the Protein Group lost 7.53 + /- 1.44 kg . Weight loss in the Protein Group was partitioned to a significantly higher loss of fat/lean ( 6.3 + /- 1.2 g/g ) compared with the CHO Group ( 3.8 + /- 0.9 ) . Both groups had significant reductions in serum cholesterol ( approximately 10 % ) , whereas the Protein Group also had significant reductions in triacylglycerols ( TAG ) ( 21 % ) and the ratio of TAG/HDL cholesterol ( 23 % ) . Women in the CHO Group had higher insulin responses to meals and postpr and ial hypoglycemia , whereas women in the Protein Group reported greater satiety . This study demonstrates that increasing the proportion of protein to carbohydrate in the diet of adult women has positive effects on body composition , blood lipids , glucose homeostasis and satiety during weight loss",
"OBJECTIVE : To study the effect on weight loss in obese subjects by replacement of carbohydrate by protein in ad libitum consumed fat-reduced diets . DESIGN : R and omized dietary intervention study over six months comparing two ad libitum fat reduced diets ( 30 % of total energy ) strictly controlled in composition : High-carbohydrate ( HC , protein 12 % of total energy ) or high-protein ( HP , protein 25 % of total energy ) . SETTING AND PARTICIPANTS : Subjects were 65 healthy , overweight and obese subjects ( 50 women , 15 men , aged 18–55 y ) r and omly assigned to HC ( n=25 ) , HP ( n=25 ) or a control group ( C , n=15 ) . All food was provided by self- selection in a shop at the department , and compliance to the diet composition was evaluated by urinary nitrogen excretion . MAIN OUTCOME MEASURE : Change in body weight , body composition and blood lipids . RESULTS : More than 90 % completed the trial . Weight loss after six months was 5.1 kg in the HC group and 8.9 kg in the HP group ( difference 3.7 kg , 95 % confidence interval (CI)(1.3–6.2 kg ) P and fat loss was 4.3 kg and 7.6 kg , respectively ( difference 3.3 kg ( 1.1–5.5 kg ) P lost > 10 kg in the HP group ( 35 % ) than in the HC group ( 9 % ) . The HP diet only decreased fasting plasma triglycerides and free fatty acids significantly . CONCLUSIONS : Replacement of some dietary carbohydrate by protein in an ad libitum fat-reduced diet , improves weight loss and increases the proportion of subjects achieving a clinical ly relevant weight loss . More freedom to choose between protein-rich and complex carbohydrate-rich foods may allow obese subjects to choose more lean meat and dairy products , and hence improve adherence to low-fat diets in weight reduction programs",
"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 Gastric restrictive surgery induces a marked change in eating behavior . However , the relationship between preoperative and postoperative eating behavior and weight loss outcome has received limited attention . OBJECTIVE This study assessed a range of eating behaviors before and 1 year after laparoscopic adjustable gastric b and ing ( LAGB ) and explored the nature and extent of change in eating patterns , their clinical associates , and impact on weight loss . METHODS AND PROCEDURES A 12-month observational study assessed presurgical and postsurgical binge eating disorder ( BED ) , uncontrolled eating , night eating syndrome ( NES ) , grazing , nutrient intake and eating-related behaviors , and markers of psychological distress . A total of 129 subjects ( 26 male and 103 female , mean age 45.2 + /- 11.5 and BMI 44.3 + /- 6.8 ) participated in this study . RESULTS Presurgical BED , uncontrolled eating , and NES occurred in 14 % , 31 % , and 17.1 % of subjects , which reduced after surgery to 3.1 % , 22.5 % , and 7.8 % , respectively ( P = 0.05 for all ) . Grazing was prevalent before ( 26.3 % ) and after surgery ( 38.0 % ) . Preoperative BED most frequently became grazers ( P = 0.029 ) . The average percentage weight loss ( % WL ) was 20.8 + /- 8.5 % ; range -0.67 to 50.0 % and percentage of excess weight loss ( % EWL ) 50.0 + /- 20.7 % ; range -1.44 to 106.9 % ( P Uncontrolled eating and grazing after surgery showed high overlap and were associated with poorer % WL ( P = 0.008 and P distress . DISCUSSION Consistent with recent studies , uncontrolled eating and grazing were identified as two high-risk eating patterns after surgery . Clearer characterization of favorable and unfavorable postsurgical eating behaviors , reliable methods to assess their presence , and empirically tested postsurgical intervention strategies are required to optimize weight loss outcomes and facilitate psychological well-being in at-risk groups",
"BACKGROUND Obesity is associated with increased mortality . Weight loss improves cardiovascular risk factors , but no prospect i ve interventional studies have reported whether weight loss decreases overall mortality . In fact , many observational studies suggest that weight reduction is associated with increased mortality . METHODS The prospect i ve , controlled Swedish Obese Subjects study involved 4047 obese subjects . Of these subjects , 2010 underwent bariatric surgery ( surgery group ) and 2037 received conventional treatment ( matched control group ) . We report on overall mortality during an average of 10.9 years of follow-up . At the time of the analysis ( November 1 , 2005 ) , vital status was known for all but three subjects ( follow-up rate , 99.9 % ) . RESULTS The average weight change in control subjects was less than + /-2 % during the period of up to 15 years during which weights were recorded . Maximum weight losses in the surgical subgroups were observed after 1 to 2 years : gastric bypass , 32 % ; vertical-b and ed gastroplasty , 25 % ; and b and ing , 20 % . After 10 years , the weight losses from baseline were stabilized at 25 % , 16 % , and 14 % , respectively . There were 129 deaths in the control group and 101 deaths in the surgery group . The unadjusted overall hazard ratio was 0.76 in the surgery group ( P=0.04 ) , as compared with the control group , and the hazard ratio adjusted for sex , age , and risk factors was 0.71 ( P=0.01 ) . The most common causes of death were myocardial infa rct ion ( control group , 25 subjects ; surgery group , 13 subjects ) and cancer ( control group , 47 ; surgery group , 29 ) . CONCLUSIONS Bariatric surgery for severe obesity is associated with long-term weight loss and decreased overall mortality",
"Background Few long-term studies regarding the outcome of laparoscopic adjustable gastric b and ing for morbid obesity have so far been published . We report our 11-year experience with the technique by looking closely at the first 123 patients that have at least 5 years ( mean 86 months ) of follow-up . Methods Data have been collected prospect ively among 280 patients operated since March 1996 . Until March 2002 ( minimum 5-year follow-up ) , 123 patients have been operated laparoscopically with the Swedish b and . We report major late complications , reoperations , excess weight losses ( EWL ) and failure rates among these patients , with a mean ( range ) follow-up time of 86 months ( 60–132 ) . EWL 50 % was considered a success . Results Mean ( range ) age of the patients ( male/female ratio 31:92 ) was 43 years ( 21–44 ) . Mean ( range ) preoperative weight was 130 kg ( 92–191 ) . Mean ( range ) preoperative body mass index was 49.28 kg/m2 ( 35.01–66.60 ) . Patients lost to follow-up was nearly 20 % at 5 years and 30 % at 8 years . Major late complications ( including b and erosions 3.3 % , slippage 6.5 % , leakage 9.8 % ) leading to major reoperation occurred in 30 patients ( 24.4 % ) . Nearly 40 % of the reoperations was performed during the third year after the operation . The mean EWL at 7 years was 56 % in patients with the b and in place , but 46 % in all patients . The failure rates increased from about 15 % during years 1 to 3 to nearly 40 % during years 8 and 9 . The success rate declined from nearly 60 % at 3 years to 35 % at 8 and 9 years . Conclusions Complications requiring reoperations are common during the third year after the operation , and almost 25 % of the patients will need at least one reoperation . Mean EWL in all patients does not exceed 50 % in 7 years or 40 % in 9 years and failure rates increase with time , up to 40 % at 9 years",
"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 Gastric bypass ( GBP ) is more efficient than adjustable gastric b and ing ( AGB ) on weight loss and comorbidities , but potentially induces more nutritional deficits . However , no study has compared the prevalence of nutritional deficiencies after these two bariatric procedures .We prospect ively comparedTo prospect ively compare the prevalence of nutritional deficiencies after AGB and GBP . Methods We have performed a 1-year prospect i ve study of nutritional parameters in 70 consecutive severe obese patients , who had undergone bariatric surgery , 21 AGB and 49 GBP . After GBP , multivitamin supplements were systematic ally prescribed and vitamin B12 supplementation was introduced if a deficiency was observed . Results Patients lost more weight after GBP than after AGB ( 40 ± 13 vs 16 ± 8 kg , p ) . Vitamins B1 and C and iron deficiencies were frequent before surgery but were not worsened by GBP . AGB only induced a slight decrease of vitamin B1 at 1 year , whereas GBP induced significant decreases of vitamins B12 and E , serum prealbumin , and creatinine concentrations , with only minor clinical consequences . Anemia was observed in 10 % of the patients after bariatric surgery . Hemoglobin concentration was not correlated to vitamin B12 or folate concentrations but was related to iron status . Risk of iron deficiency anemia was better assessed by transferrin saturation than by serum ferritin concentration in this obese population . ConclusionS evere nutritional deficits can be avoided after bariatric surgery if patients are systematic ally supplemented with multivitamin and carefully monitored . However , specific care is required to avoid iron and vitamin B12 deficiencies , anemia , and protein malnutrition ",
"Background : Since its introduction about 10 years ago , and because of its encouraging early results regarding weight loss and morbidity , laparoscopic gastric b and ing ( LGB ) has been considered by many as the treatment of choice for morbid obesity . Few long-term studies have been published . We present our results after up to 8 years ( mean 74 months ) of follow-up . Methods : Prospect i ve data of patients who had LGB have been collected since 1995 , with exclusion of the first 30 patients ( learning curve ) . Major late complications are defined as those requiring b and removal ( major reoperation ) , with or without conversion to another procedure . Failure is defined as an excess weight loss ( EWL ) of reoperation . Results : Between June 1997 and June 2003 , LGB was performed in 317 patients , 43 men and 274 women . Mean age was 38 years ( 19 - 69 ) , mean weight was 119 kg ( 79 - 179 ) , and mean BMI was 43.5 kg/m2 ( 34 - 78 ) . 97.8 % of the patients were available for follow-up after 3 years , 88.2 % after 5 years , and 81.5 % after 7 years . Overall , 105 ( 33.1 % ) of the patients developed late complications , including b and erosion in 9.5 % , pouch dilatation/slippage in 6.3 % , and catheter- or port-related problems in 7.6 % . Major reoperation was required in 21.7 % of the patients . The mean EWL at 5 years was 58.5 % in patients with the b and still in place . The failure rate increased from 13.2 % after 18 months to 23.8 % at 3 , 31.5 % at 5 , and 36.9 % at 7 years . Conclusions : LGB appeared promising during the first few years after its introduction , but results worsen over time , despite improvements in the operative technique and material . Only about 60 % of the patients without major complication maintain an acceptable EWL in the long term . Each year adds 3 - 4 % to the major complication rate , which contributes to the total failure rate . With a nearly 40 % 5-year failure rate , and a 43 % 7-year success rate ( EWL > 50 % ) , LGB should no longer be considered as the procedure of choice for obesity . Until reliable selection criteria for patients at low risk for long-term complications are developed , other longer lasting procedures should be used",
"Objective : To assess body composition , eating pattern , and basal metabolic rate in patients undergoing obesity surgery in a r and omized trial . Introduction : There is limited knowledge regarding how different bariatric surgical techniques function in terms of altering body composition , dietary intake , and basic metabolic rate . Methods : Non-superobese patients were r and omized to laparoscopic Roux-en-Y gastric bypass ( LGBP , n = 37 ) or laparoscopic vertical b and ed gastroplasty ( LVBG , n = 46 ) . Anthropometry , dual-energy x-ray absorptiometry ( DEXA ) , computed tomography ( CT ) , indirect calorimetry , and reported dietary intake were registered prior to and 1 year after surgery . Results : Follow-up rate was 97.6 % . LGBP patients had significantly greater reduction of waist circumference and sagittal diameter compared with LVBG . DEXA demonstrated a larger reduction of body fat in all compartments after LGBP , especially at the trunk ( P visceral fat ( P=0.016 ) . Patients were able to eat all types of food after LGBP , although about 30 % cl aim ed they avoided fats . LGBP patients decreased their proportion of dietary fat significantly more than those operated on with LVBG ( P = 0.005 ) , who consumed more sweet foods and avoided whole meat and vegetables . Lean tissue mass ( LTM ) was proportionally less reduced , especially in men , after LGBP . The decreases in BMR postoperatively reflected the lower body mass in a pattern that did not differ among the groups . Conclusion : LGBP patients demonstrated better outcomes compared with LVBG patients in terms of body composition . Energy expenditure developed as expected postoperatively . A “ steering ” away from fatty foods after LGBP may be an important mechanism of action in gastric bypass",
"The health and quality -of-life implication s of overweight and obesity span all ages in the United States . We investigated the association between dietary protein intake and loss of lean mass during weight loss in postmenopausal women through a retrospective analysis of a 20-week r and omized , controlled diet and exercise intervention in women aged 50 to 70 years . Weight loss was achieved by differing levels of caloric restriction and exercise . The diet-only group reduced caloric intake by 2,800 kcal/week , and the exercise groups reduced caloric intake by 2,400 kcal/week and expended approximately 400 kcal/week through aerobic exercise . Total and appendicular lean mass was measured using dual energy x-ray absorptiometry . Linear regression analysis was used to examine the association between changes in lean mass and appendicular lean mass and dietary protein intake . Average weight loss was 10.8+/-4.0 kg , with an average of 32 % of total weight lost as lean mass . Protein intake averaged 0.62 g/kg body weight/day ( range=0.47 to 0.8 g/kg body weight/day ) . Participants who consumed higher amounts of dietary protein lost less lean mass and appendicular lean mass ( r=0.3 , P=0.01 and r=0.41 , P body-composition changes in postmenopausal women"
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BACKGROUND When human milk is not available for feeding preterm infants , protein hydrolysate rather than st and ard cow 's milk formulas ( with intact proteins ) are often used because they are perceived as being tolerated better and less likely to lead to complications . However , protein hydrolysate formulas are more expensive than st and ard formulas , and concern exists that their use in practice is not supported by high- quality evidence . OBJECTIVES To assess the effect of feeding preterm infants with hydrolysed formula ( versus st and ard cow 's milk formulas ) on the risk of feed intolerance , necrotising enterocolitis , and other morbidity and mortality in preterm infants . SEARCH METHODS We used the st and ard Cochrane Neonatal search strategy including electronic search es of the Cochrane Central Register of Controlled Trials ( CENTRAL ; 2017 , Issue 4 ) , Ovid MEDLINE , Ovid Embase , and the Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) ( to April 2017 ) , as well as conference proceedings and previous review s. SELECTION CRITERIA R and omised and quasi-r and omised controlled trials that compared feeding preterm infants with protein hydrolysate versus st and ard ( non-hydrolysed ) cow 's milk formula . DATA COLLECTION AND ANALYSIS Two review authors assessed trial eligibility and risk of bias and extracted data independently . We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data , and mean differences for continuous data , with respective 95 % confidence intervals ( CI ) . We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in sensitivity analyses . We assessed quality of evidence at the outcome level using the GRADE approach . MAIN RESULTS We identified 11 trials for inclusion in the review . All trials were small ( total participants 665 ) and had various method ological limitations including uncertainty about methods to ensure allocation concealment and blinding . Most participants were clinical ly stable preterm infants of gestational age less than about 34 weeks or birth weight less than about 1750 g. Fewer participants were extremely preterm , extremely low birth weight , or growth-restricted . Most trials found no effects on feed intolerance assessed variously as mean prefeed gastric residual volume , incidence of abdominal distention or other concerning gastrointestinal signs , or time taken to achieve full enteral feeds ( meta- analysis was limited because studies used different measures ) . Meta- analysis found no effect on the risk of necrotising enterocolitis ( typical risk ratio 1.10 , 95 % CI 0.36 to 3.34 ; risk difference 0.00 , 95 % CI -0.03 to 0.04 ; 5 trials , 385 infants ) ( low quality evidence ; down grade d for imprecision and design weaknesses ) . AUTHORS ' CONCLUSIONS The identified trials provide only low quality evidence about the effects of feeding preterm infants with protein hydrolysate versus st and ard formula . The existing data did not support conclusions that feeding with protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis . Further large , pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness
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"Vomiting , large gastric residuals and abdominal distension are common in very immature infants on formula feeding . The present trial investigated whether a protein hydrolysate formula reduces the gastrointestinal transit time in preterm infants . Fifteen preterm infants ( median gestational age 29 ( 24–32 ) wk , birthweight 1241 ( 660–1900 ) g , postnatal age 18 ( 5–54 ) d ) on full enteral feeds ( > 150 ml/kg*d ) were enrolled . It was hypothesized that the gastrointestinal transit time is at least 2 h shorter when protein hydrolysate formula is fed compared with st and ard preterm formula . In a r and omized cross‐over design study , each formula was fed for 5 d. On days 4 and 9 the gastrointestinal transit time was estimated using carmine red . The protein hydrolysate formula had a markedly shorter gastrointestinal transit time ( 9.8 h ) than the st and ard formula ( 19 h ) ( p= 0.0022 , two‐sided Mann‐Whitney U test )",
"BACKGROUND Gastro-esophageal reflux ( GER ) is diagnosed frequently in preterm infants . Pharmacological treatment of GER has some potential side effects . Conservative treatment of GER should be the first-line approach and should include body positioning and diet modifications . Formula-fed preterm infants experience frequently symptoms of feeding intolerance . Hydrolyzed protein formula ( HPF ) is often used in these infants due to their effects on gastrointestinal motility . AIMS To investigate the role of an extensively HPF ( eHPF ) on GER indexes in formula-fed preterm infants with symptoms of both GER and feeding intolerance . STUDY DESIGN R and omized crossover trial . SUBJECTS Preterm infants ( gestational age ≤33 weeks ) with symptoms of feeding intolerance ( large gastric residuals , abdominal distension and constipation ) and GER ( frequent regurgitations and /or postpr and ial desaturations ) . OUTCOME MEASURES GER indexes detected by 24-h combined multichannel intraluminal impedance and pH monitoring . GER indexes detected after 4 feeds of an eHPF were compared to those detected after 4 feeds of a st and ard preterm formula ( SPF ) by Wilcoxon signed ranks test . A p reduced the number of GERs detected by pH monitoring ( p=0.036 ) and also the reflux index ( p=0.044 ) compared to SPF . No differences in impedance bolus exposure indexes nor in GER height were detected . CONCLUSIONS The use of an eHPF should be evaluated for reducing esophageal acid exposure in preterm infants with feeding intolerance and symptoms of GER . Future research should focus on the evaluation of an eHPF adequate for preterm infants in improving clinical symptoms of GER",
"The allergy preventive effect of extensively ( N ) and partially ( PH ) hydrolysed cows ’ milk formulas compared with a regular formula ( RM ) was assessed in 155 infants with a family history of allergy . No cows ’ milk was given during the first nine months of life and no egg and fish up to 12 months of age . Breast feeding mothers avoided the same foods . At weaning the infants were r and omised to one of the formula groups . The cumulative incidence of atopic symptoms at 18 months was 51 , 64 , and 84 % in the N , PH , and RM groups , respectively . From 6 to 18 months there were significantly less cumulative atopic symptoms in the N group compared with the RM group , and significantly less than the PH group up to 6 ( N = 25 % ; PH = 46 % ) and 9 months ( N = 34 % , PH = 58 % ) . At 9 months significantly fewer infants in the N group ( 10 % ) than in the PH group ( 33 % ) had a positive skin prick test to eggs . The findings support an allergy preventive effect of an extensively hydrolysed formula , but not of a partially hydrolysed formula , during the first 18 months of life of high risk infants",
"Objective : To compare feeding tolerance , nutrient intake and growth in preterm infants ( ⩽32 weeks , ⩽1750 g ) fed either a st and ard nonhydrolyzed whey – casein ( nHWC ) or a partially hydrolyzed whey ( pHW ) preterm infant formula . Study Design : In this double-blind r and omized controlled trial infants were fed either formula for at least 3 weeks . Intake was monitored daily , serum chemistries and growth weekly . Data were analyzed using analysis of covariance . Result : A total of 80 infants were enrolled , 72 completed the study . No differences were noted in demographic characteristics . No differences were detected in feeding tolerance , intakes ( 118±21 vs 119±14 ; nHWC vs pHW ) or growth weight , 28±1.5 vs 28±1.6 g per day ; length , 1.0±0.7 vs 1.0±0.6 cm per week ; head circumference , 0.9±0.4 vs 1.0±0.44 cm per week ) . At the end of study , blood urea nitrogen ( 5.2±3.1 ) , total serum proteins ( 4.7±0.4 > 4.4±0.5 g per 100 ml ) and albumin ( 2.7±0.3 > 2.6±0.4 g per 100 ml ) differed . Conclusion : A pHW preterm infant formula was not associated with improved feeding tolerance , enteral intake or growth but differences in serum chemistries . These are unlikely to be clinical ly relevant because values were well within normal limits for preterm infants , whereas growth was identical in both groups and paralleled that ‘ in utero ’",
"Background The average incidence of preterm birth in the world is up to 11.1 % , and deaths of preterm children account for more than 50 % of neonatal deaths . Gastrointestinal function of preterm children with a gestational age less than 34 weeks is immaturely developed . For preterm children who can only be fed with formula due to their mothers ’ sickness , choosing a suitable formula can not only meet the high nutritional needs of preterm children , but also solve their low gastrointestinal tolerability , and is thus very important . Methods / Design The study is a prospect i ve , r and omized , single-blind and controlled clinical trial . Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who can not be breastfed will be included . To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population , preterm children will be r and omized into two groups , 185 subjects in each group . The observation group will be fed with extensively hydrolyzed milk protein ( 100 % whey protein ) formula , while the control group will be fed with preterm children ’s formula until the children are discharged from the neonatal intensive care unit ( NICU ) . All the formula involved in this study will be from Dumex . After discharge , both groups will be uniformly fed with formula for 0 to 6-month-old infants . For statistical analysis , a chi-square test and Student ’s t test will be applied using SAS 9.4 . Discussion This will be the first r and omized controlled clinical study with long-term observation of the growth and development of preterm children during the NICU stay and at 3-month follow-up after discharge from the NICU . Results from this study will be used to determine whether the extensively hydrolyzed formula is more suitable for the low gastrointestinal tolerability of preterm children , and also whether feeding preterm children who are fed with such formula during the NICU stay with ordinary infant formula after discharge from the NICU would affect the normal growth and development of preterm children in the early stage of their lives . Trial registration This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with number ChiCTR-IOR-14005696 , on December 22 , 2014",
"Background Because infant formulas containing hydrolyzed cow milk protein are used to reduce feeding intolerance and to improve gastric emptying , the effect on gastrointestinal motility of a hydrolysate formula was compared with that of a st and ard preterm formula . Methods Thirty-six preterm newborns with a gestational age of 32.2 ± 2.3 weeks were assigned r and omly to st and ard formula or hydrolyzed formula . Cutaneous electrogastrography and ultrasound examination of gastric emptying were performed simultaneously to evaluate gastrointestinal motility before and after the test meal . All recording sessions were performed 1 week after infants had reached full enteral feeding . Results No significant difference in gastrointestinal symptoms was noted in the newborns fed the different formulas . In particular , regurgitation and vomiting were observed in 78 % versus 64 % of preterm newborns after st and ard and hydrolyzed formula , respectively ( Fisher exact test , not significant ) . No differences were found in terms of gastric electrical activity and gastric emptying time between the two groups . Conclusions It seems unnecessary to use hydrolysate formulas to improve motility in preterm infants ",
"OBJECTIVE To study the effects of extensively hydrolyzed protein formula ( eHF ) on the feeding and growth in preterm infants through a multicenter controlled clinical study . METHODS Preterm infants admitted to eight upper first-class hospitals in China between February 2012 and December 2013 were r and omly selected . They were divided into two observation groups and two control groups . The first observation group consisted of preterm infants with a gestational age of , who were fed with eHF for 10 - 14 days after birth and then with st and ard preterm formula ( SPF ) until discharge . The second observation group consisted of preterm infants with a gestational age of 32 - 34 weeks , who were fed with SPF after birth , but were switched to eHF ( 7 - 14 days ) if suffering feeding intolerance at 6 - 8 days after birth . The two control groups with corresponding gestational ages kept to be fed with SPF after birth . Clinical data were recorded to compare feeding condition , physical growth , blood biochemical indices , and major complications between different groups . RESULTS A total of 328 preterm infants were enrolled . Preterm infants with a gestational age of shorter meconium evacuation time than in the corresponding control group ( P lower levels of serum total bilirubin at weeks 1 and 2 after birth compared with the control group ( P reaching enteral nutrition ( EN ) basic energy uptake of 50 kcal/(kg·d ) , partial parenteral nutrition ( PPN ) , hospitalization , and corrected gestational age at discharge compared with the controlled infants ( P the incidence of extrauterine growth retardation ( EUGR ) at discharge between the two groups ( P>0.05 ) . Preterm infants with a gestational age of 32 - 34 weeks in the observation group had significantly lower serum total bilirubin levels at 2 weeks after birth compared with the corresponding control group ( P achieving EN basic energy and PPN than in the control group ( P the incidence of EUGR at discharge between the two groups ( P>0.05 ) . CONCLUSIONS For preterm infants , eHF can improve gastrointestinal motility , accelerate bilirubin metabolism and excretion and does not increase the incidence of EUGR ",
"BACKGROUND Feeding intolerance is common in very low birth weight ( VLBW ; Hydrolyzed protein preterm infant formula ( HPF ) has been shown to accelerate the gastrointestinal transit of formula . The aim of this study was to investigate whether HPF improves early feeding tolerance compared with st and ard preterm infant formula ( SPF ) . We hypothesized that HPF would accelerate early enteral feeding advancement . METHODS Primary outcome was the time from initiation of milk feeds until full feeds ( 150 mL/kg birth weight/d ) were achieved in infants who received HM ) to exclude HM as a confounder . Because the availability of HM was not predictable at the time of enrollment , all eligible VLBW infants ( n = 129 ) were r and omly assigned in a r and omized , controlled trial to receive HPF or SPF if HM was not available . Infants who received > 10 % HM ( n = 42 ) were excluded . Milk bolus feeding every 2 to 3 hours was started at the discretion of the attending physician and advanced by 16 mL/kg/d . Prepr and ial gastric residuals were tolerated up to 5 mL/kg ; otherwise , feedings were reduced or withheld . Data are shown as median ( 5th and 95th percentile ) . RESULTS Forty-six and 41 ( HPF vs SPF ) infants received HM . There was no significant difference with regard to birth weight , gestational age , and onset of milk feeds ( day 3 [ 1 - 8 ] vs 4 [ 2 - 6 ] ) . The time from initiation of milk feeds to full feeds was significantly shorter with HPF feeding ( 10 [ 9 - 27 ] vs 12 [ 9 - 28 ] days ) . CONCLUSION HPF improved the feeding tolerance and enabled a more rapid establishment of full enteral feeding in VLBW infants compared with SPF",
"Background Decreased nitrogen levels , calcium intestinal absorption rates , and plasma amino acid imbalances were reported for preterm infants who were fed partially hydrolyzed preterm formulas . In this pilot study , we evaluated a new formula with modified nitrogen and calcium sources . Methods During their second week of life , 16 preterm infants were r and omly assigned to one of two groups : 9 were fed the new partially hydrolyzed formula and 7 were fed a conventional formula . Nutrient balance was performed at the end of the first month of life . Amino acid concentrations and anthropometric parameters were measured at theoretical term . Results Birth weight and gestational age ( mean ± SD ) were similar in the two groups ( 28.9 ± 7.0 weeks and 1183 ± 242 g vs. 27.7 ± 1.0 weeks and 1139 ± 162 g ) . Median nitrogen absorption rates ( 85 % vs. 89%;P = 0.03 ) and biological values ( 59 % vs. 69%;P = 0.13 ) were lower for infants who were fed the new formula than for those fed the conventional formula . After correction for difference in nitrogen intake , there was no significant difference in nitrogen retained between the two groups ( P = 0.11 ) . Plasma amino acid concentrations were also similar in the two groups . Median calcium absorption tended to be higher in the new-formula group than in the conventional-formula group ( 54 % vs. 45 % , P = 0.19 ) . At theoretical term , infants fed the conventional formula were heavier than infants fed the new formula ( 3559 ± 362 g vs. 3193 ± 384 g , P = 0.04 ) . Conclusions Because nitrogen content is 10 % higher in hydrolyzed-protein formula than in entire-protein formula , appropriate nitrogen retention , plasma amino acid profile , and mineral use can be achieved with the new partially hydrolyzed formula . Further studies with larger groups are needed to evaluate the effect on growth",
"The influence of early feeding on the risk of atopic diseases has been studied in full-term newborns , not in very low birth weight infants ( VLBW ) . The study evaluated effect of early feeding of VLBW infants with either cow 's milk-based formula ( CMF ) or extensively hydrolyzed milk formula ( HF ) on incidence of atopic diseases and markers of atopy at 5 - 7 years of age . This was a follow-up of the r and omized , double-blind study evaluating the influence of different enteral feeding protocol s on the early morbidity of VLBW infants . In the original study 80 children were r and omly allocated into 2 groups receiving during first month of life HF ( experimental group ) or CMF ( control group ) . At the age of 5 - 7 years , 62 children among 74 available ( 84 % ) with mean birthweight 1124 g were evaluated according to st and ardized ISAAC ( International Study of Asthma and Allergies in Childhood ) protocol . Total IgE level , specific IgE , lymphocyte CD4+CCR4+/CD4+CXCR3 + ratio and skin prick tests ( SPT ) were done . Prevalence of obvious allergic diseases was not significantly different between the studied groups ( HF : 12/33 ; CMF : 6/29 ; RR [ relative risk ] HF vs CMF : 1.76 ; 95%CI [ confidence interval ] : 0.76 - 4.09 ) . Comparison of atopic status across groups revealed similar rate of positive markers of atopy : IgE ( RR : 2.57 95%CI : 0.91 - 8,08 ) , SPT ( RR : 5.13 ; 95%CI : 0.93 - 31.6 ) , lymphocyte CD4+CCR4+/CD4+CXCR3 + ratio ( OR : 2.32 ; 95%CI : 0.78 - 7.53 ) in the both studied groups . Based on the carried out follow-up study we were unable to confirm the usefulness of hydrolyzed formula in prevention of allergy in an unselected cohort of very low birth weight infants",
"Aim : A r and omized , double‐blind study was conducted to evaluate whether use of protein hydrolysate‐based preterm formulas in infants with an atopic predisposition helps prevent the development of allergic diseases . Methods : Preterm infants ( n= 122 ) with at least one first‐degree relative ( parent or sibling ) with allergic disease were r and omly assigned to receive an extensively or partially hydrolysed preterm formula ( intervention groups ) or a st and ard preterm formula until 4 to 5 mo of age . Infants whose parents preferred that they be breastfed received their mothers ' fortified breast milk . Results : Intention‐to‐treat analysis showed that the overall incidence of allergic diseases did not significantly differ between groups at both 4–5 and 12 mo of age . However , by 12 mo , use of the extensively hydrolysed versus the st and ard preterm formula had significantly reduced the risk of atopic dermatitis . At 4–5 and 12 mo , there was a significantly increased risk of non‐acceptance of the extensively hydrolysed formula compared with the other formulas",
"Aim : Protein hydrolysates have been introduced in preterm formulae , but it is not clear whether they are needed for the feeding of preterm infants . We design ed a r and omized , controlled trial to test the effects of a preterm formula with hydrolysed cow 's milk proteins on short‐term growth and urinary and plasma amino acids levels . Methods : Infants with a birthweight 1750 g and gestational age 34 wk fed a conventional preterm infant formula ( formula B ) or a hydrolysed formula ( formula A ) . Weight was measured daily ; length , head circumference , mid‐arm circumference and total skinfold thickness were measured weekly . Blood and urine were analysed for amino acid concentrations at start , 14 and 28 d. Results : Twenty‐one infants met the criteria for r and omization . The daily feeding volumes were : formula A 172.8±5.6 vs formula B 170.1±2.8 ml/kg/d . Infants fed with formula A showed slower weight gain ( 17.4±3.4 vs 20.5±3.3 g/kg/d ; p=0.045 ) and lower mean change in Z‐scores for weight ( −0.18±0.16 vs 0.00±0.09 ; p=0.009 ) and for head circumference ( −0.06±0.13 vs 0.06±0.13 ; p=0.049 ) . After 14 d , infants receiving formula A had statistically significant higher urinary levels of essential amino acids compared to infants receiving formula",
"The aim of the study was to compare , during the first month of life , growth parameters , biochemical indices of protein metabolism and plasma amino acid concentrations in newborn infants fed either human milk ( n = 23 ) , three different whey hydrolysate formulae ( WHF 1 , n = 13 ; WHF 2 , n = 10 ; WHF 3 , n = 13 ) , a soy-collagen hydrolysate formula ( SCHF n = 18 ) or a whey-casein hydrolysate formula ( WCHF , n = 20 ) . Growth parameters and the various protein concentrations determined in the infants fed WHF 1 and WHF 2 were similar to the values observed with human milk . With WHF 3 , growth in weight , length and head circumference and serum total protein concentrations were reduced significantly whereas blood urea nitrogen was increased . With SCHF , growth in weight and length as well as serum total protein and transferrin concentration were decreased significantly , whereas serum IgG concentration was increased . With WCHF growth in length and serum transferrin concentration were decreased compared to the human milk group . In the various groups , the plasma amino acid pattern reflected the amino acid content of the formula . Whey hydrolysate formula induced mainly an increase in threonine and a decrease in tyrosine concentrations . Soy-collagen hydrolysate formula led to an increase of non-essential amino acids , such as glycine and hydroxyproline , and a decrease in plasma lysine and cystine . Whey-casein hydrolysate formula induced a plasma amino acid pattern close to the profile observed with human milk . Nevertheless , the plasma concentrations of most of the various amino acids were higher . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Growth parameters , biochemical indice of protein metabolism and plasma Amino acid ( AA ) concentrations were investigated during the first month of life in term infants ( n = 61 ) fed various protein hydrolysate formulas ( whey ( WHF , n = 3 ) , soy collagen ( SCHF , n = 1 ) and whey-casein hydrolysate formulas ( WCHF , n = 1 ) ) . In addition , metabolic balance studies were performed in 10 infants fed WHF and in 5 fed WCHF . Comparatively to breast fed infants , growth reduction and decrease in plasma protein concentrations were observed with the use of one of the WHF and in a lesser extent with the SCHF and the WCHF . Plasma amino acid pattern reflected the AA content of the formulas . Whey hydrolysate formulas induced mainly an increase in threonine and a decrease in tyrosine concentrations . Soy-collagen hydrolysate formula led to an increase of non-essential amino acids , such as glycine and hydroxyproline and a decrease in plasma lysine and cystine . Whey-casein hydrolysate formula induced a plasma amino acid pattern close to the profile observed in breast fed infant . Metabolic balance studies showed a relative reduction in nitrogen absorption and utilisation in the infants fed the WHF and the WCHF . In addition a drastic reduction in fat , calcium and phosphorus absorption was also observed with the use of the WCHF . In preterm infants ( n = 19 ) fed whey predominant hydrolysed preterm formulas ( n = 3 ) , metabolic balance studies an plasma AA concentration were evaluated at the end of the first month of life at 34 weeks of gestation age . Comparatively to similar preterm infants fed conventional preterm formulas , a relative reduction in nitrogen absorption ( 83 % vs 90 % ) and retention ( 64 vs 70 % ) as well as in phosphorus absorption ( 78 vs 89 % ) was observed . Calcium retention was similar ( 48 vs 45 mg/kg/d ) but calcium intake was significantly higher in infants fed hydrolysate formulas 120 vs 91 mg/kg/d . Plasma amino acid concentrations were related to amino acid composition of the formulas . Compared with the st and ard preterm formulas , all three protein hydrolysate formulas led to a significant increase in plasma threonine and a decrease in tyrosine and phenylalanine concentrations . In addition , there was a reduction in plasma histidine , valine , leucine , cystine , methionine and /or tryptophane with some of the hydrolysate formulas used . In conclusion , these studies provide evidence that protein hydrolysed formulas are not equivalent to whole protein formulas in terms of nutritional efficiency for preterm and term infants . Therefore further extensive nutritional studies on growth , biochemical indices of protein metabolism and metabolic balance , including minerals and trace elements , appear to be necessary before maintaining and promoting the use of such formulas for teh potential benefits on atopic disease in preterm and in full-term newborn infants",
"The data from the present investigation differ from those of the previous study . The new version of hydrolysed protein formula did not induce changes in insulinaemia or in the insulinaemia/glycaemia ratio in pre‐ and postpr and ial sample s when compared with the intact protein formula . The investigation also confirmed that branch chain aminoacids regulate insulin secretion and that the length of chain is insulinotropic for fatty acids , while the degree of unsaturation is not able to reduce insulin secretion in the newborn baby . This could be caused by stimulation of insulin output activated by the C20:5 n 3 ; the effects of fatty acids are probably related more to the variable composition of cell membrane than to the fatty acids circulating levels",
"An ultrasonic technique was used to compare gastric emptying after a feed of expressed breast milk and formula milk in a blind , cross over study of preterm infants . Fourteen infants ( median gestational age 33 weeks ) were studied on 46 occasions . Each infant received a nasogastric feed of either expressed breast milk or formula milk , and the alternative at the next feed . Real time ultrasound images of the gastric antrum were obtained and measurements of antral cross sectional area ( ACSA ) were made before the feed and then sequentially after its completion until the ACSA returned to its prefeed value . The half emptying time ( 50 % delta ACSA ) was calculated as the time taken for the ACSA to decrease to half the maximum increment . On average , expressed breast milk emptied twice as fast as formula milk : mean 50 % delta ACSA expressed breast milk 36 minutes ; formula milk 72 minutes . The technique was reproducible and there was no significant difference between the emptying rates of feeds of the same type for an individual infant . These data show that breast milk has a major effect on gastric emptying , which may have important implication s for preterm infants who have a feed intolerance due to delayed gastric emptying",
"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",
"BACKGROUND Nutrient intakes meeting recommended dietary intakes ( RDIs ) take time to establish and once established are rarely maintained throughout hospital stay in preterm infants . A nutrient deficit , therefore , accrues . RDI are based on needs for maintenance and growth , with no provision to replace this deficit . We , therefore , hypothesized that postnatal malnutrition and growth retardation were inevitable in infants fed current RDI . METHODOLOGY Dietary intakes were prospect ively collected , by a single observer ( N.P. ) , on a daily basis in a group of preterm infants ( n = 105 ; birth weight Actual was subtracted from recommended energy ( 120 kcal/kg/day ) and protein ( 3 g/kg/day ) intakes and nutritional deficits calculated . Infants were weighed on admission and throughout hospital stay . The data were analyzed using a combination of repeated measures analysis of variance and stepwise regression analysis . RESULTS Nutrient intakes meeting current RDIs were rarely achieved during early life . By the end of the first week , cumulative energy and protein deficits were 406 + /- 92 and 335 + /- 86 kcal/kg and 14 + /- 3 and 12 + /- 4 g/kg in infants /=31 weeks . By the end of the fifth week , cumulative energy and protein deficits were 813 + /- 542 and 382 + /- 263 kcal/kg and 23 + /- 12 and 13 + /- 15 g/kg and the z scores were -1.14 + /-.6 and -.82 + /-.5 for infants at /=31 weeks . Stepwise regression analysis indicated that variation in dietary intake accounted for 45 % of the variation in changes in z score . CONCLUSIONS Preterm infants inevitably accumulate a significant nutrient deficit in the first few weeks of life that will not be replaced when current RDIs are fed . This deficit can be directly related to subsequent postnatal growth retardation.postnatal growth retardation , preterm infants",
"BACKGROUND Plasma amino acid concentrations were measured in preterm infants who were fed either a new hydrolyzed cow 's milk protein formula or a st and ard preterm infant formula . It was hypothesized that feeding with the hydrolysate results in prepr and ial amino acid concentrations that are significantly different from the concentrations found when feeding with the st and ard formula . METHODS Fifteen preterm infants , median gestational age , 29 weeks ( range , 24 - 32 weeks ) ; birth weight , 1241 g ( range , 660 - 1900 g ) ; and postnatal age , 18 days ( range , 7 - 54 days ) receiving full enteral feedings ( > 150 ml/kg x day ) , were enrolled . The intervention was r and omized allocation to the formula with hydrolyzed or natural cow 's milk protein ( the whey/casein ratio was 60:40 in both formulas ) . In a crossover design , each formula was fed for 5 days , and plasma amino acids were analyzed on day 4 or 5 of each 5-day period . RESULTS In spite of the 12 % higher amino acid intake with hydrolysate formula , the median individual plasma amino acid concentrations were virtually identical with both formulas , and they were within the 10th and the 90th percentile of the reference of levels in the umbilical cord artery after elective cesarean delivery or of breast-fed newborn infants . The median concentrations of lysine and aspartic acid were higher with hydrolyzed formula feeding ( p single amino acid concentrations were out of the reference values . CONCLUSION Virtually identical plasma amino acid concentration patterns were measured with the new hydrolyzed preterm infant formula and the st and ard preterm infant formula , but longitudinal studies are required before the studied protein hydrolysate can be recommended for preterm feeding in general",
"OBJECTIVE To study the effect of extensively hydrolyzed formula on the growth and development in very low birth weight ( VLBW ) and extremely low birth weight ( ELBW ) infants . METHODS A total of 375 VLBW or ELBW infants were enrolled and divided into an observation group ( 187 infants ) and a control group ( 188 infants ) using a r and om number table . The infants in the observation group were given extensively hydrolyzed formula , and when the amount of extensively hydrolyzed formula reached 10 mL/time , it was changed to the st and ard formula for preterm infants . The infants in the control group were given st and ard formula for preterm infants . Both groups were fed for 4 consecutive weeks and were compared in terms of incidence rate of feeding intolerance , time to establish full enteral feeding , time to complete meconium excretion , number of spontaneous bowel movements , growth and development , motilin level at 4 and 10 days after feeding , and incidence rate of infection . RESULTS Compared with the control group , the observation group had a lower rate of feeding intolerance ( P shorter duration to full enteral feeding and time to complete meconium excretion ( P higher mean number of daily spontaneous bowel movements ( P higher body weight ( 1 793±317 g vs 1 621±138 g ; P , head circumference ( 30.5±1.1 cm vs 30.0±1.6 cm ; P and body length ( 43.9±1.2 cm vs 42.1±2.0 cm ; P higher motilin level at 4 and 10 days after feeding ( P significantly lower infection rate ( P Extensively hydrolyzed formula can increase motilin level , improve gastrointestinal feeding tolerance , promote early growth and development , and reduce the incidence of infection in VLBW and ELBW infants",
"Background : Gaestroesophageal reflux ( GER ) occurs commonly in infants especially preterm infants . Current anti-reflux medication has shown limited therapeutic benefits for this age group . Our study aims to evaluate the efficacy of extensively hydrolyzed formula feed ( EHFF ) compared to st and ard infant formula ( SF ) on GER episodes in preterm infants using Multichannel intraluminal impedance and pH monitoring ( MII-pH ) . Methods : This is a prospect i ve crossover trial involving preterm infants > 29 weeks corrected gestation age with symptoms of GER . All patiets were recruited from a single tertiary neonatal unit in Singapore . MII-pH was performed over 48 hours . For the first 24 hours the infants were either fed on st and ardized infant formula ( SF ) or Expressed Breast Milk ( EBM ) depending on maternal choice . For the second 24 hours their feeds were changed to EHFF . All infants were on orogastric/nasagastric tube feeding and were given 2 to 3 hourly bolus feeding throughout the study period . Results : 23 infants completed the study : 14males : 9 females . Mean weight 2971 g ( SD + 1569 g ) . None of the patients were on any anti-reflux medications ( apart from one ) . Type of feeds during first 24 hours were EBM 8/23(35 % ) , SF 5/23(22 % ) or mixed feeding 10/23(43 % ) . GER symptoms were : desaturations16/23(70 % ) , cough 8/23(35 % ) , arching7/23 ( 30 % ) , vomit 3/23(13 % ) , crying2/23(8 % ) and apnoea1/23 ( 4 % ) . The median total GER episodes ( detected by pH and MII ) was significantly lower during the EHFF period compared to SF/EBM period 42(21–71 ) vs 68(32–104 ) p The median acidic reflux episodes detected by pH was also significantly lower in EHFF vs SF/EBM period 8(4–24 ) vs 23(3–58 ) p detected by MII showed a significant reduction for EHFF compared to SF/EBM : 17(11–56 ) vs 46(20–65 ) p no difference in reflux index , MII bolus exposure indexes , and number of long lasting episodes ( > 5 min ) between the 2 groups . There were no significant difference in the number of symptoms recorded between the two study period . Conclusions : Our data suggest that the number of gastroesophageal reflux was significantly lower in preterm infants fed with EHFF compared to st and ard formula as measured by pH-MII monitoring . EHFF may potentially be an effective treatment modality for gastroesophageal reflux disease in infants with minimal side-effects . The lack of symptom reduction during EHFF despite fewer GER episodes suggests that other pathology other than GER should be considered . A larger study is required to further evaluate the efficacy and mechanism of EHFF on reduction of GER in infants"
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There has been a growing interest in the role of vitamin E supplementation in the treatment and /or prevention of nonalcoholic fatty liver ( NAFLD ) . We performed a systematic review of the medical literature from inception through 15 June 2018 by utilizing PubMed and search ing for key terms such as NAFLD , vitamin E , alpha-tocopherol , and nonalcoholic steatohepatitis ( NASH ) . Data from studies and medical literature focusing on the role of vitamin E therapy in patients with NAFLD and nonalcoholic steatohepatitis ( NASH ) were review ed . Most studies assessing the impact of vitamin E in NAFLD were design ed to evaluate patients with NASH with documented biochemical and histological abnormalities . These studies demonstrated improvement in biochemical profiles , with a decline in or normalization of liver enzymes . Furthermore , histological assessment showed favorable outcomes in lobular inflammation and hepatic steatosis following treatment with vitamin E. Current guidelines regarding the use of vitamin E in the setting of NAFLD recommend that vitamin E-based treatment be restricted to biopsy-proven nondiabetic patients with NASH only . However , some concerns have been raised regarding the use of vitamin E in patients with NASH due to its adverse effects profile and lack of significant improvement in hepatic fibrosis . In conclusion , the antioxidant , anti-inflammatory , and anti-apoptotic properties of vitamin E accompanied by ease-of-use and exceptional tolerability have made vitamin E a pragmatic therapeutic choice in non-diabetic patients with histologic evidence of NASH . Future clinical trials with study design to assess vitamin E in combination with other anti-fibrotic agents may yield an additive or synergistic therapeutic effect
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"BACKGROUND / AIMS Despite a proposed role of oxidative stress in the pathogenesis of nonalcoholic steatohepatitis , antioxidant approaches have not been investigated sufficiently in the therapy of nonalcoholic steatohepatitis . Our aim was to determine whether vitamin E plus C therapy is effective in normalization of liver enzymes compared to ursodeoxycholic acid treatment in patients with fatty liver disease . METHODS This was an open-labeled , prospect i ve , r and omized study enrolling patients with histologically proven fatty liver disease who had chronically elevated alanine aminotransferase , despite a three-month reducing diet . Patients consuming alcohol ( more than 20 g/day ) were excluded . The patients were r and omly prescribed either oral vitamin E ( 600 IU/day ) plus vitamin C ( 500 mg/day ) or ursodeoxycholic acid ( 10 mg/kg/day ) . Patients were r and omized as two groups to receive vitamin E plus vitamin C combination ( 28 patients , 10 F ) or ursodeoxycholic acid treatment ( 29 patients , 13 F ) . RESULTS There was no significant change in body mass index before and after the treatment in both groups . At the end of six months of therapy , serum aspartate aminotransferase and aminotransferase levels significantly decreased in both treatment options . Vitamin E and C combination was more efficacious on serum aminotransferase levels than ursodeoxycholic acid , but the difference was not significant . Alanine aminotransferase decreased to normal levels in 17 of 27 ( 63 % ) and in 16 of 29 patients ( 55 % ) , respectively , in the two groups . Gamma-glutamyl transpeptidase decreased in patients receiving ursodeoxycholic acid , but no change was obtained in the vitamin-treated patients . CONCLUSIONS Vitamin E plus C combination treatment is a safe , inexpensive and effective treatment option in patients with fatty liver disease , with results comparable to those obtained with ursodeoxycholic acid . Since more effective new therapeutic options are lacking , patients with fatty liver disease should be encouraged to take vitamin E and C supplements , which are safe and affordable",
"BACKGROUND Low serum vitamin D has been associated with metabolic syndrome and Non-alcoholic fatty liver disease ( NAFLD ) . This study aim ed to investigate the impact of vitamin D supplementation in treatment of patients with NAFLD . METHODS In a double blind , r and omized , placebo controlled trial patients with NAFLD were r and omized to receive one weekly pearl of placebo , 50,000 U vitamin D3 ( cholecalciferol ) pearl per week and 0.25 mg calcitriol ( 1,25 dihydroxycholecalciferol ) pearl per day for 3 months . RESULTS 106 NAFLD patients were r and omized to receive calcitriol , vitamin D3 and placebo pearls for 12 weeks and data for 91 patients were analyzed . After 12 weeks of treatment , serum alkaline phosphatase levels was significantly decreased from baseline levels in vitamin D and calcitriol treated groups ( P Serum and gamma glutamyl transferase ( GGT ) level was also significantly decreased compared to the baseline levels after 12 weeks of treatment with vitamin D. There was no statistically significant difference between placebo , calcitriol , vitamin D groups in terms of serum aminotransferase , alkaline phosphatase , serum GGT and lipid profile ( P > 0.05 ) . CONCLUSION While significant reduction of serum alkaline phosphatase and GGT were seen with vitamin D and calcitriol supplementation from baseline levels , no beneficial effects was seen when comparing vitamin D , calcitriol and placebo groups at the end of trial",
"OBJECTIVE Obesity and insulin resistance play important roles in the pathogenesis of non-alcoholic fatty liver disease ( NAFLD ) . Mg intake is linked to a reduced risk of metabolic syndrome and insulin resistance ; people with NAFLD or alcoholic liver disease are at high risk of Mg deficiency . The present study aim ed to investigate whether Mg and Ca intakes were associated with risk of fatty liver disease and prediabetes by alcohol drinking status . DESIGN We analysed the association between Ca or Mg intake and fatty liver disease , prediabetes or both prediabetes and fatty liver disease in cross-sectional analyses . SETTING Third National Health and Nutrition Examination Survey ( NHANES III ) follow-up cohort of US adults . SUBJECTS Nationally representative sample of US adults in NHANES ( n 13 489 ) . RESULTS After adjusting for potential confounders , Mg intake was associated with approximately 30 % reduced odds of fatty liver disease and prediabetes , comparing the highest intake quartile v. the lowest . Mg intake may only be related to reduced odds of fatty liver disease and prediabetes in those whose Ca intake is less than 1200 mg/d . Mg intake may also only be associated with reduced odds of fatty liver disease among alcohol drinkers . CONCLUSIONS The study suggests that high intake of Mg may be associated with reduced risks of fatty liver disease and prediabetes . Further large studies , particularly prospect i ve cohort studies , are warranted to confirm the findings",
"The aim of this study was to investigate the effects of vitamin D supplementation on serum aminotransferases , insulin resistance , oxidative stress , and inflammatory biomarkers in adult patients with non-alcoholic fatty liver disease ( NAFLD ) . Fifty-three patients with NAFLD were enrolled in a parallel , double-blind , placebo-controlled study . The patients were r and omly allocated to receive either one oral pearl consisting of 50,000 IU vitamin D3 ( n = 27 ) or a placebo ( n = 26 ) , every 14 days for 4 months . Serum aminotransferases , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor α , malondialdehyde ( MDA ) , total antioxidant capacity , transforming growth factor β1 , as well as grade of hepatic steatosis and homeostasis model assessment of insulin resistance were assessed pre- and post-intervention . In patients who received vitamin D supplement compared to the controls , the median of serum 25(OH)D3 significantly increased ( 16.2 vs. 1.6 ng/ml , P decrease in serum MDA ( −2.09 vs. −1.23 ng/ml , P = 0.03 ) and near significant changes in serum hs-CRP ( −0.25 vs. 0.22 mg/l , P = 0.06 ) . These between-group differences remained significant even after controlling for baseline covariates . Other variables showed no significant changes . Improved vitamin D status led to amelioration in serum hs-CRP and MDA in patients with NAFLD . This might be considered as an adjunctive therapy to attenuate systemic inflammation and lipid peroxidation alongside other treatments for NAFLD patients",
"OBJECTIVES : Nonalcoholic fatty liver disease ( NAFLD ) is defined as the spectrum of benign fatty liver to necroinflammation and fibrosis . Its prevalence has been found to be as high as 39 % . It is estimated that up to 15 % of those affected will go on to have progressive liver disease . Currently , there is no proven therapy for NAFLD . In this study , we aim to determine whether statin therapy may be an effective treatment for NAFLD and identify independent predictors of NAFLD . METHODS : In all , 1,005 men and women , aged 50–70 years were r and omized to receive either a daily combination of atorvastatin 20 mg , vitamin C 1 g , and vitamin E 1,000 IU vs. matching placebo , as part of the St Francis Heart Study r and omized clinical trial . Liver to spleen ( LS ) ratios were calculated on 455 subjects with available computed tomography scans performed at baseline and follow-up to determine NAFLD prevalence . Baseline and final LS ratios were compared within treatment groups , and results were compared between the treatment and placebo groups using univariate and multivariate analyses . Mean duration of follow-up was 3.6 years . RESULTS : There were 80 patients with NAFLD at baseline . We identified baseline triglyceride levels ( odds ratio (OR)=1.003 , P and body mass index ( OR=0.10 , P atorvastatin combined with vitamins E and C significantly reduced the odds of NAFLD at the end of follow-up , 70 vs. 34 % ( OR=0.29 , P atorvastatin 20 mg combined with vitamins C and E is effective in reducing the odds of having hepatic steatosis by 71 % in healthy individuals with NAFLD at baseline after 4 years of active therapy",
"Nonalcoholic steatohepatitis ( NASH ) , a progressive form of nonalcoholic fatty liver disease , is one of the most common hepatic diseases in children . We conducted a r and omized controlled clinical trial on children with biopsy-proven NASH based on a combinatorial nutritional approach compared with placebo . Participants were assigned to lifestyle modification plus placebo or lifestyle modification plus a mix containing docosahexaenoic acid , choline , and vitamin E ( DHA-CHO-VE ) . Forty children and adolescents participated in the entire trial . The primary outcome was the improvement of liver hyperechogenicity . Secondary outcomes included alterations of alanine aminotransferase ( ALT ) and other metabolic parameters . Furthermore , changes of serum bile acids ( BA ) and plasma fibroblast growth factor 19 ( FGF19 ) levels were evaluated as inverse biomarkers of disease severity . At the end of the study , we observed a significant decrease in severe steatosis in the treatment group ( 50 % to 5 % , p = 0.001 ) . Furthermore , although the anthropometric and biochemical measurements in the placebo and DHA-CHO-VE groups were comparable at baseline , at the end of the study ALT and fasting glucose levels improved only in the treatment group . Finally , we found that BA levels were not influenced whereas FGF19 levels were significantly increased by DHA-CHO-VE . The results suggest that a combination of DHA , VE , and CHO could improve steatosis and reduce ALT and glucose levels in children with NASH . However , further studies are needed to assess the impact of a DHA and VE combination on repair of liver damage in paediatric NASH",
"UNLABELLED No proven treatment exists for nonalcoholic fatty liver disease ( NAFLD ) in children and adolescents . We sought to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD . A total of 53 patients ( age 5.7 - 18.8 years , 37 boys ) were included . Lifestyle intervention consisting of a diet tailored to the patient 's calorie needs , and increased physical activity was prescribed in all . Patients were concomitantly r and omized to alpha-tocopherol 600 IU/day plus ascorbic acid 500 mg/day ( n = 25 ) or placebo ( n = 28 ) , and treated for 24 months . The study was an extension of a previous study aim ed at evaluating the effect of 12-month lifestyle intervention and antioxidant therapy on serum levels of aminotransferases . The primary end point of the present study was change in liver histology on repeated biopsy at 24 months . Secondary end points were changes in body weight , liver enzymes , and insulin sensitivity indices on 2-hour oral glucose tolerance test . The amount of weight lost at 24 months was similar in the placebo and antioxidant groups ( -4.75 [ range , -16 - 4.0 ] versus -5.5 [ range , -12.2 - 0.4 ] kg , respectively , P = 0.9 ) . A significant improvement occurred in the grade of steatosis , lobular inflammation , and hepatocyte ballooning , and in the NAFLD activity score in both groups . Levels of aminotransferases , triglycerides , cholesterol , fasting glucose , and insulin , and insulin sensitivity indices improved significantly as well . The improvement in all these parameters was not significantly different between the two groups . CONCLUSION Lifestyle intervention with diet and increased physical activity induces weight loss and is associated with a significant improvement in liver histology and laboratory abnormalities in pediatric NAFLD . Alpha-tocopherol plus ascorbic acid does not seem to increase the efficacy of lifestyle intervention alone",
"BACKGROUND & AIMS Insulin resistance and oxidative stress contribute to the pathogenesis of nonalcoholic steatohepatitis ( NASH ) . We conducted a pilot study for the following reasons : ( 1 ) to test the hypothesis that a combination of an antioxidant ( vitamin E ) and an insulin sensitizer ( pioglitazone ) would be superior to vitamin E alone for the treatment of NASH , and ( 2 ) to define the effects of these interventions on insulin-sensitive metabolic functions and correlate the effects with changes in liver histology . METHODS A r and omized prospect i ve trial was performed to compare the efficacy and safety of vitamin E alone ( 400 IU/day ) vs. vitamin E ( 400 IU/day ) and pioglitazone ( 30 mg/day ) in nondiabetic , noncirrhotic subjects with NASH . Metabolic functions were assessed by a 2-step , hyperinsulinemic ( 10 and 40 mU/m2/min ) euglycemic clamp . RESULTS A total of 10 patients were r and omized to each arm . Two patients on combination therapy discontinued treatment ; one because of pregnancy and the other because of hepatotoxicity . Treatment with vitamin E only produced a significant decrease in steatosis ( mean grade , 2.2 vs. 1.4 ; P steatosis ( mean , 2.3 vs. 1 ; P cytologic ballooning ( 1.3 vs. 0.2 ; P Mallory 's hyaline ( 0.7 vs. 0.2 ; P pericellular fibrosis ( 1.2 vs. 0.6 ; P vitamin E had no significant effects , combination therapy produced a significant increase in metabolic clearance of glucose and a decrease in fasting free fatty acid ( FFA ) and insulin . The decrease in fasting FFA and insulin independently predicted improvement in hepatic steatosis and cytologic ballooning . CONCLUSIONS A combination of vitamin E and pioglitazone produces a greater improvement in NASH histology . The improvement in steatosis and cytologic ballooning are related to treatment-associated decreases in fasting FFA and insulin levels",
"OBJECTIVE : Nonalcoholic steatohepatitis ( NASH ) is a common cause of liver disease . Although usually indolent , this disease can progress to cirrhosis in some patients . There is currently no proven medical therapy for the treatment of NASH . The aim of our study was to evaluate the efficacy of combination α-tocopherol ( vitamin E ) and vitamin C in reducing histologic inflammation and fibrosis . METHODS : This was a prospect i ve , double-blind , r and omized , placebo-controlled trial with a total enrollment of 49 patients ; 45 patients completed the study . All patients were r and omized to receive either vitamins E and C ( 1000 IU and 1000 mg , respectively ) or placebo daily for 6 months , based on their initial histologic diagnosis of NASH . Additionally , all patients were given st and ard weight-loss counseling and encouraged to follow a low fat diet ( fibrosis , and a score of 0–6 was possible for inflammation and hepatocyte degeneration and necrosis . In addition , body mass index , glycohemoglobin , lipids , and liver enzymes were followed throughout the study . RESULTS : Forty-five patients completed 6 months of therapy without significant side effects . Vitamin treatment result ed in a statistically significant improvement in fibrosis score ( p = 0.002 ) . No changes were noted in inflammation with treatment . CONCLUSIONS : Vitamin E and vitamin C , in the doses used in this study , were well tolerated and were effective in improving fibrosis scores in NASH patients . No improvement in necroinflammatory activity or ALT was seen with this combination of drug therapy . A larger , multicenter , longer-term trial with vitamin E and vitamin C seems to be warranted",
"CONTEXT Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in US children and adolescents and can present with advanced fibrosis or nonalcoholic steatohepatitis ( NASH ) . No treatment has been established . OBJECTIVE To determine whether children with NAFLD would improve from therapeutic intervention with vitamin E or metformin . DESIGN , SETTING , AND PATIENTS R and omized , double-blind , double-dummy , placebo-controlled clinical trial conducted at 10 university clinical research centers in 173 patients ( aged 8 - 17 years ) with biopsy-confirmed NAFLD conducted between September 2005 and March 2010 . Interventions Daily dosing of 800 IU of vitamin E ( 58 patients ) , 1000 mg of metformin ( 57 patients ) , or placebo ( 58 patients ) for 96 weeks . MAIN OUTCOME MEASURES The primary outcome was sustained reduction in alanine aminotransferase ( ALT ) defined as 50 % or less of the baseline level or 40 U/L or less at visits every 12 weeks from 48 to 96 weeks of treatment . Improvements in histological features of NAFLD and resolution of NASH were secondary outcome measures . RESULTS Sustained reduction in ALT level was similar to placebo ( 10/58 ; 17 % ; 95 % CI , 9 % to 29 % ) in both the vitamin E ( 15/58 ; 26 % ; 95 % CI , 15 % to 39 % ; P = .26 ) and metformin treatment groups ( 9/57 ; 16 % ; 95 % CI , 7 % to 28 % ; P = .83 ) . The mean change in ALT level from baseline to 96 weeks was -35.2 U/L ( 95 % CI , -56.9 to -13.5 ) with placebo vs -48.3 U/L ( 95 % CI , -66.8 to -29.8 ) with vitamin E ( P = .07 ) and -41.7 U/L ( 95 % CI , -62.9 to -20.5 ) with metformin ( P = .40 ) . The mean change at 96 weeks in hepatocellular ballooning scores was 0.1 with placebo ( 95 % CI , -0.2 to 0.3 ) vs -0.5 with vitamin E ( 95 % CI , -0.8 to -0.3 ; P = .006 ) and -0.3 with metformin ( 95 % CI , -0.6 to -0.0 ; P = .04 ) ; and in NAFLD activity score , -0.7 with placebo ( 95 % CI , -1.3 to -0.2 ) vs -1.8 with vitamin E ( 95 % CI , -2.4 to -1.2 ; P = .02 ) and -1.1 with metformin ( 95 % CI , -1.7 to -0.5 ; P = .25 ) . Among children with NASH , the proportion who resolved at 96 weeks was 28 % with placebo ( 95 % CI , 15 % to 45 % ; 11/39 ) vs 58 % with vitamin E ( 95 % CI , 42 % to 73 % ; 25/43 ; P = .006 ) and 41 % with metformin ( 95 % CI , 26 % to 58 % ; 16/39 ; P = .23 ) . Compared with placebo , neither therapy demonstrated significant improvements in other histological features . CONCLUSION Neither vitamin E nor metformin was superior to placebo in attaining the primary outcome of sustained reduction in ALT level in patients with pediatric NAFLD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00063635",
"Oxidative stress and low- grade systemic inflammation may contribute to the pathogenesis of obesity-induced comorbidities , including nonalcoholic fatty liver disease . Increasing intake of dietary antioxidants might be beneficial , but there are few data in obese children . To examine the effect of antioxidant supplementation on biomarkers of oxidative stress , inflammation , and liver function , we r and omly assigned overweight or obese children and adolescents ( n = 44 ; mean ± SD age : 12.7 ± 1.5 y ) participating in a lifestyle modification program to a 4-mo intervention with daily antioxidants ( vitamin E , 400 IU ; vitamin C , 500 mg ; selenium , 50 μg ) or placebo . We measured anthropometrics , antioxidant status , oxidative stress ( F(2)-isoprostanes , F(2)-isoprostane metabolites ) , inflammation , liver enzymes , fasting insulin and glucose , and lipid profile at baseline and endpoint . There was a significant treatment effect of antioxidant supplementation on antioxidant status [ α-tocopherol , β = 23.2 ( 95 % CI : 18.0 , 28.4 ) ; ascorbic acid , β = 70.6 ( 95 % CI : 51.7 , 89.4 ) ; selenium , β = 0.07 ( 95 % CI : 0.01 , 0.12 ) ] and oxidative stress [ 8-iso-prostagl and in F2α , β = -0.11 ( 95 % CI : -0.19 , -0.02 ) ] but not on any of the inflammatory markers measured . There was a significant treatment effect on alanine aminotransferase [ β = -0.13 ( 95 % CI : -0.23 , -0.03 ) ] , a trend toward a significant effect on aspartate aminotransferase [ β = -0.04 ( 95 % CI : -0.09 , 0.01 ) ] , and no significant effect on γ-glutamyltransferase [ β = -0.03 ( 95 % CI : -0.11 , 0.06 ) ] . In summary , antioxidant supplementation for 4 mo improved antioxidant-oxidant balance and modestly improved liver function tests ; however , it did not reduce markers of systemic inflammation despite significant baseline correlations between oxidative stress and inflammation . The study was registered at clinical trials.gov as NCT01316081",
"OBJECTIVES : Metformin proved useful in the treatment of nonalcoholic fatty liver disease ( NAFLD ) , but its superiority over nutritional treatment and antioxidants has never been demonstrated . We aim ed to compare the usefulness of metformin versus prescriptive diet or vitamin E. METHODS : In an open label , r and omized trial , nondiabetic NAFLD patients were given metformin ( 2 g/day ; n = 55 ) for 12 months . The control cases were given either vitamin E ( 800 IU/day ; n = 28 ) or were treated by a prescriptive , weight-reducing diet ( n = 27 ) . Outcome measures were liver enzymes , insulin resistance ( homeostasis model assessment ) , parameters of the metabolic syndrome , and histology . RESULTS : Aminotransferase levels improved in all groups , in association with weight loss . The effects in the metformin arm were larger ( p alanine aminotransferase normalized in 56 % of cases ( odds ratio ( OR ) versus . controls , 3.11 ; 95 % confidence interval ( CI ) , 1.56–6.20 ; p = 0.0013 ) . In multivariate analysis , metformin treatment was associated with higher rates of aminotransferase normalization , after correction for age , gender , basal aminotransferases , and change in body mass index ( OR , 5.98 ; 95 % CI , 2.05–17.45 ) . Differences were maintained when the two control groups were separately analyzed . The distribution of positive criteria for the metabolic syndrome was reduced only in the metformin arm ( p = 0.001 , signed rank test ) . A control biopsy in 17 metformin-treated cases ( 14 nonresponders ) showed a significant decrease in liver fat ( p = 0.0004 ) , necroinflammation , and fibrosis ( p = 0.012 for both ) . No side effects were observed during metformin treatment . CONCLUSIONS : Metformin treatment is better than a prescriptive diet or vitamin E in the therapy of NAFLD patients receiving nutritional counseling . Limited histological data support an association between improved aminotransferases and biopsy findings , which require confirmation in a double-blind trial with appropriate statistical power based on liver histology",
"AIM To investigate the effect of lifestyle intervention on non-alcoholic fatty liver disease ( NAFLD ) in Chinese obese children . METHODS Seventy-six obese children aged from 10 to 17 years with NAFLD were enrolled for a one-month intervention and divided r and omly into three groups . Group1 , consisting of 38 obese children , was an untreated control group without any intervention . Group 2 , consisting of 19 obese children in summer camp , was strictly controlled only by life style intervention . Group 3 , consisting of 19 obese children , received oral vitamin E therapy at a dose of 100 mg/d . The height , weight , fasting blood glucose ( FBG ) , fasting serum insulin ( FINS ) , plasma alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , triglyceride ( TG ) , total cholesterol ( TCHO ) and homeostasis model assent-insulin resistance ( HOMA-IR ) were measured at baseline and after one month . All patients were underwent to an ultrasonographic study of the liver performed by one operator who was blinded to the groups . RESULTS The monitor indices of BMI , ALT , AST , TG , TCHO and HOMA-IR were successfully improved except in group 1 . BMI and ALT in group 2 were reduced more significantly than in group 3 ( 2.44 + /- 0.82 vs 1.45 + /- 0.80 , P = 0.001 ; 88.58 + /- 39.99 vs 63.69 + /- 27.05 , P = 0.040 , respectively ) . CONCLUSION Both a short-term lifestyle intervention and vitamin E therapy have an effect on NAFLD in obese children . Compared with vitamin E , lifestyle intervention is more effective . Therefore , lifestyle intervention should represent the first step in the management of children with NAFLD",
"Objective A beneficial role of antioxidants in hepatopathic obese individuals has hitherto been inferred only from uncontrolled pilot studies . The authors compared the effect of vitamin E and weight loss on transaminase values and on ultrasonographic bright liver in a controlled group of children with obesity-related liver dysfunction . Methods Twenty-eight children with obesity-related hypertransaminasemia and bright liver were r and omly allocated to two single-blind groups : group 1 ( n = 14 ) treated with a low-calorie diet associated with oral placebo for 5 months , and group 2 ( n = 14 ) treated with a low-calorie diet associated with oral vitamin E ( 400 mg/d × 2 months , 100 mg/d × 3 months ) . Transaminase values and ultrasonographic liver brightness along with weight loss and vitamin E levels were monitored . Results Variations in transaminase levels and percentage of patients with normalized transaminase values were comparable in the two groups . The disappearance of bright liver was observed only in patients who lost weight and was twice as common in patients from group 1 . Two subgroups of patients with complete normalization of transaminase values emerged as a consequence of controlled adherence to diet alone ( n = 6 ; significant decrease of percent overweight : P = 0.0019 ) and to vitamin E alone ( n = 7 ; unmodified percent overweight and significant increase of vitamin E/cholesterol ratio : P ) . Changes in treatment-induced alanine aminotransferase levels in these two subgroups were comparable at month 2 , whereas values at month 5 were significantly lower in the subgroup adherent to diet alone ( P = 0.04 ) . In the subgroup adherent to vitamin E alone , after 2 months washout , transaminase remained stable in 5 patients and increased in 2 ; bright liver persisted in all . Conclusions Oral vitamin E warrants consideration in obesity-related liver dysfunction for children unable to adhere to low-calorie diets",
"Background : Studies have shown that zinc and selenium deficiency is common in nonalcoholic fatty liver disease ( NAFLD ) . However , the effects of zinc and selenium co-supplementation before and /or after disease progression on NAFLD are not clear enough . The aim of this study was to compare the effects of zinc and selenium co-supplementation before and /or after disease progression on NAFLD prognosis . Material s and Methods : Forty male Sprague – Dawley rats ( 197±4 g ) were r and omly assigned to 4 dietary groups : normal-fat diet ( NFD ; receiving 9 % of calories as fat ) , high-fat diet ( HFD ; receiving 82 % of calories as fat ) , supplementation before disease progression ( S+HFD ) , and supplementation after disease progression ( HFD+S ) . The diets were implemented over a 20-week period in all the groups . Biochemical and histologic parameters were compared between the 4 groups , and between-group comparisons were also carried out . Results : There were significant differences in the average food dietary intake ( P weight ( P ) , fasting blood sugar ( P=0.005 ) , triglyceride ( P , total cholesterol ( P low-density lipoprotein cholesterol ( P=0.002 ) , high-density lipoprotein cholesterol ( P=0.001 ) , alanine aminotransferase ( P and aspartate aminotransferase ( P groups . Serum triglyceride and total cholesterol were significantly lower in the HFD+S Group than in the S+HFD Group ( P . Fat accumulation was significantly reduced in the HFD+S Group ( P Conclusion : Zinc and selenium co-supplementation after disease progression improved biochemical and histologic parameters in an experimental model of NAFLD",
"Studies have shown that non-alcoholic fatty liver disease ( NAFLD ) patients are more prone to cardiovascular disease ( CVD ) . Zinc and selenium deficiency are common in NAFLD . But the effects of zinc and selenium co-supplementation before and /or after disease progression on CVD markers are not clear in NAFLD patients . This study aim ed to compare the effects of zinc and selenium co-supplementation before and /or after disease progression on some of the CVD markers in an experimental model of NAFLD . Forty male Sprague Dawley rats ( 197 ± 4 g ) were r and omly assigned into four dietary groups : control group ( C ; received 9 % of calorie as fat ) , model group ( M ; received 82 % of calorie as fat ) , and supplementation before ( BS ) or after ( AS ) disease progression . Animals were fed diets for 20 weeks in all groups . Fasting plasma glucose ( FPG ) , insulin , HOMA-IR , ALT , AST , lipid profile , malondialdehyde ( MDA ) and vascular endothelial growth factor ( VEGF ) levels were measured as CVD indices . Serum ALT , AST , FPG , insulin , MDA , VEGF and HOMA-IR were significantly higher in the M than C group . Co-supplementation reduced serum ALT and AST levels in the BS and AS groups compared with the M group . FPG , insulin , HOMA-IR , VEGF , MDA , LDL/HDL-c and TC/HDL-c ratio were significantly reduced in the AS compared with the M group . TG/HDL-c ratio was significantly reduced in the BS and AS compared with the M group . Serum MDA , VEGF , Insulin and HOMA-IR were significantly lowered in the AS than BS group ( p after NAFLD progression reduced CVD risk indices in an experimental model",
"BACKGROUND The combination of ursodeoxycholic acid ( UDCA ) and vitamin E is a therapeutic option for nonalcoholic steatohepatitis ( NASH ) but r and omized controlled studies have produced inconsistent results . The objective of this study was to report the long-term tolerability and efficacy of this combination in our ten-year single center experience . METHODS The study group included 101 adult patients with persistent elevation of serum aminotransferases ( AST and ALT ) and /or γ glutamyl-transferase ( GGT ) , in whom a histological diagnosis of NASH was made from January 1998 to January 2009 , and who were treated with a combination of UDCA with vitamin E. RESULTS Median body mass index ( 30 kg/m(2 ) ) remained unchanged during the study . UDCA and vitamin E were well tolerated ( 5 % withdrawal for side effects ) . Mean serum AST , ALT and GGT levels ( expressed as times of Upper Normal Limit ) diminished significantly ( 1.39 ± 0.74 to 0.78 ± 0.34 for AST , 1.72 ± 0.92 to 0.91 ± 0.69 for AST and 3.25 ± 2.85 to 1.30 ± 1.30 for GGT ) . AST , ALT and GGT reached normal range in 80 % , 70 % and 65 % of the patients , respectively . From the ten patients who had a second liver biopsy during follow-up , NAS score improved in seven , and worsened in one . CONCLUSIONS The combination of UDCA with vitamin E significantly improves liver function tests in long-term and is very well tolerated",
"BACKGROUND Nonalcoholic steatohepatitis is a common liver disease that can progress to cirrhosis . Currently , there is no established treatment for this disease . METHODS We r and omly assigned 247 adults with nonalcoholic steatohepatitis and without diabetes to receive pioglitazone at a dose of 30 mg daily ( 80 subjects ) , vitamin E at a dose of 800 IU daily ( 84 subjects ) , or placebo ( 83 subjects ) , for 96 weeks . The primary outcome was an improvement in histologic features of nonalcoholic steatohepatitis , as assessed with the use of a composite of st and ardized scores for steatosis , lobular inflammation , hepatocellular ballooning , and fibrosis . Given the two planned primary comparisons , P values of less than 0.025 were considered to indicate statistical significance . RESULTS Vitamin E therapy , as compared with placebo , was associated with a significantly higher rate of improvement in nonalcoholic steatohepatitis ( 43 % vs. 19 % , P=0.001 ) , but the difference in the rate of improvement with pioglitazone as compared with placebo was not significant ( 34 % and 19 % , respectively ; P=0.04 ) . Serum alanine and aspartate aminotransferase levels were reduced with vitamin E and with pioglitazone , as compared with placebo ( P hepatic steatosis ( P=0.005 for vitamin E and P lobular inflammation ( P=0.02 for vitamin E and P=0.004 for pioglitazone ) but not with improvement in fibrosis scores ( P=0.24 for vitamin E and P=0.12 for pioglitazone ) . Subjects who received pioglitazone gained more weight than did those who received vitamin E or placebo ; the rates of other side effects were similar among the three groups . CONCLUSIONS Vitamin E was superior to placebo for the treatment of nonalcoholic steatohepatitis in adults without diabetes . There was no benefit of pioglitazone over placebo for the primary outcome ; however , significant benefits of pioglitazone were observed for some of the secondary outcomes . ( Clinical Trials.gov number , NCT00063622 .",
"BACKGROUND & AIMS Nonalcoholic steatohepatitis ( NASH ) is a frequent liver disease that can progress to cirrhosis and for which there is no recognized therapy . UDCA and vitamin E have been considered separately as therapeutic options and have not been shown to be effective . This study tested their combination . METHODS Patients with elevated aminotransferase levels and drinking less than 40 g alcohol/week with biopsy-proven NASH were r and omly assigned to receive UDCA 12 - 15 mg.kg-1.day-1 with vitamin E 400 IU twice a day ( UDCA/Vit E ) , UDCA with placebo ( UDCA/P ) , or placebo/placebo ( P/P ) . After 2 years , they underwent a second liver biopsy . Biopsy specimens were collected , blinded , and scored by a single liver pathologist . RESULTS Forty eight patients were included , 15 in the UDCA/Vit E group , 18 in the UDCA/P group , and 15 in the P/P group ; 8 patients dropped out , none because of side effects . Baseline parameters were not significantly different between the 3 groups . Body mass index remained unchanged during the study . Serum aspartate aminotransferase ( AST ) and alanine aminotransferase ( ALT ) levels diminished significantly in the UDCA/Vit E group . Neither the AST nor the ALT levels improved in the P/P group and only the ALT levels in the UDCA/P group . Histologically , the activity index was unchanged at the end of the study in the P/P and UDCA/P groups , but it was significantly better in the UDCA/Vit E group , mostly as a result of regression of steatosis . CONCLUSIONS Two years of treatment with UDCA in combination with vitamin E improved laboratory values and hepatic steatosis of patients with NASH . Larger trials are warranted",
"BACKGROUND Non-alcoholic steatohepatitis is a distinct entity , characterized by fatty change , lobular inflammation and fibrosis of the liver . Some cases of non-alcoholic steatohepatitis progress to cirrhosis , but it is not easy to distinguish this disease from non-alcoholic fatty liver by non-invasive examinations . No proven therapy for non-alcoholic steatohepatitis exists . Transforming growth factor-beta1 is implicated in the development of liver fibrosis , and is inhibited by alpha-tocopherol ( vitamin E ) in the liver . Therefore , in this study , the significance of the measurement of the level of plasma transforming growth factor-beta1 and the effect of alpha-tocopherol on the clinical course of non-alcoholic steatohepatitis were investigated . METHODS Twelve patients with non-alcoholic steatohepatitis and 10 patients with non-alcoholic fatty liver , with a diagnosis confirmed by liver biopsy , were studied . None of the patients had a history of alcohol abuse , habitual medicine or malignant or inflammatory diseases . All patients were negative for hepatitis B , C and G virus . Patients were given dietary instruction for 6 months , and then alpha-tocopherol ( 300 mg/day ) was given for 1 year . Blood chemistries , measurement of plasma transforming growth factor-beta1 level and liver biopsies were undertaken before and after the 1-year alpha-tocopherol treatment . RESULTS The serum alanine transaminase level decreased in non-alcoholic fatty liver patients , but not in non-alcoholic steatohepatitis patients , after 6 months of dietary therapy . Although the serum alanine transaminase level in non-alcoholic steatohepatitis patients was reduced during the 1-year alpha-tocopherol treatment , alpha-tocopherol had no effect on the serum alanine transaminase level in non-alcoholic fatty liver patients . The histological findings , such as steatosis , inflammation and fibrosis , of the non-alcoholic steatohepatitis patients were improved after alpha-tocopherol treatment . The plasma transforming growth factor-beta1 level in non-alcoholic steatohepatitis patients was significantly elevated compared with that in non-alcoholic fatty liver patients and healthy controls , and decreased , accompanied by an improvement in serum alanine transaminase level , with alpha-tocopherol treatment . CONCLUSIONS Our data suggest that the measurement of the level of plasma transforming growth factor-beta1 represents a possible method of distinguishing between non-alcoholic steatohepatitis and non-alcoholic fatty liver . Long-term alpha-tocopherol treatment may be safe and effective for non-alcoholic steatohepatitis . A r and omized , controlled , double-blind trial is needed to confirm the full potential of alpha-tocopherol in the management of non-alcoholic steatohepatitis ",
"BACKGROUND This study investigates the levels of superoxide dismutase ( SOD ) activity in serum and saliva of patients with chronic periodontitis ( CP ) . In addition , the outcome of scaling and root planing ( SRP ) with and without vitamin E supplementation is evaluated in terms of changes in periodontal parameters and SOD activity in patients with CP . METHODS Serum and salivary SOD activity in 38 patients with CP were compared with those of 22 systemically and periodontally healthy individuals ( control group ) . At periodontal examination , serum and saliva sample s were obtained . Patients with CP were r and omly divided into treatment groups 1 ( TG-1 ) and 2 ( TG-2 ) . SRP was performed for both groups , and TG-2 also received 200 mg ( 300 IU ) vitamin E every other day . Periodontal parameters and SOD activity were evaluated after 3 months . SOD activity was determined using an SOD assay and enzyme-linked immunosorbent assay reader at 450 nm . RESULTS SOD activity in both serum ( P saliva ( P SOD activity improved in both treatment groups ; however , the improvement in TG-2 was higher than in TG-1 , along with more improvement in periodontal parameters . Serum SOD levels in TG-2 increased even above the level of the control group . CONCLUSIONS Systemic and local SOD levels are lowered in CP . Adjunctive vitamin E supplementation improves periodontal healing as well as antioxidant defense"
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Background The role of resistant starch ( RS ) in glucose , insulin , insulin resistance or sensitivity , and lipid parameters have been reported in several studies and remained controversial . A pooled analysis which assessed these parameters has not been performed . Thus , we conducted a meta- analysis to sum up existing evidence about the issue . Methods We search ed in MEDLINE and PUBMED for studies that were published before November 2018 . Meta- analysis of diabetics and nondiabetics trials were performed by use of a r and om-effects model . Results A total of 13 case – control studies that included 428 subjects with body mass index ≥25 were identified . RS supplementation reduced fasting insulin in overall and stratified ( diabetics and nondiabetics trials ) analysis ( SMD = –0.72 ; 95 % CI : –1.13 to –0.31 ; SMD = –1.26 ; 95 % CI : –1.66 to –0.86 and SMD = –0.64 ; 95 % CI : –1.10 to –0.18 , respectively ) , and reduced fasting glucose in overall and stratified analysis for diabetic trials ( SMD = –0.26 ; 95 % CI : –0.5 to –0.02 and SMD = –0.28 ; 95 % CI : –0.54 to –0.01 , respectively ) . RS supplementation increased HOMA-S% ( SMD = 1.19 ; 95 % CI : 0.59–1.78 ) and reduced HOMA-B ( SMD = –1.2 ; 95 % CI : –1.64 to –0.77 ) , LDL-c concentration ( SMD = –0.35 ; 95 % CI : –0.61 to −0.09 ) , and HbA1c ( SMD = –0.43 ; 95 % CI : –0.74 to –0.13 ) in overall analysis . Conclusions This meta- analysis has provided evidence that RS supplementation can improve fasting glucose , fasting insulin , insulin resistance and sensitivity , especially for diabetic with overweight or obesity . However , owing to potential sophistication , individual difference and composition of intestinal microbiota , this result should be carefully taken into account
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"Background Resistant starch ( RS ) is a type of dietary fiber that can improve glucose metabolism , but its effects may be modulated by sex or baseline insulin sensitivity . This study was design ed to examine the effect of high-amylose maize resistant starch ( HAM-RS2 ) on insulin sensitivity ( SI ) in women , and to determine if SI status affects the response to RS . Methods This was a r and omized , placebo-controlled , double-blind , cross-over study . Participants were 40 healthy , non-diabetic women aged 22–67 years in the normal-weight to obese BMI range ( 20.6–47.4 kg/m2 ) . Two doses of HAM-RS2 were tested , 15 and 30 g per day , administered in the form of cookies . Participants were r and omized to the order in which they received the experimental and placebo product . Each arm was 4 weeks , with a 4-week wash-out period in between . SI was assessed at the end of each 4-week arm of product consumption by frequently- sample d , insulin-modified , intravenous glucose tolerance test and minimal modeling . Participants were categorized as being insulin resistant ( IR ; SI based on Gaussian analysis . The effect of treatment arm on SI was examined by mixed-model analysis within IR and IS sub-groups , using all available data . In addition , SI was examined by ANOVA among just those women who completed all three arms of the study with valid SI results . Results Among IR participants , SI was on average ~16 % higher after the 30 g arm when compared to the control arm by mixed-model analysis ( n = 40 , P 0.06 ) . HAM-RS2 did not affect SI in IS women . Conclusion Consumption of HAM-RS2 at 30 g/day in the form of a snack food item was associated with improved insulin sensitivity in women with insulin resistance . Clinical trials registry numberNCT01521806",
"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",
"This study evaluated the effects of 2 levels of intake of high-amylose maize type 2 resistant starch ( HAM-RS2 ) on insulin sensitivity ( SI ) in participants with waist circumference ≥89 ( women ) or ≥102 cm ( men ) . Participants received 0 ( control starch ) , 15 , or 30 g/d ( double-blind ) of HAM-RS2 in r and om order for 4-wk periods separated by 3-wk washouts . Minimal model SI was assessed at the end of each period using the insulin-modified i.v . glucose tolerance test . The efficacy evaluable sample included 11 men and 22 women ( mean ± SEM ) age 49.5 ± 1.6 y , with a BMI of 30.6 ± 0.5 kg/m2 and waist circumference 105.3 ± 1.3 cm . A treatment main effect ( P = 0.018 ) and a treatment × sex interaction ( P = 0.033 ) were present . In men , least squares geometric mean analysis for SI did not differ after intake of 15 g/d HAM-RS2 ( 6.90 × 10−5 pmol−1 · L−1 × min−1 ) and 30 g/d HAM-RS2 ( 7.13 × 10−5 pmol−1 · L−1 × min−1 ) , but both were higher than after the control treatment ( 4.66 × 10−5 pmol−1 · L−1 × min−1 ) ( P of HAM-RS2 improves SI in men . Additional research is needed to underst and the mechanisms that might account for the treatment × sex interaction observed",
"BACKGROUND Type 2 diabetes ( T2D ) incidence continues to rise . Although increasing dietary fiber intake is an established strategy for improved glycemic control , most adults consume insufficient amounts . Fiber-enhanced functional foods can increase fiber intake , and there is particular interest in resistant starch ( RS ) as a high-fiber ingredient . Studies show that high-amylose maize resistant starch , type 2 ( HAM-RS2 ) improves acute and chronic glycemic responses , but more studies are needed in individuals at high risk of T2D with RS delivered in commonly consumed foods . OBJECTIVE The objective of this study was to examine the chronic effects of consuming bagels high in HAM-RS2 on fasting and postpr and ial glycemic markers in adults at increased risk of T2D . METHODS With the use of a r and omized , double-blind crossover design , 24 men and women with a mean ± SE age of 55.3 ± 1.59 y and body mass index ( in kg/m2 ) of 30.2 ± 0.57 consumed 1 bagel containing 25 g HAM-RS2/d or 1 control wheat bagel/d for 56 d each , separated by a 4-wk washout . Fasting and postpr and ial oral-glucose-tolerance test ( OGTT ) glucose and insulin were measured on study days 1 and 57 of each bagel treatment . RESULTS The RS bagel treatment result ed in significantly lower fasting ( 22.1 % , P = 0.04 ) , 2-h ( 23.3 % , P 0.05 ) insulin incremental areas under the curve and fasting insulin resistance ( homeostasis model assessment of insulin resistance ; 23.1 % , P = 0.04 ) than did the control bagel treatment . Fasting and postpr and ial OGTT glucose concentrations did not differ between the RS and control bagel treatments on study days 1 or 57 . CONCLUSIONS These data suggest that consumption of a high-HAM-RS2 bagel improves glycemic efficiency by reducing the amount of insulin required to manage postpr and ial glucose while improving fasting insulin sensitivity in adults at increased risk of T2D . This research provides support for a feasible dietary strategy for T2D risk reduction . This trial was registered at clinical trials.gov as NCT02129946",
"Previous work has shown increased insulin sensitivity , increased hepatic insulin clearance and lower postpr and ial insulin responses following treatment with resistant starch , a type of dietary fibre . The objective of this study was to further explore the effects of resistant starch on insulin secretion . Twelve overweight ( BMI 28.2±0.4 kg/m2 ) individuals participated in this r and omized , subject-blind crossover study . Participants consumed either 40 g type 2 resistant starch or the energy and carbohydrate-matched placebo daily for four weeks . Assessment of the effect on insulin secretion was made at the end of each intervention using an insulin-modified frequently sample d intravenous glucose tolerance test ( FSIVGTT ) . Insulin and C-peptide concentrations were significantly higher during the FSIVGTT following the resistant starch compared with the placebo . Modelling of the data showed significantly improved first-phase insulin secretion with resistant starch . These effects were observed without any changes to either body weight or habitual food intake . This study showed that just four weeks of resistant starch intake significantly increased the first-phase insulin secretion in individuals at risk of developing type 2 diabetes . Further studies exploring this effect in individuals with type 2 diabetes are required",
"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",
"BACKGROUND The elderly often have a diet lacking resistant starch ( RS ) which is thought to lead to gut microbiome dysbiosis that may result in deterioration of gut colonocytes . OBJECTIVE The primary objective was to assess if elderly ( ELD ; ≥ 70 years age ) had microbiome dysbiosis compared to mid-age ( MID ; 30 - 50 years age ) adults and then determine the impact of daily consumption of MSPrebiotic ® ( a RS ) or placebo over 3 months on gut microbiome composition . Secondary objectives included assessment of stool short-chain fatty acids ( SCFA ) and inflammatory markers in ELD and MID Canadian adults . DESIGN This was a prospect i ve , placebo controlled , r and omized , double-blinded study . Stool was collected at enrollment and 6 , 10 and 14 weeks after r and omization to placebo or MSPrebiotic ® . Microbiome analysis was done using 16S rRNA sequencing of DNA extracted from stool . SCFA analysis of stool was performed using gas chromatography . RESULTS There were 42 ELD and 42 MID participants r and omized to either placebo or MSPrebiotic ® who completed the study . There was significantly higher abundance of Proteobacteria ( Escherichia coli/Shigella ) in ELD compared to MID at enrollment ( p MSPrebiotic ® consumption . There was a significant increase in Bifidobacterium in both ELD and MID compared to placebo ( p = 0.047 and 0.006 , respectively ) . There was a small but significant increase in the stool SCFA butyrate levels in the ELD on MSPrebiotic ® versus placebo . CONCLUSIONS The study data demonstrated that MSPrebiotic ® meets the criteria of a prebiotic and can stimulate an increased abundance of endogenous Bifidobacteria in both ELD and MID without additional probiotic supplementation . MSPrebiotic ® consumption also eliminated the dysbiosis of gut Proteobacteria observed in ELD at baseline . CLINICAL TRIAL REGISTRY NUMBER NCT01977183 listed on NIH website : Clinical Trials.gov . The full trial protocol is available on request from the corresponding author . NUCLEOTIDE SEQUENCE ACCESSION NUMBERS The 16S rRNA sequencing data and meta data generated in this study have been su bmi tted to the NCBI Sequence Read Archive ( SRA : http://www.ncbi.nlm.nih.gov/bioproject/381931 )",
"Background Adipose tissue patterning has a major influence on the risk of developing chronic disease . Environmental influences on both body fat patterning and appetite regulation are not fully understood . This study was performed to investigate the impact of resistant starch ( RS ) on adipose tissue deposition and central regulation of appetite in mice . Methodology and Principle Findings Forty mice were r and omised to a diet supplemented with either the high resistant starch ( HRS ) , or the readily digestible starch ( LRS ) . Using 1H magnetic resonance ( MR ) methods , whole body adiposity , intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured . Manganese-enhanced MRI ( MEMRI ) was used to investigate neuronal activity in hypothalamic regions involved in appetite control when fed ad libitum . At the end of the interventional period , adipocytes were isolated from epididymal adipose tissue and fasting plasma collected for hormonal and adipokine measurement . Mice on the HRS and LRS diet had similar body weights although total body adiposity , subcutaneous and visceral fat , IHCL , plasma leptin , plasma adiponectin plasma insulin/glucose ratios was significantly greater in the latter group . Adipocytes isolated from the LRS group were significantly larger and had lower insulin-stimulated glucose uptake . MEMRI data obtained from the ventromedial and paraventricular hypothalamic nuclei suggests a satiating effect of the HRS diet despite a lower energy intake . Conclusion and Significance Dietary RS significantly impacts on adipose tissue patterning , adipocyte morphology and metabolism , glucose and insulin metabolism , as well as affecting appetite regulation , supported by changes in neuronal activity in hypothalamic appetite regulation centres which are suggestive of satiation",
"Resistant starch ( RS ) includes the sum of starch and degradation products of starch that resist small intestinal digestion and enter the colon . This study was planned to examine the effect of resistant starch on hypolipidemic actions , blood glucose , insulin levels and humoral immune responses in healthy overweight subjects . Healthy overweight subjects ( over 120 % of their ideal body weights ) were fed either 24 g/d of resistant corn starch ( RS ) or regular corn starch ( CS ) for 21 d with their regular meals . Although this double-blind feeding regiment result ed in no significant changes in their weights or other physical parameters for the relatively acute period of intakes , there were significant lowering effects of serum total cholesterol ( p serum LDL-cholesterol ( p mean fasting serum glucose concentrations ( p starch supplement result ed in the increase in serum immunoglobulin G ( IgG ) concentrations . Serum insulin and complement 3 ( C3 ) were unaffected . Tested resistant starch supplementation was reported to be palatable with minimal bowel discomfort . These results suggest that RS supplementation improves the blood lipid profile and controls the blood glucose levels in healthy overweight subjects without bowel discomfort . Therefore , RS has a potential to be used as one of the promising food ingredients for reducing risk factors involved in the development of atherosclerosis and type 2 diabetes in overweight individuals . However , in order to prove RS as a novel therapeutic agent of cardiovascular diseases and diabetes , controlled trials with larger sample sizes and longer duration are warranted",
"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"
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Financial incentive interventions are increasingly used as a method of encouraging healthy behaviours , from attending for vaccinations to taking part in regular physical activity . There is a growing body of research on the effectiveness of financial incentive interventions for health behaviours . Wide variations in the nature of these interventions make it difficult to draw firm conclusions about what makes an effective incentive , for whom and under what circumstances . Whilst there has been some recognition of the theoretical complexity of financial incentive interventions for health behaviours , there is no framework that categorises these interventions . This limits the research community 's ability to clearly establish which components of financial incentives interventions are more and less effective , and how these components might interact to enable behavioural change . We propose a framework for describing health-promoting financial incentive interventions . Drawing on our experience of a recently completed systematic review , we identify nine domains that are required to describe any financial incentive intervention design ed to help individuals change their health behaviours . These are : direction , form , magnitude , certainty , target , frequency , immediacy , schedule and recipient . Our framework should help research ers and policy-makers identify the most effective incentive configurations for helping individuals adopt healthy behaviours
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"Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs",
"Consider the following paradox : few people would balk if research ers offered smokers $ 1,000 to participate in a year-long r and omized trial of a smoking cessation intervention , yet many would find it distasteful for a large employer to pay its smoking employees an extra $ 1,000 if they remained smoke-free for one year . Such discrepant judgments are underst and able from the perspective of classical economics . Research participants merit compensation for the risks and opportunity costs they endure in the service of public health , whereas individuals should need no reward for promoting their own well being . However , contrary to traditional theories of rationality , people frequently fail to make health-promoting choices , particularly when such choices require short-term sacrifices to foster long-term goals .1,2 Thus , corporate and government health plan leaders are increasingly applying extrinsic motivations such as financial incentives and other programs to augment health – particularly cardiovascular health – while hopefully increasing productivity and restraining costs.3 , 4 Early evidence suggests that financial incentives can effectively promote the cardioprotective behaviors of smoking cessation,5 , 6 weight loss,7 , 8 and cholesterol reduction.9 Incentives are also currently being studied as a means of promoting warfarin adherence.10 Although the results of these early studies are promising , further research is needed to determine which incentive structures and amounts are optimal , assess the ability of incentives to produce sustained behavior changes , and evaluate the cost-effectiveness of implementing incentive programs . Ethical dimensions of the incentives themselves are also in need of further analysis . For example , some have charged that financial incentive programs are coercive , inequitable , and inconsistent with shared social values.11 Others have even suggested that implementing incentive programs serves to punish patients for their illnesses.12 In this essay , we outline the rationale for incentive programs to promote cardiovascular health , identify the ethical arguments that have been used to challenge such programs , and assess the merits of these arguments",
"BACKGROUND Smoking is the leading preventable cause of premature death in the United States . Previous studies of financial incentives for smoking cessation in work setting s have not shown that such incentives have significant effects on cessation rates , but these studies have had limited power , and the incentives used may have been insufficient . METHODS We r and omly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs ( 442 employees ) or to receive information about programs plus financial incentives ( 436 employees ) . The financial incentives were $ 100 for completion of a smoking-cessation program , $ 250 for cessation of smoking within 6 months after study enrollment , as confirmed by a biochemical test , and $ 400 for abstinence for an additional 6 months after the initial cessation , as confirmed by a biochemical test . Individual participants were stratified according to work site , heavy or nonheavy smoking , and income . The primary end point was smoking cessation 9 or 12 months after enrollment , depending on whether initial cessation was reported at 3 or 6 months . Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs . RESULTS The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment ( 14.7 % vs. 5.0 % , P Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program ( 15.4 % vs. 5.4 % , P completion of a smoking-cessation program ( 10.8 % vs. 2.5 % , P smoking cessation within the first 6 months after enrollment ( 20.9 % vs. 11.8 % , P financial incentives for smoking cessation significantly increased the rates of smoking cessation . ( Clinical Trials.gov number , NCT00128375 .",
"Background The use of financial incentives and penalties to encourage uptake of healthy behaviors is increasingly seen as a viable intervention in developed countries . Previous review s of the effectiveness of financial incentives and penalties for encouraging the uptake of healthy behaviors have focused on individual behaviors making it difficult to draw overall conclusions about the effectiveness of such interventions . This systematic review will explore the effectiveness of financial incentives and penalties for encouraging a wide range of behaviors , including : smoking cessation , increased physical activity , healthier dietary intake , sensible patterns of alcohol consumption , safe sun , safe sex , and primary preventive clinical behaviors . Methods Systematic methods will be used to search existing literature and screen studies for inclusion . All studies that meet the following inclusion criteria will be included in the review : participants were 18 years old or older and living in high-income countries ; interventions included cash or cash-like incentives to promote the uptake of healthy behaviors , or cash or cash-like penalties to discourage unhealthy behaviors ; the comparator was usual care or no intervention ; study design was r and omized controlled trial , cluster r and omized controlled trial , controlled before and after study , or interrupted time series analysis . Two review ers will independently screen the publications to ensure they meet the inclusion criteria . Quality will be assessed by two research ers , working independently , using the Cochrane risk of bias tool . Meta- analysis will be conducted , if appropriate . Any studies identified as at ‘ high risk of bias ’ will be excluded from meta- analysis . Discussion This systematic review will provide policy-relevant recommendations for the use of financial incentives and penalties as a method of encouraging uptake of healthy behaviors",
"BACKGROUND Evidence from cost-effective smoking cessation programs is scarce . This study determined the cost-effectiveness of 3 smoking cessation strategies as provided by general practitioners ( GPs ) in Germany . METHODS In a cluster-r and omized smoking cessation trial , rates and intervention costs for 577 smoking patients of 82 GPs were followed up for 12 months . Three smoking cessation treatments were tested : ( 1 ) GP training plus GP remuneration for each abstinent patient , ( 2 ) GP training plus cost-free nicotine replacement medication and /or bupropion hydrochloride for the patient , and ( 3 ) a combination of both strategies . Smoking abstinence at 12 months was the primary outcome used to calculate incremental cost-effectiveness ratios and net monetary benefits . RESULTS Intervention 1 was not effective compared with treatment as usual ( TAU ) . Interventions 2 and 3 each proved to be cost-effective compared separately with TAU . When applying a 95 % level of certainty of cost-effectiveness against TAU , euro 9.80 or euro 6.96 , respectively , had to be paid for each additional 1 % of patients abstinent at 12 months ( maximum willingness to pay ) . That means that in intervention 2 , euro 92.12 per patient in the program must be invested to gain 1 additional quitter ( as opposed to euro 39.10 paid per patient during the trial ) . In intervention 2 , the cost was euro 82.82 , as opposed to euro 50.04 . Neither of these 2 cost-effective treatments proved to be superior to the other . The cost-effectiveness of both treatments was stable against TAU in sensitivity analyses . ( The exchange rate from October 1 , 2003 , was used ; euro1 = $ 1.17 . ) CONCLUSIONS Both treatments have a high potential to reduce smoking-related morbidity at a low cost . It is highly recommended that they be implemented as a routine service offered by GPs because in many countries , health insurance plans currently do not fund nicotine replacement therapy",
"This study examined the relative reinforcing potency of vouchers and cash in drug-dependent pregnant women ( N = 48 ) across voucher values ( US 10 dollars , US 50 dollars , and US 100 dollars ) by use of a series of choices to underst and how exchange-delay features of voucher reinforcers influence their reinforcing potency compared with cash . The study also examined a no delay vs. 2-day delay of the cash alternative . Generally , cash was selected at 80%-90 % of voucher face values . Vouchers were also discounted less when a 2-day delay was imposed on the cash option compared to the immediately available cash . These results suggest that voucher discounting does occur among patients in drug treatment . However , vouchers retain 80%-90 % of their cash value and thus remain relatively potent reinforcers",
"Marijuana-dependent young adults ( N = 136 ) , all referred by the criminal justice system , were r and omized to 1 of 4 treatment conditions : a motivational/skills-building intervention ( motivational enhancement therapy/cognitive-behavioral therapy ; MET/CBT ) plus incentives contingent on session attendance or su bmi ssion of marijuana-free urine specimens ( contingency management ; CM ) , MET/CBT without CM , individual drug counseling ( DC ) plus CM , and DC without CM . There was a significant main effect of CM on treatment retention and marijuana-free urine specimens . Moreover , the combination of MET/CBT plus CM was significantly more effective than MET/CBT without CM or DC plus CM , which were in turn more effective than DC without CM for treatment attendance and percentage of marijuana-free urine specimens . Participants assigned to MET/CBT continued to reduce the frequency of their marijuana use through a 6-month follow-up",
"This study evaluated the impact of a year-long incentives-based worksite smoking-cessation program . Nineteen moderate-sized worksites , employing a total of approximately 1100 smokers , were r and omized to Incentive or No Incentive conditions . All identified smokers in the worksite were considered as subjects , whether or not they participated in the intervention . Analyses were conducted at both the worksite and individual level , and using both self-reported and biochemically vali date d cessation as endpoints . The incentive program did not significantly improve cessation rates at either the 1-year or 2-year follow-up assessment s. We conclude that more broadly focused interventions that also address worksite smoking policies , skills training , and cessation re sources , or programs that target additional risk factors are needed to substantially enhance quit rates",
"OBJECTIVES This study assessed the independent and combined effects of different levels of monetary incentives and a theory-based educational intervention on return for tuberculosis ( TB ) skin test reading in a sample of active injection drug and crack cocaine users . Prevalence of TB infection in this sample was also determined . METHODS Active or recent drug users ( n = 1004 ) , recruited via street outreach techniques , were skin tested for TB . They were r and omly assigned to 1 of 2 levels of monetary incentive ( $ 5 and $ 10 ) provided at return for skin test reading , alone or in combination with a brief motivational education session . RESULTS More than 90 % of those who received $ 10 returned for skin test reading , in comparison with 85 % of those who received $ 5 and 33 % of those who received no monetary incentive . The education session had no impact on return for skin test reading . The prevalence of a positive tuberculin test was 18.3 % . CONCLUSIONS Monetary incentives dramatically increase the return rate for TB skin test reading among drug users who are at high risk of TB infection ",
"OBJECTIVE Less than half of all U.S. adults meet public health recommendations for physical activity , and even fewer older adults ( aged 50 years and over ) are sufficiently active . Because inactivity increases the risk of costly medical complications , successful efforts to increase physical activity among older adults may potentially be cost-effective . We sought to test if financial incentives for walking could increase physical activity among sedentary older adults . METHODS We conducted a 4-week r and omized controlled study using pedometers . A total of 51 adults age 50 + from the Raleigh-Durham area of North Carolina participated in the study in April-May 2007 . Individuals were r and omized into one of two arms . The control group received a fixed payment of $ 75 ; the intervention group received a fixed payment of $ 50 plus up to $ 25 more per week depending on the number of weekly aerobic minutes , defined as 10 + minutes of continuous walking or jogging . RESULTS The control group logged 2.3 h per week , on average . The intervention group logged 4.1 h per week and received an additional weekly payment of $ 17.50 , on average . CONCLUSION Modest financial incentives tied to aerobic minutes are an effective , and potentially cost-effective , approach for increasing physical activity among sedentary older adults ",
"BACKGROUND To minimize absenteeism result ing from influenza , employers frequently offer on-site influenza vaccination to employees . Yet the level of uptake of vaccine is low among working adults . This study was design ed to increase workplace influenza vaccination rates by offering both a choice of intranasal ( LAIV ) and injectable ( TIV ) influenza vaccines to eligible employees , and an incentive for being vaccinated , and by increasing awareness of the vaccine clinic . DESIGN This study used a stratified r and omized cluster trial . SETTING / PARTICIPANTS A total of 12,222 employees in 53 U.S. companies with previous influenza vaccine clinics were examined . INTERVENTIONS Control sites advertised and offered vaccine clinics as previously done . Choice sites offered LAIV or TIV and maintained their previous advertising level but promoted the choice of vaccines . Choice Plus sites increased advertising and promoted and offered a choice of vaccines and a nominal incentive . MAIN OUTCOME MEASURES These included vaccination rates among eligible employees . Hierarchic linear modeling ( HLM ) was used to determine factors associated with vaccination . RESULTS The overall vaccination rate increased from 39 % in 2007 - 2008 to 46 % in 2008 - 2009 ( p difference in vaccination rates for LAIV was 6.5 % for Choice versus Control and 9.9 % for Choice Plus versus Control ( both p Rates of TIV increased by 15.9 percentage points in the Choice Plus arm versus Control for workers aged > or = 50 years ( p=0.024 ) . Rates of TIV did not change in workers aged 18 - 49 years in either intervention arm or in workers aged > or = 50 years in the Choice arm . In HLM analyses , factors significantly associated with increased vaccination were older age , female gender , previous company vaccination rate , and the Choice Plus intervention . CONCLUSIONS An incentive for vaccination , an intensified advertising campaign , and offering a choice of influenza vaccines improved vaccination rates in the workplace",
"OBJECTIVE Reinforcement-based treatments , based on behavioral economics models , can improve outcomes of medical conditions with behavioral components . This study evaluated the efficacy of a low-cost reinforcement intervention to produce initial weight loss . METHODS Overweight individuals ( n=56 ) were r and omized to one of two 12-week treatments : Lifestyle , Exercise , Attitudes , Relationships , Nutrition manual with supportive counseling or that same treatment with opportunities to win $ 1 to $ 100 prizes for losing weight and completing weight-loss activities . RESULTS Patients receiving reinforcement lost significantly more weight ( 6.0 % ± 4.9 % baseline bodyweight ) than patients in the non-reinforcement condition ( 3.5 % ± 4.1 % ; P=.04 ) . Moreover , 64.3 % of patients receiving reinforcement achieved weight loss of ≥ 5 % baseline bodyweight versus 25.0 % of those in the non-reinforcement condition ( P=.003 ) . Proportional weight loss was significantly related to reductions in total cholesterol and 24-hour ambulatory heart rate . CONCLUSION This reinforcement-based intervention substantially enhances short-term weight loss , and reductions in weight are associated with important changes in clinical biomarkers . Larger-scale evaluation of reinforcement-based treatments for weight loss is warranted"
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OBJECTIVE To evaluate the long-term clinical performance of direct versus indirect composite inlays/onlays in posterior teeth . DATA Screening for inclusion eligibility , quality assessment of studies and data extraction was performed independently by two authors . SOURCES The electronic data bases MEDLINE , EMBASE , Cochrane Oral Health Group 's Trials Register and CENTRAL were search ed ( 14.12.2015 ) , with no restriction to publication date or language . We included only r and omised controlled trials ( RCTs ) and evaluated them according to Cochrane risk of bias tool . The main outcome assessed was the restoration failure , determined by several clinical parameters . STUDY SELECTION Two studies concerning direct and indirect inlays ( 82 patients with 248 restorations ) and one study for onlays ( 157 patients with 176 restorations ) satisfied the inclusion criteria . Two trials , one of unclear and one of high risk of bias , could be mathematically combined . The meta- analysis indicated no statistically significant difference in the risk failure between direct and indirect inlays , after 5 years ( RR : 1.54 ; 95 % Cl : 0.42 , 5.58 ; p=0.52 ) or 11 years of function ( RR : 0.95 ; 95 % Cl : 0.34 , 2.63 ; p=0.92 ) . Only one parameter , the marginal discoloration , slightly favored direct inlays after 11 years ( RR : 0.41 ; 95 % Cl : 0.17 , 0.96 ; p=0.04 ) . Only one study dealt with onlays ; an overall 5-year survival of 87 % ( 95 % CI : 81 - 93 % ) was reported . CONCLUSION The difference of the two techniques did not reach statistical significance in order to recommend one technique over the other . The scarcity of primary studies support the need for further well- design ed long-term studies in order to reach firm conclusions about both techniques . CLINICAL SIGNIFICANCE Resin composite material s , placed directly or indirectly , exhibit a promising long-term clinical performance when rehabilitation of posterior teeth is needed . Although many years in clinical practice , the selection of the best treatment protocol still remains subjective . The available studies , and their synthesis , can not provide reliable evidence in this field
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"The purpose of this r and omized , clinical study was to evaluate the clinical performance of composite resin material s used for fillings and indirect inlays . Twenty-eight sets of five class II restorations ( two fillings , three inlays ) were placed in 88 premolars and 52 molars in 28 adults . Brilliant Dentin and Estilux Posterior were used for both fillings and inlays , and SR-Isosit for inlays only . After 11 years , 27 sets of restorations ( 96 % ) were evaluated clinical ly using modified United States Public Health Service criteria . Replaced or repaired restorations were observed in 16 % of the fillings and 17 % of the inlays , and a further 5 % of the restorations were replaced for reasons not related to the restoration . The remaining 107 restorations exhibited optimal ratings in 30 % of the fillings and 12 % of the inlays ( P acceptable ratings in 70 % and 88 % , respectively . The reasons for failure were fracture of restoration ( four fillings , five inlays ) , secondary caries ( two fillings , four inlays ) , fracture of tooth ( two inlays ) , loss of proximal contact ( two fillings ) , and loss of restoration ( one inlay ) . Failures were seen more frequently in molar than premolar restorations ( P0.05 )",
"OBJECTIVES This longitudinal r and omized controlled clinical trial evaluated the longevity of composite resin inlays in single- or multi-surface cavities up to 4 years . METHODS 21 dental students placed 75 Artglass and 80 Charisma composite resin inlays in class I and II cavities in posterior teeth ( 89 adult patients ) luted with dual-curing resin cements . Clinical evaluation was performed up to 4 years using modified USPHS criteria . RESULTS 87.2 % of Artglass and 76.6 % of Charisma inlays were assessed to be clinical ly excellent or acceptable . Up to the 4-year recall 5 Artglass and 11 Charisma inlays failed mainly because of postoperative symptoms , bulk fracture , and loss of marginal integrity . No significant differences between both composite resin material s could be detected at 4 years for all clinical criteria ( Mann-Whitney U-test , p>0.05 ) . The comparison of restoration performance with time yielded a significant increase in marginal discolouration and postoperative symptoms ( p deterioration of surface texture quality , marginal and restoration integrity ( p Artglass inlays ( p Artglass and Charisma composite resin inlays exhibited an annual failure rate of 3.2 % and 5.9 % that is within the range of published data . Within the limitations of this study indirect composite inlays are a competitive restorative procedure in stress-bearing preparations",
"The purpose of this study was to compare the use of direct ( USPHS ) and indirect ( M-L ) systems of evaluating the occlusal wear of posterior composite restorations . Additionally , this study has utilized the USPHS method to compare the in vivo performance of posterior resin composite restorations made from four different visible-light-cured material s. Of the 202 restorations placed for this r and omized clinical trial , only those restorations that were scored by both direct and indirect evaluation systems were included in these comparisons . Restorations were evaluated by two calibrated examiners from baseline to 36 months . While there were some differences noted among the four material s , the majority ( 99 % ) of the restorations evaluated in this study received \" alpha \" or \" bravo \" scores for all USPHS parameters , indicating acceptable in vivo performance . The results of this study also indicate that there was a consistent relationship between the direct ( USPHS ) and indirect ( M-L scale ) scoring systems . For those restorations that changed anatomic form scores , the mean wear at the alfa/bravo transition was 100 + /- 80 microns . By the 24-month recall examination , the use of the USPHS evaluation system category of anatomic form enabled examiners to differentiate restorations and material s that had experienced little occlusal wear from those that had experienced greater amounts of wear",
"The objective of this r and omized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps . In 157 patients , 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp . Ninety-two direct and 84 indirect resin composite restorations were placed by two operators , following a strict protocol . Treatment technique and operator were assigned r and omly . Follow-up period was at least 4.5 yrs . Survival rates were determined with time to reparable failure and complete failure as endpoints . Kaplan-Meier five-year survival rates were 86.6 % ( SE 0.27 % ) for reparable failure and 87.2 % ( SE 0.27 % ) for complete failure . Differences between survival rates of direct and indirect restorations [ 89.9 % ( SE 0.34 % ) vs. 83.2 % ( SE 0.42 % ) for reparable failure and 91.2 % ( SE 0.32 % ) vs. 83.2 % ( SE 0.42 % ) for complete failure ] were not statistically significant ( p = .23 for reparable failure ; p = .15 for complete failure ) . Mode of failure was predominantly adhesive . The results suggest that direct and indirect techniques provide comparable results over the long term ( trial registration number : IS RCT N29200848 )",
"PURPOSE This study aim ed to assess the efficacy and short-term effectiveness of the morphology and function of direct and indirect cusp-replacing resin composite restorations . MATERIAL S AND METHODS In 94 patients , 106 cusp-replacing restorations for maxillary premolars were fabricated to restore Class II caries lesions with 1 cusp missing . Fifty-four direct ( Clearfil AP-X ) and 52 indirect ( Estenia ) resin composite restorations were placed following a strict protocol . The treatment technique and operator were assigned r and omly . Treatment time was recorded for all restorations . One-month postoperative evaluation included assessment of postoperative sensitivity and presence of occlusal and proximal contacts . RESULTS Treatment time for the indirect technique ( 68 + /- 17 min ) was longer than for the direct technique ( 45 + /- 13 min ) . Regression analysis revealed that the restorative method , operator , and location of the preparation outline had a statistically significant effect on the total treatment time . Occlusal contacts were observed in 94 % of the direct restorations and in 98 % of the indirect restorations ( chi-square , P>.05 ) . Mesial proximal contacts were present in 98 % of the direct and in 97 % of the indirect restorations ( chi-square , P > .05 ) . Distal contacts were present in 100 % of the restorations for both techniques . Postoperative sensitivity within 1 week posttreatment was reported for 11 % of the direct restorations and for 13 % of the indirect restorations , but decreased to 4 % and 6 % , respectively , after 1 month ( chi-square , P > .05 ) . CONCLUSION The results of this study suggest that in the short term , both direct and indirect adhesive techniques are adequate to restore the morphology and function of premolars presenting with Class II caries lesions and a missing cusp",
"STATEMENT OF THE PROBLEM Objective long-term clinical data are necessary to assess the performance of modern posterior composites as direct and indirect restorations . PURPOSE This prospect i ve , long-term clinical trial evaluated direct and indirect composite restorations for clinical acceptability as posterior restoratives in single or multisurface cavities and provided a survey on the 3-year results . MATERIAL AND METHODS Under the supervision of an experienced dentist , 9 dental students placed 88 composite restorations ( Tetric , blend-a-lux , Pertac-Hybrid Unifil ) , 43 direct composite restorations , and 45 indirect inlays . Clinical evaluation was performed at baseline and in yearly intervals after placement by 2 other experienced dentists , using modified USPHS criteria . A third follow-up of 60 restorations took place within 33 to 36 months after placement . RESULTS A total of 93 % of indirect and 87 % of direct restorations were assessed to be clinical ly excellent or acceptable . During the third year , 1 direct restoration in a molar failed because of margin opening . Indirect inlays exhibited a significantly better anatomic form of the surface than direct composite restorations . Premolars revealed a significantly better marginal integrity and anatomic form of the surface than molars . Restorations in molars exhibited a significantly higher failure rate compared with premolars . CONCLUSION Posterior composite restorations provided a satisfactory clinical performance over a 3-year period , even if placed by relatively inexperienced but supervised students",
"This study compared microleakage between indirect composite inlays and direct composite restorations . Forty-eight st and ard inlay MOD cavities , with cervical margins located either in enamel or dentin , were prepared in extracted human third molars . The specimens were r and omly divided into 3 groups ( n=16 ) . In the control group , the cavities were restored with the composite Filtek Z250 ( 3 M ESPE ) . For the experimental groups , indirect restorations were made with the Artglass ( Heraeus-Kulzer ) or Belleglass HP ( Kerr Laboratories ) systems and cemented with the dual curing cement RelyX ARC ( 3 M ESPE ) . The adhesive system Single Bond ( 3 M ESPE ) was applied on all groups . The specimens were su bmi tted to thermolcycling , coated with nail varnish , then immersed in 2 % basic fuchsine aqueous solution for 24 hours . The teeth were then sectioned and leakage scores were evaluated ( 40x ) , based on a st and ard ranking . Data were su bmi tted to statistical analysis ( Mann-Whitney and Kruskal-Wallis tests ) with a 95 % confidence level . No statistical difference was found between substrates ( p=0.595 ) , and the material s performed similarly in dentin ( p=0.482 ) . Direct restorations showed higher leakage than indirect restorations at the enamel margins ( p=0.004 ) . Within the limitations of this experimental design , overall leakage was similar between both substrates , while the indirect systems provided a better sealing than direct composites only in enamel",
"This study compared the clinical performance of indirectly manufactured ceramic Evopress inlays with those of directly placed , fine particle hybrid Filtek Z250 composite restorations in posterior teeth . From January 2000 to October 2003 , 109 patients received 264 Evopress ( Wegold ) ceramic inlays and 68 patients received 145 Filtek Z250 ( 3 M ESPE ) composite restorations in a dental office . Two-hundred and fifty ceramic inlays ( 95 % ) and 135 composite restorations ( 93 % ) were re-examined up to 57 months after placement . Modified USPHS criteria were used for the study . The worst finding of all the assessment s was the overall assessment of individual restorations . On the basis of these criteria , 220 ( 88 % ) Evopress ceramic inlays were assessed as Alpha at the time of clinical re-examination , 26 ( 10 % ) were judged Beta and four ceramic inlays ( 2 % ) were rated Delta in the re-examination interval and thus categorized as failures . At the time of re-examination , 91 of the 135 composite restorations ( 67 % ) were judged Alpha , 36 restorations ( 26 % ) were rated Beta and three restorations ( 2 % ) were judged Charlie . Five restorations ( 4 % ) were categorized as failures ( Delta ) . In two cases , there were marginal gap formations ; there were also two cases of secondary caries after 28 and 35 months , as well as a fracture after 13 months . According to Kaplan and Meier , the survival rate after 57 months was 94 % for ceramic inlays and 93 % for composite restorations . The log rank test showed no significant differences in the survival curves . The current study showed that indirectly manufactured Evopress ceramic inlays performed better than direct Filtek Z250 composite restorations in marginal adaptation , color match and anatomic form . However , with regard to survival probability , there was no significant difference",
"OBJECTIVE The study evaluated the clinical performance and marginal adaptation of direct and semi-direct class II composite restorations in a split-mouth design over 3.5 years . DESIGN 44 upper posterior teeth in 11 adults with primary carious lesions were treated with 22 direct and 22 semi-direct restorations . Conventional cavities were prepared for both types of restorations . A fine fine hybrid composite ( APH ) and a multifunctional adhesive system ( Prisma universal bond 3 ) were used for all restorations . The incremental \" 3-sited light curing \" technique was applied to direct restorations . Semi-direct inlays were prefabricated on silicone casts and post-cured using light and heat . Clinical performance was evaluated using modified USPHS parameters , while marginal adaptation was judged on replicas , using SEM and a st and ardized evaluation technique . RESULTS Clinical results after 3.5 years revealed a 100 % retention rate with no fractures , sensitivity or recurrent caries for both types of restorations . SEM-evaluation of the occlusal margins showed at the tooth-restoration interface relatively low rates of marginal openings over the observation period ( 4 - 8 % ) . Marginal restoration fractures ranged between 1 and 2 % , marginal tooth fractures between 3 and 9 % . Differences between the restorative techniques and after the different time observation periods were not statistically significant . Proportions of marginal fractures and openings at the restoration-luting composite interface were less than 10 % after 3.5 years . CONCLUSION The results indicated no significant differences for direct and semi-direct fine hybrid composite restorations in medium size cavities in posterior teeth with respect to clinical performance and marginal adaptation over 3.5 years",
"OBJECTIVE The aims of this prospect i ve clinical study were ( 1 ) to evaluate the clinical performance of Signum composite inlays over a 3-year period ; ( 2 ) to investigate the clinical efficacy of composite inlays in premolars versus molars ; and ( 3 ) to evaluate differences between 1- or 2-surface inlays and multisurface inlays . METHOD AND MATERIAL S One hundred thirteen composite inlays were placed in 30 patients by a clinician . All the inlays were made by the same laboratory technician using only one composite material ( Signum , Heraeus Kulzer ) . All the restorations were bonded with a 3-step bonding system and a composite luting cement . The restorations were assessed after placement by a clinician who had not been involved with the placement of the restorations , in accordance with the modified US Public Health Service criteria . RESULTS Three of the 113 experimental restorations had to be replaced ; the total failure rate was 2.6 % after 3 years . At baseline , 88.5 % to 100 % of the inlay restorations were rated as excellent ( Alpha ) . Statistically significant ( P surface roughness , anatomic form at the margin , marginal integrity , and inlay integrity . The comparison of the clinical outcome of inlays in premolars versus molars and with 1 or 2 surfaces versus multisurfaces showed no significant differences , except for the parameters anatomic form at the margin and marginal integrity . CONCLUSION Composite inlays demonstrated a very high success rate ( 97.4 % ) after 3 years . Neither the size of the restorations nor the tooth type significantly affected the clinical outcome of the restorations",
"A clinical trial of direct composite inlays versus conventionally ( incrementally ) placed restorations made from the same material was started in January 1989 . Restorations were r and omly allocated to matched pairs of cavities . This study reports the 3-year performance of 71 of the 100 pairs of restorations placed over a 2-year period and followed-up every 6 months . Clinical assessment s were made using USPHS criteria ( indirect measurements of occlusal wear were made using Ivoclar st and ard dies ) and annual bite wing radiographs . Direct inlays showed significantly less occlusal wear than conventional restorations , but the difference was small . The clinical performance of both types of restoration was similar and compared favourably with studies of other material s. No secondary decay was diagnosed . The direct inlays , however , took longer to place and did not reduce postoperative sensitivity or failure rate ( 8 % failure of inlays and 4 % of conventional composites over 3 years ) . Contouring of proximal and occlusal aspects was not facilitated with direct inlays but may be easier with indirect inlays on removable"
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INTRODUCTION Probiotics are a complementary and integrative therapy useful in the treatment and prevention of urogenital infections in women . This study extends the work of research ers who systematic ally investigated the scientific literature on probiotics to prevent or treat urogenital infections . METHODS A systematic review was conducted to determine the efficacy of probiotics for prevention and /or treatment of urogenital infections in adult women from January 1 , 2008 , through June 30 , 2015 . We search ed in CINAHL , MEDLINE , Cochrane Central Register of Controlled Trials , Web of Science , Dissertations and Theses , and Alt-HealthWatch . After removing duplicates and studies that did not meet inclusion criteria , 20 studies were review ed . All included at least one species of Lactobacillus probiotic as an intervention for treatment or prevention of urogenital infections . Data extracted included sample s , setting s , study design s , intervention types , reported outcomes , follow-up periods , and results . We evaluated all r and omized controlled trials for risk of bias and made quality appraisal s on all studies . RESULTS Fourteen of the studies focused on bacterial vaginosis ( BV ) , 3 on urinary tract infections ( UTIs ) , 2 on vulvovaginal c and idiasis , and one on human papillomavirus ( HPV ) as identified on Papanicolaou test . Studies were heterogeneous in terms of design , intervention , and outcomes . Four studies were of good quality , 9 of fair , and 7 poor . Probiotic interventions were effective for treatment and prevention of BV , prevention of recurrences of c and idiasis and UTIs , and clearing HPV lesions . No study reported significant adverse events related to the probiotic intervention . DISCUSSION The quality of the studies in this systematic review varied . Although clinical practice recommendations were limited by the strength of evidence , probiotic interventions were effective in treatment and prevention of urogenital infections as alternatives or co-treatments . More good quality research is needed to strengthen the body of evidence needed for application by clinicians
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"Background To determine if oral metronidazole ( MTZ-400 mg bid ) with 2 % vaginal clindamycin-cream ( Clind ) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol ( Prob ) reduces 6-month bacterial vaginosis ( BV ) recurrence . Methods Double-blind placebo-controlled parallel-group single-site study with balanced r and omization ( 1∶1∶1 ) conducted at Melbourne Sexual Health Centre , Australia . Participants with symptomatic BV [ Nugent Score ( NS ) = 7–10 or ≥3 Amsel 's criteria and NS = 4–10 ] , were r and omly allocated to MTZ-Clind , MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months . MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days . Primary outcome was BV recurrence ( NS of 7–10 ) on self-collected vaginal-swabs over 6-months . Cumulative BV recurrence rates were compared between groups by Chi-squared statistics . Kaplan-Meier , log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups . Results 450 18–50 year old females were r and omized and 408 ( 91 % ) , equally distributed between groups , provided ≥1 NS post-r and omization and were included in analyses ; 42 ( 9 % ) participants with no post-r and omization data were excluded . Six-month retention rates were 78 % ( n = 351 ) . One-month BV recurrence ( NS 7–10 ) rates were 3.6 % ( 5/140 ) , 6.8 % ( 9/133 ) and 9.6 % ( 13/135 ) in the MTZ-Clind , MTZ-Prob and MTZ-Placebo groups respectively , p = 0.13 . Hazard ratios ( HR ) for BV recurrence at one-month , adjusted for adherence to vaginal therapy , were 0.43 ( 95%CI 0.15–1.22 ) and 0.75 ( 95 % CI 0.32–1.76 ) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively . Cumulative 6-month BV recurrence was 28.2 % ; ( 95%CI 24.0–32.7 % ) with no difference between groups , p = 0.82 ; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac , adjusted for adherence to vaginal therapy were 1.09(95 % CI = 0.70–1.70 ) and 1.03(95 % CI = 0.65–1.63 ) , respectively . No serious adverse events occurred . Conclusion Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin , or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic , does not reduce BV recurrence . Trial Registration ANZCTR.org.au",
"Background : Bacterial vaginosis ( BV ) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment . Methods : A phase 2a study assessed colonization efficiency , safety , tolerability , and acceptability of Lactobacillus crispatus CTV-05 ( LACTIN-V ) administered by a vaginal applicator . Twenty-four women with BV were r and omized in a 3:1 ratio of active product to placebo . Participants used LACTIN-V at 2 × 109 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days , followed by a weekly application over 2 weeks . They returned for follow-up on Days 10 and 28 . Results : Sixty-one percent of the 18 women r and omized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28 . Among LACTIN-V users with complete adherence to the study regimen , 78 % were colonized at Day 10 or Day 28 . Of the 120 adverse events ( AEs ) that occurred , 108 ( 90 % ) and 12 ( 10 % ) were of mild and moderate severity , respectively . AEs were evenly distributed between the LACTIN-V and placebo group . Of the total AEs , 93 ( 78 % ) were genitourinary in origin . The most common genitourinary AEs included vaginal discharge ( 46 % ) , abdominal pain ( 46 % ) , dysuria ( 21 % ) , pollakiuria ( 21 % ) , vaginal odor ( 21 % ) , and genital pruritus ( 17 % ) . No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation . The product was well tolerated and accepted . Conclusions : LACTIN-V colonized well , and was safe and acceptable in women treated for BV",
"BACKGROUND Urinary tract infections ( UTIs ) are common among women and frequently recur . Depletion of vaginal lactobacilli is associated with UTI risk , which suggests that repletion may be beneficial . We conducted a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic ( Lactin-V ; Osel ) for prevention of recurrent UTI in premenopausal women . METHODS One hundred young women with a history of recurrent UTI received antimicrobials for acute UTI and then were r and omized to receive either Lactin-V or placebo daily for 5 d , then once weekly for 10 weeks . Participants were followed up at 1 week and 10 weeks after intervention and for UTIs ; urine sample s for culture and vaginal swabs for real-time quantitative 16S ribosomal RNA gene polymerase chain reaction for L. crispatus were collected . RESULTS Recurrent UTI occurred in 7/48 15 % of women receiving Lactin-V compared with 13/48 27 % of women receiving placebo ( relative risk [ RR ] , .5 ; 95 % confidence interval , .2 - 1.2 ) . High-level vaginal colonization with L. crispatus ( ≥10(6 ) 16S RNA gene copies per swab ) throughout follow-up was associated with a significant reduction in recurrent UTI only for Lactin-V ( RR for Lactin-V , .07 ; RR for placebo , 1.1 ; P CONCLUSIONS Lactin-V after treatment for cystitis is associated with a reduction in recurrent UTI . Larger efficacy trials of this novel preventive method for recurrent UTI are warranted . CLINICAL TRIALS REGISTRATION . NCT00305227",
"Bacterial vaginosis ( BV ) is the most prevalent vaginal infection worldwide and is characterized by depletion of the indigenous lactobacilli . Antimicrobial therapy is often ineffective . We hypothesized that probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 might provide an adjunct to antimicrobial treatment and improve cure rates . Sixty-four Brazilian women diagnosed with BV were r and omly assigned to receive a single dose of tinidazole ( 2 g ) supplemented with either 2 placebo capsules or 2 capsules containing L. rhamnosus GR-1 and L. reuteri RC-14 every morning for the following 4 weeks . At the end of treatment ( day 28 ) , the probiotic group had a significantly higher cure rate of BV ( 87.5 % ) than the placebo group ( 50.0 % ) ( p = 0.001 ) . In addition , according to the Gram-stain Nugent score , more women were assessed with \" normal \" vaginal microbiota in the probiotic group ( 75.0 % vs. 34.4 % in the placebo group ; p = 0.011 ) . This study shows that probiotic lactobacilli can provide benefits to women being treated with antibiotics for an infectious condition",
"Background Bacterial vaginosis ( BV ) is the most prevalent vaginal disorder in adult women worldwide . A number of clinical studies indicate that re-establishment of the physiological ecosystem by re-colonization of vaginal mucosa by lactobacilli may be an effective therapy for BV both after initial antimicrobial therapy or when given alone . A vaginal pH with Lactobacillus rhamnosus ( NORMOGIN ® ) on the vaginal pH and on the clinical symptoms in a group of 40 women affected by BV diagnosed by the Amsel criteria . Method A prospect i ve open clinical trial was performed in 40 consecutive cases evaluated for B.V. by the Amsel criteria . Results Vaginal pH was above the physiological value of 4.5 in 36 out of 40 patients at the first visit . It returned under 4.5 value in 24/40 and 32/40 women after 12 and 24 months of treatment , respectively . pH values were significantly decreased at 12 month treatment ( P reduction in pH values was found at 24 months of treatment ( P a vaginal physiological pH was associated with a reduction of the intensity of symptoms as shown by the decrease in the symptoms score . Conclusions The present study supports the use of pH measurement for sensitive , objective , and simple therapy follow-up in women with BV and shows that long-term administration of vaginal tablets containing Lactobacillus rhamnosus represents an effective and safe treatment for restoring the physiological vaginal pH and controlling BV symptoms",
"Abstract The purpose of this study was to evaluate the effectiveness of lactobacilli on vaginal health and proinflammatory cytokines . Sixty-seven patients with bacterial vaginosis ( BV ) , 50 with intermediate flora and 42 with normal vaginal flora were enrolled in this double-blind study . The subjects were r and omized to receive probiotic lactobacilli vaginal tablets ( L. brevis CD2 , L. salivarius subsp . salicinius , L. plantarum ) or the vaginal pH tablet ( active comparator ) . Cervico-vaginal lavage was collected to measure the concentrations of IL-1β , TNFα and IL-6 by ELISA . Neutral sphingomyelinase activity was also quantified in both arms before and after treatment . The probiotic vaginal tablet was well tolerated and no side effects were reported . The study demonstrated a cure rate of nearly 80 % ; i.e. , 32 % of the women could restore normal vaginal flora and 47 % had improved Nugent score , whereas 20 % of the subjects did not clear BV in the first follow-up ( after 8 days treatment ) . The pH tablet containing pH lowering compounds induced resolution of BV and restoration of normal vaginal flora in 74 % and 26 % , respectively . The lactobacilli tablet was found to be better than the pH tablet in preventing BV in healthy subjects . A significant reduction in IL-1β and IL-6 vaginal cytokines was observed after treatment with lactobacilli , while the active comparator did not have any effect on local proinflammatory cytokines . Vaginal neutral sphingomyelinase activity was not modified in either group . Vaginal tablets containing lactobacilli can cure BV and reduce vaginal inflammatory response ",
"Eighty-four patients with bacterial vaginosis diagnosed according to Amsel 's criteria were r and omized to receive either oral metronidazole 500 mg twice a day for seven days , or one vaginal tablet containing freeze-dried Lactobacillus rhamnosus once a week at bedtime for two months starting one week after the last antibiotic administration . Followup was performed at days 30 , 90 and 180 . Chi-squared analysis showed a significant difference between the two treatment groups at day 90 ( P = 0.05 ) . Safe and effective long-term vaginal administration of Lactobacillus rhamnosus appears to be a useful complementary approach in the management of bacterial vaginosis",
"Objective : To assess the effectiveness of the association of 2 specific strains , Lactobacillus fermentum LF10 ( DSM 19187 ) and Lactobacillus acidophilus LA02 ( DSM 21717 ) , specifically formulated in slow-release effervescent tablets , in patients with recurrent vulvovaginal c and idiasis . Study Design : The study was a clinical trial of 58 women diagnosed with recurrent VVC ( ≥4 culture-confirmed episodes in a 12-mo period ) . All patients were given 200 mg of fluconazole orally as an induction dose for 3 alternate days during the first treatment week . Afterward , the patients were given a new product formulated in slow-release vaginal tablets containing at least 0.4 billion live cells of each of lactobacillus L. fermentum LF10 and L. acidophilus LA02 ( first phase of the prophylactic period ) , on alternate days for 10 consecutive nights . Patients who were still free of symptoms were given 1 vaginal tablet every week for the next 10 weeks ( second phase of the prophylactic period ) . Patients asymptomatic after the total duration of the observation phase ( 7 mo ) were considered as responders . Results : During the second 10-week prophylactic phase , 49 of 57 ( 86.0 % ) patients remained free of clinical recurrence , whereas symptomatic VVC occurred in 8 patients ( 14.0 % ) . During the 7-month follow-up , 42 patients of 49 ( 85.7 % ) were symptom free at the end of the protocol , whereas clinical recurrences occurred in 7 women ( 14.3 % ) . Overall , 42 of 58 women enrolled in the study ( 72.4 % ) experienced no clinical recurrence throughout the 7-month observation phase ( responders ) . Conclusions : This study strengthens the evidence supporting the use of specific lactobacilli with well-demonstrated activities associated with the creation and maintenance of a vaginal biofilm that hinders the persistence of an infection caused by C and ida",
"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",
"Background : Bacterial vaginosis ( BV ) is the most common reason for abnormal vaginal discharge in reproductive-age women and one of its most important causative agents is the gram-variable bacterium Gardnerella vaginalis . BV is not accompanied by significant local inflammation , whereas the “ fishy odor ” test is always positive . In contrast , aerobic vaginitis ( AV ) is predominantly associated with Escherichia coli , but Streptococcus agalactiae and Staphylococcus aureus are also involved . St and ard treatment of BV consists of oral or intravaginal antibiotics , although these are unable to spontaneously restore normal flora characterized by a high concentration of lactobacilli . The main limitation is the inability to offer a long-term defensive barrier , thus facilitating relapses and recurrences . This study was undertaken firstly to assess the ability of selected lactobacilli to in vitro antagonize G. vaginalis to determine an association with a strain able to inhibit E. coli , thus identifying a possible use in AV . The second step of the study was to conduct a human pilot trial in women affected by BV using an association of the most promising and active bacteria . Material s and Methods : For this purpose , neutralized supernatants of individual lactobacilli were tested at percentages ranging from 0.5 % to 4 % to determine their ability to hinder the growth of G. vaginalis American Type Culture Collection 10231 . The bacterium that was able to exert the strongest inhibition was subsequently tested with Lactobacillus plantarum LP01 in a human intervention , placebo-controlled , pilot trial involving 34 female subjects ( aged between 18 and 50 , mean 34.7±8.9 , no menopausal women ) diagnosed with BV . The 2 microorganisms Lactobacillus fermentum LF15 ( DSM 26955 ) and L. plantarum LP01 ( LMG P-21021 ) were delivered to the vagina by means of slow-release vaginal tablets , also containing 50 mg of tara gum . The amount of each strain was 400 million live cells per dose . The women were instructed to apply a vaginal tablet once a day for 7 consecutive nights , followed by 1 tablet every 3 nights for a further 3-week application ( acute phase ) and , finally , 1 tablet per week to maintain a long-term vaginal colonization against possible recurrences . A clinical examination was performed and the Nugent score was quantified for each patient at enrollment ( d0 ) , after 28 days ( d28 ) , and at the end of the second month of relapse prevention ( d56 ) . A statistical comparison was made between d28 , or d56 , and d0 , and between d56 and d28 to quantify the efficacy against possible recurrences . Results : L. fermentum LF15 showed the strongest in vitro inhibitory activity towards G. vaginalis American Type Culture Collection ( ATCC ) 10231 after both 24 and 48 hours . In the human trial , the 2 lactobacilli selected , namely L. fermentum LF15 and L. plantarum LP01 , significantly reduced the Nugent score below the threshold of 7 after 28 days in 22 patients of 24 in the active group ( 91.7 % , P Nugent score between 4 and 6 , evidence of an intermediate situation , whereas the remaining 14 ( 58.3 % ) showed a score Nugent score > 7 , definable as BV ( 16.7 % , P=0.065 compared with d28 ) . In the placebo group , no significant differences were recorded at any time . Conclusions : BV , also known as vaginal bacteriosis is the most common cause of vaginal infection in women of childbearing age . Furthermore , BV is often asymptomatic as about 50 % of women with this condition have no symptoms at all and the prevalence rate in apparently healthy women is around 10 % . This study suggests the ability of the 2 strains L. fermentum LF15 and L. plantarum LP01 to counteract acute Gardnerella infections effectively and significantly improve the related uncomfortable symptoms in a very high percentage of women . This could be partially attributed to the presence of tara gum , which is able to create a mechanical barrier against Gardnerella on the surface of vaginal mucosa as a primary mechanism . Furthermore , long-term physiological protection seems to be established , thanks to the integration of the 2 lactobacilli into the vaginal microbiota and to their adhesion to the epithelial cells of the mucosa . In the light of the additional in vitro inhibitory activity against E. coli , their prospect i ve use in AV could also prove interesting",
"QUESTION There has been a great deal of discussion in both the medical and lay literature about the use of probiotics to improve general health . Subsequently , pregnant women have been asking me if probiotics used for treating conditions such as bacterial vaginosis and diarrhea are safe to use during pregnancy and lactation . ANSWER Current data suggest that probiotic supplementation is rarely systemically absorbed when used by healthy individuals . One meta- analysis and several r and omized controlled trials conducted with women during the third trimester of pregnancy did not report an increase in adverse fetal outcomes . There have been no published studies addressing Saccharomyces species use in pregnancy . Probiotics are unlikely to be transferred into breast milk",
"Probiotics have been proposed for a number of urogenital infectious conditions . In this study , we examine a possible effect on human papillomavirus (HPV)-related precancerous lesions in cervical cytology . We conducted a prospect i ve controlled pilot study , in which 54 women with an HPV+low- grade squamous intraepithelial lesion diagnosis in their PAP smear were followed for 6 months . The intervention group consumed a daily probiotic drink during the study period ; the control group received no treatment , according to common care policy . Outcome measures were the control PAP smear and HPV status after 6 months . Probiotic users had a twice as high chance of clearance of cytological abnormalities ( 60 vs. 31 % , P=0.05 ) . HPV was cleared in 19 % of control patients versus 29 % of probiotic users ( P=0.41 ) . This exploratory pilot study suggests that the probiotic studied promotes the clearance of HPV-related cytological abnormalities . If confirmed , this would represent an entirely new option to manage cervical cancer precursors",
"This r and omized double-blind placebo controlled study assessed the vaginal colonization of lactic acid bacteria and clinical outcome . Vaginal capsules containing L gasseri LN40 , Lactobacillus fermentum LN99 , L. casei subsp . rhamnosus LN113 and P. acidilactici LN23 , or placebos were administered for five days to 95 women after conventional treatment of bacterial vaginosis and /or vulvovaginal c and idiasis . Vulvovaginal examinations and vaginal samplings were performed before and after administration , after the first and second menstruation , and after six months . Presence of LN strains was assessed using RAPD analysis . LN strains were present 2 - 3 days after administration in 89 % of the women receiving LN strains ( placebo : 0 % , p colonized by at least one LN strain . Nine percent were still colonized six months after administration . Ninety-three percent of the women receiving LN strains were cured 2 - 3 days after administration ( placebo : 83 % ) , and 78 % after one menstruation ( placebo : 71 % ) ( ns ) . The intervention group experienced less malodorous discharge 2 - 3 days after administration ( p = 0.03 ) and after the second menstruation ( p = 0.04 ) , compared with placebo . In summary , five days of vaginal administration of LN strains after conventional treatment of bacterial vaginosis and /or vulvovaginal c and idiasis lead to vaginal colonization , somewhat fewer recurrences and less malodorous discharge"
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Introduction Direct pulp capping therapies use bio material s to protect exposed tissues , inducing repair through the production of a mineralized barrier . The purpose of this study was to compare the effectiveness of bio material s and techniques by means of a systematic review and meta‐ analysis . Methods The PubMed , Cochrane , and Embase data bases were used to search the literature published from January 1 , 1980 until August 31 , 2017 . Studies that met inclusion criteria were screened by 2 authors individually . The meta‐ analysis was performed on mineral trioxide aggregate ( MTA ) cement vs calcium hydroxide cement , tricalcium silicate cement vs MTA cement , and adhesive systems vs CaOH cement and evaluated the success rate , inflammatory response , and dentin bridge formation . Results Forty‐six studies were included in the systematic review , while 22 studies were included in the meta‐ analysis . There was no significant heterogeneity between the studies . MTA cements showed a significantly higher success rate , in all parameters , compared with calcium hydroxide cements ( odds ratio = 2.72 ; 95 % confidence interval [ CI ] = 1.90‐3.90 ; P = 0.000 ) . However , when compared with the tricalcium silicate cements , there were no statistically significant differences ( odds ratio = 1.18 ; 95 % CI = 0.53‐2.65 ; P = 0.672 ) . Adhesive systems showed a significantly lower success rate , in all parameters , compared with calcium hydroxide cements ( odds ratio = 0.062 ; 95 % CI = 0.024‐0.157 ; P = 0.000 ) . Conclusions MTA cements have a higher success rate , with a lower inflammatory response and a more predictable hard dentin barrier formation than calcium hydroxide cements . However , there were no differences , in these parameters , when MTA cement was compared with tricalcium silicate cements . Dental adhesives systems showed the lowest success rates
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"OBJECTIVES The objective was to evaluate the response of human pulps capped with different components from a total-etch three-step adhesive system . METHODS Direct pulp capping was performed in 25 caries-free human premolars scheduled for extraction due to orthodontic treatment . The teeth were r and omly divided in five groups , and capped with the following material s : Group 1-acid+primer+adhesive were used as recommended ; Group 2-only primer was applied ; Group 3-only bonding resin ( light-cured for 10s ) ; Group 4-only composite resin ( light-cured for 40s ) ; Group 5-calcium hydroxide . After capping , all teeth were restored with ScotchBond Multi Purpose Plus and Z-100 was placed incrementally . After 60 days , the teeth were extracted and processed for light microscopic examination ( H/E ) according to a histological score system . These were subjected to non-parametric tests ( alpha histological features showed that groups 1 - 4 were quite similar and inferior to group 5 . In groups 1 - 4 the pulp response varied from acute inflammatory cell infiltrate with varying degrees to necrosis . The groups 3 and 4 showed a trend towards better pulp response , since a normal connective tissue could be observed in more than half of the sample . All teeth from group 5 showed normal connective tissue below an amorphous dentin bridge . SIGNIFICANCE Adhesive components ( primer or adhesive ) as well as a composite should be avoided for pulp capping . Ca(OH)(2 ) should be the first choice for pulp capping",
"PURPOSE To evaluate the clinical , radiographical and histological findings in human third molars in which mechanical pulp exposures were capped with white ProRoot mineral trioxide aggregate ( WMTA ) . METHODS Forty-eight human third molars , caries-free or with incipient caries , scheduled to be extracted , were used and r and omly divided into two groups : Group A : ( n= 24 ) received WMTA and control Group B : ( n= 24 ) received chemical set calcium hydroxide ( Dycal ) . The teeth were isolated with rubber dam and Class I cavities prepared . Pulp exposure was performed using a sterile diamond bur and confirmed by frank bleeding . A sterile cotton pellet dipped in saline solution was placed over the exposure for 60 seconds . The preparation was then lightly rinsed with water and gently air-dried . WMTA or CH was placed over the exposure site followed by a small amount of a light-cured compomer . After etching with 35 % phosphoric acid gel for 15 seconds , rinsing and blot drying , Prime and Bond NT adhesive was applied and light-cured . The cavity was then restored with a resin composite and light-cured . Evaluations were performed by phone after 7 days and clinical ly at 30 + /- 5 and 136 + /- 24 days , using st and ardized tests and radiographs . The teeth were extracted after 136 + /- 24 days ; the roots were cut + /- 4 - 5 mm from the apex to allow for rapid fixation in 10 % neutral buffered formalin . They were then processed for routine histological evaluation , embedded in paraffin , sectioned and stained with hematoxylin and eosin and Brown and Brenn for recognition of bacteria . Statistical analyses were performed using a Mann-Whitney U-test , a Chi-square test , a Fisher 's exact test and an ANOVA . RESULTS No significant differences in post-operative sensitivity were reported after 7 days between the two material s ( P > 0.05 ) . Clinical examination demonstrated no significant differences at 30 + /- 5 days ( P > 0.05 ) and at 136 + /- 24 days ( P > 0.05 ) . Histological findings : 45 of 48 teeth were suitable for microscopic evaluation ( 22 with WMTA and 23 with CH ) . Twenty from the WMTA and 18 from the CH group had developed a bridge . No statistically significant differences were found for superficial and deep inflammatory cell response ( P > 0.05 ) , presence of a dentin bridge ( P > 0.01 ) , and pulp vitality ( P > 0.01 ) , between WMTA and calcium hydroxide . A statistically significant difference was found for the diameter of exposure ( P clinical and histological findings could be established for either material",
"AIM To characterize the hard tissue formed in human teeth experimentally pulp capped either with calcium hydroxide or with Emdogain Gel ( Biora AB , Malmö , Sweden ) - a derivative of enamel matrix ( EMD ) , using two markers for dentine ; dentine sialoprotein ( DSP ) and type 1 collagen ( Col I ) . METHODOLOGY Affinity-purified rabbit anti-Col I and anti-DSP polyclonal antibodies were used to stain histological sections from nine pairs of contra-lateral premolars that had been experimentally pulp amputated and r and omly capped with EMDgel or calcium hydroxide . Twelve weeks after the teeth had been pulp capped , they were extracted , fixed , demineralized and serially sectioned prior to immunohistochemical staining . RESULTS In the calcium hydroxide treated teeth DSP was seen in the new hard tissue which formed a bridge . DSP was also seen in the newly formed hard tissue in the EMDgel-treated teeth . Proliferated pulp tissue partly filled the space initially occupied by EMDgel and DSP-stained hard tissue was observed alongside exposed dentine surfaces as well as in isolated masses within the proliferated pulp tissue , although the new hard tissue did not cover the pulp exposure . DSP staining was also seen in the cells lining the hard tissue in both groups . Col I staining was seen in the newly formed hard tissue in both groups . CONCLUSIONS The new hard tissue formed after pulp capping with EMDgel or calcium hydroxide contained DSP and Col I , considered to be markers for dentine . Thus , the newly formed hard tissue can be characterized as dentine rather than unspecific hard tissue",
"Objective . This study presents a clinical and histological evaluation of human pulp tissue responses after direct capping using a new dentin adhesive system . Methods . Twenty-eight caries-free third molar teeth scheduled for extraction were evaluated . The pulps of 22 teeth were mechanically exposed and r and omly assigned to 1 of 2 groups : Single Bond Universal or calcium hydroxide . Another group of 6 teeth acted as the intact control group . The periapical response was assayed , and a clinical examination was performed . The teeth were extracted after 6 weeks , and a histological analysis was performed . The pulp status was assessed , and the thickness of the dentin bridge was measured and categorized using a histological scoring system . Results . The clinical phase was asymptomatic for Single Bond Universal patients . Patients in the calcium hydroxide group reported mild symptoms of pain , although the histological examination revealed that dentin bridges with or without limited pulpitis had begun forming in each tooth . The universal adhesive system exhibited nonsignificantly increased histological signs of pulpitis ( P > 0.05 ) and a significantly weaker thin mineralized tissue layer ( P calcium hydroxide group . Conclusion . The results suggest that Single Bond Universal is inappropriate for human pulp capping ; however , further long-term studies are needed to determine the biocompatibility of this agent",
"This practice -based , r and omized clinical trial evaluated and compared the success of direct pulp capping in permanent teeth with MTA ( mineral trioxide aggregate ) or CaOH ( calcium hydroxide ) . Thirty-five practice s in Northwest PRECEDENT were r and omized to perform direct pulp caps with either CaOH ( 16 practice s ) or MTA ( 19 practice s ) . Three hundred seventy-six individuals received a direct pulp cap with CaOH ( n = 181 ) or MTA ( n = 195 ) . They were followed for up to 2 yrs at regular recall appointments , or as dictated by tooth symptoms . The primary outcomes were the need for extraction or root canal therapy . Teeth were also evaluated for pulp vitality , and radiographs were taken at the dentist ’s discretion . The probability of failure at 24 mos was 31.5 % for CaOH vs. 19.7 % for MTA ( permutation log-rank test , p = .046 ) . This large r and omized clinical trial provided confirmatory evidence for a superior performance with MTA as a direct pulp-capping agent as compared with CaOH when evaluated in a practice -based research network for up to 2 yrs ( Clinical Trials.gov NCT00812887 )",
"Introduction Direct pulp capping treatment is intended to preserve pulp vitality , to avoid or retard root canal treatment , and , in cases with an open apex , to allow continued root development . Historically , calcium hydroxide ( CH ) was the gold st and ard material , but nowadays calcium silicate material s ( CSMs ) are displacing CH because of their high bioactivity , biocompatibility , sealing ability , and mechanical properties . However , more r and omized clinical trials are needed to confirm the appropriateness of CSMs as replacement material s for CH in direct pulp capping procedures . Methods A r and omized clinical trial was conducted that included 169 patients ( mean age , 11.3 years ) from the Maipo district ( Chile ) . The inclusion criterion was patients with 1 carious permanent tooth with pulpal exposure , a c and i date for a direct pulp capping procedure . The patients were r and omly allocated to one of the experimental groups ( CH , Biodentine , or mineral trioxide aggregate [ MTA ] ) . Clinical follow‐up examinations were performed at 1 week , 3 months , 6 months , and 1 year . The Fisher exact test was performed . Results At the follow‐up examination at 1 week , the patients showed 100 % clinical success . At 3 months , there was 1 failure in the CH group . At 6 months , there were 4 new failures ( 1 in the CH group and 3 in the MTA group ) . At 1 year , there was another failure in the CH group . There were no statistically significant differences among the experimental groups . Conclusions CSMs appear to be suitable material s to replace CH . Although no significant differences were found among the material s studied , Biodentine and MTA offered some advantages over CH . HighlightsThis trial compared the efficacy of calcium hydroxide , MTA , and Biodentine as pulp capping material s in young permanent molars . MTA and Biodentine are suitable material s to replace calcium hydroxide in pulp capping procedures .Pulp capping in carious teeth is a successful treatment when done under good clinical protocol",
"At the present time , evidence -based , best practice s have yet to be established for maintaining the vitality of teeth by managing caries-associated pulp exposure in permanent teeth . In terms of biomechanical and esthetic considerations , pulp capping has proven to be more effective than root-canal therapy . Given the low success rate of conventional methods , new techniques , such as laser-assisted repairs , should be developed . The purpose of this study was to compare the effectiveness of conventional and diode laser-assisted methods in direct pulp capping of carious teeth . Ten patients ranging in age from 12 to 40 were assigned r and omly to experimental and control groups in this clinical trial in which the participants ’ teeth were treated with different techniques , i.e. , conventional treatment and diode 808-nm , laser-assisted treatment . For each of these groups , five cases were chosen for treatment with the same method under rubber dam isolation . The data were analyzed by the runs test using SPSS software . The success rate was significantly different between conventional ( 60 % ) and diode 808-nm , laser-assisted ( 100 % ) groups after one year ( P > 0.05 ) . The laser-assisted procedure proved to be more effective than the conventional technique in enhancing the outcomes of pulp-capping therapy in carious exposures",
"AIM Pulp capping represents the boundary between conservative and endodontic therapy . The importance of this technique , which considerably improves the prognosis of the tooth , justifies the quest for new techniques and technologies : the most recent literature reports more predictable results ( approximately 90 % ) with cappings performed using laser of different wavelengths , compared to traditional procedures , which report a success rate of approximately 60 % . The purpose of this work is to assess the efficiency of laser technology combined with the use of a self-hardening calcium hydroxide base in pulp capping procedures performed on decayed permanent teeth . MATERIAL S AND METHODS This study was carried out on 34 patients , aged between 11 and 18 years ( average 14,5 ) who needed pulp cappings for deep caries affecting permanent teeth ( 8 front and 26 back ) . They were divided into three groups based on the operative protocol employed : traditional technique , laser-assisted technique using Er , Cr : YSGG lasers ( 2780 nm ) and laser assisted technique using Erbium : YAG lasers ( 2940 nm ) ; all patients were asked to return for follow-up visits ( anamnesis , vitality testing and intraoral x-ray ) scheduled at 1 , 3 , 6 , 12 months , 2 and 4 years ; other 30 cases on adult patients ( 19 to 40 years , average 27,1 ) , treated with the same methods , were used as control group . RESULTS Traditional technique group showed a success of 63 % ( adult control group 50 % ) ; Er , Cr : YSGG laser-assisted technique showed a success rate of 80 % ( adult control group 80 % ) ; Erbium : YAG lasers laser-assisted technique showed a success rate of 75 % ( adult control group 70 % ) . All age groups had good success rates with the pulp capping technique , regardless of the technique used . CONCLUSION Laser technology proved effective in improving the prognosis of pulp capping procedures on teeth affected by deep caries pathology",
"UNLABELLED Carious pulp exposure in permanent molars of children is a common incident . Mineral trioxide aggregate is a new material that possesses numerous exciting possibilities for pulp therapy . AIM The purpose of this study was to evaluate the efficiency of MTA as a direct pulp capping agent in young permanent teeth . METHODS Thirty asymptomatic permanent molars with pulp exposures were treated by pulp capping using MTA . At each recall ( 6 12 , 18 and 24 months ) , the teeth were assessed clinical ly , through pulpal sensitivity tests , as well as radiographically to evaluate periapical healing . RESULTS None of the cases reported spontaneous pain at the six months follow up and the pulp showed signs of vitality and absence of periapical radiolucency . At 24 months , the clinical and radiographic success rate was 93 % with evidence of continued root growth . CONCLUSION Pulp capping with MTA is recommended for teeth with carious pulp exposures specially immature teeth with high potential for healing",
"Aim : To prospect ively compare the clinical success rate of partial pulpotomy treatment in permanent molars using calcium hydroxide ( CH ) and mineral trioxide aggregates ( MTA ) as pulp dressing agents . Methods : Restorable permanent first molars ( 64 ) with carious pulp exposures were r and omly assigned to two groups ; CH and MTA . A st and ardized operative procedure was followed in both groups . Following isolation and caries removal , the exposed superficial pulp tissue layers were removed with a sterile flame shape diamond bur to a depth of 2–4 mm . Bleeding was controlled and pulp dressed with either a paste of non- setting Ca(OH)2 followed by a setting layer of Ca(OH)2 , or with grey MTA . The dressing material s in both groups were then covered with a layer of light cured glass ionomer cement . The teeth were either restored using amalgam , or where grossly carious with preformed metal crowns . Patients were scheduled for follow-up at 3 , 6 , 12 months and annually thereafter . Results : There were 34 patients ( 17 males and 17 females ) with 51 teeth available for evaluation . The age of patients at the time of restoration ranged between 6.8 to 13.3 years ( mean of 10.3 ±1.8 years ) . The follow-up period ranged from 25.4 to 45.6 months with an average of 34.8 ± 4.4 months . There was no statistically significant difference in the success rate of teeth treated with CH ( 91 % ) in comparison to teeth treated with MTA ( 93 % ) . Radiographically , a hard tissue barrier under CH was noticed in 12 ( 55 % ) teeth compared with 18 ( 64 % ) teeth under MTA ( p=0.4 ) . Conclusions : MTA has clinical success rate comparable to CH as a pulp dressing material for partial pulpotomy in permanent molars with carious",
"OBJECTIVE To study human pulp reactions to direct cappings with a dentin adhesive compared with a calcium hydroxide cement , especially with respect to formation of hard tissue in the exposure site . STUDY DESIGN Direct pulp cappings were made in 34 caries-free premolars scheduled for extraction due to orthodontic treatment . Half of the teeth were capped with a dentin adhesive , the other half with a calcium hydroxide cement . After periods of from 7 to 70 days , the teeth were extracted and processed for light microscopical examination . RESULTS No postoperative sensitivity was experienced . A slight inflammatory reaction was seen in both groups in the short observation period . In the long observation period , significantly more \" dentin bridging \" was seen in the calcium hydroxide group than in the dentin adhesive group ( P dentin adhesives for direct pulp capping",
"INTRODUCTION Biodentine is a new bioactive cement that is similar to the widely used mineral trioxide aggregate ( MTA ) . It has dentin-like mechanical properties , which may be considered a suitable material for clinical indications of dentin-pulp complex regeneration such as direct pulp capping . The purpose of the present study was to compare the response of the pulp-dentin complex in human teeth after direct capping with this new tricalcium silicate-based cement with that of MTA . METHODS Pulps in 28 caries-free maxillary and m and ibular permanent intact human molars scheduled for extraction for orthodontic reasons were mechanically exposed and assigned to 1 of 2 experimental groups , Biodentine or MTA , and 1 control group . Assay of periapical response and clinical examination were performed . After 6 weeks , the teeth were extracted , stained with hematoxylin-eosin , and categorized by using a histologic scoring system . RESULTS The majority of specimens showed complete dentinal bridge formation and an absence of inflammatory pulp response . Layers of well-arranged odontoblast and odontoblast-like cells were found to form tubular dentin under the osteodentin . Statistical analysis showed no significant differences between the Biodentine and MTA experimental groups during the observation period . CONCLUSIONS Within the limitations of this study , Biodentine had a similar efficacy in the clinical setting and may be considered an interesting alternative to MTA in pulp-capping treatment during vital pulp therapy",
"INTRODUCTION This clinical trial was conducted to evaluate the response of human dental pulp to direct capping with betamethasone/gentamicin ( BG ) cream and mineral trioxide aggregate ( MTA ) . We hypothesized that the results of direct pulp capping with a topical BG combination would be similar to or better than those with MTA . METHODS Thirty-six human first premolar teeth scheduled for orthodontic extraction were r and omly divided into 4 groups : BG1 group ( n = 9 ) , BG cream with 2-week follow-up ; BG2 group ( n = 10 ) , BG cream with 8-week follow-up ; MTA1 group ( n = 8) , MTA with 2-week follow-up ; and MTA2 group ( n = 9 ) , MTA with 8-week follow-up . Teeth were extracted and evaluated at respective time intervals . Micro-computed tomography scanning and histologic analyses were performed for all specimens . Pulp pathology ( inflammation , pulp abscesses , and pulp necrosis ) and reparative reaction ( formation of dentin bridges ) were recorded . RESULTS Both BG cream and MTA result ed in significantly better pulpal responses at 8 weeks than at 2 weeks . Dentin bridge formation was significantly thicker in the MTA group at 8 weeks than in any other group ( P Inflammation was of the acute type in all groups ; no statistically significant differences in the distribution of inflammatory cells were found among the groups . Pulpal abscesses and /or necrosis were observed more often in teeth capped with BG than with MTA . CONCLUSIONS Direct pulp capping with both BG cream and MTA was associated with dentin bridge formation . MTA result ed in a significantly better pulpal response , with less inflammation and a thicker dentin bridge at 8 weeks",
"PURPOSE To evaluate histological findings in human immature permanent premolars scheduled for extraction for orthodontic reasons , in which mechanical pulp exposures were capped with white ProRoot Mineral Trioxide Aggregate ( WMTA ) or calcium hydroxide ( CH ) . METHODS Forty-eight human immature premolars in 23 patients ( age 10 - 18 years ) were r and omly treated with WMTA or CH . After rubber dam isolation Cl I cavities were prepared and the pulps exposed . After hemostasis the pulps were capped with either material . The preparations were restored using an acid etch , bonding agent , flowable composite and composite resin technique . The teeth were extracted after 47 to 609 days and processed for routine histological examination , stained with hematoxylin and eosin and Brown and Brenn for recognition of bacteria . Statistical analyses of inflammation , bridge formation and bacterial leakage were performed using a Chi-square test and ANOVA . RESULTS Forty-four of 48 teeth were suitable for microscopic evaluation , 30 with WMTA , 14 with CH . Of the WMTA group , 29 teeth were vital , 28 had formed a bridge , and one specimen had failed . Twelve of 14 teeth with CH were vital , while three teeth failed to form a bridge . No statistically significant differences between WMTA and CH were found , except for superficial and deep inflammatory cell response ( P < or = 0.05 ) . Pulp capping of intentionally exposed human immature premolars performed slightly better when using MTA",
"AIM To investigate the effect of Emdogain Gel ( Biora AB , Malmo , Sweden ) , consisting of a enamel matrix derivative ( EMD ) in a propylene glycol alginate ( PGA ) vehicle , on experimentally exposed human pulps and to register postoperative symptoms . METHODOLOGY Nine pairs of contralateral premolars scheduled for extraction on orthodontic indications were included . Following a superficial pulp amputation performed with a small ( 016 ) diamond bur , either EMDgel or a mix of calcium hydroxide and sterile saline was placed at r and om in contact with the pulp wound . The subjects made records of symptoms and were also interviewed about pain/discomfort by a blinded examiner . After 12 weeks the teeth were extracted , prepared and subjected to light microscopic examination in which the inflammation and newly formed hard tissue in the pulp were analysed . Immunohistochemistry was performed using affinity-purified rabbit anti-EMD polyclonal antibodies . RESULTS Postoperative symptoms were less frequent in the EMDgel-treated than in the calcium hydroxide-treated teeth , especially during the first six weeks . In the EMDgel-treated teeth , new tissue partly filled the space initially occupied by the gel and hard tissue was formed alongside the exposed dentine surfaces and in patches in the adjacent pulp tissue . EMD was detected in the areas where new hard tissue had been formed . The wound area of the EMDgel-treated teeth exhibited inflammation in the majority of the teeth whereas less inflammation was seen in the calcium hydroxide-treated teeth where the hard tissue was formed as a bridge . CONCLUSIONS In the EMDgel-treated teeth , postoperative symptoms were less frequent and the amount and pattern of hard tissue formation were markedly different than in the teeth treated with calcium hydroxide . However , the operative procedure and the formulation with EMD in a PGA vehicle do not seem to be effective for the formation of a hard tissue barrier",
"INTRODUCTION The purpose of this study was to assess the long-term clinical outcomes of direct pulp capping ( DPC ) with ProRoot MTA ( Dentsply , Tulsa , OK ) and Endocem ( Maruchi , Wonju , Korea ) as pulp capping material s. To this end , the 1-year cumulative successes of both material s were evaluated and compared with those of the 3-month outcomes in a prospect i ve , r and omized controlled trial . METHODS Patients were recruited from the Department of Conservative Dentistry of the Yonsei University Dental Hospital , Seoul , South Korea , from January to May 2013 . Of the 48 teeth that met the inclusion criteria , 46 teeth were r and omly allocated to either ProRoot MTA or Endocem groups ( n = 23 ) . Direct pulp capping was performed , and clinical and radiographic examinations were conducted over 1 year after the treatment . Survival analyses were conducted to compare the cumulative successes between ProRoot MTA and Endocem and to evaluate other clinical variables . RESULTS Forty-one teeth were recalled 1 year after the treatments ( recall rate = 89.13 % ) . There were no significant differences between the cumulative successes of ProRoot MTA and Endocem in either log-rank or Cox proportional hazard regression analyses ( P > .05 ) . Among the other clinical variables , cavity type ( class I , II , III vs class V ) was determined to be significant in both the log-rank test ( P = .001 ) and Cox regression analysis ( P = .006 ) . CONCLUSIONS Both ProRoot MTA and Endocem exhibited similar cumulative successes as direct pulp capping material s up to 1 year . The teeth restored with class V cavities exhibited significantly lower cumulative success rates after direct pulp capping compared with the teeth restored with other types of cavities",
"OBJECTIVE The objective was to evaluate the influence of rubber dam isolation on the response of human pulps capped with calcium hydroxide and an adhesive system . METHODS AND MATERIAL S Direct pulp capping was performed in 40 caries-free human premolars scheduled for extraction as part of orthodontic treatment . The teeth were r and omly divided into 8 groups ( n = 5 ) according to the combination of treatment factors : capping agent ( adhesive resin or calcium hydroxide ) , isolation ( rubber dam or cotton pellets only ) , and period of evaluation ( 30 or 60 days ) . Class 2 cavities were prepared , and pulp exposures were created on the occlusal floor . After capping , all teeth were restored with Z-100 placed incrementally . After 30 or 60 days , patients were asked about their symptoms , teeth were extracted , and serial sections were evaluated . The data were subjected to a nonparametric test . RESULTS Overall , the histologic features showed that the pulp response was worse for groups capped with adhesive . For adhesive-capped groups , the pulp response varied from pulp necrosis to acute inflammatory cell infiltrate , and most of the pulps capped without rubber dam isolation showed severe inflammatory cell infiltrate involving the coronal pulp with chronic abscesses . For the calcium hydroxide groups , all specimens showed dentin bridge formation , regardless of the type of isolation used . CONCLUSION Calcium hydroxide should be used as the material of choice for pulp capping with or without rubber dam isolation . The use of adhesive systems in vital pulp capping is contraindicated , especially if rubber dam isolation is not implemented",
"AIM The present r and omized , controlled prospect i ve study evaluated the histomorphological response of human dental pulps capped with two grey mineral trioxide aggregate ( MTA ) compounds . METHODOLOGY Pulp exposures were performed on the occlusal floor of 40 human permanent pre-molars . The pulp was capped either with ProRoot ( Dentsply ) or MTA-Angelus ( Angelus ) and restored with zinc oxide eugenol cement . After 30 and 60 days , teeth were extracted and processed for histological examination and the effects on the pulp were scored . The data were subjected to Kruskal-Wallis and Conover tests ( alpha = 0.05 ) . RESULTS In five out of the 40 teeth bacteria were present in pulp tissue . No significant difference was observed between the two material s ( P > 0.05 ) in terms of overall histological features ( hard tissue bridge , inflammatory response , giant cells and particles of capping material s ) . Overall , 94 % and 88 % of the specimens capped with MTA-Angelus and ProRoot , respectively , showed either total or partial hard tissue bridge formation ( P > 0.05 ) . CONCLUSIONS Both commercial material s ProRoot ( Dentsply ) and MTA-Angelus ( Angelus ) produced similar responses in the pulp when used for pulp capping in intact , caries-free teeth",
"AIM To compare the effect of enamel matrix derivative ( EMD ) and calcium hydroxide [ Ca(OH)(2 ) ] on exposed human pulp . METHODOLOGY Fifteen pairs of human contralateral premolars were intentionally and partially pulpotomized . The exposed pulps were r and omly capped with either EMDgel ( Emdogain ) or a mix of Ca(OH)(2 ) and sterile water . The subjects recorded pain or discomfort during the first 10 days and were also interviewed and examined by a blinded examiner at 1 day , 2 weeks , 3 and 6 months post-operation . Periapical radiographs were taken prior to the operation , and 3 and 6 months post-operation . After 6 months , the teeth were extracted and processed for histological evaluation . The data were described and analysed using McNemar test and Kaplan-Meier survival analysis . RESULTS The EMDgel-treated teeth had significantly less tooth hypersensitivity than the Ca(OH)(2)-treated teeth during the first 2 weeks ( P = 0.031 ) but were not significantly different after 2 weeks ( P = 0.125 ) . No detectable periapical radiographic changes were observed in any teeth and radiographic evidence of dentine bridge formation from both groups were not significantly different during the follow-up periods ( P > 0.05 ) . Histological evaluation demonstrated that the Ca(OH)(2)-treated teeth had less inflammation and more dentine bridge formation than those in the EMDgel-treated teeth . CONCLUSIONS After 6 months , healthy pulps capped with Ca(OH)(2 ) had more favourable results than counterparts capped with EMDgel . However , similar clinical and radiographic results were seen in both groups",
"INTRODUCTION The purpose of the present study was to evaluate and compare the short-term clinical outcomes of direct pulp capping using ProRoot MTA ( Dentsply , Tulsa , OK ) or Endocem ( Maruchi , Wonju , Korea ) as capping material s in a prospect i ve r and omized controlled study . MATERIAL S AND METHODS This study was conducted with subjects who were recruited from the pool of patients from the Department of Conservative Dentistry at the Dental College of Yonsei University , Seoul , Korea , between January and May 2013 . Of the 48 teeth confirmed to be eligible for direct pulp capping , a total of 46 teeth were r and omly assigned to either the ProRoot MTA or the Endocem group ( 23 teeth per group ) . Direct pulp capping was performed using these 2 material s , and clinical and radiographic evaluations were performed at 1 , 2 , 4 , and 12 weeks after the treatments . Teeth with no response to pulp vitality test and those exhibiting clinical or radiographic signs and /or symptoms of irreversible pulpitis or pulp necrosis were considered to be failures . RESULTS Thirty-two patients ( 43 teeth ) were examined at the 3-month follow-up ( patient recall rate = 91.4 % ) ; 22 of these teeth were in the ProRoot MTA group , and 21 were in the Endocem group . The overall success rate was 93 % , and the success rates in the ProRoot MTA and Endocem groups were 95.5 % ( 21/22 teeth ) and 90.5 % ( 19/21 teeth ) , respectively . Statistical analyses of these success rates did not reveal any significant difference between the groups ( P = .522 ) . CONCLUSIONS In this r and omized controlled study , no significant difference in the short-term clinical outcomes of direct pulp capping using ProRoot MTA or Endocem as the capping material was found . Furthermore , the favorable short-term outcome success rate of 93 % indicates that direct pulp capping may be a reliable treatment for pulp exposure in adult teeth"
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4116db34-06ff-11f0-808a-c43d1ab1c353
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Background The Short Physical Performance Battery ( SPPB ) is a well-established tool to assess lower extremity physical performance status . Its predictive ability for all-cause mortality has been sparsely reported , but with conflicting results in different subsets of participants . The aim of this study was to perform a meta- analysis investigating the relationship between SPPB score and all-cause mortality . Methods Articles were search ed in MEDLINE , the Cochrane Library , Google Scholar , and BioMed Central between July and September 2015 and up date d in January 2016 . Inclusion criteria were observational studies ; > 50 participants ; stratification of population according to SPPB value ; data on all-cause mortality ; English language publications . Twenty-four articles were selected from available evidence . Data of interest ( i.e. , clinical characteristics , information after stratification of the sample into four SPPB groups [ 0–3 , 4–6 , 7–9 , 10–12 ] ) were retrieved from the articles and /or obtained by the study authors . The odds ratio ( OR ) and /or hazard ratio ( HR ) was obtained for all-cause mortality according to SPPB category ( with SPPB scores 10–12 considered as reference ) with adjustment for age , sex , and body mass index . Results St and ardized data were obtained for 17 studies ( n = 16,534 , mean age 76 ± 3 years ) . As compared to SPPB scores 10–12 , values of 0–3 ( OR 3.25 , 95%CI 2.86–3.79 ) , 4–6 ( OR 2.14 , 95%CI 1.92–2.39 ) , and 7–9 ( OR 1.50 , 95%CI 1.32–1.71 ) were each associated with an increased risk of all-cause mortality . The association between poor performance on SPPB and all-cause mortality remained highly consistent independent of follow-up length , subsets of participants , geographic area , and age of the population . R and om effects meta-regression showed that OR for all-cause mortality with SPPB values 7–9 was higher in the younger population , diabetics , and men . Conclusions An SPPB score lower than 10 is predictive of all-cause mortality . The systematic implementation of the SPPB in clinical practice setting s may provide useful prognostic information about the risk of all-cause mortality . Moreover , the SPPB could be used as a surrogate endpoint of all-cause mortality in trials needing to quantify benefit and health improvements of specific treatments or rehabilitation programs . The study protocol was published on PROSPERO ( CRD42015024916 )
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"Background : objective measures of physical activity and function with a diverse cohort of UK adults in their 70s and 80s were used to investigate relative risk of all-cause mortality and diagnoses of new diseases over a 4-year period . Participants : two hundred and forty older adults were r and omly recruited from 12 general practice s in urban and suburban areas of a city in the United Kingdom . Follow-up included 213 of the baseline sample . Methods : socio-demographic variables , height and weight , and self-reported diagnosed diseases were recorded at baseline . Seven-day accelerometry was used to assess total physical activity , moderate-to-vigorous activity and sedentary time . A log recorded trips from home . Lower limb function was assessed using the Short Physical Performance Battery . Medical records were accessed on average 50 months post baseline , when new diseases and deaths were recorded . Analyses : ANOVAs were used to assess socio-demographic , physical activity and lower limb function group differences in diseases at baseline and new diseases during follow-up . Regression models were constructed to assess the prospect i ve associations between physical activity and function with mortality and new disease . Results : for every 1,000 steps walked per day , the risk of mortality was 36 % lower ( hazard ratios 0.64 , 95 % confidence interval ( CI ) 0.44–0.91 , P = 0.013 ) . Low levels of moderate-to-vigorous physical activity ( incident rate ratio ( IRR ) 1.67 , 95 % CI 1.04–2.68 , P = 0.030 ) and low frequency of trips from home ( IRR 1.41 , 95 % CI 0.98–2.05 , P = 0.045 ) were associated with diagnoses of more new diseases . Conclusion : physical activity should be supported for adults in their 70s and 80s , as it is associated with reduced risk of mortality and new disease development",
"BACKGROUND Hospitalization represents a stressful and potentially hazardous event for older persons . We evaluated the value of the Short Physical Performance Battery ( SPPB ) in predicting rates of functional decline , rehospitalization , and death in older acutely ill patients in the year after discharge from the hospital . METHODS Prospect i ve cohort study of 87 patients aged 65 years and older who were able to walk and with a Mini-Mental State Examination score ≥ 18 and admitted to the hospital with a clinical diagnosis of congestive heart failure , pneumonia , chronic obstructive pulmonary disease , or minor stroke . Patients were evaluated with the SPPB at hospital admission , were reevaluated the day of hospital discharge , and 1 month later . Subsequently , they were followed every 3 months by telephone interviews to ascertain functional decline , new hospitalizations , and vital status . RESULTS After adjustment for potential confounders , including self-report activity of daily living and comorbidity , the SPPB score at discharge was inversely correlated with the rate of decline in activity of daily living performance over the follow-up ( p poor SPPB scores at hospital discharge ( 0 - 4 ) had a greater risk of rehospitalization or death ( odds ratio : 5.38 , 95 % confidence interval : 1.82 - 15.9 ) compared with those with better SPPB scores ( 8 - 12 ) . Patients with early decline in SPPB score after discharge also had steeper increase in activity of daily living difficulty and higher risk of rehospitalization or death over the next year . CONCLUSIONS In older acutely ill patients who have been hospitalized , the SPPB provides important prognostic information . Lower extremity performance-based functional assessment might identify older patients at high risk of poor outcomes after hospital discharge",
"BACKGROUND This study examines the effects of mobility and cognition on mortality risk in women late in life . METHODS A prospect i ve study was conducted among 1,495 women ( mean age 87.6 years ) participating in the Study of Osteoporotic Fractures Year 20 examination ( 2006 - 2008 ) . Mobility ( ascertained by Short Physical Performance Battery [ SPPB ] ) was categorized as poor ( SPPB 0 - 3 , n = 312 ) , intermediate ( SPPB 4 - 9 , n = 799 ) , or good ( SPPB 10 - 12 , n = 384 ) . Cognitive status ( adjudicated based on neuropsychological tests ) was classified as normal ( n = 873 ) , mild cognitive impairment ( n = 354 ) , or dementia ( n = 268 ) . Deaths ( n = 749 ) were identified from Year 20 through July 31 , 2014 ( average follow-up 4.9 years ) . RESULTS There was not strong evidence of an interaction between mobility and cognition for prediction of mortality risk ( p interaction term .16 ) . Compared to women with good mobility , mortality risks were increased among women with intermediate mobility ( hazard ratio [ HR ] 1.26 , 95 % confidence interval [ CI ] 1.02 - 1.57 ) and those with poor mobility ( HR 1.64 , 95 % CI 1.24 - 2.16 ) after consideration of cognition and other mortality risk factors . Similarly , mortality risks were higher among women with mild cognitive impairment ( HR 1.46 , 95 % CI 1.21 - 1.76 ) and those with dementia ( HR 1.88 , 95 % CI 1.54 - 2.31 ) compared to women with normal cognition after consideration of mobility and other mortality risk factors . CONCLUSIONS Among women late in life , 5-year mortality risk was substantially increased among women with deficits in mobility even after accounting for cognition and traditional prognostic indicators . Similarly , deficits in cognition were associated with increased 5-year mortality despite consideration of mobility and conventional risk factors",
"OBJECTIVES To evaluate the predictive value of muscle strength and physical performance in the oldest old for all-cause mortality ; hospitalization ; and the onset of disability , defined as a decline in activities of daily living ( ADLs ) , independent of muscle mass , inflammatory markers , and comorbidities . DESIGN A prospect i ve , observational , population -based follow-up study . SETTING Three well-circumscribed areas of Belgium . PARTICIPANTS Five hundred sixty participants aged 80 and older were followed for 33.5 months ( interquartile range 31.1 - 35.6 months ) . MEASUREMENTS Grip strength , Short Physical Performance Battery ( SPPB ) score , and muscle mass were measured at baseline ; ADLs at baseline and after 20 months ; and all-cause mortality and time to first hospitalization from inclusion onward . Kaplan-Meier curves and Cox proportional hazards models were calculated for all-cause mortality and hospitalization . Logistic regression analysis was used to determine predictors of decline in ADLs . RESULTS Kaplan-Meier curves showed significantly higher all-cause mortality and hospitalization in subjects in the lowest tertile of grip strength and SPPB score . The adjusted Cox proportional hazards model showed that participants with high grip strength or a high SPPB score had a lower risk of mortality and hospitalization , independent of muscle mass , inflammatory markers , and comorbidity . A relationship was found between SPPB score and decline in ADLs , independent of muscle mass , inflammation , and comorbidity . CONCLUSION In people aged 80 and older , physical performance is a strong predictor of mortality , hospitalization , and disability , and muscle strength is a strong predictor of mortality and hospitalization . All of these relationships were independent of muscle mass , inflammatory markers , and comorbidity",
"This study aims to determine the cardiac dysfunction prevalence , to investigate the relationship between the Short Physical Performance Battery ( SPPB ) test and structural and functional echocardiographic parameters and to determine whether SPPB scores and cardiac dysfunction are independent mortality predictors in an elderly Russian population . A r and om sample of 284 community-dwelling adults aged 65 and older were selected from a population -based register and divided into two age groups ( 65 - 74 and ≥75 ) . The SPPB test , echocardiography and all-cause mortality were measured . The prevalence of cardiac dysfunction was 12 % in the 65 - 74 group and 23 % in the ≥75 group . The multivariate models could explain 15 % and 23 % of the SPPB score total variance for the 65 - 74 and ≥75 age groups , respectively . In the younger age group , the mean follow-up time was 2.6±0.46 years , and the adjusted hazard ratio ( HR ) for risk of mortality from cardiac dysfunction was 4.9 . In the older age group , the mean follow-up time was 2.4±0.61 years , and both cardiac dysfunction and poor physical performance were found to be independent predictors of mortality ( adjusted HR=3.4 and adjusted HR=4.2 , respectively ) . The cardiac dysfunction prevalence in this elderly Russian population was found to be comparable to , or even lower than , reported prevalences for Western countries . Furthermore , the observed correlations between echocardiographic abnormalities and SPPB scores were limited . Cardiac dysfunction was shown to be a strong mortality predictor in both age groups , and poor physical performance was identified as an independent mortality predictor in the oldest subjects",
" We investigated the predictive value of geriatric assessment ( GA ) on overall survival ( OS ) for older adults with acute myelogenous leukemia ( AML ) . Consecutive patients ≥ 60 years with newly diagnosed AML and planned intensive chemotherapy were enrolled at a single institution . Pretreatment GA included evaluation of cognition , depression , distress , physical function ( PF ) ( self-reported and objective ly measured ) , and comorbidity . Objective PF was assessed using the Short Physical Performance Battery ( SPPB , timed 4-m walk , chair st and s , st and ing balance ) and grip strength . Cox proportional hazards models were fit for each GA measure as a predictor of OS . Among 74 patients , the mean age was 70 years , and 78.4 % had an Eastern Cooperative Oncology Group ( ECOG ) score ≤ 1 . OS was significantly shorter for participants who screened positive for impairment in cognition and objective ly measured PF . Adjusting for age , gender , ECOG score , cytogenetic risk group , myelodysplastic syndrome , and hemoglobin , impaired cognition ( Modified Mini-Mental State Exam impaired objective PF ( SPPB worse OS . GA methods , with a focus on cognitive and PF , improve risk stratification and may inform interventions to improve outcomes for older AML patients",
"Objective : To evaluate whether HIV infection was associated with reduced physical performance , and to examine if reduced physical performance predicted mortality in our aging cohort of HIV-infected and HIV-uninfected persons . Design : Prospect i ve , observational cohort of current and former injection drug users in the AIDS Linked to the IntraVenous Experience study in Baltimore , Maryl and , USA . Methods : The Short Physical Performance Battery ( SPPB ) was used as an objective measure of physical performance and measured semiannually along with behavioral and demographic data . Correlates of reduced physical performance ( SPPB score ⩽10 ) were identified and the relationship between reduced physical performance , HIV infection and mortality was analyzed by Cox regression . Results : Among 12 270 person-visits contributed by 1627 participants , the median age was 51 , 30.3 % were HIV-infected and 32.6 % had an SPPB score 10 or less . In multivariable models , HIV infection was independently associated with 30 % increased odds of reduced physical performance [ odds ratio 1.30 ; 95 % confidence interval (CI):1.12–1.52 ] . Reduced physical performance predicted mortality in a dose-response manner and within all HIV disease strata . Whereas reduced physical performance alone ( hazard ratio 2.52 , 95 % CI : 1.59–4.00 ) and HIV infection alone ( hazard ratio 2.78 , 95 % CI : 1.70–4.54 ) increased mortality , HIV-infected participants with reduced physical performance had a six-fold increased mortality risk ( hazard ratio 6.03 , 95 % CI : 3.80–10.0 ) compared with HIV-uninfected participants with higher physical performance . Conclusion : HIV infection was independently associated with reduced physical performance . HIV and reduced physical performance have independent and joint effects on mortality . Physical performance measurement may be an important research and clinical tool to predict adverse outcomes among aging HIV-infected persons",
"BACKGROUND The Short Physical Performance Battery ( SPPB ) , which includes walking , balance , and chair st and s tests , independently predicts mobility disability and activities of daily living disability . To date , however , there is no definitive evidence from r and omized controlled trials that SPPB scores can be improved . Our objective was to assess the effect of a comprehensive physical activity ( PA ) intervention on the SPPB and other physical performance measures . METHODS A total of 424 sedentary persons at risk for disability ( ages 70 - 89 years ) were r and omized to a moderate-intensity PA intervention or a successful aging ( SA ) health education intervention and were followed for an average of 1.2 years . RESULTS The mean baseline SPPB score on a scale of 0 - 12 , with 12 corresponding to highest performance , was 7.5 . At 6 and 12 months , the PA versus SA group adjusted SPPB ( + /- st and ard error ) scores were 8.7 + /- 0.1 versus 8.0 + /- 0.1 , and 8.5 + /- 0.1 versus 7.9 + /- 0.2 , respectively ( p 400-meter walking speed was also significantly improved in the PA group . The PA group had a lower incidence of major mobility disability defined as incapacity to complete a 400-meter walk ( hazard ratio = 0.71 , 95 % confidence interval = 0.44 - 1.20 ) . CONCLUSIONS A structured PA intervention improved the SPPB score and other measures of physical performance . An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes , such as mobility disability",
"OBJECTIVES To examine the validity of the Walking While Talking Test ( WWT ) , a mobility stress test , to predict frailty , disability , and death in high-functioning older adults . DESIGN Prospect i ve cohort study . SETTING Community sample . PARTICIPANTS Six hundred thirty-one community-residing adults aged 70 and older participating in the Einstein Aging Study ( mean follow-up 32 months ) . High-functioning status at baseline was defined as absence of disability and dementia and normal walking speeds . MEASUREMENTS Hazard ratios ( HRs ) for frailty , disability , and all-cause mortality . Frailty was defined as presence of three out of the following five attributes : weight loss , weakness , exhaustion , low physical activity , and slow gait . The predictive validity of the WWT was also compared with that of the Short Physical Performance Battery ( SPPB ) for study outcomes . RESULTS Two hundred eighteen participants developed frailty , 88 developed disability , and 49 died . Each 10-cm/s decrease in WWT speed was associated with greater risk of frailty ( HR = 1.12 , 95 % confidence interval ( CI ) = 1.06 - 1.18 ) , disability ( HR = 1.13 , 95 % CI = 1.03 - 1.23 ) , and mortality ( HR = 1.13 , 95 % CI = 1.01 - 1.27 ) . Most associations remained robust even after accounting for potential confounders and gait speed . Comparisons of HRs and model fit suggest that the WWT may better predict frailty whereas SPPB may better predict disability . CONCLUSION Mobility stress tests such as the WWT are robust predictors of risk of frailty , disability , and mortality in high-functioning older adults",
"BACKGROUND This study examines , in initially nondisabled older persons , the impact of reduced lower extremity performance on subsequent hospitalizations . METHODS A 4-year prospect i ve cohort study was conducted among 3381 persons , aged 71 years and older , who initially reported no disability . At baseline , lower extremity performance was measured by an assessment of st and ing balance , a timed 2.4-m walk , and a timed test of rising from a chair five times . Data on subsequent hospital admissions and discharge diagnoses over 4 years were obtained from the Medicare data base . RESULTS During the follow-up period , nondisabled persons with poor lower extremity performance spent significantly more days in the hospital ( 17.7 days ) than those with intermediate and high performance ( 11.6 and 9.7 days , respectively ) . Poor lower extremity performance in nondisabled persons significantly predicted subsequent hospitalization over 4 years ( relative risk for hospitalization in those with poor vs high performance : 1.78 ; 95 % confidence interval , 1.45 - 2.17 ) . This increased hospitalization risk could not be explained by several indicators of baseline health status . Increased hospitalization risks were especially found for geriatric conditions , such as dementia , decubitus ulcer , hip fractures , other fractures , pneumonia , dehydration , and acute infections . CONCLUSIONS Even in persons who are currently nondisabled , a simple measure of lower extremity performance is predictive of subsequent hospitalization , especially for geriatric conditions",
"This prospect i ve cohort study evaluate the predictive value of physical performance measures for mortality in older French women , in particular those with a high health status . The subjects were 7,250 community-dwelling non-disabled French women aged 75 years or older , enrolled in the Epidémiologie de l’ostéoporose ( EPIDOS ) study . The short physical performance battery ( SPPB ) , including walking speed , repeated chair st and s , and balance tests , was administered and h and grip strength was measured . Anthropometric measurements , physical function , cognitive performance , sensory status , smoking , medical history , medication use , subjective self- assessment of health status , and physical activity level were assessed at the baseline visit . During a mean follow-up of 3.8 years , 754 ( 10.4 % ) participants died . Complementary analysis was performed on the 2,157 non-disabled healthiest participants ( no disease at baseline ) . The SPPB and h and grip strength distinguished a gradient of risk for mortality from a low to high functional spectrum . Risk of death was 2.04-fold higher in poor ( SPPB 0–6 ) than in good ( SPPB 10–12 ) performers and 1.56-fold higher in participants with lower tertile grip strength . Walking speed alone also distinguished a gradient of mortality risk . After adjustment for confounders , low SPPB , grip strength score and slow walking speed remained significantly associated with death . In the non-disabled healthiest women , no physical performance measure predicted death . In community-dwelling elderly French women , physical performance measures significantly and independently predicted mortality . Increased risk of death was partly explained by baseline health status and was absent in the healthiest elderly",
"RATIONALE Frailty is associated with morbidity and mortality in abdominal organ transplantation but has not been examined in lung transplantation . OBJECTIVES To examine the construct and predictive validity of frailty phenotypes in lung transplant c and i date s. METHODS In a multicenter prospect i ve cohort , we measured frailty with the Fried Frailty Phenotype ( FFP ) and Short Physical Performance Battery ( SPPB ) . We evaluated construct validity through comparisons with conceptually related factors . In a nested case-control study of frail and nonfrail subjects , we measured serum IL-6 , tumor necrosis factor receptor 1 , insulin-like growth factor I , and leptin . We estimated the association between frailty and disability using the Lung Transplant Valued Life Activities disability scale . We estimated the association between frailty and risk of delisting or death before transplant using multivariate logistic and Cox models , respectively . MEASUREMENTS AND MAIN RESULTS Of 395 subjects , 354 completed FFP assessment s and 262 completed SPPB assessment s ; 28 % were frail by FFP ( 95 % confidence interval [ CI ] , 24 - 33 % ) and 10 % based on the SPPB ( 95 % CI , 7 - 14 % ) . By either measure , frailty correlated more strongly with exercise capacity and grip strength than with lung function . Frail subjects tended to have higher plasma IL-6 and tumor necrosis factor receptor 1 and lower insulin-like growth factor I and leptin . Frailty by either measure was associated with greater disability . After adjusting for age , sex , diagnosis , and transplant center , both FFP and SPPB were associated with increased risk of delisting or death before lung transplant . For every 1-point worsening in score , hazard ratios were 1.30 ( 95 % CI , 1.01 - 1.67 ) for FFP and 1.53 ( 95 % CI , 1.19 - 1.59 ) for SPPB . CONCLUSIONS Frailty is prevalent among lung transplant c and i date s and is independently associated with greater disability and an increased risk of delisting or death",
"IMPORTANCE In older adults reduced mobility is common and is an independent risk factor for morbidity , hospitalization , disability , and mortality . Limited evidence suggests that physical activity may help prevent mobility disability ; however , there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability . OBJECTIVE To test the hypothesis that a long-term structured physical activity program is more effective than a health education program ( also referred to as a successful aging program ) in reducing the risk of major mobility disability . DESIGN , SETTING , AND PARTICIPANTS The Lifestyle Interventions and Independence for Elders ( LIFE ) study was a multicenter , r and omized trial that enrolled participants between February 2010 and December 2011 , who participated for an average of 2.6 years . Follow-up ended in December 2013 . Outcome assessors were blinded to the intervention assignment . Participants were recruited from urban , suburban , and rural communities at 8 centers throughout the United States . We r and omized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations , defined as a score on the Short Physical Performance Battery of 9 or below , but were able to walk 400 m. INTERVENTIONS Participants were r and omized to a structured , moderate-intensity physical activity program ( n = 818 ) conducted in a center ( twice/wk ) and at home ( 3 - 4 times/wk ) that included aerobic , resistance , and flexibility training activities or to a health education program ( n = 817 ) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises . MAIN OUTCOMES AND MEASURES The primary outcome was major mobility disability objective ly defined by loss of ability to walk 400 m. RESULTS Incident major mobility disability occurred in 30.1 % ( 246 participants ) of the physical activity group and 35.5 % ( 290 participants ) of the health education group ( hazard ratio [ HR ] , 0.82 [ 95 % CI , 0.69 - 0.98 ] , P = .03).Persistent mobility disability was experienced by 120 participants ( 14.7 % ) in the physical activity group and 162 participants ( 19.8 % ) in the health education group ( HR , 0.72 [ 95 % CI , 0.57 - 0.91 ] ; P = .006 ) . Serious adverse events were reported by 404 participants ( 49.4 % ) in the physical activity group and 373 participants ( 45.7 % ) in the health education group ( risk ratio , 1.08 [ 95 % CI , 0.98 - 1.20 ] ) . CONCLUSIONS AND RELEVANCE A structured , moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability . These findings suggest mobility benefit from such a program in vulnerable older adults . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01072500",
"BACKGROUND Scientific societies recommend assessing lower limb function in usual clinical practice . The Short Physical Performance Battery ( SPPB ) is one of the most vali date d tools to assess this , but its capacity to predict long-term mortality in very old population attending primary care has not been studied . OBJECTIVE To assess the ability of the SPPB to predict 10-year survival in individuals aged 75 and over . METHODS Prospect i ve cohort study with a 10-year follow-up . A representative sample of people aged 75 years or older without severe dependence ( Barthel Index > 20 ) treated at a Spanish primary care centre ( n = 315 ) . Baseline evaluation included geriatric assessment with most well-known death predictors . The three SPPB subtasks ( st and ing balance , walking speed and chair st and tests ) were administered . Kaplan-Meier curves and Cox proportional hazard models were calculated for all-cause mortality . RESULTS Mean age was 81.9 years ( 60.6 % female ) . Ten-year survival of elders with SPPB score age , gender , number of drugs prescribed , cognitive status , body mass index and visual sharpness ( adjusted hazard ratio = 1.37 ; 95 % confidence interval : 1.01 - 1.86 ) . Also , walking speed and chair st and subtasks were both individual-independent predictors of 10-year survival . CONCLUSIONS Our findings indicate that SPPB is an independent predictor of long-term survival . The chair st and subtask could be a predictor as useful as the full performance battery , becoming a good alternative for primary care where the burden of performing all three subtasks could be excessive"
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A summary of systematic review s and meta-analyses addressing the benefits and risks of dietary protein intakes for bone health in adults suggests that dietary protein levels even above the current RDA may be beneficial in reducing bone loss and hip fracture risk , provided calcium intakes are adequate . Several systematic review s and meta-analyses have addressed the benefits and risks of dietary protein intakes for bone health in adults . This narrative review of the literature summarizes and synthesizes recent systematic review s and meta-analyses and highlights key messages . Adequate supplies of dietary protein are required for optimal bone growth and maintenance of healthy bone . Variation in protein intakes within the “ normal ” range accounts for 2–4 % of BMD variance in adults . In older people with osteoporosis , higher protein intake ( ≥ 0.8-g/kg body weight/day , i.e. , above the current RDA ) is associated with higher BMD , a slower rate of bone loss , and reduced risk of hip fracture , provided that dietary calcium intakes are adequate . Intervention with dietary protein supplements attenuate age-related BMD decrease and reduce bone turnover marker levels , together with an increase in IGF-I and a decrease in PTH . There is no evidence that diet-derived acid load is deleterious for bone health . Thus , insufficient dietary protein intakes may be a more severe problem than protein excess in the elderly . Long-term , well-controlled r and omized trials are required to further assess the influence of dietary protein intakes on fracture risk
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"Dietary data from a prospect i ve study were used to relate factors influencing calcium balance ( estimates of dietary calcium intake , protein intake from nondairy animal sources ( meat , fish , and eggs ) , and coffee consumption ) to the incidence of hip fracture . During the years 1977 - 1983 , women and men born between 1925 and 1940 and living in one of three Norwegian counties were invited to a cardiovascular screening that included a dietary survey . The attendance rate at screening was 91.1 % , and 90.7 % of these persons ( 19,752 women and 20,035 men ) filled in and returned a semiquantitative dietary question naire . This cohort was followed for an average of 11.4 years ( range , 0.01 - 13.8 years ) with respect to hip fracture , defined as cervical or trochanteric fracture . During follow-up , 213 hip fractures were identified , excluding fractures associated with high-energy trauma and metastatic bone disease . There was no clear association between calcium intake or nondairy animal protein intake and hip fracture in this cohort . However , an elevated risk of fracture was found in women with a high intake of protein from nondairy animal sources in the presence of low calcium intake ( relative risk = 1.96 ( 95 % confidence interval 1.09 - 3.56 ) for the highest quarter of nondairy protein intake and the lowest quarter of calcium intake vs. the three lower quarters of protein intake and the three higher quarters of calcium intake ) . Women who drank nine or more cups of coffee per day also had an increased risk of fracture , while there was no association between coffee consumption and hip fracture in men . Although these findings do not necessarily imply causal relations , they suggest the presence of risk factors for hip fracture that act through a negative calcium balance in this population",
"Low dietary Ca intake and vitamin D insufficiency have been implicated as part of the aetiology leading to osteoporosis . The aim of the present study was to examine the effects of a 30-month dietary intervention that combined supplementation of dairy products fortified with Ca and vitamin D3 and lifestyle and nutrition counselling sessions on bone mineral density ( BMD ) of postmenopausal women . Sixty-six postmenopausal women ( aged 55 - 65 years ) were r and omised into a dietary group ( DG ; n 35 ) , receiving daily and for the first 12 months 1200 mg Ca and 7.5 microg vitamin D3 , while for the next 18 months of intervention 1200 mg Ca and 22.5 microg vitamin D3 through fortified dairy products , and a control group ( CG ; n 31 ) receiving neither counselling nor dairy products . The DG was found to have more favourable changes in arms ( P ) , total spine ( P = 0.001 ) and total body BMD ( P lumbar spine BMD ( 0.056 ; 95 % CI 0.009 , 0.103 ) , which was not found to differentiate significantly compared with the change observed in the CG ( P = 0.075 ) . In conclusion , the present study showed that intakes of vitamin D of about 22.5 microg/d and of Ca close to the recommended level of 1200 mg from fortified dairy foods for 30 months , with compliance ensured by lifestyle and nutrition counselling sessions , can induce favourable changes in arms , total spine and total body BMD of postmenopausal women",
"Dietary protein increases urinary calcium losses and has been associated with higher rates of hip fracture in cross-cultural studies . However , the relation between protein and risk of osteoporotic bone fractures among individuals has not been examined in detail . In this prospect i ve study , usual dietary intake was measured in 1980 in a cohort of 85,900 women , aged 35 - 59 years , who were participants in the Nurses ' Health Study . A mailed food frequency question naire was used and incident hip ( n = 234 ) and distal forearm ( n = 1,628 ) fractures were identified by self-report during the following 12 years . Information on other factors related to osteoporosis , including obesity , use of postmenopausal estrogen , smoking , and physical activity , was collected on biennial question naires . Dietary measures were up date d in 1984 and 1986 . Protein was associated with an increased risk of forearm fracture ( relative risk ( RR ) = 1.22 , 95 % confidence interval ( Cl ) 1.04 - 1.43 , p for trend = 0.01 ) for women who consumed more than 95 g per day compared with those who consumed less than 68 g per day . A similar increase in risk was observed for animal protein , but no association was found for consumption of vegetable protein . Women who consumed five or more servings of red meat per week also had a significantly increased risk of forearm fracture ( RR = 1.23 , 95 % Cl 1.01 - 1.50 ) compared with women who ate red meat less than once per week . Recall of teenage diet did not reveal any increased risk of forearm fracture for women with higher consumption of animal protein or red meat during this earlier period of life . No association was observed between adult protein intake and the incidence of hip fractures , though power to assess this association was low",
"BACKGROUND The effects of dietary protein on bone health are controversial . OBJECTIVE We examined the relation between protein intake with fracture and bone mineral density ( BMD ) within the Women 's Health Initiative ( WHI ) . DESIGN This prospect i ve analysis included 144,580 women aged 50 - 79 y at baseline in the WHI clinical trials ( CTs ) and observational study ( OS ) that recruited participants in 1993 - 1998 with follow-up through 2011 . Self-reported clinical fractures were collected semiannually through the original end of the trials ( WHI CTs ) and annually ( WHI OS ) by question naires . Hip fracture was adjudicated by a central review of radiology reports . BMDs for total body , hip , and spine were measured at baseline and 3 and 6 y in 9062 women at 3 WHI clinics by using dual-energy X-ray absorptiometry . Protein intake was assessed via food-frequency question naire and calibrated by using biomarkers of energy and protein intakes . Associations between protein intake and fracture were estimated by using Cox proportional hazards regression , and the relation between protein intake and BMD was estimated by using linear regression . RESULTS Median biomarker-calibrated protein intake was 15 % of energy intake . Per 20 % increase in calibrated protein intake ( percentage of energy ) , there was no significant association with total fracture ( HR : 0.99 ; 95 % CI : 0.97 , 1.02 ) or hip fracture ( HR : 0.91 ; 95 % CI : 0.84 , 1.00 ) , but there was an inverse association with forearm fracture ( HR : 0.93 ; 95 % CI : 0.88 , 0.98 ) . Each 20 % increase in calibrated protein intake was associated with a significantly higher BMD for total body ( mean 3-y change : 0.003 g/cm² ; 95 % CI : 0.001 , 0.005 g/cm² ) and hip ( mean 3-y change : 0.002 g/cm² ; 95 % CI : 0.001 , 0.004 g/cm² ) . CONCLUSIONS Higher biomarker-calibrated protein intake within the range of usual intake was inversely associated with forearm fracture and was associated with better maintenance of total and hip BMDs . These data suggest higher protein intake is not detrimental to bone health in postmenopausal women",
"BACKGROUND & AIMS Patients with anorexia nervosa ( AN ) have low serum IGF-I levels that may contribute to a lower bone mineral mass . We investigated the effects of a fermented , protein-fortified , dairy product on serum IGF-I levels in patients with AN during an in-hospital refeeding program . METHODS In this multicenter , r and omized , double-blind , placebo-controlled , clinical trial conducted at 3 university hospitals and 3 private clinics in France and Switzerl and , 62 women recently admitted with confirmed AN and with a baseline low serum IGF-I level were r and omized to 2 daily isocaloric fresh cheese pots containing either 15 g/150 g or 3 g/150 g ( controls ) of protein for 4 weeks . The primary outcome was the change in IGF-I levels . RESULTS In the primary intention-to-treat analysis , mean serum IGF-I levels increased during the intervention phase from 22.9 ± 1.5 to 28.6 ± 1.3 nmol/L ( means ± SEM ) ( + 20.2 % ) in the intervention group and from 20.2 ± 1.2 to 25.7 ± 1.5 nmol/L ( + 16.8 % ) in controls . In a preplanned analysis of covariance with repeated measures , the between-group difference was close to statistical significance ( P = 0.071 ) . In a post-hoc mixed-regression model analysis , the difference was statistically significant ( 4.9 nmol/l increase ; P = 0.003 ) , as was the change of the ratio IGF-I/IGF-BP3 ( P=0.004 ) . There was no between-group difference in biochemical markers of bone turnover ( osteocalcin , P1NP , CTX ) or in serum parathyroid hormone level . Serum calcium levels slightly increased during the intervention phase in the higher protein group ( P = 0.02 ) . IGF-BP2 decreased significantly more in the intervention group during the follow up period at week 4 after supplements cessation ( P = 0.019 ) . CONCLUSIONS Intake of a fermented , protein-fortified , isocaloric dairy product during 4 weeks may slightly increase serum IGF-I levels in women with AN , without significant changes in bone turnover markers . CLINICAL TRIAL REGISTRATION NUMBER NCT01823822 ( www . clinical trials.gov )",
"The importance of vegetable and fruit intakes for the prevention of fracture in older women is not well understood . Few studies have explored vegetable and fruit intakes separately , or the associations of specific types of vegetables and fruits with fracture hospitalisations . The objective of this study was to examine the associations of vegetable and fruit intakes , separately , and specific types of vegetables and fruits with fracture-related hospitalisations in a prospect i ve cohort of women aged ≥70 years . Vegetable and fruit intakes were assessed at baseline ( 1998 ) in 1468 women using a food frequency question naire . The incidence of fracture-related hospitalisations over 14.5 years of follow-up was determined using the Hospital Morbidity Data Collection , linked via the Western Australian Data Linkage System . Fractures were identified in 415 ( 28.3 % ) women , of which 158 ( 10.8 % ) were hip fractures . Higher intakes of vegetables , but not fruits , were associated with lower fracture incidence . In multivariable-adjusted models for vegetable types , cruciferous and allium vegetables were inversely associated with all fractures , with a hazard ratio ( HR ) ( 95 % confidence interval ) of 0.72 ( 0.54 , 0.95 ) and 0.66 ( 0.49 , 0.88 ) , respectively , for the highest vs. lowest quartiles . Increasing vegetable intake , with an emphasis on cruciferous and allium vegetables , may prevent fractures in older postmenopausal women",
"Weight loss causes bone mineral loss . Higher protein diets continue to be criticized for further potential harmful bone effects , including elevated urinary calcium , but may promote bone health if protein sources include dairy . Overweight middle-aged subjects ( n = 130 , 59 males ) were r and omized to a diet providing 1.4 g.kg(-1).d(-1 ) protein and 3 daily servings of dairy ( PRO ) or 0.8 g.kg(-1).d(-1 ) protein and 2 daily servings of dairy ( CARB ) for 4 mo of weight loss plus 8 mo of weight maintenance . Diets prescribed 6276 kJ/d for females and 7113 kJ/d for males . Bone mineral content and density ( BMD ) for whole body ( WB ) , lumbar spine ( LS ) and total hip ( TH ) were measured using dual X-ray absorptiometry , and dietary intake using 3-d weighed food records . Urinary calcium was measured using 24-h collection at 0 and 8 mo for a sub sample ( n = 42 ) . Participants lost body weight ( mean , 95 % CI ) of 8.2 % ( 7.5 - 8.9 % ) at 4 mo , 10.6 % ( 9.5 - 11.8 % ) at 8 mo , and 10.5 % ( 8.9 - 12.0 % ) at 12 mo without differences between groups at any time ( P = 0.64 ) . At 12 mo , PRO BMD was higher by 1.6 % ( 0.3 - 3.0 % ) at WB , 2.1 % ( 0.6 - 3.7 % ) at LS , and 1.4 % ( 0.2 - 2.5 % ) at TH compared with CARB . PRO calcium intake was higher ( PRO : 1140 + /- 58 mg/d , CARB : 766 + /- 46 ; P urinary calcium ( PRO : 163 + /- 15 mg/d , CARB : 100 + /- 9.2 ; P reduced-energy diet supplying 1.4 g.kg(-1).d(-1 ) protein and 3 dairy servings increased urinary calcium excretion but provided improved calcium intake and attenuated bone loss over 4 mo of weight loss and 8 additional mo of weight maintenance",
"BACKGROUND There is currently no consensus on the effect of dietary protein intake on the skeleton , but there is some indication that low calcium intakes adversely influence the effect of dietary protein on fracture risk . OBJECTIVE The objective of the present study was to determine whether supplemental calcium citrate malate and vitamin D influence any associations between protein intake and change in bone mineral density ( BMD ) . DESIGN Associations between protein intake and change in BMD were examined in 342 healthy men and women ( aged > or = 65 y ) who had completed a 3-y , r and omized , placebo-controlled trial of calcium and vitamin D supplementation . Protein intake was assessed at the midpoint of the study with the use of a food-frequency question naire and BMD was assessed every 6 mo by dual-energy X-ray absorptiometry . RESULTS The mean ( + /-SD ) protein intake of all subjects was 79.1 + /- 25.6 g/d and the mean total calcium intakes of the supplemented and placebo groups were 1346 + /- 358 and 871 + /- 413 mg/d , respectively . Higher protein intake was significantly associated with a favorable 3-y change in total-body BMD in the supplemented group ( in a model containing terms for age , sex , weight , total energy intake , and dietary calcium intake ) but not in the placebo group . The pattern of change in femoral neck BMD with increasing protein intake in the supplemented group was similar to that for the total body . CONCLUSION Increasing protein intake may have a favorable effect on change in BMD in elderly subjects supplemented with calcium citrate malate and vitamin",
"BACKGROUND Different sources of dietary protein may have different effects on bone metabolism . Animal foods provide predominantly acid precursors , whereas protein in vegetable foods is accompanied by base precursors not found in animal foods . Imbalance between dietary acid and base precursors leads to a chronic net dietary acid load that may have adverse consequences on bone . OBJECTIVE We wanted to test the hypothesis that a high dietary ratio of animal to vegetable foods , quantified by protein content , increases bone loss and the risk of fracture . DESIGN This was a prospect i ve cohort study with a mean ( + /-SD ) of 7.0+/-1.5 y of follow-up of 1035 community-dwelling white women aged > 65 y. Protein intake was measured by using a food-frequency question naire and bone mineral density was measured by dual-energy X-ray absorptiometry . RESULTS Bone mineral density was not significantly associated with the ratio of animal to vegetable protein intake . Women with a high ratio had a higher rate of bone loss at the femoral neck than did those with a low ratio ( P = 0.02 ) and a greater risk of hip fracture ( relative risk = 3.7 , P = 0.04 ) . These associations were unaffected by adjustment for age , weight , estrogen use , tobacco use , exercise , total calcium intake , and total protein intake . CONCLUSIONS Elderly women with a high dietary ratio of animal to vegetable protein intake have more rapid femoral neck bone loss and a greater risk of hip fracture than do those with a low ratio . This suggests that an increase in vegetable protein intake and a decrease in animal protein intake may decrease bone loss and the risk of hip fracture . This possibility should be confirmed in other prospect i ve studies and tested in a r and omized trial",
"The role of fruit and vegetable intake in relation to fracture prevention during adulthood and beyond is not adequately understood . We investigated the potential association between fruit and vegetable intake and hip fracture incidence in a large sample of older adults from Europe and the United States . A total of 142,018 individuals ( 116,509 women ) aged ≥60 years , from five cohorts , were followed up prospect ively for 1,911,482 person-years , accumulating 5552 hip fractures . Fruit and vegetable intake was assessed by vali date d , cohort-specific , food-frequency question naires ( FFQ ) . Ηip fractures were ascertained through national patient registers or telephone interviews/ question naires . Adjusted hazard ratios ( HRs ) derived by Cox proportional hazards regression were estimated for each cohort and subsequently pooled using r and om effects meta- analysis . Intake of ≤1 serving/day of fruit and vegetables combined was associated with 39 % higher hip fracture risk ( pooled adjusted HR , 1.39 ; 95 % confidence interval [ CI ] , 1.20 to 1.58 ) in comparison with moderate intake ( > 3 and ≤5 servings/day ) ( pfor heterogeneity = 0.505 ) , whereas higher intakes ( > 5 servings/day ) were not associated with lower risk in comparison with the same reference . Associations were more evident among women . We concluded that a daily intake of 1 or increased hip fracture risk in relation to moderate daily intakes . Older adults with such low fruit and vegetable consumption may benefit from raising their intakes to moderate amounts in order to reduce their hip fracture risk . © 2016 American Society for Bone and Mineral Research",
"Summary In 30 adults , increasing intake of aromatic amino acids increased calcium excretion and serum IGF-1 , but not indices of bone turnover , when compared with similar increases in intake of branched-chain amino acids . The mechanisms involved are not certain but these findings suggest a role for the calcium sensor receptor . Introduction In contrast to branched-chain amino acids ( BCAAs ) , aromatic amino acids ( AAAs ) bind to the calcium sensing receptor ( CaR ) and thus have an increased potential to affect calcium homeostasis . In this study we compare the effects of increased intake of AAAs versus BCAAs on calcium excretion , serum IGF-1 , markers of bone turnover , and 4-hr calcium excretion after an oral calcium load . Methods After two weeks on low-protein metabolic diets , 30 healthy subjects were r and omized to a fivefold increase in intake of AAAs or BCAAs for two weeks . Changes in calcium excretion and other measures were compared in the two groups . Results With the increase in amino acid intake , 24-hr calcium excretion ( P = 0.027 ) , IGF-1 ( P = 0.022 ) , and 4-hr calcium excretion after an oral load ( P = 0.023 ) increased significantly in the AAA relative to the BCAA group . Group changes in turnover markers did not differ significantly . Conclusion In comparison with BCAAs , AAAs promoted calcium excretion . The calciuria does not appear to result from increases in bone resorption and may occur by increasing calcium absorption . The AAAs also increased circulating levels of IGF-1 . Collectively these findings raise the possibility that AAAs may selectively influence calcium homeostasis through their interactions with the",
"OBJECTIVE We compared the effect of supplementation with a fortified skimmed milk product ( high calcium skim milk ) with or without added phylloquinone ( vitamin K(1 ) ) on markers of bone formation and resorption in premenopausal women . METHODS Eighty-two women 20 to 35 y of age were r and omly allocated to three groups . Two groups received two daily servings of high calcium skim milk ( 1000 mg/d of extra calcium ) with or without added phylloquinone ( 80 microg/d ) for 16 wk , and a third control group received no supplementation . Bone density was assessed at baseline and the bone markers , total osteocalcin , type I N-terminal procollagen peptide , and cross-linked C-telopeptide of type I collagen were measured at baseline and at weeks 2 , 12 , and 16 . Serum phylloquinone and undercarboxylated osteocalcin were measured in the control and vitamin K-supplemented groups at weeks 0 and 16 . RESULTS Baseline values for age , body mass index , and bone density did not differ across groups . In vitamin K-supplemented women , mean serum phylloquinone concentrations increased from 0.27 to 0.76 microg/L ( P undercarboxylated osteocalcin concentrations decreased from 9.68 to 4.46 microg/L ( P Plasma cross-linked C-telopeptide of type I collagen , total osteocalcin , and type I N-terminal procollagen peptide levels decreased significantly in both supplemented groups compared with the control group over 16 wk ( cross-linked C-telopeptide of type I collagen > 30 % , total osteocalcin and type I N-terminal procollagen peptide > 15 % ) . CONCLUSION Fortified milk supplementation in premenopausal women reduced bone turnover significantly . Phylloquinone fortification substantially improved vitamin K status but had no demonstrable additive effect on bone turnover in this short-term study",
"Increased postmenopausal bone turnover leads to bone loss and fragility fracture risk . In the absence of osteoporosis , risk preventive measures , particularly those modifying nutritional lifestyle , are appropriate . We tested the hypothesis that milk supplementation affects bone turnover related to biochemical markers in a direction that , in the long term , may be expected to reduce postmenopausal bone loss . Thirty healthy postmenopausal women aged 59.3 ( SD 3.3 ) years were enrolled in a prospect i ve crossover trial of 16 weeks . After a 4-week period of adaptation with diet providing 600 mg calcium plus 300 mg ingested as 250 ml semi-skimmed milk , participants were maintained during 6 weeks under the same 600 mg calcium diet and r and omized to receive either 500 ml semi-skimmed milk , thus providing a total of 1200 mg calcium , or no milk supplement . In the next 6 weeks they were switched to the alternative regimen . At the end of the each period , i.e. after 4 , 10 and 16 weeks , blood and urinary sample s were collected . The changes in blood variables between the periods of 6 weeks without and with milk supplementation were : for parathyroid hormone , -3.2 pg/ml ( P=0.0054 ) ; for crosslinked telopeptide of type I collagen , -624 pg/ml ( P propeptide of type I procollagen , -5.5 ng/ml ( P=0.0092 ) ; for osteocalcin , -2.8 ng/ml ( P=0.0014 ) . In conclusion , a 6-week period of milk supplementation induced a decrease in several biochemical variables compatible with diminished bone turnover mediated by reduction in parathyroid hormone secretion . This nutritional approach to postmenopausal alteration in bone metabolism may be a valuable measure in the primary prevention of osteoporosis",
"Summary Because kidney dysfunction reduces the ability to excrete dietary acid excess , we hypothesized that underlying kidney function may have confounded the mixed studies linking dietary acid load with the risk of osteoporosis and fractures in the community . In a relatively large survey of elderly men and women , we report that dietary acid load did neither associate with DEXA-estimated bone mineral density nor with fracture risk . Underlying kidney function did not modify these None findings . Our results do not support the dietary acid-base hypothesis of bone loss . Introduction Impaired renal function reduces the ability to excrete dietary acid excess . We here investigate the association between dietary acid load and bone mineral density ( BMD ) , osteoporosis , and fracture risk by renal function status . Methods An observational study was conducted in 861 community-dwelling 70-year-old men and women ( 49 % men ) with complete dietary data from the Prospect i ve Investigation of the Vasculature in Uppsala Seniors ( PIVUS ) . The exposure was dietary acid load as estimated from 7-day food records by the net endogenous acid production ( NEAP ) and potential renal acid load ( PRAL ) algorithms . Renal function assessed by cystatin C estimated glomerular filtration rate was reduced in 21 % of the individuals . Study outcomes were BMD and osteoporosis state ( assessed by DEXA ) and time to fracture ( median follow-up of 9.2 years ) . Results In cross-section , dietary acid load had no significant associations with BMD or with the diagnosis of osteoporosis . During follow-up , 131 fractures were vali date d. Neither NEAP ( adjusted hazard ratios ( HR ) ( 95 % confidence interval ( CI ) ) , 1.01 ( 0.85–1.21 ) , per 1 SD increment ) nor PRAL ( adjusted HR ( 95 % CI ) , 1.07 ( 0.88–1.30 ) , per 1 SD increment ) associated with fracture risk . Further multivariate adjustment for kidney function or stratification by the presence of kidney disease did not modify these None associations . Conclusions The hypothesis that dietary acid load associates with reduced BMD or increased fracture risk was not supported by this study in community-dwelling elderly individuals . Renal function did not influence on this None finding",
"Data on overall dietary pattern and osteoporotic fracture risk from population -based cohorts are limited , especially from Asian population s. This study examined the relation between overall diet and hip fracture risk by using principal components analysis ( PCA ) to identify dietary pattern specific to the study population and by using the Alternative Healthy Eating Index ( AHEI ) 2010 to assess dietary quality . The Singapore Chinese Health Study is a prospect i ve population -based cohort that enrolled 63,257 Chinese men and women ( including both pre- and postmenopausal women ) aged 45 - 74 y between 1993 and 1998 in Singapore . Habitual diet was assessed by using a vali date d food-frequency question naire . Two dietary patterns , the vegetable-fruit-soy ( VFS ) pattern and the meat-dim-sum ( MDS ) pattern , were derived by PCA . Overall dietary quality was assessed according to the AHEI 2010 , which was defined a priori for chronic disease prevention . A Cox regression model was applied with adjustment for potential confounders . In both genders , higher scores for the VFS pattern and the AHEI 2010 were associated with lower risk of hip fracture in a dose-dependent manner ( all P-trend ≤ 0.008 ) . Compared with the lowest quintile , participants in the highest quintile had a 34 % reduction in risk ( HR : 0.66 ; 95 % CI : 0.55 , 0.78 ) for the VFS pattern and a 32 % reduction in risk ( HR : 0.68 ; 95 % CI : 0.58 , 0.79 ) for the AHEI 2010 . The MDS pattern score was not associated with hip fracture risk . An Asian diet rich in plant-based foods , namely vegetables , fruit , and legumes such as soy , may reduce the risk of hip fracture ",
"A Western-type diet is associated with osteoporosis and calcium nephrolithiasis . On the basis of observations that calcium retention and inhibition of bone resorption result from alkali administration , it is assumed that the acid load inherent in this diet is responsible for increased bone resorption and calcium loss from bone . However , it is not known whether the dietary acid load acts directly or indirectly ( i.e. , via endocrine changes ) on bone metabolism . It is also unclear whether alkali administration affects bone resorption/calcium balance directly or whether alkali-induced calcium retention is dependent on the cation ( i.e. , potassium ) supplied with administered base . The effects of neutralization of dietary acid load ( equimolar amounts of NaHCO(3 ) and KHCO(3 ) substituted for NaCl and KCl ) in nine healthy subjects ( 6 men , 3 women ) under metabolic balance conditions on calcium balance , bone markers , and endocrine systems relevant to bone [ glucocorticoid secretion , IGF-1 , parathyroid hormone (PTH)/1,25(OH)(2 ) vitamin D and thyroid hormones ] were studied . Neutralization for 7 days induced a significant cumulative calcium retention ( 10.7 + /- 0.4 mmol ) and significantly reduced the urinary excretion of deoxypyridinoline , pyridinoline , and n-telopeptide . Mean daily plasma cortisol decreased from 264 + /- 45 to 232 + /- 43 nmol/l ( P = 0.032 ) , and urinary excretion of tetrahydrocortisol ( THF ) decreased from 2,410 + /- 210 to 2,098 + /- 190 microg/24 h ( P = 0.027 ) . No significant effect was found on free IGF-1 , PTH/1,25(OH)(2 ) vitamin D , or thyroid hormones . An acidogenic Western diet results in mild metabolic acidosis in association with a state of cortisol excess , altered divalent ion metabolism , and increased bone resorptive indices . Acidosis-induced increases in cortisol secretion and plasma concentration may play a role in mild acidosis-induced alterations in bone metabolism and possibly in osteoporosis associated with an acidogenic Western diet",
"PURPOSE We aim ed to determine whether women consuming fat-free milk versus isoenergetic carbohydrate after resistance exercise would see augmented gains in lean mass and reductions in fat mass similar to what we observed in young men . METHODS Young women were r and omized to drink either fat-free milk ( MILK : n = 10 ; age ( mean + /- SD ) = 23.2 + /- 2.8 yr ; BMI = 26.2 + /- 4.2 kg x m(-2 ) ) or isoenergetic carbohydrate ( CON : n = 10 ; age = 22.4 + /- 2.4 yr ; BMI = 25.2 + /- 3.8 kg x m(-2 ) ) immediately after and 1 h after exercise ( 2 x 500 mL ) . Subjects exercised 5 d x wk(-1 ) for 12 wk . Body composition changes were measured by dual-energy x-ray absorptiometry , and subjects ' strength and fasting blood were measured before and after training . RESULTS CON gained weight after training ( CON : + 0.86 + /- 0.4 kg , P Lean mass increased with training in both groups ( P Fat mass decreased with training in MILK only ( -1.6 + /- 0.4 kg , P Isotonic strength increased more in MILK than CON ( P Serum 25-hydroxyvitamin D increased in both groups but to a greater extent in MILK than CON ( + 6.5 + /- 1.1 vs + 2.8 + /- 1.3 nM , respectively , P parathyroid hormone decreased only in MILK ( -1.2 + /- 0.2 pM , P muscle mass accretion , strength gains , fat mass loss , and a possible reduction in bone turnover in women after 12 wk . Our results , similar to those in men , highlight that milk is an effective drink to support favorable body composition changes in women with resistance training",
"Objective : To compare fracture rates in four diet groups ( meat eaters , fish eaters , vegetarians and vegans ) in the Oxford cohort of the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Oxford ) . Design : Prospect i ve cohort study of self-reported fracture risk at follow-up . Setting : The United Kingdom . Subjects : A total of 7947 men and 26 749 women aged 20–89 years , including 19 249 meat eaters , 4901 fish eaters , 9420 vegetarians and 1126 vegans , recruited by postal methods and through general practice surgeries . Methods : Cox regression . Results : Over an average of 5.2 years of follow-up , 343 men and 1555 women reported one or more fractures . Compared with meat eaters , fracture incidence rate ratios in men and women combined adjusted for sex , age and non-dietary factors were 1.01 ( 95 % CI 0.88–1.17 ) for fish eaters , 1.00 ( 0.89–1.13 ) for vegetarians and 1.30 ( 1.02–1.66 ) for vegans . After further adjustment for dietary energy and calcium intake the incidence rate ratio among vegans compared with meat eaters was 1.15 ( 0.89–1.49 ) . Among subjects consuming at least 525 mg/day calcium the corresponding incidence rate ratios were 1.05 ( 0.90–1.21 ) for fish eaters , 1.02 ( 0.90–1.15 ) for vegetarians and 1.00 ( 0.69–1.44 ) for vegans . Conclusions : In this population , fracture risk was similar for meat eaters , fish eaters and vegetarians . The higher fracture risk in the vegans appeared to be a consequence of their considerably lower mean calcium intake . An adequate calcium intake is essential for bone health , irrespective of dietary preferences . Sponsorship : The EPIC-Oxford study is supported by The Medical Research Council and Cancer Research UK",
"Purpose This study aim ed to determine whether there is a relationship between iron status and bone metabolism , and to compare the effects of the consumption , as part of the usual diet , of an iron or iron and vitamin D-fortified skimmed milk on bone remodelling in iron-deficient women . Methods Young healthy iron-deficient or iron-sufficient women ( serum ferritin ≤30 ng/mL or > 30 ng/mL , respectively ) were recruited . Iron-deficient women were assigned to a nutritional intervention consisting of a r and omised , controlled , double-blind , parallel design trial of 16 weeks during winter . They consumed , as part of their usual diet , an iron ( Fe group , n = 54 ) or iron and vitamin D-fortified ( Fe+D group , n = 55 ) flavoured skimmed milk ( iron , 15 mg/day ; vitamin D3 , 5 μg/day , 200 IU ) . The iron-sufficient women followed their usual diet without supplementation ( R group , n = 56 ) . Dietary intake , body weight , iron biomarkers , 25-hydroxyvitamin D ( 25OHD ) , parathyroid hormone ( PTH ) , procollagen-type 1 N-terminal propeptide ( P1NP ) , and aminoterminal telopeptide of collagen I ( NTx ) were determined . Results Negative correlations were found between baseline log-ferritin and log-NTx ( p = 0.002 ) . Serum 25OHD increased ( from 62 ± 21 to 71 ± 21 nmol/L , mean ± SD , p 0.001 ) while P1NP and NTx decreased in Fe+D during the assay ( p = 0.004 and p respectively ) . NTx was lower in Fe+D compared to Fe at week 8 ( p higher bone resorption in young women . Consumption of a dairy product that supplies 5 μg/day of vitamin D3 reduces bone turnover and increases circulating 25OHD to nearly reach an optimal vitamin D status , defined as 25OHD over 75",
"Although there is some epidemiologic evidence that soy may reduce risk of osteoporotic fracture in women , it is not known whether this risk reduction also occurs for men . The authors examined gender-specific associations between soy intake and hip fracture risk in the Singapore Chinese Health Study , a prospect i ve cohort of 63,257 Chinese living in Singapore . At recruitment between 1993 and 1998 , each subject was administered a food frequency question naire and questions on medical history and lifestyle factors . As of December 31 , 2006 , 276 incident cases of hip fracture in men and 692 cases in women were identified via linkage with hospital discharge data bases . For both genders , hip fracture risk was positively associated with cigarette smoking and was inversely associated with body mass index . There was a statistically significant association of tofu equivalents , soy protein , and isoflavones with hip fracture risk among women but not among men . Compared with women in the lowest quartile of intakes for tofu equivalents ( Risk levels were comparable across the second , third , and fourth quartiles of soy intake categories",
"Excess dietary proteins and \" acid ash \" diets have been suspected to increase the risk of osteoporosis , but experimental and epidemiological evidence is mixed . We aim ed to determine whether the association between protein intake and the overall acid-base equilibrium of the diet ( as renal net acid excretion [ RNAE ] estimate ) and fracture risk vary according to calcium intake . During an average of 8.37 + /- 1.73 yr of follow-up , 2408 women reported a fracture ( excluding high-impact trauma ) among 36,217 postmenopausal women from the E3N prospect i ve study . We used Cox regression models to study the interaction between calcium and , respectively , proteins and RNAE , from the 1993 dietary question naire for fracture risk determination , adjusting for potential confounders . There was no overall association between fracture risk and total protein or RNAE . However , in the lowest quartile of calcium ( fracture risk ( RR = 1.51 for highest versus lowest quartile ; 95 % CI , 1.17 - 1.94 ) . An increasing fracture risk with increasing animal protein intake was also observed ( trend , p interaction for fracture risk was observed between RNAE and calcium . In this Western population of postmenopausal women with normal to high protein intake and fairly high calcium intake , there was no overall association between total protein or RNAE and fracture risk . However , there was some evidence that high protein-high acid ash diets were associated with an increased risk of fracture when calcium intake was low ( < 400 mg/1000 kcal )",
"Dietary guidelines recommend a daily intake of 5 servings of fruits and vegetables . Whether such intakes are associated with a lower risk of hip fracture is at present unclear . The aim of the present study was to investigate the dose-response association between habitual fruit and vegetable intake and hip fracture in a cohort study based on 40,644 men from the Cohort of Swedish Men ( COSM ) and 34,947 women from the Swedish Mammography Cohort ( SMC ) ( total n = 75,591 ) , free from cardiovascular disease and cancer , who answered lifestyle question naires in 1997 ( age 45 to 83 years ) . Intake of fruits and vegetables ( servings/day ) was assessed by food frequency question naire and incident hip fractures were retrieved from the Swedish Patient Register ( 1998 to 2010 ) . The mean follow-up time was 14.2 years . One-third of the participants reported an intake of fruits and vegetables of > 5 servings/day , one-third reported > 3 to ≤5 servings/day , 28 % reported > 1 to ≤3 servings/day , and 6 % reported ≤1 serving/day . During 1,037,645 person-years we observed 3644 hip fractures ( 2266 or 62 % in women ) . The dose-response association was found to be strongly nonlinear ( p higher rate of hip fracture compared with those consuming 5 servings/day ; adjusted hazard ratio ( HR ) was 1.88 ( 95 % CI , 1.53 to 2.32 ) . The rate was gradually lower with higher intakes ; adjusted HR for 1 versus 5 servings/day was 1.35 ( 95 % CI , 1.21 to 1.58 ) . However , more than 5 servings/day did not confer additionally lower HRs ( adjusted HR for 8 versus 5 servings/day was 0.96 ; 95 % CI , 0.90 to 1.03 ) . Similar results were observed when men and women were analyzed separately . We conclude that there is a dose-response association between fruit and vegetable intake and hip fracture such that an intake below the recommended five servings/day confers higher rates of hip fracture . Intakes above this recommendation do not seem to further lower the risk",
"Summary Eighteen months of daily consumption of milk containing 250 mg calcium prevented bone mineral density ( BMD ) loss at the hip and the femoral neck in postmenopausal Chinese women aged 45 to 65 . Introduction Estrogen-related bone loss in postmenopausal women can be prevented by the consumption of milk with high doses of calcium and soymilk with high doses of isoflavones . However , high doses of calcium and isoflavones may not be necessary to attain a beneficial effect of milk and soymilk on BMD . We hypothesized that BMD will increase in postmenopausal Chinese women who consume daily 250 mg calcium in milk or soymilk . Milk prevented bone loss at the hip and the femoral neck in postmenopausal Chinese women . Methods A total of 141 eligible Chinese women without osteoporosis , aged 45–65 , and postmenopausal for more than 2 years were r and omized into groups receiving for 18 months ( A ) milk with 250 mg calcium daily , ( B ) soymilk with 250 mg calcium daily , or ( C ) neither milk nor soymilk . Dual-energy X-ray absorptiometry measured the BMD of the spine and hip at 0 , 6 , 12 , and 18 months . Results The BMD in the hip ( 2.52 % ) and the femoral neck ( 2.82 % ) of the women consuming milk was significantly higher ( hip , P = 0.01 ; femoral neck , P reduction in BMD at all sites ; the reduction in BMD was only significant at the hip during 12 months ( P = 0.008 ) and at the femoral neck during 18 months ( P = 0.005 ) . Conclusions Daily consumption of milk containing 250 mg calcium over 18 months prevents BMD loss at the hip and the femoral neck in postmenopausal Chinese women",
"CONTEXT It has been assumed that the increase in urine calcium ( Ca ) that accompanies an increase in dietary protein was due to increased bone resorption . However , studies using stable Ca isotopes have found that dietary protein increases Ca absorption without increasing bone resorption . OBJECTIVE The objective of the study was to investigate the impact of a moderately high protein diet on bone mineral density ( BMD ) . DESIGN This was a r and omized , double-blind , placebo-controlled trial of protein supplementation daily for 18 months . SETTING The study was conducted at two institutional research centers . PARTICIPANTS Two hundred eight older women and men with a body mass index between 19 and 32 kg/m(2 ) and a self-reported protein intake between 0.6 and 1.0 g/kg participated in the study . INTERVENTION Subjects were asked to incorporate either a 45-g whey protein or isocaloric maltodextrin supplement into their usual diet for 18 months . MAIN OUTCOME MEASURE BMD by dual-energy x-ray absorptiometry , body composition , and markers of skeletal and mineral metabolism were measured at baseline and at 9 and 18 months . RESULTS There were no significant differences between groups for changes in L-spine BMD ( primary outcome ) or the other skeletal sites of interest . Truncal lean mass was significantly higher in the protein group at 18 months ( P = .048 ) . C-terminal telopeptide ( P = .0414 ) , IGF-1 ( P = .0054 ) , and urinary urea ( P estimated glomerular filtration rate at 18 months . CONCLUSION Our data suggest that protein supplementation above the recommended dietary allowance ( 0.8 g/kg ) may preserve fat-free mass without adversely affecting skeletal health or renal function in healthy older adults",
"UNLABELLED In this 2-year r and omized controlled study of 167 men > 50 years of age , supplementation with calcium-vitamin D3-fortified milk providing an additional 1000 mg of calcium and 800 IU of vitamin D3 per day was effective for suppressing PTH and stopping or slowing bone loss at several clinical ly important skeletal sites at risk for fracture . INTRODUCTION Low dietary calcium and inadequate vitamin D stores have long been implicated in age-related bone loss and osteoporosis . The aim of this study was to assess the effects of calcium and vitamin D3 fortified milk on BMD in community living men > 50 years of age . MATERIAL S AND METHODS This was a 2-year r and omized controlled study in which 167 men ( mean age + /- SD , 61.9 + /- 7.7 years ) were assigned to receive either 400 ml/day of reduced fat ( approximately 1 % ) ultra-high temperature ( UHT ) milk containing 1000 mg of calcium plus 800 IU of vitamin D3 or to a control group receiving no additional milk . Primary endpoints were changes in BMD , serum 25(OH)D , and PTH . RESULTS One hundred forty-nine men completed the study . Baseline characteristics between the groups were not different ; mean dietary calcium and serum 25(OH)D levels were 941 + /- 387 mg/day and 77 + /- 23 nM , respectively . After 2 years , the mean percent change in BMD was 0.9 - 1.6 % less in the milk supplementation compared with control group at the femoral neck , total hip , and ultradistal radius ( range , p lumbar spine BMD in the milk supplementation group after 12 and 18 months ( 0.8 - 1.0 % , p Serum 25(OH)D increased and PTH decreased in the milk supplementation relative to control group after the first year ( 31 % and -18 % , respectively ; both p Body weight remained unchanged in both groups at the completion of the study . CONCLUSIONS Supplementing the diet of men > 50 years of age with reduced-fat calcium- and vitamin D3-enriched milk may represent a simple , nutritionally sound and cost-effective strategy to reduce age-related bone loss at several skeletal sites at risk for fracture in the elderly",
"Acceleration of bone remodelling increases the risk of fragility fractures . The objective of the present study was to explore in elderly women whether a vitamin D and Ca-fortified dairy product providing about 17 - 25 % of the recommended intakes in vitamin D , Ca and proteins would reduce secondary hyperparathyroidism and bone remodelling in a way that may attenuate age-related bone loss in the long term . Thirty-seven institutionalised women , aged 84.8 ( sd 8.1 ) years , with low serum 25-hydroxyvitamin D ( 5.5 ( sd 1.7 ) ng/ml ) were enrolled into a multicentre open trial to consume during 1 month two servings of soft plain cheese made of semi-skimmed milk providing daily 686 kJ ( 164 kcal ) , 2.5 microg vitamin D , 302 mg Ca and 14.2 g proteins . The primary endpoint was the change in serum carboxy terminal cross-linked telopeptide of type I collagen ( CTX ) , selected as a marker of bone resorption . Thirty-five subjects remained compliant . Mean serum changes were : 25-hydroyvitamin D , + 14.5 % ( P = 0.0051 ) ; parathyroid hormone ( PTH ) , - 12.3 % ( P = 0.0011 ) ; CTX , - 7.5 % ( P = 0.01 ) ; tartrate-resistant acid phosphatase isoform 5b ( TRAP 5b ) , - 9.9 % ( P albumin , + 6.2 % ( P insulin-like growth factor-I (IGF-I),+16.9 % ( P osteocalcin , + 8.3 % ( P = 0.0166 ) ; amino-terminal propeptide of type 1 procollagen (P1NP),+19.3 % ( P = 0.0031 ) . The present open trial suggests that fortified soft plain cheese consumed by elderly women with vitamin D insufficiency can reduce bone resorption markers by positively influencing Ca and protein economy , as expressed by decreased PTH and increased IGF-I , respectively . The rise in the bone formation marker P1NP could be explained by a protein-mediated increase in IGF-I. Thus , such a dietary intervention might uncouple , at least transiently , bone resorption from bone formation and thereby attenuate age-related bone loss",
"Summary We examined the independent and combined effects of a multi-component exercise program and calcium – vitamin-D3-fortified milk on bone mineral density ( BMD ) in older men . Exercise result ed in a 1.8 % net gain in femoral neck BMD , but additional calcium – vitamin D3 did not enhance the response in this group of older well-nourished men . Introduction This 12-month r and omised controlled trial assessed whether calcium – vitamin-D3-fortified milk could enhance the effects of a multi-component exercise program on BMD in older men . Methods Men ( n = 180 ) aged 50–79 years were r and omised into : ( 1 ) exercise + fortified milk ; ( 2 ) exercise ; ( 3 ) fortified milk ; or ( 4 ) controls . Exercise consisted of high intensity progressive resistance training with weight-bearing impact exercise . Men assigned to fortified milk consumed 400 mL/day of low fat milk providing an additional 1,000 mg/day calcium and 800 IU/day vitamin D3 . Femoral neck ( FN ) , total hip , lumbar spine and trochanter BMD and body composition ( DXA ) , muscle strength 25-hydroxyvitamin D and parathyroid hormone ( PTH ) were assessed . Results There were no exercise-by-fortified milk interactions at any skeletal site . Exercise result ed in a 1.8 % net gain in FN BMD relative to no-exercise ( p ; lean mass ( 0.6 kg , p and muscle strength ( 20–52 % , p For lumbar spine BMD , there was a net 1.4–1.5 % increase in all treatment groups relative to controls ( all p fortified milk at any skeletal site . Conclusion A multi-component community-based exercise program was effective for increasing FN BMD in older men , but additional calcium – vitamin D3 did not enhance the osteogenic response",
"OBJECTIVE The risk factors for fractures are incompletely understood . An outst and ing question concerns the optimal amount of dietary calcium needed to minimise the risk of fracture . DESIGN We examined the associations of dietary calcium and other nutrients with self-reported fracture risk in a prospect i ve cohort study . Nutrient intakes were estimated using a semi-quantitative food-frequency question naire administered at recruitment . SETTING The UK . PARTICIPANTS A total of 26 749 women and 7947 men aged 20 - 89 years . RESULTS Over an average of 5.2 years of follow-up , 1555 women and 343 men reported one or more fractures , 72 % of these result ing from a fall . Among women , fracture risk was higher at lower calcium intakes , with a relative risk of 1.75 ( 95 % confidence interval ( CI ) 1.33 - 2.29 ) among women with a calcium intake of dietary calcium with fracture risk was stronger among women aged under 50 years at recruitment than among women aged 50 and above . Dietary calcium intake was not associated with fracture risk in men . Fracture risk was not related to the dietary intake of any other nutrient examined . CONCLUSION In this population , women with a low dietary calcium intake had an increased risk of bone fracture , and this association was more marked among younger women than among older women",
"The prevention of increased bone remodeling in postmenopausal women at low 10-y risk of osteoporotic fractures essentially relies on reinforcement of environmental factors known to positively influence bone health , among which nutrition plays an important role . In institutionalized women in their mid-eighties , we previously found that consumption of fortified soft plain cheese increased vitamin D , calcium , and protein intakes , reduced bone resorption biochemical markers , particularly the serum bone specific acid phosphatase tartrate resistant acid phosphatase , isoform 5b ( TRAP 5b ) that reflects osteoclast activity , and stimulated the serum bone anabolic factor insulin-like growth factor-I ( IGF-I ) . Whether these effects occur in much younger women was tested in a prospect i ve control study . Seventy-one healthy postmenopausal women aged 56.6 ± 3.9 y ( mean ± SD ) with low spontaneous supply of both Ca and vitamin D were r and omized to consume daily ( treated , n = 36 ) or not ( controls , n = 35 ) two servings ( 2 × 100 g ) of skimmed-milk , soft plain cheese for 6 wk . The vitamin D and Ca-fortified dairy product provided daily : 661 kJ , 2.5 μg vitamin D , 400 mg calcium , and 13.8 g protein . At the end of the intervention , the decrease in TRAP 5b and the increase in IGF-I were greater in the treated than in the control group ( P changes in serum carboxy terminal crosslinked telopeptide of type I collagen did not differ significantly between the two groups . In conclusion , like in elderly women , consumption by healthy postmenopausal women of a vitamin D and calcium-fortified dairy product that also increases the protein intake , reduces the serum concentration of the bone resorption biomarker TRAP 5b . This response , combined with the increase in serum IGF-I , is compatible with a nutrition-induced reduction in postmenopausal bone loss rate ",
"Although high-protein diets induce hypercalciuria in humans , the source of the additional urinary calcium remains unclear . One hypothesis is that the high endogenous acid load of a high-protein diet is partially buffered by bone , leading to increased skeletal resorption and hypercalciuria . We used dual stable calcium isotopes to quantify the effect of a high-protein diet on calcium kinetics in women . The study consisted of 2 wk of a lead-in , well-balanced diet followed by 10 d of an experimental diet containing either moderate ( 1.0 g/kg ) or high ( 2.1 g/kg ) protein . Thirteen healthy women received both levels of protein in r and om order . Intestinal calcium absorption increased during the high-protein diet in comparison with the moderate ( 26.2 + /- 1.9 % vs. 18.5 + /- 1.6 % , P urinary calcium ( 5.23 + /- 0.37 vs. 3.57 + /- 0.35 mmol/d , P fraction of urinary calcium of bone origin and a nonsignificant trend toward a reduction in the rate of bone turnover . There were no protein-induced effects on net bone balance . These data directly demonstrate that , at least in the short term , high-protein diets are not detrimental to bone",
"BACKGROUND Calcium is an essential cotherapy in osteoporosis treatment . The relative effectiveness of various calcium salts for this purpose is uncertain . Many older women with osteoporosis have phosphorus intakes of Recommended Dietary Allowance . OBJECTIVE Our objective was to test the hypothesis that calcium phosphate would better support anabolic bone building than would calcium carbonate . DESIGN This study was a 12-mo , r and omized , positive-comparator , 2-arm , single-blind clinical trial in 211 patients treated with teriparatide who consumed phosphorus/d . Participants were r and omly assigned to receive , in addition to teriparatide and 1000 IU cholecalciferol , 1800 mg calcium/d as either tricalcium phosphate or calcium carbonate . The primary endpoints were changes in lumbar spine and total hip bone mineral densities ( BMDs ) ; secondary endpoints were changes in bone resorption biomarkers and serum and urine calcium and phosphorus concentrations . RESULTS In the combined group , the lumbar spine BMD increased by 7.2 % , and total hip BMD increased by 2.1 % ( P serum calcium and phosphorus concentrations or in urine calcium concentrations . Bone resorption biomarkers increased in both groups , as expected with teriparatide , but the increases in the 2 calcium groups did not differ significantly . CONCLUSIONS Tricalcium phosphate and calcium carbonate appear to be approximately equally effective in supporting bone building with a potent anabolic agent ; phosphate salt may be preferable in patients with restricted phosphorus intakes . This trial was registered at clinical trials.gov as NCT00074711",
"Objective Calcium dem and is increased during pregnancy . However , few r and omized controlled trials examined the effects of calcium supplementation on bone mass during pregnancy . This study determined effects of calcium and milk supplementation on maternal bone mineral density ( BMD ) and bone turnover in pregnant Chinese women with habitual low calcium intake . Methods In this r and omized controlled trial , 36 Chinese pregnant women ( 24–31 years , 18 gestational weeks ) were r and omly assigned to the following three arms ( 12 each ) : I , usual diet ; II , “ I ” + 45 g milk powder ( containing 350 mg calcium ) ; or III , “ II ” + 600 mg calcium/day from gestational age of 20 weeks to 6 weeks post-partum ( PP ) . BMD was measured post-treatment using dual-energy X-ray absorptiometry . Dietary intakes , 24-h urinary calcium , bone resorption ( urinary hydroxyproline ) and formation ( serum osteocalcin ) biomarkers were examined at the gestational age of 20 and 34 weeks , and 6 weeks PP . Results A dose-dependent relationship was observed between calcium intake and BMDs . The BMD values were significantly higher in subjects with calcium and milk supplementation than those in the controls at the whole body and spine ( p of urinary hydroxyproline , and significant increases in serum osteocalcin during the intervention period in the calcium/milk intervention groups than those in the control group ( all p Conclusion Calcium/milk supplementation during pregnancy is associated with greater BMD at the spine and whole body and suppresses bone resorption in Chinese women with habitual low calcium intake",
"Dietary studies often report low calcium intake amongst post-menopausal Malaysian women and calcium deficiency has been implicated as part of the etiology of age-related bone loss leading to osteoporosis . Therefore , the objective of this study was to examine the effectiveness of high calcium skimmed milk ( Anlene Gold ™ , New Zeal and Milk , Wellington , New Zeal and ) to reduce bone loss in Chinese postmenopausal women . Two hundred subjects aged 55–65 years and who were more than 5 years postmenopausal were r and omized to a milk group and control group . The milk group consumed 50 g of high calcium skimmed milk powder daily , which contained 1200 mg calcium ( taken as two glasses of milk a day ) . The control group continued with their usual diet . Using repeated measures ANCOVA , the milk supplement was found to significantly reduce the percentage of bone loss at the total body compared to the control group at 24 months ( control −1.04 % , milk −0.13 % ; P the lumbar spine , the percentage of bone loss in the control group was significantly higher ( −0.90 % ) when compared to the milk ( −0.13 % ) supplemented group at 24 months ( P reduced the percentage of bone loss at the femoral neck ( control −1.21 % , milk 0.51 % ) ( P total hip ( control −2.17 % , milk −0.50 % ) ( P significant weight gain over the 24 months . The serum 25-hydroxy vitamin D level improved significantly ( P high calcium skimmed milk was effective in reducing the rate of bone loss at clinical ly important lumbar spine and hip sites in postmenopausal Chinese women in Malaysia . Supplementing with milk had additional benefits of improving the serum 25-hydroxy vitamin D status of the subjects",
"This prospect i ve population -based study assessed predictors of hip fracture risk in white men . Participants were members of the Epidemiologic Follow-up Study cohort of the First National Health and Nutrition Examination Survey , a nationally representative sample of noninstitutionalized civilians who were followed for a maximum of 22 years . A cohort of 2879 white men ( 2249 in the nutrition and weight-loss sub sample , 1437 in the bone density sub sample ) aged 45 - 74 years at baseline ( 1971 - 1975 ) were observed through 1992 . Ninety-four percent of the original cohort were successfully traced . Hospital records and death certificates were used to identify a total of 71 hip fracture cases ( 61 in the nutrition and weight-loss sub sample , 26 in the bone-density sub sample ) . Among the factors evaluated were age at baseline , previous fractures other than hip , body mass index , smoking status , alcohol consumption , nonrecreational physical activity , weight loss from maximum , calcium intake , number of calories , protein consumption , chronic disease prevalence , and phalangeal bone density . The risk adjusted relative risk ( RR ) of hip fracture was significantly associated with presence of one or more chronic conditions ( RR = 1.91 , 95 % confidence interval [ CI ] = 1.19 - 3.06 ) , weight loss from maximum > or = 10 % ( RR = 2.27 , 95 % CI 1.13 - 4.59 ) , and 1 SD change in phalangeal bone density ( RR = 1.73 , 95 % CI 1.11 - 2.68 ) . No other variables were significantly related to hip fracture risk . Although based on a small number of cases , this is one of the first prospect i ve studies to relate weight loss and bone density to hip fracture risk in men",
"BACKGROUND Skeletal loading and proper nutrition are necessary for optimal bone health . The appropriate amount of dietary protein to maximize skeletal health , however , is under constant debate . OBJECTIVE To determine if 6 months of protein supplementation in conjunction with a strength and conditioning training program improves areal and volumetric bone mineral density ( BMD ) . DESIGN Fifty-two apparently healthy males and females ages 18 - 25 years were r and omized to protein supplement ( PRO , Myoplex , EAS , Inc. Golden CO ) containing 280 kcal , 42 g protein , 21 g carbohydrate , and 1.5 g fat ) or calorically equivalent carbohydrate control ( CS ) . All subjects participated in a 5 sessions/week strength and conditioning program . Volumetric and areal BMD measurements were made by peripheral quantitative computed tomography ( pQCT ) of the tibia and whole body DXA . pSSI a measure of torsional bone strength , based on structural and material properties was obtained by pQCT . RESULTS Measurements at the 20 % tibia by pQCT revealed that overall there were significant increases in cortical vBMD ( 4.3 + /- 1.3 mg/cm(3 ) ) , cortical area ( 1.9 + /- 0.6 cm(2 ) ) , cortical thickness ( 0.05 + /- 0.02 mm ) and pSSI ( 67 + /- 24 mm(3 ) ) , and a decrease in endosteal circumference ( - 0.5 + /- 0.2 mm ) over the intervention period ( all , P whole body BMC among the carbohydrate compared to protein supplemented group and a greater increase among males ( 16 + /- 8 g ) compared to females ( -9 + /- 9 g ) ( P = 0.06 ) . CONCLUSIONS The results of this study indicate that the consumption of additional protein does not improve measurements of vBMD or bone size during a 6-month strength and conditioning program . Longer duration studies may be necessary to determine the influence of increased dietary protein on bone in young adults . Males and females may have different bone responses to increased protein intake while participating in a strength and conditioning program",
"Summary Association between dietary protein and fracture risk is unclear . We examined association between energy-adjusted protein intake and hip fracture risk in elders . The risk of hip fracture was reduced in upper quartiles of protein intake when compared with lowest quartile . Introduction Studies of the association between dietary protein intake and hip fracture risk are conflicting . Therefore , we examined protein intake and hip fracture risk in a population -based group of elderly men and women . Methods Five hundred seventy-six women and 370 men from the Framingham Osteoporosis Study with no previous history of hip fracture completed Food Frequency Question naires . Energy-adjusted protein intake was evaluated as a continuous variable and as quartiles . Incidence rates and hazard ratios were calculated , adjusting for age , BMI , sex , and energy intake . Results Among 946 participants ( mean age 75 years ) , mean protein intake was found to be 68 gm/d . Increased protein intake was associated with a decreased risk of hip fracture compared to those in the lowest quartile of protein intake ( Q2 HR = 0.70 , Q3 HR = 0.56 , and Q4 HR = 0.63 ; all p values ≥ 0.044 ) , p for trend was 0.07 . When a threshold effect was considered ( Q2–4 vs Q1 ) , intakes in the higher quartiles combined were associated with a significantly lower risk for hip fracture ( HR = 0.63 ; p = 0.04 ) . Conclusion Our results are consistent with reduced risk of hip fracture with higher dietary protein intake . Larger prospect i ve studies are needed to confirm and extend this finding in elderly men and women",
"The long-term effects of calcium and vitamin D supplementation on bone material and structural properties in older men are not known . The aim of this study was to examine the effects of high calcium ( 1000 mg/day)- and vitamin-D(3 ) ( 800 IU/day)-fortified milk on cortical and trabecular volumetric BMD ( vBMD ) and bone geometry at the axial and appendicular skeleton in men aged over 50 years . One hundred and eleven men who were part of a larger 2-year r and omized controlled trial had QCT scans of the mid-femur and lumbar spine ( L(1)-L(3 ) ) to assess vBMD , bone geometry and indices of bone strength [ polar moment of inertia ( I(polar ) ) ] . After 2 years , there were no significant differences between the milk supplementation and control group for the change in any mid-femur or L(1)-L(3 ) bone parameters for all men aged over 50 years . However , the mid-femur skeletal responses to the fortified milk varied according to age , with a split of 62 years being the most significant for discriminating the changes between the two groups . Subsequent analysis revealed that , in the older men ( > 62 years ) , the expansion in mid-femur medullary area was 2.8 % ( P milk supplementation compared to control group , which helped to preserve cortical area in the milk supplementation group ( between group difference 1.1 % , P mid-femur cortical vBMD and I(polar ) , the net loss was 2.3 and 2.8 % less in the milk supplementation compared to control group ( P calcium-vitamin-D(3)-fortified milk may represent an effective strategy to maintain bone strength by preventing endocortical bone loss and slowing the loss in cortical vBMD in elderly men",
"The aim of the present study was to examine whether a holistic approach combining nutrition and lifestyle counselling with the consumption of milk and yoghurt enriched with calcium , vitamin D3 and phylloquinone ( vitamin K1 ) or menaquinone ( vitamin K2 ) would have any additional benefit on bone mineral density ( BMD ) indices measured at various skeletal sites using two different techniques , dual energy X-ray absorptiometry and quantitative ultrasonography ( QUS ) . A sample of 115 postmenopausal women were r and omized to three intervention groups , receiving daily via fortified milk and yoghurt and for 12 months , 800 mg calcium and 10 μg vitamin D3 ( CaD group , n = 26 ) ; 800 mg calcium , 10 μg vitamin D3 and 100 μg vitamin K1 ( CaDK1 group , n = 26 ) ; 800 mg calcium , 10 μg vitamin D3 and 100 μg vitamin K2 ( CaDK2 group , n = 24 ) ; and a control group ( CO group , n = 39 ) following their usual diet . All three intervention groups attended biweekly nutrition and lifestyle counselling sessions . Total BMD significantly increased in all three intervention groups and these changes were significantly higher compared to the CO ( P increases observed for L2–L4 BMD in the CaDK1 and CaDK2 groups were found to be significantly higher compared to the decrease observed in the CO ( P = 0.001 ) . No significant differences were observed for QUS parameters . The combined approach used in the current study led to favourable changes for all three intervention groups in total body BMD , while an additional benefit was observed for L2–L4 BMD in CaDK1 and CaDK2 groups . No significant differences were observed among groups in any of the QUS parameters ",
"CONTEXT Protein is an essential component of muscle and bone . However , the acidic byproducts of protein metabolism may have a negative impact on the musculoskeletal system , particularly in older individuals with declining renal function . OBJECTIVE We sought to determine whether adding an alkaline salt , potassium bicarbonate ( KHCO3 ) , allows protein to have a more favorable net impact on intermediary indices of muscle and bone conservation than it does in the usual acidic environment . DESIGN We conducted a 41-d r and omized , placebo-controlled , double-blind study of KHCO3 or placebo with a 16-d phase-in and two successive 10-d metabolic diets containing low ( 0.5 g/kg ) or high ( 1.5 g/kg ) protein in r and om order with a 5-d washout between diets . SETTING The study was conducted in a metabolic research unit . PARTICIPANTS Nineteen healthy subjects ages 54 - 82 yr participated . INTERVENTION KHCO3 ( up to 90 mmol/d ) or placebo was administered for 41 d. MAIN OUTCOME MEASURES We measured 24-h urinary nitrogen excretion , IGF-I , 24-h urinary calcium excretion , and fractional calcium absorption . RESULTS KHCO3 reduced the rise in urinary nitrogen excretion that accompanied an increase in protein intake ( P = 0.015 ) and was associated with higher IGF-I levels on the low-protein diet ( P = 0.027 ) with a similar trend on the high-protein diet ( P = 0.050 ) . KHCO3 was also associated with higher fractional calcium absorption on the low-protein diet ( P = 0.041 ) with a similar trend on the high-protein diet ( P = 0.064 ) . CONCLUSIONS In older adults , KHCO3 attenuates the protein-induced rise in urinary nitrogen excretion , and this may be mediated by IGF-I. KHCO3 may also promote calcium absorption independent of the dietary protein content",
"The dietary acid load created by the typical Western diet may adversely impact the skeleton by disrupting calcium metabolism . Whether neutralizing dietary acid with alkaline potassium salts results in sustained improvements in calcium balance remains controversial . In this r and omized , double-blind , placebo-controlled study , 52 men and women ( mean age 65.2 ± 6.2 years ) were r and omly assigned to potassium citrate 60 mmol/d , 90 mmol/d , or placebo daily with measurements of bone turnover markers , net acid excretion , and calcium metabolism , including intestinal fractional calcium absorption and calcium balance , obtained at baseline and at 6 months . At 6 months , net acid excretion was significantly lower in both treatment groups compared to placebo and it was negative , meaning subjects ' dietary acid was completely neutralized ( -11.3 mmol/d on 60 mmol/d ; -29.5 mmol/d on 90 mmol/d , p months , 24-hour urine calcium was significantly reduced in persons taking potassium citrate 60 mmol/d ( -46 ± 15.9 mg/d ) and 90 mmol/d ( -59 ± 31.6 mg/d ) compared with placebo ( p was not changed by potassium citrate supplementation . Net calcium balance was significantly improved in participants taking potassium citrate 90 mmol/d compared to placebo ( 142 ± 80 mg/d on 90 mmol/d versus -80 ± 54 mg/d on placebo ; p = 0.02 ) . Calcium balance was also improved on potassium citrate 60 mmol/d , but this did not reach statistical significance ( p = 0.18 ) . Serum C-telopeptide decreased significantly in both potassium citrate groups compared to placebo ( -34.6 ± 39.1 ng/L on 90 mmol/d , p = 0.05 ; -71.6 ± 40.7 ng/L on 60 mmol/d , p = 0.02 ) whereas bone-specific alkaline phosphatase did not change . Intact parathyroid hormone was significantly decreased in the 90 mmol/d group ( p = 0.01 ) . Readily available , safe , and easily administered in an oral form , potassium citrate has the potential to improve skeletal health . Longer-term trials with definitive outcomes such as bone density and fracture are needed",
"UNLABELLED The role of protein intake in osteoporosis is unclear . In a case-control study in Utah ( n = 2501 ) , increasing level of protein intake was associated with a decreased risk of hip fracture in men and women 50 - 69 years of age but not in those 70 - 89 years of age . Protein intake may be important for optimal bone health . INTRODUCTION Protein is an important component of bone , but the role of dietary protein intake in osteoporosis and fracture risk remains controversial . MATERIAL AND METHODS The role of dietary protein intake in osteoporotic hip fracture was evaluated in a statewide case-control study in Utah . Patients , 50 - 89 years of age , with hip fracture ( cases ) were ascertained through surveillance of 18 Utah hospitals during 1997 - 2001 . Age- and gender-matched controls were r and omly selected . Participants were interviewed in their place of residence , and diet was assessed using a picture-sort food frequency question naire previously reported to give a useful measure of usual dietary intake in the elderly Utah population . The association between protein intake and risk of hip fracture was examined across quartiles of protein intake and stratified by age group for 1167 cases ( 831 women , 336 men ) and 1334 controls ( 885 women , 449 men ) . RESULTS In logistic regression analyses that controlled for gender , body mass index , smoking status , alcohol use , calcium , vitamin D , potassium , physical activity , and estrogen use in women , the odds ratios ( OR ) of hip fracture decreased across increasing quartiles of total protein intake for participants 50 - 69 years of age ( OR : 1.0 [ reference ] ; 0.51 [ 95 % CI : 0.30 - 0.87 ] ; 0.53 [ 0.31 - 0.89 ] ; 0.35 [ 0.21 - 0.59 ] ; p calcium and potassium intake did not differ appreciably from the results presented above . CONCLUSION Higher total protein intake was associated with a reduced risk of hip fracture in men and women 50 - 69 years of age but not in men and women 70 - 89 years of age . The association between dietary protein intake and risk of hip fracture may be modified by age . Our study supports the hypothesis that adequate dietary protein is important for optimal bone health in the elderly 50 - 69 years of age",
"The effects of dietary protein on bone structure and metabolism have been controversial , with evidence for and against beneficial effects . Because no long-term r and omized , controlled studies have been performed , a two-year study of protein supplementation in 219 healthy ambulant women aged 70 to 80 years was undertaken . Participants were r and omized to either a high-protein drink containing 30 g of whey protein ( n = 109 ) or a placebo drink identical in energy content , appearance , and taste containing 2.1 g of protein ( n = 110 ) . Both drinks provided 600 mg of calcium . Dual-energy X-ray absorptiometric ( DXA ) hip areal bone mineral density ( aBMD ) , 24-hour urinary calcium excretion , and serum insulin-like growth factor 1 ( IGF-1 ) were measured at baseline and at 1 and 2 years . Quantitative computed tomographic ( QCT ) hip volumetric bone mineral density ( vBMD ) and a femoral neck engineering strength analysis were undertaken at baseline and at 2 years . Baseline average protein intake was 1.1 g/kg of body weight per day . There was a significant decrease in hip DXA aBMD and QCT vBMD over 2 years with no between-group differences . Femoral neck strength was unchanged in either group over time . The 24-hour urinary calcium excretion increased significantly from baseline in both groups at 1 year but returned to baseline in the placebo group at 2 years , at which time the protein group had a marginally higher value . Compared with the placebo group , the protein group had significantly higher serum IGF-1 level at 1 and 2 years ( 7.3 % to 8.0 % , p protein-replete healthy ambulant women , 30 g of extra protein increased IGF-1 but did not have beneficial or deleterious effects on bone mass or strength . The effect of protein supplementation in population s with low dietary protein intake requires urgent attention",
"The Chinese diet is low in calcium ( less than 500 mg/day on average ) , and previous observational studies have suggested an association between a low calcium intake and risk of hip and vertebral fracture . In this study , we r and omly assigned 200 postmenopausal Chinese women ( age range , 55 - 59 years ) to receive 50 g of milk powder containing 800 mg of calcium per day or to a control group . The following are the mean percentage changes ( and SEs ) in height and bone mineral density ( BMD ) over 24 months : for height , -0.1 + /- 0.2 cm in the milk supplementation group and -0.2 + /- 0.1 cm in the control group ; for BMD at the total hip , -0.06 + /- 0.22 % in the milk supplementation group and -0.88 + /- 0.26 % in the control group ; for BMD at the spine ( L1-L4 ) , -0.56 + /- 0.29 % in the milk supplementation group and -1.5 + /- 0.29 % in the control group ; for total body BMD , -0.32 + /- 0.16 % in the milk supplementation group and -1.2 + /- 0.19 % in the control group ( p loss in terms of both height and BMD than the control group ( p Serum parathyroid hormone ( PTH ) concentration was lower and serum 25-hyroxyvitamin D [ 25(OH)D ] level was higher in the milk supplementation group than the control group at 12 months ( p diet of postmenopausal Chinese women with high calcium milk powder retards bone loss",
"Fracture of the proximal femur is the most dramatic clinical sequela of osteoporosis [ 1 , 2 ] . It is associated with a high mortality rate , need for long-term medical care , and prolonged disability [ 3 - 5 ] . Protein malnutrition is often seen in elderly persons and is more severe in patients with hip fracture [ 6 - 11 ] . Protein deficiency may contribute to the occurrence of hip fracture by reducing muscle strength , impairing movement coordination , and diminishing the protective layer of soft tissue padding [ 9 , 10 , 12 - 14 ] It may also be associated with lower bone mineral density at the proximal femur [ 15 ] . Furthermore , malnutrition in general and protein deficiency in particular at admission and during recovery may adversely influence clinical outcome after hip fracture [ 7 , 9 , 10 , 16 - 18 ] . Protein restriction has been shown to reduce plasma levels of insulin-like growth factor-I ( IGF-I ) by inducing resistance to the action of growth hormone in the liver and increasing the metabolic clearance rate of the growth factor [ 19 - 23 ] . Furthermore , evidence shows that protein depletion may blunt the effect of IGF-I on target organs [ 20 ] . Thus , low protein intake in elderly persons may be detrimental to skeletal integrity , muscle strength , and immune response [ 11 , 24 - 27 ] because of decreased production and action of IGF-I , which favorably influences these systems [ 28 - 33 ] . Previous studies [ 16 , 17 ] have shown that a 5-week course of protein supplements can reduce the medical complication rate and duration of hospital stay in patients with recent hip fracture . These findings were independent of energy , calcium , and vitamin D intake [ 17 ] . Whether these observations were related to the restoration of decreased IGF-I levels and whether bone may benefit from long-term protein supplementation are not known . We investigated whether protein supplements in vitamin D-replete patients with a recent hip fracture who were receiving calcium supplements could increase circulating IGF-I levels and favorably influence bone mineral density . Methods Patients Patients were recruited in the orthopedic ward of Geneva University Hospital , the referral center that receives 94.6 % of all patients with hip fracture from an area with a population of approximately 400 000 persons [ 5 ] . The protocol was approved by the ethical committee of the Geneva University Hospital Department of Surgery . Inclusion criteria were age greater than 60 years ; recent hip fracture ( within 2 weeks ) attributable to osteoporosis ( that is , a fracture after a minor trauma , such as a fall from st and ing height ) ; and the ability to give written , informed consent . Exclusion criteria were pathologic fracture ; fracture caused by severe trauma ; history of contralateral hip fracture ; severe mental impairment ; active metabolic bone disease ; renal failure ( plasma creatinine concentration 200 mol/L ) ; acute illness that could interfere with the study protocol ; severe malnutrition ( serum albumin level Using a r and om number table , we assigned patients to receive an oral protein supplement composed of 90 % milk proteins or a placebo made isocaloric by the addition of maltodextrins . Patients took the assigned intervention 5 days a week for 6 months in addition to their regular diet . All patients received one oral dose of vitamin D3 , 200 000 IU ( vitamine D3B.O.N. , Doms-Adrian , Courbevoie , France ) , to correct any possible vitamin D deficiency [ 34 ] . The daily protein supplement ( Meritene , S and oz Nutrition Ltd. , Berne , Switzerl and ) provided 1050 kJ ( 250 kcal ) of energy in the form of 20 g of proteins , 3.1 g of lipids , and 35.7 g of carbohydrates ( 54.4 g in placebo ) . The other constituents of the 65 g powder supplement were vitamin A ( 1000 IU ) , vitamin K1 ( 30 g ) , vitamin C ( 20 mg ) , calcium ( 550 mg ) , magnesium ( 91 mg ) , phosphorus ( 429 mg ) , and sodium ( 228 mg ) . The supplement is design ed to normalize but not overcompensate for the insufficient dietary intake of protein of elderly persons with a recent fracture of the proximal femur [ 16 ] . Compliance was verified by weekly phone calls and by counting the remaining nutritional supplement bags , which were forwarded monthly by mail . Clinical Data Medical history , clinical characteristics , anthropometric data , and performance status according to an Activities of Daily Living score [ 35 ] were evaluated . Dietary intakes were recorded by using a food-frequency question naire [ 36 ] about the week before the fracture . Food intakes were analyzed by using a nutrient software system ( Fruitdor , Astra-Calve , Paris , France ) . Dietary intake of calcium , phosphorus , and protein was calculated from intake of dairy products , meat , fish , and vegetables . Because many patients were unable to st and a few days after hip fracture , their height was determined with a fathom measure while they were recumbent . Body weight was determined with a scale that correlated highly with that provided by measurement of whole body bone , fat , and lean mass as assessed by dual x-ray absorptiometry [ 37 ] . Mid-arm circumference was measured with a tape measure ( coefficient of variation , 2 % ) . Isometric muscle strength of the biceps of the dominant arm was evaluated with a dynamometer ( Lido , Lidoactive Isokinetic System , Loredan Biomedical Inc. , West Sacramento , California ) , which measures the peak torque ( coefficient of variation dynamometer ( Vigorimeter , Martin Medizin-Technik , Tuttlingen , Germany ) [ 38 ] . The mean of three measurements was used for calculation . Biochemical Data Within 120 hours after surgery , we used st and ard methods to analyze venous blood sample s for protein-corrected plasma levels of calcium , phosphate , creatinine , total proteins , albumin , and prealbumin . We also measured levels of IGF-I ( Nichols Institute , San Juan Capistrano , California ) after acid-ethanol extraction and cryoprecipitation [ 39 ] , intact parathyroid hormone ( Immulite , Diagnostic Products , Los Angeles , California ) , calcitriol , calcidiol ( Incstar , Stillwater , Minnesota ) , and osteocalcin ( CIS-BIO International , Gif-sur-Yvette , France ) . Biochemical measurements were repeated 6 and 12 months after the fracture . Serum IGF-I binding proteins were measured by Western lig and blot analysis [ 40 ] . Briefly , 3 L of serum was boiled and separated onto 15 % sodium dodecylsulfate polyacrilamide gel electrophoresis under nonreducing conditions . Proteins were electrically blotted onto a nitrocellulose membrane , and IGF-I binding proteins were detected after incubating the membranes with radioiodinated IGF-I at 4C for 24 hours . Insulin-like growth factor binding proteins were quantified by phosphorimaging ( Molecular Dynamics , Sunnyvale , California ) . The intensity of the b and s corresponding to the appropriate molecular weights [ 40 ] was expressed as the percentage of total bound radioactive IGF-I. Measurements of calcium , phosphate , and creatinine were obtained from the second fasting morning urine . The ratio of hydroxyproline to creatinine in the same sample was taken as a reflection of bone resorption . Markers of bone resorption ( pyridinoline and deoxypyridinoline ) in the first morning spot urine were measured by detecting fluorescence emission after acid hydrolysis and separation with isocratic reverse-phase high-performance liquid chromatography ( BioRad System , Munich , Germany ) , and the values were adjusted to the creatinine concentration . Immunologic Data Concentrations of IgA , IgG , IgM , and isohemagglutinins were measured by using st and ard methods . Cell-mediated immunity was assessed by using a skin-test antigens for cellular hypersensitivity system ( STACH , Institut Merieux , Lyon , France ) , which evaluates the size of the skin reaction to various antigens injected intradermally [ 41 ] . Bone Mass Assessment We measured areal bone mineral density at the lumbar spine ( anteroposterior and lateral views ) , the contralateral proximal femur ( femoral neck and trochanter ) , and the contralateral mid-femoral shaft . We also measured whole-body bone mineral content , fat , and lean mass by using dual x-ray absorptiometry ( Hologic QDR-2000 , Waltham , Massachusetts ) . The coefficients of variation of these measurements are reported elsewhere [ 37 , 42 ] . Vertebral Deformity Two series of lateral radiography of the thoracic and lumbar spine were taken at the start of the study and at 12 months . The films were examined by a single investigator ( who was unaware of treatment group assignment ) according to a 6-point analysis procedure for each vertebral body from T4 to L4 [ 43 , 44 ] ( intra-observer coefficient of variation , 1.8 % to 3.1 % ) . At baseline , fracture was defined by a decrease of 20 % in the ratio of anterior or middle height to posterior height . Patients were considered to have a new vertebral deformity if the anterior , middle , or posterior height decreased by more than 20 % between the two examinations . Statistical Analysis All values are given as the mean SD for baseline measurement and the mean SE for comparisons of outcome results . All analyses were performed by using the SAS procedure ( Cary , North Carolina ) . One-way analysis of variance was used . A two-tailed P value less than 0.05 was considered significant . Role of the Funding Sources This study was supported by grants from S and oz Nutrition Ltd. , Berne , Switzerl and , and the Swiss National Research Science Foundation . The skin-test antigens for cellular hypersensitivity system was supplied by Rhone-Poulenc , Thalwil , Switzerl and . No organization influenced the design , conduct , or reporting of the study . Results Of 842 patients evaluated from April 1992 to February 1994 , 82 were recruited into the r and omized , double-blind , placebo-controlled trial . This low enrollment rate was due to patients ' poor medical or cognitive conditions and reluctance to give informed consent .",
"BACKGROUND Milk is potentially beneficial for bone health , particularly for Chinese population s where consumption of dairy products is low . There are few data about milk consumption by Chinese women aged 20 - 35 years . This study examines whether milk supplement over 2 years caused increased bone mineral density ( BMD ) in Chinese women aged 20 - 35 years . METHODS Four hundred forty-one community-living women living in Hong Kong SAR ( 221 ) and Beijing ( 220 ) China were r and omized to receive milk supplement or nothing . The supplement consisted of two sachets of milk powder ( 1000 mg calcium , 80 microg vitamin K(1 ) ) , for 24 months . BMD at total hip , total spine , and whole body was measured at baseline and at 6 , 12 , 18 , and 24 months ; blood specimens were analyzed at baseline and at 3 and 24 months for biochemical indices of bone turnover and vitamin K. Urine sample s also were collected . Analysis was by intention to treat as well as per protocol . Differences in change from baseline between the milk and control groups were analyzed using the mixed models approach to repeated measures , including the baseline value as a covariate . RESULTS Both groups had an increase in BMD and a decrease in bone turnover markers over time , as an indicator of the process of attainment of peak bone mass during this period . Apart from a higher total spine BMD at 6 months in the milk group using per protocol analysis , there was little significant difference observed between the milk group and the control group . CONCLUSIONS Age-related bone metabolism and lack of compliance most likely explain the lack of consistent changes in BMD or bone biochemical measures in response to milk supplementation for 2 years in Chinese women aged 20 - 35 years",
"This study investigated three aspects of general nutritional status ( dietary intake , biochemical markers , and anthropometric measurements ) in relation to subsequent hip fracture risk by using prospect i ve data from the First National Health and Nutrition Examination Survey ( NHANES I ) epidemiologic follow-up studies . A cohort of 2,513 white women 45 years and over who participated in the NHANES I survey in 1971 - 1975 were subsequently followed in the three follow-up studies in 1982 - 1984 , 1986 , and 1987 , respectively . Multiple nutritional variables were measured at baseline , and 130 incident hip fractures were identified by hospital records or by death certificates during the follow-up period . Cox regression analyses showed that baseline dietary energy intake ; serum albumin ; and weight , body mass index , skinfold , and arm muscle area were significantly and inversely related to subsequent hip fracture risk ( relative risks for a 1-st and ard deviation increment in these variables ranged from 0.68 to 0.83 ) . The authors suggest that poor nutritional status , evident in inadequate dietary intake , reduced serum albumin , and decreased body mass and soft tissues , increases the risk for subsequent hip fracture . The study also showed that age and previous fracture history were significant risk factors ; however , self-reported physical activity , parity , and alcohol use were not significantly related to subsequent hip fracture",
"Previously published results from a 2 year r and omized , controlled clinical trial on supplementing the diet of postmenopausal Chinese women with high-calcium milk powder ( containing 800 mg of calcium ) showed that bone loss , as measured by bone mineral density ( BMD ) , was prevented . To determine whether the effect of calcium supplementation could be sustained , the study was extended for 1 additional year . According to the intention-to-treat analysis , the differences in the rate of bone loss ( percentage decrease in control group -- percentage decrease in milk supplementation group ) in the third year of the study were : total body BMD , 0.23 % ( 95 % confidence interval [ CI ] 0.07%-0.39 % ) ; total spine BMD , 0.31 % ( 95 % CI - 0.02%-0.65 % ) ; and total hip BMD , 0.44 % ( 95 % CI 0.19%-0.69 % ) . Analysis by the per- protocol method showed a similar effect size . These results indicate that the effects of milk supplementation in preventing bone loss in postmenopausal Chinese women were sustained after 2 years",
"Almost 30 % of hip fractures occur in men ; the mortality , morbidity , and loss of independence after hip fractures are greater in men than in women . To comprehensively evaluate risk factors for hip fracture in older men , we performed a prospect i ve study of 5994 men , primarily white , age 65 + years recruited at six US clinical centers . During a mean of 8.6 years of 97 % complete follow-up , 178 men experienced incident hip fractures . Information on risk factors including femoral neck bone mineral density ( FNBMD ) was obtained at the baseline visit . Cox proportional hazards models were used to calculate the hazard ratio ( HR ) with 95 % confidence intervals ; Fine and Gray models adjusted for competing mortality risk . Older age ( ≥75 years ) , low FNBMD , currently smoking , greater height and height loss since age 25 years , history of fracture , use of tricyclic antidepressants , history of myocardial infa rct ion or angina , hyperthyroidism or Parkinson 's disease , lower protein intake , and lower executive function were all associated with an increased hip fracture risk . Further adjustment for competing mortality attenuated HR for smoking , hyperthyroidism , and Parkinson 's disease . The incidence rate of hip fracture per 1000 person-years ( PY ) was greatest in men with FNBMD T-scores experienced hip fracture at rates of 14.52 versus 0.88 per 1000 PY in men age Older men with low FNBMD , multiple risk factors , and multimorbidity have a high risk of hip fracture . Many of these assessment s can easily be incorporated into routine clinical practice and may lead to improved risk stratification . © 2016 American Society for Bone and Mineral Research",
"We studied the effects of daily intake of milk basic protein ( MBP ) on radial bone mineral density ( BMD ) in healthy adult women . Thirty-three healthy women were r and omly assigned to a 6-month trial with either placebo or MBP ( 40 mg per day ) . The radial BMD of each volunteer was measured at the beginning of and at six months after the trial . The mean BMD value at the 6th month in the MBP group increased significantly at both 1/6 and 1/10 portion from the distal end of the radius , whereas that in the control group did not . The BMD gain of each volunteer in the MBP group was significantly higher than that in the placebo group . Thus a daily MBP supplementation of 40 mg in healthy adult women can significantly increase radial BMD",
"The acid load accompanying modern diets may have adverse effects on bone and muscle metabolism . Treatment with alkaline salts of potassium can neutralize the acid load , but the optimal amount of alkali is not established . Our objective was to determine the effectiveness of two doses of potassium bicarbonate ( KHCO3 ) compared with placebo on biochemical markers of bone turnover , and calcium and nitrogen ( N ) excretion . In this double-blind , r and omized , placebo-controlled study , 244 men and women age 50 years and older were r and omized to placebo or 1 mmol/kg or 1.5 mmol/kg of KHCO3 daily for 3 months ; 233 completed the study . The primary outcomes were changes in 24-hour urinary N-telopeptide ( NTX ) and N ; changes in these measures were compared across the treatment groups . Exploratory outcomes included 24-hour urinary calcium excretion , serum amino-terminal propeptide of type I procollagen ( P1NP ) , and muscle strength and function assessment s. The median administered doses in the low-dose and high-dose groups were 81 mmol/day and 122 mmol/day , respectively . When compared with placebo , urinary NTX declined significantly in the low-dose group ( p = 0.012 , after adjustment for baseline NTX , gender , and change in urine creatinine ) and serum P1NP declined significantly in the low-dose group ( p = 0.004 , adjusted for baseline P1NP and gender ) . Urinary calcium declined significantly in both KHCO3 groups versus placebo ( p KHCO3 on urinary N excretion or on the physical strength and function measures . KHCO3 has favorable effects on bone turnover and calcium excretion and the lower dose appears to be the more effective dose . Long-term trials to assess the effect of alkali on bone mass and fracture risk are needed",
"BACKGROUND Controversy exists concerning the effects of higher total protein intake ( TPro ) on bone health , which may be associated with reduced bone mineral density ( BMD ) . However , whey protein ( WP ) may induce bone formation because of its basic component , milk basic protein . OBJECTIVE This study assessed the effects of WP supplementation , TPro , and change in TPro ( postsupplementation - presupplementation ) on BMD and bone mineral content ( BMC ; total body , lumbar spine , total femur , and femoral neck ) in overweight and class I obese middle-aged adults following an exercise intervention . METHODS This analysis used data from a double-blind , r and omized , placebo-controlled 36-wk WP supplementation trial , wherein participants consumed a 1.7-MJ ( 400-kcal ) supplement ( 0 , 20 , 40 , or 60 g WP/d ) along with their otherwise unrestricted diet while participating in a resistance and aerobic exercise intervention ( 3 d/wk ) . TPro was the summation of WP and habitual dietary intakes ( 4-d food record ) . Statistical analyses for WP were based on group and bone data [ n = 186 , 108 women ; mean ± SD age : 49 ± 8 y ; body mass index ( BMI ; in kg/m2 ) : 30.1 ± 2.8 ] , whereas TPro was based on dietary and bone data ( n = 113 , 70 women ; age 50 ± 8 y ; BMI 30.1 ± 2.9 ) . RESULTS WP supplementation , regardless of dose , did not influence BMD or BMC following the intervention . By using a multiple linear regression model , TPro ( expressed as g/d or g · kg-1 · d-1 ) and change in TPro ( expressed as g/d ) were not associated with responses over time in total or regional BMD or BMC . By using a cluster analysis approach [ with responses in total or regional BMD or BMC over time . CONCLUSION WP supplementation and total dietary protein intake did not negatively or beneficially influence bone quantity in overweight and obese adults during a 9-mo exercise intervention . This trial was registered at clinical trials.gov as NCT00812409",
"BACKGROUND A previous study on a r and omized controlled trial in 173 postmenopausal Chinese women in Kuala Lumpur showed that milk supplementation was effective to reduce bone loss at the total body , lumbar spine , femoral neck and total hip compared to the control group on a usual diet ( Chee et al. 2003 ) . OBJECTIVE The objective was to determine whether the results were sustained after the conclusion of the study . DESIGN A follow-up study , 18 months after a r and omized controlled trial of milk supplementation was concluded . A total of 139 participants were followed up 21 months after the study ended . Bone mineral density ( BMD ) was measured at the total body , lumbar spine , femoral neck and total hip by dual energy X-ray absorptiometry , and anthropometric measurements as well as changes in dietary habits were measured . RESULTS At the follow-up , the milk supplement group did not show significant bone loss from baseline at most sites ( mean differences + /- SE ) ( total body 0.42 + /- 0.25 % , femoral neck 0.44 + /- 0.58 % , total hip -0.06 + /- 0.46 % ) , unlike the control group ( total body -1.07 + /- 0.28 % p bone loss from baseline at the lumbar spine ( milk -2.01 % , control -3.29 % , p superior 0.05 ) . The calcium intake of the milk group remained significantly higher than the control group ( milk 710 mg/day , control 466 mg/day , p milk supplement . CONCLUSIONS The results showed that some of the beneficial effects of a milk supplement were still evident at follow-up and it was possible to motivate subjects to adopt a positive change in dietary calcium intake after intervention",
"Weight reduction induces bone loss by several factors , and the effect of higher protein ( HP ) intake during caloric restriction on bone mineral density ( BMD ) is not known . Previous study design s examining the longer-term effects of HP diets have not controlled for total calcium intake between groups and have not examined the relationship between bone and endocrine changes . In this r and omized , controlled study , we examined how BMD ( areal and volumetric ) , turnover markers , and hormones [ insulin-like growth factor 1 ( IGF-1 ) , IGF-binding protein 3 ( IGFBP-3 ) , 25-hydroxyvitamin D , parathyroid hormone ( PTH ) , and estradiol ] respond to caloric restriction during a 1-year trial using two levels of protein intake . Forty-seven postmenopausal women ( 58.0 ± 4.4 years ; body mass index of 32.1 ± 4.6 kg/m(2 ) ) completed the 1-year weight-loss trial and were on a higher ( HP , 24 % , n = 26 ) or normal protein ( NP , 18 % , n = 21 ) and fat intake ( 28 % ) with controlled calcium intake of 1.2 g/d . After 1 year , subjects lost 7.0 % ± 4.5 % of body weight , and protein intake was 86 and 60 g/d in the HP and NP groups , respectively . HP compared with NP diet attenuated loss of BMD at the ultradistal radius , lumbar spine , and total hip and trabecular volumetric BMD and bone mineral content of the tibia . This is consistent with the higher final values of IGF-1 and IGFBP-3 and lower bone-resorption marker ( deoxypyridinoline ) in the HP group than in the NP group ( p higher dietary protein during weight reduction increases serum IGF-1 and attenuates total and trabecular bone loss at certain sites in postmenopausal women",
"CONTEXT The acid load imposed by a modern diet may play an important role in the pathophysiology of osteoporosis . OBJECTIVE Our objective was to evaluate the skeletal efficacy and safety and the effect on fracture prediction of K-citrate to neutralize diet-induced acid loads . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled trial at a teaching hospital . SUBJECTS Subjects included 201 elderly ( > 65 yr old ) healthy men and women ( t-score of -0.6 at lumbar spine ) . INTERVENTION Intervention was 60 mEq of K-citrate daily or placebo by mouth . All subjects received calcium and vitamin D. OUTCOME MEASURES The primary outcome was change in areal bone mineral density ( aBMD ) at the lumbar spine by dual-energy x-ray absorptiometry after 24 months . Secondary endpoints included changes in volumetric density and microarchitectural parameters by high-resolution peripheral quantitative computed tomography in both radii and both tibiae and fracture risk assessment by FRAX ( Switzerl and ) . RESULTS K-citrate increased aBMD at lumbar spine from baseline by 1.7 ± 1.5 % [ 95 % confidence interval ( CI ) = 1.0 - 2.3 , P High-resolution peripheral quantitative computed tomography-measured trabecular densities increased at nondominant tibia ( 1.3 ± 1.3 % , CI = 0.7 - 1.9 , P trabecular bone volume/tissue volume increased by 0.9 ± 0.8 % , ( CI = 0.1 - 1.7 ) , trabecular thickness by 1.5 ± 1.6 % ( CI = 0.7 - 2.3 ) , and trabecular number by 1.9 ± 1.8 % ( CI = 0.7 - 3.1 , for all , P 0.05 ) . K-citrate diminished fracture prediction score by FRAX significantly in both sexes . CONCLUSIONS Among a group of healthy elderly persons without osteoporosis , treatment with K-citrate for 24 months result ed in a significant increase in aBMD and volumetric BMD at several sites tested , while also improving bone microarchitecture . Based on the effect on fracture prediction , an effect on future fractures by K-citrate is possible"
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Background / Objectives We performed this systematic review and meta- analysis to evaluate effects of probiotics on inflammation , uremic toxins , and gastrointestinal ( GI ) symptoms in end-stage renal disease ( ESRD ) patients . Methods A literature search was conducted utilizing MEDLINE , EMBASE , and Cochrane Data base from inception through October 2017 . We included studies that assessed assessing effects of probiotics on inflammatory markers , protein-bound uremic toxins ( PBUTs ) , and GI symptoms in ESRD patients on dialysis . Effect estimates from the individual study were extracted and combined utilizing r and om effect , generic inverse variance method of DerSimonian and Laird . The protocol for this meta- analysis is registered with PROSPERO ; No. CRD42017082137 . Results Seven clinical trials with 178 ESRD patients were enrolled . There was a significant reduction in serum C-reactive protein ( CRP ) from baseline to post-probiotic course ( ≥ 2 months after treatment ) with st and ardized mean difference ( SMD ) of − 0.42 ( 95 % CI − 0.68 to − 0.16 , p = 0.002 ) . When compared to control , patients who received probiotics also had a significant higher degree of reduction in CRP level with SMDs of − 0.37 ( 95 % CI − 0.72 to 0.03 , p = 0.04 ) . However , there were no significant changes in serum TNF-alpha or albumin with SMDs of − 0.32 ( 95 % CI − 0.92 to 0.28 , p = 0.29 ) and 0.16 ( 95 % CI − 0.20 to 0.53 , p = 0.39 ) , respectively . After probiotic course , there were also significant decrease in PBUTs and improvement in overall GI symptoms ( reduction in GI symptom scores ) with SMDs of − 0.61 ( 95 % CI − 1.16 to − 0.07 , p = 0.03 ) and − 1.04 ( 95 % CI − 1.70 to − 0.38 , p = 0.002 ) , respectively . Conclusion Our study demonstrates potential beneficial effects of probiotics on inflammation , uremic toxins , and GI Symptoms in ESRD patients . Future large-scale clinical studies are required to assess its benefits on other important clinical outcomes including patient mortality
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"BACKGROUND AND OBJECTIVES The generation of key uremic nephrovascular toxins , indoxyl sulfate ( IS ) , and p-cresyl sulfate ( PCS ) , is attributed to the dysbiotic gut microbiota in CKD . The aim of our study was to evaluate whether synbiotic ( pre- and probiotic ) therapy alters the gut microbiota and reduces serum concentrations of microbiome-generated uremic toxins , IS and PCS , in patients with CKD . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Predialysis adult participants with CKD ( eGFR=10 - 30 ml/min per 1.73 m(2 ) ) were recruited between January 5 , 2013 and November 12 , 2013 to a r and omized , double-blind , placebo-controlled , crossover trial of synbiotic therapy over 6 weeks ( 4-week washout ) . The primary outcome was serum IS . Secondary outcomes included serum PCS , stool microbiota profile , eGFR , proteinuria-albuminuria , urinary kidney injury molecule-1 , serum inflammatory biomarkers ( IL-1β , IL-6 , IL-10 , and TNF-α ) , serum oxidative stress biomarkers ( F2-isoprostanes and glutathione peroxidase ) , serum LPS , patient-reported health , Gastrointestinal Symptom Score , and dietary intake . A prespecified subgroup analysis explored the effect of antibiotic use on treatment effect . RESULTS Of 37 individuals r and omized ( age = 69±10 years old ; 57 % men ; eGFR=24±8 ml/min per 1.73 m(2 ) ) , 31 completed the study . Synbiotic therapy did not significantly reduce serum IS ( -2 μmol/L ; 95 % confidence interval [ 95 % CI ] , -5 to 1 μmol/L ) but did significantly reduce serum PCS ( -14 μmol/L ; 95 % CI , -27 to -2 μmol/L ) . Decreases in both PCS and IS concentrations were more pronounced in patients who did not receive antibiotics during the study ( n=21 ; serum PCS , -25 μmol/L ; 95 % CI , -38 to -12 μmol/L ; serum IS , -5 μmol/L ; 95 % CI , -8 to -1 μmol/L ) . Synbiotics also altered the stool microbiome , particularly with enrichment of Bifidobacterium and depletion of Ruminococcaceae . Except for an increase in albuminuria of 38 mg/24 h ( P=0.03 ) in the synbiotic arm , no changes were observed in the other secondary outcomes . CONCLUSION In patients with CKD , synbiotics did not significantly reduce serum IS but did decrease serum PCS and favorably modified the stool microbiome . Large-scale clinical trials are justified",
"Gastrointestinal ( GI ) symptoms and irritable bowel ( IB ) symptoms have been associated with chronic fatigue syndrome/myalgic encephalomyelitis ( CFS/ME ) . The aim of this study was to conduct a systematic review of these symptoms in CFS/ME , along with any evidence for probiotics as treatment . Pubmed , Scopus , Medline ( EBSCOHost ) and EMBASE data bases were search ed to source relevant studies for CFS/ME . The review included any studies examining GI symptoms , irritable bowel syndrome ( IBS ) and /or probiotic use . Studies were required to report criteria for CFS/ME and study design , intervention and outcome measures . Quality assessment was also completed to summarise the level of evidence available . A total of 3381 publications were returned using our search terms . Twenty-five studies were included in the review . R and omised control trials were the predominant study type ( n = 24 ) . Most of the studies identified examined the effect of probiotic supplementation on the improvement of IB symptoms in IBS patients , or IB symptoms in CFS/ME patients , as well as some other significant secondary outcomes ( e.g. quality of life , other gastrointestinal symptoms , psychological symptoms ) . The level of evidence identified for the use of probiotics in IBS was excellent in quality ; however , the evidence available for the use of probiotic interventions in CFS/ME was poor and limited . There is currently insufficient evidence for the use of probiotics in CFS/ME patients , despite probiotic interventions being useful in IBS . The studies pertaining to probiotic interventions in CFS/ME patients were limited and of poor quality overall . St and ardisation of protocol s and methodology in these studies is required",
"Components present in the diet , l-carnitine , choline , and betaine are metabolized by gut microbiota to produce metabolites such as trimethylamine-N-oxide ( TMAO ) that appear to promote cardiovascular disease in chronic kidney disease ( CKD ) patients . The objective of this pilot study was to evaluate the effects of probiotic supplementation for 3 months on plasma TMAO levels in CKD patients on hemodialysis ( HD ) . A r and omized , double-blind trial was performed in 21 patients [ 54.8 ± 10.4 years , nine men , BMI 26.1 ± 4.8 kg/m2 , dialysis vintage 68.5 ( 34.2–120.7 ) months ] . Ten patients were r and omly allocated to the placebo group and 11 to the probiotic group [ three capsules , totaling 9 × 1013 colony-forming units per day of Streptococcus thermophilus ( KB19 ) , Lactobacillus acidophilus ( KB27 ) , and Bifidobacteria longum ( KB31 ) . Plasma TMAO , choline , and betaine levels were measured by LC-MS/MS at baseline and after 3 months . While TMAO did not change after probiotic supplementation , there was a significant increase in betaine plasma levels . In contrast , the placebo group showed a significant decrease in plasma choline levels . Short-term probiotic supplementation does not appear to influence plasma TMAO levels in HD patients . Long-term studies are needed to determine whether probiotics may affect TMAO production in CKD patients",
"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",
"The present study was to test the hypothesis that selected bacteria instilled into the gastrointestinal tract could help in converting nitrogenous wastes accumulated due to renal insufficiency into nontoxic compounds ; thereby , ameliorating the biochemical imbalance . Herein we describe a prospect i ve , blinded , placebo-controlled pilot study , using 5/6th nephrectomized Sprague Dawley rat as a chronic renal failure model . The study group consisted of 36 nephrectomized and 7 non-nephrectomized ( control ) rats . After two-week nephrectomy stabilization , cohorts of six nephrectomized rats were fed casein-based diet plus one of the following regimens : ( A ) Control , ( B ) Placebo ( casein-based diet without probiotics ) , ( C ) Bacillus pasteurii , ( D ) Sporolac ® , ( E ) Kibow cocktail , ( F ) CHR Hansen Cocktail , and ( G ) ECONORMTM . Subsequently , blood ( retro-orbital ) and urine ( collected for measurements of blood urea-nitrogen and creatinine respectively ) , body weight and bacterial counts ( feces ) were obtained at regular intervals . The study end-points were to determine if any of the probiotic dietary supplements facilitated , ( 1 ) decreased blood concentrations of uremic toxins , ( 2 ) altered renal function , and ( 3 ) prolonged survival . After 16 weeks of treatment , regimens C and D significantly prolonged the life span of uremic rats , in addition to showing a reduction in blood urea-nitrogen levels , concluding that supplementation of probiotic formulation to uremic rats slows the progression of azotemia , which may correlate with prolonged life span of uremic rats . Derivative trials of probiotic treatment of larger animals and humans will further assess the potential role of probiotic formulations in delaying the onset and clinical severity of clinical illness at different stages of renal failure",
"BACKGROUND AND AIMS In patients with chronic kidney disease ( CKD ) , alterations in gut microbiome are posited to be responsible for gastrointestinal symptoms and generation of p-cresol , a uremic toxin that has been associated with CKD progression and cardiovascular mortality . This pilot study investigated whether Probinul-neutro ® , a synbiotic that normalizes intestinal microflora , may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in non-dialyzed CKD patients . METHODS AND RESULTS This was a double-blind , r and omized placebo-controlled trial . Thirty patients on 3 - 4 CKD stages were r and omized to receive either Probinul neutro ® or placebo for 4 weeks . Total plasma p-cresol concentration was assessed at baseline , and 15 and 30 days after treatment start . At the same study times , ease and frequency of defecation , upper and lower abdominal pain , stool shape , borborygmi , and flatus were quantified by subjective assessment question naires . Compared to baseline total plasma p-cresol median concentrations on 15th and 30th day were significantly lower in patients receiving Probinul-neutro ® ( 2.31 and 0.78 vs. 3.05 μg/ml , p of plasma p-cresol concentrations were recorded in placebo-treated patients . No significant changes in gastrointestinal symptoms were observed during the study both in Probinul-neutro ® -treated and placebo-treated patients . CONCLUSION Probinul-neutro ® lowered total plasma p-cresol concentrations but did not ameliorate gastrointestinal symptoms in non-dialyzed CKD patients . Because high plasma concentrations of p-cresol in early phases of CKD are predictive of progression to end-stage renal disease , the results of our study suggest that synbiotics deserve attention as possible tools to delay CKD progression towards end-stage renal disease ( ESRD ) . CLINICAL TRIALSGOV IDENTIFIER NCT02008331",
"OBJECTIVE The study aim ed to assess the effect of a symbiotic gel on presence and severity of gastrointestinal symptoms ( GIS ) in hemodialysis patients . DESIGN A double-blinded , placebo-controlled , r and omized , clinical trial was design ed . The study was conducted at 2 public hospitals in Guadalajara , Mexico . SUBJECTS AND INTERVENTION Twenty-two patients were r and omized to the intervention group ( nutritional counseling + symbiotic gel ) and 20 patients were r and omized to the control group ( nutritional counseling + placebo ) , during 2 months of follow-up . MAIN OUTCOME MEASURE Presence and monthly episodes of GIS were assessed by direct interview and severity by using the self-administered GIS question naire . Additionally , biochemical parameters , inflammatory markers , and nutritional status ( dietary intake , subjective global assessment , anthropometry , and body composition ) were evaluated . RESULTS After a 2-month treatment , intervention group had a significant reduction in prevalence and monthly episodes of vomit , heartburn , and stomachache , as well as a significant decrease in GIS severity compared with control group . Moreover , intervention group had a greater yet not significant decrease in the prevalence of malnutrition and a trend to reduce their C-reactive protein and tumor necrosis factor α levels compared with control group . No symbiotic-related adverse side effects were shown in these patients . Clinical studies with longer follow-up and sample size are needed to confirm these results . CONCLUSIONS We concluded that administration of a symbiotic gel is a safe and simple way to improve common GIS in dialysis patients",
"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",
"Background Emerging evidence suggests modulating the microbiota in the large bowel of patients with chronic kidney disease ( CKD ) through pre- and /probiotic supplementation may inhibit the development of key nephrovascular toxins . To date , quality intervention trials investigating this novel treatment in CKD are lacking . The aim of SYNERGY is to assess the effectiveness of synbiotics ( co-administration of pre- and probiotics ) as a potential treatment targeting the synthesis of uremic toxins , specifically , indoxyl sulphate ( IS ) and p-cresyl sulphate ( PCS ) . Methods / design Thirty-seven patients with moderate to severe CKD ( Stage IV and V , pre-dialysis ) will be recruited to a double-blind , placebo-controlled , r and omised cross-over trial . Patients will be provided with synbiotic therapy or placebo for 6 weeks , with a 4 week washout before cross-over . The primary outcome is serum IS , total and free ( unbound ) concentrations , measured using ultra-performance liquid chromatography . Secondary outcomes include serum PCS , total and free ( unbound ) concentrations ; cardiovascular risk , measured by serum lipopolysaccharides , serum trimethylamine-N-oxide ( TMAO ) and inflammation and oxidative stress markers ; kidney damage , measured by 24 hour proteinuria and albuminuria , estimated glomerular filtration rate and renal tubule damage ( urinary kidney injury molecule-1 ) ; patients ’ self assessed quality of life ; and gastrointestinal symptoms . In addition , the effects on the community structure of the stool microbiota will be explored in a subset of patients to vali date the mechanistic rationale underpinning the synbiotic therapy . Discussion IS and PCS are two novel uremic toxins implicated in both cardiovascular disease ( CVD ) and progression of CKD . Preliminary studies indicate that synbiotic therapy maybe a promising strategy when considering a targeted , tolerable and cost-efficient therapy for lowering serum IS and PCS concentrations . This trial will provide high quality ‘ proof-of-concept ’ data to eluci date both the efficacy of synbiotic therapy for lowering the toxins and whether reductions in serum IS and PCS translate into clinical benefits . Considering the potential of pre- and probiotics to not only shift toxin levels , but to also impede CVD and CKD progression , SYNERGY will provide vital insight into the effectiveness of this innocuous nutritional therapy . Trial Registration Universal Trial Number : U1111 - 1142 - 4363 . Australian New Zeal and Clinical Trials Registry Number : ACTRN12613000493741 , date registered : 2nd May 2013",
"BACKGROUND Patients with inflammatory bowel disease have a 10- to 100-fold increased risk of nephrolithiasis , with enteric hyperoxaluria being the major risk factor for these and other patients with fat malabsorptive states . Endogenous components of the intestinal microflora can potentially limit dietary oxalate absorption . METHODS Ten patients were studied with chronic fat malabsorption , calcium oxalate stones , and hyperoxaluria thought to be caused by jejunoileal bypass ( 1 ) and Roux-en-Y gastric bypass surgery for obesity ( 4 ) , dumping syndrome secondary to gastrectomy ( 2 ) , celiac sprue ( 1 ) , chronic pancreatitis ( 1 ) , and ulcerative colitis in remission ( 1 ) . For 3 months , patients received increasing doses of a lactic acid bacteria mixture ( Oxadrop ) , VSL Pharmaceuticals ) , followed by a washout month . Twenty-four-hour urine collection s were performed at baseline and after each month . RESULTS Mean urinary oxalate excretion fell by 19 % after 1 month ( 1 dose per day , P oxalate excretion remained reduced by 24 % during the second month ( 2 doses per day , P oxalate excretion increased slightly , so that the mean was close to the baseline established off treatment . Urinary oxalate again fell 20 % from baseline during the washout period . Calcium oxalate supersaturation was reduced while on Oxadrop , largely due to the decrease in oxalate excretion , although mean changes did not reach statistical significance . CONCLUSION Manipulation of gastrointestinal ( GI ) flora can influence urinary oxalate excretion to reduce urinary supersaturation levels . These changes could have a salutary effect on stone formation rates . Further studies will be needed to establish the optimal dosing regimen",
"INTRODUCTION Chronic kidney disease ( CKD ) is a progressive and irreversible impairment of kidney function ; if it progresses to the end-stage of CKD , dialysis or kidney transplant is needed . In general , there are no definitive treatment to slow the progression of CKD . This study aim ed to determine the effect of synbiotic supplementations on azotemia in patients with CKD . MATERIAL S AND METHODS A r and omized controlled trial was conducted on 66 patients with CKD ( stages 3 and 4 ) . The participants were r and omly divided into 2 groups to receive synbiotic supplement , 1000 mg/d , and placebo ( 2 capsules a day ) for 6 weeks . At the beginning and end of the study , blood parameters and kidney function were evaluated . RESULTS Of the 66 patients studied , 16 patients ( 24.2 % ) were women and 50 ( 75.8 % ) were men . The mean age and body mass index of the participants were 61 ± 7.65 years and 28.52 ± 4.06 kg/m2 , respectively . The level of blood urea nitrogen showed a significant reduction following the intake of synbiotic supplement ( from 40.80 ± 22.11 mg/dL to 36.14 ± 20.52 mg/dL , P = .01 ) . Serum creatinine , uric acid , and other indicators of kidney function showed no significant change . CONCLUSIONS The intake of synbiotic supplement could reduce blood urea nitrogen in patients with CKD in stages 3 and 4 ; however , it had no effect on the other markers of kidney function",
"Background : Recent studies suggest that prebiotic and /or probiotic treatments ameliorate kidney function in humans and animals by improving the gut environment . However , the gut microbiota and kidney disease interactions remain to be determined . This study investigated whether synbiotics modulate the gut microbiota and ameliorate kidney function using a rat model of chronic kidney disease ( CKD ) . As uremic toxins are associated with CKD-related mineral and bone disorder , the secondary aim was to evaluate the relationship between synbiotics and secondary hyperparathyroidism ( SHPT ) . Methods : 5/6 nephrectomy ( Nx ) rats were developed as the CKD model . Sham-operated ( sham ) rats were used as the control . To investigate the effectiveness of prebiotics ( glutamine , dietary fiber , and oligosaccharide ) and probiotics ( Bifidobacterium longum strain ; GFOB diet ) , rats were r and omly assigned to 4 groups : Nx group fed the GFOB diet ( n = 10 ) ; Nx group fed the control ( CON ) diet ( n = 10 ) ; sham group fed the GFOB diet ( n = 5 ) ; and sham group fed the control diet ( n = 5 ) . Blood , feces , and kidney sample s were collected and analyzed . Results : Serum creatinine ( Cre ) and blood urea nitrogen in the Nx GFOB group were significantly lower than those in the Nx CON group . Serum indoxyl sulfate in the Nx GFOB group was lower than that in the Nx CON group , and significantly correlated with serum Cre . Inorganic phosphorus and intact parathyroid hormone in the Nx GFOB group were significantly lower than those in the Nx CON group . Conclusion : Improving the gut environment using synbiotics ameliorated kidney function and might be a pharmacological treatment for SHPT without any serious adverse events",
"OBJECTIVES Gut microbiota provides beneficial effects under physiological conditions , but is able to contribute to inflammatory diseases in susceptible individuals . Thus , we design ed this study to test whether additional intake of symbiotic gel affects specific modifications of gut microbiota in patients with end-stage renal disease ( ESRD ) . METHODS Eighteen patients with ESRD diagnosis with renal replacement therapy ( hemodialysis ) were included in this study . They were r and omly assigned to 2 treatment groups : ( 1 ) test group ( nutritional counseling + symbiotic ) and ( 2 ) control group ( nutritional counseling + placebo ) . Clinical history and the evaluation of Gastrointestinal Symptom Rating Scale were performed . Gut microbiota composition was analyzed by real-time polymerase chain reaction from fecal sample s. All subjects were followed for 2 months . RESULTS Bifidobacterial counts were higher in the second sample s ( mean : 5.5 ± 1.72 log10 cells/g ) than in first sample s ( 4.2 ± 0.88 log 10 cells/g ) in the patients of the test group ( P = .0344 ) . Also , lactobacilli counts had a little decrease in the test group ( 2.3 ± 0.75 to 2.0 ± 0.88 log 10 cells/g ) and the control group ( 2.2 ± 0.90 to 1.8 ± 1.33 log 10 cells/g ) , between the first and the second sample s. Gastrointestinal symptoms scores ( scale 8 - 40 ) were reduced in the test group ( start 12 [ 10 - 14 ] and end 9 [ 8 - 10 ] ) compared with control group ( start 11 [ 8 - 21 ] and end 11 [ 9 - 15 ] ) . CONCLUSIONS Short-term symbiotic treatment in patients with ESRD can lead to the increase of Bifidobacterium counts , maintaining the intestinal microbial balance",
"In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies",
"Small bowel bacterial overgrowth ( SBBO ) , well known to occur in end-stage kidney failure , is responsible for producing uremic toxins and contributing to the patient 's decreased nutritional well-being . In this study , 8 hemodialysis patients were treated with a course of oral Lactobacillus acidophilus ( LBA ) in an attempt to alter this SBBO . LBA treatment was effective in lowering 2 compounds generated in vivo . Serum dimethylamine ( DMA ) levels dropped from 224 + /- 47 to 154 + /- 47 micrograms/dl at the end of LBA treatment ( p Nitrosodimethylamine , a carcinogen , levels also decreased significantly from 178 + /- 67 ( untreated ) to 83 + /- 49 ng/kg ( after LBA treatment ) . Patients nutritional status , assessed as serum albumin , body weight , caloric intake , midarm muscle area ( MAMA ) and appetite improved modestly , but not significantly . LBA changed small bowel pathobiology by modifying metabolic actions of SBBO , reducing in vivo generation of toxins and carcinogens and promoting nutrition with no adverse side effects",
"Introduction Uremic syndrome consists of nitrogenous waste retention , deficiency in kidney-derived hormones , and reduced acid excretion , and , if untreated , may progress to coma and eventual death . Previous experience suggests that oral administration of a probiotic formulation of selected microbial strains may extend renoprotection via intraintestinal extraction of toxic waste solutes in patients with chronic kidney disease (CKD)stages 3 and 4 . This report presents preliminary data from a pilot study . Methods This was a 6-month prospect i ve , r and omized , double-blind , placebo-controlled crossover trial of a probiotic bacterial formulation conducted in four countries , at five institutions , on 46 out patients with CKD stages 3 an nd 4 : USA ( n=10 ) , Canada ( n=113 ) , Nigeria ( n=115 ) , and Argentina ( n=8 ) . Outcomes were compared using biochemical parameters : blood urea nitrogen ( BUN ) , serum creatinine , and uric acid . General well-being was assessed as a secondary parameter by a quality of life ( QQOL ) question naire on a subjective scale of 1–10 . Results Oral ingestion of probiotics ( 90 billion colony forming units [CFUs]/day ) was well tolerated and safe during the entire trial period at all sites . BUN levels decreased in 29 patients ( 63 % , P creatinine levels decreased in 20 patients ( 43 % , no statistical significance ) , and uric acid levels decreased in 15 patients ( 33 % , no statistical significance ) . Almost all subjects expressed a perceived substantial overall improvement in QOL ( 86 % , P significant reduction of BUN , enhanced well-being , and absence of serious adverse effects , thus supporting the use of the chosen probiotic formulation for bowel-based toxic solute extraction . QOL and BUN levels showed statistically significant differences in outcome ( P 46 patients ) . A major limitation of this trial is the small sample size nd elated inconsistencies",
"Inflammatory markers such as interleukin (IL)-6 and tumour necrosis factor-alpha ( TNF-α ) are elevated in dialysis patients and can predict cardiovascular events and all-cause mortality . Endotoxin is an important source and also another marker of inflammation in patients with chronic kidney disease . The aim of this study was to evaluate the impact of oral probiotics on serum levels of endotoxemia and cytokines in peritoneal dialysis ( PD ) patients . The decline of residual renal function , peritonitis episodes , and cardiovascular events were also recorded . From July 2011 to June 2012 , a r and omised , double-blind , placebo-controlled trial was conducted in PD patients . The intervention group received one capsule of probiotics containing 10(9 ) cfu Bifobacterium bifidum A218 , 10(9 ) cfu Bifidobacterium catenulatum A302 , 10(9 ) cfu Bifidobacterium longum A101 , and 10(9 ) cfu Lactobacillus plantarum A87 daily for six months , while the placebo group received similar capsules containing maltodextrin for the same duration . Levels of serum TNF-α , interferon gamma , IL-5 , IL-6 , IL-10 , IL-17 , and endotoxin were measured before and six months after intervention . 39 patients completed the study ( 21 in the probiotics group and 18 in the placebo group ) . In patients receiving probiotics , levels of serum TNF-α , IL-5 , IL-6 , and endotoxin significantly decreased after six months of treatment , while levels of serum IL-10 significantly increased . In contrast , there were no significant changes in levels of serum cytokines and endotoxin in the placebo group after six months . In addition , the residual renal function was preserved in patients receiving probiotics . In conclusion , probiotics could significantly reduce the serum levels of endotoxin , pro-inflammatory cytokines ( TNF-α and IL-6 ) , IL-5 , increase the serum levels of anti-inflammatory cytokine ( IL-10 ) , and preserve residual renal function in PD patients",
"BACKGROUND One of the main goals in chronic kidney disease ( CKD ) patients is to diminish the accumulation of uremic toxins and to slow the progression of renal failure . We investigated whether prebiotic and probiotic supplementation along with low protein diet retards the progression of CKD . METHODS This is a 12-month prospect i ve observation study with a r and omized control and open-label design . A total of 24 stable CKD stage III to V patients , who are not on renal replacement therapy , were enrolled in this study . Patients were r and omly assigned to 2 groups : low protein diet + prebiotic + probiotic supplementation ( N.=12 ) , receiving 3 tablets of prebiotic + probiotic supplementation daily for 6 months , and the control group receiving low protein diet only ( N.=12 ) . We examined the effects of prebiotic and probiotic supplementation on estimated glomerular filtration rate ( eGFR ) in CKD . RESULTS The declining GFR during prebiotic and probiotic supplementation were significantly lower ( -11.6±8.6 vs. -3.4±4.6 mL/min per 1.73 m2 per year , 95 % CI -6.45 - -9.86 , P CONCLUSIONS Prebiotic and probiotic supplementation along with low protein diet delayed the progression of CKD"
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This paper is a systematic review of scientific papers that studied postpartum weight retention . The identification of the studies was conducted in the Medline , Lilacs and Digital Library of Theses and Dissertations data bases between 2000 until 2013 . The main information evaluated was : author , year of publication , sample size , year of data collection , losses and analysis thereof , age , follow-up time , weight in the baseline and in the postpartum , assessment methods of weight retention and main results . Twenty studies were selected , of which 25 % ( n = 5 ) were national . Regarding the mode of analysis , in some works the result was analyzed in different ways as continuous and categorical . Of the selected papers , 45 % ( n = 9 ) analyzed the retained weight only continuously , 5 % ( n = 1 ) only categorically and 40 % ( n = 8) both ways . One of the studies used distribution in percentiles and the other evaluated continuously , categorical and by indicators of absolute and relative weight reduction . In conclusion , the results found reveal a lack of well-defined information about the forms of anthropometric measurements of women after delivery , indicating the need for developing national proposals , consistent with the reality of our population
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"Background Pregnancy is a time of significant physiological and physical change for women . In particular , it is a time at which many women are at risk of gaining excessive weight . We describe the rationale and methods of the Health in Pregnancy and Post-birth ( HIPP ) Study , a study which aims primarily to determine the effectiveness of a specialized health coaching ( HC ) intervention during pregnancy , compared to education alone , in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth . A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth . Methods / Design The r and omized controlled trial will be conducted with 220 women who have a BMI > 18.5 ( American IOM cut-off for normal weight ) , are 18 years of age or older , English speaking , no history of disordered eating or diabetes and are less than 18 weeks gestation at recruitment . Women will be r and omly allocated to either a specialized HC intervention group or an Education Alone group . Our specialized HC intervention has two components : ( 1 ) one-on-one sessions with a Health Coach , and ( 2 ) two by two hour educational group sessions led by a Health Coach . Women in the Education Alone group will receive two by two hour educational group sessions with no HC components . Body Mass Index , waist circumference , and psychological factors including motivation , readiness to change , symptoms of depression and anxiety , and body dissatisfaction will be assessed at baseline ( 14 - 16 weeks gestation ) , and again at follow-up : 32 weeks gestation , 6 weeks , 6 months and 12 months postpartum . Discussion Our study responds to the urgent need to design effective interventions in pregnancy to prevent excessive gestational weight gain and postpartum weight retention . Our pregnancy HC intervention is novel and innovative and has been design ed to be easily adopted by health professionals who work with pregnant women , such as obstetricians , midwives , allied health professionals and health psychologists . Trial registration Australian New Zeal and Clinical Trials Registry",
"Purpose The analysis of longitudinal health-related quality of life measures ( HRQOL ) can be seriously hampered due to informative drop-out . R and om effects models assume Missing At R and om and do not take into account informative drop-out . We therefore aim to correct the bias due to informative drop-out . Methods Analyses of data from a trial comparing st and ard-dose and high-dose chemotherapy for patients with breast cancer with respect to long-term impact on HRQOL will serve as illustration . The subscale Physical Function ( PF ) of the SF36 will be used . A pattern mixture approach is proposed to account for informative drop-out . Patterns are defined based on events related to HRQOL , such as death and relapse . The results of this pattern mixture approach are compared to the results of the commonly used r and om effects model . Results The findings of the pattern mixture approach are well interpretable , and different courses over time in different patterns are distinguished . In terms of estimated differences between st and ard dose and high dose , the results of both approaches are slightly different , but have no consequences for the clinical evaluation of both doses . Conclusion Under the assumption that drop-out is at r and om within the patterns , the pattern mixture approach adjusts the estimates to a certain degree . This approach accounts in a relatively simple way for informative drop-out",
"Background Little is known about reproductive health in severely obese women . In this study , we present associations between different levels of severe obesity and a wide range of health outcomes in the mother and child . Methods From the Danish National Birth Cohort , we obtained self-reported information about prepregnant body mass index ( BMI ) for 2451 severely obese women and 2450 r and omly selected women from the remaining cohort who served as a comparison group . Information about maternal and infant outcomes was also self-reported or came from registers . Logistic regression was used to estimate the association between different levels of severe obesity and reproductive outcomes . Principal Findings Subfecundity was more frequent in severely obese women , and during pregnancy , they had an excess risk of urinary tract infections , gestational diabetes , preeclampsia and other hypertensive disorders which increased with severity of obesity . They tended to have a higher risk of both pre- and post-term birth , and risk of cesarean and instrumental deliveries increased across obesity categories . After birth , severely obese women more often failed to initiate or sustain breastfeeding . Risk of weight retention 1.5 years after birth was similar to that of other women , but after adjustment for gestational weight gain , the risk was increased , especially in women in the lowest obesity category . In infants , increasing maternal obesity was associated with decreased risk of a low birth weight and increased risk of a high birth weight . Estimates for ponderal index showed the same pattern indicating an increasing risk of neonatal fatness with severity of obesity . Infant obesity measured one year after birth was also increased in children of severely obese mothers . Conclusion Severe obesity is correlated with a substantial disease burden in reproductive health . Although the causal mechanisms remain elusive , these findings are useful for making predictions and planning health care at the individual level",
"Background Postpartum weight retention may contribute to the development of obesity . We studied whether individual counselling on diet and physical activity from 2 to 10 months postpartum has positive effects on diet and leisure time physical activity and increases the proportion of primiparas returning to their pre-pregnancy weight . Methods A controlled trial including ninety-two postpartum primiparas was conducted in three intervention and three control child health clinics in primary health care in Finl and . The intervention included individual counselling on diet and physical activity during five routine visits to a public health nurse ; the controls received the usual care . Results In total , 50 % of the intervention group and 30 % of the control group returned to their pre-pregnancy weight ( weight retention ≤ 0 kg ) by 10 months postpartum ( p = 0.06 ) . The confounder-adjusted odds ratio for returning to pre-pregnancy weight was 3.89 ( 95 % CI 1.16–13.04 , p = 0.028 ) for the intervention group compared with the controls . The mean proportion of high-fibre bread ( of total weekly amount of bread ) increased by 16.1 % ( 95 % CI 4.3–27.9 ) by 10 months postpartum in the intervention group compared with the controls when adjusted for confounders ( p = 0.008 ) . No significant differences were observed in changes in leisure time physical activity between the groups . Conclusion The intervention increased the proportion of primiparas returning to pre-pregnancy weight and the proportion of high-fibre bread in their diet . Larger r and omized controlled trials are needed to show whether counselling can improve dietary and leisure time physical activity habits in postpartum women and also to confirm the results concerning the effect on reducing postpartum weight retention . Trial registration Current Controlled Trials IS RCT",
"OBJECTIVE To identify factors potentially associated with weight retention measured 9 months after childbirth . DESIGN Prospect i ve study with four follow-up waves in time ( 0.5 , 2 , 6 and 9 months postpartum ) . SETTING Rio de Janeiro , Brazil . SUBJECTS AND METHODS Two hundred and sixty-six Brazilian women of childbearing age . Analysis was based on hierarchical logistic regression . The dependent variable was weight retention and was defined as the difference between weight at 9 months postpartum and pre-pregnancy weight , with a dichotomised cut-off at 7.5 kg . Covariates included demographic and socio-economic data , obstetric history , anthropometric data , and data on the infant . These data were grouped in blocks and ordered according to their influence on the dependent variable . RESULTS Of the women studied , 19.2 % presented weight retention values > or = 7.5 kg . According to the logistic regression analysis , the following variables remained associated with weight retention > or = 7.5 kg : total family income , difficulty or inability to read a letter , age category > or = 30 years , age at first childbirth gestational weight gain > or = 12 kg , body fat at baseline > or = 30 % and infant birth weight Infant hospitalisation was only marginally significant . CONCLUSIONS Determinant factors identified by the analysis highlight the need for nutritional intervention policies during pregnancy and in the first months postpartum as a way of minimising obesity and the diseases result ing from it",
"OBJECTIVES to examine weight retention from early pregnancy to three years postpartum in Iranian women . DESIGN a prospect i ve cohort study . SETTING 12 health centres selected at r and om in urban and rural areas in Guilan . PARTICIPANTS 1315 pregnant women ( 705 in urban areas and 610 in rural areas ) who regularly attended health centres for antenatal care and growth monitoring of their babies . MEASUREMENTS details of weight , height , pregnancy weight gain , body weight at one to three years postpartum , mother 's age , parity , duration of any breast feeding , education and employment status of women who carried singleton fetuses and delivered at term were collected at the first antenatal visit . The women were categorised based on their pre-pregnancy body mass index , weight retention at one to three years postpartum , employment status and educational levels . FINDINGS women who gained more weight than recommended during pregnancy tended to be heavier at three years postpartum than women who gained weight within the recommended ranges during pregnancy ( 7.0 + or - 5.3 versus 4.8 + or - 6.7 kg ; p inadequate pregnancy weight gain than other educational groups , and they had less weight retention at three years postpartum than other educational groups . Also , weight retention for primiparous women was higher than that for multiparous women ( 5.4 + or - 6.6 versus 3.8 + or - 6.3 kg ; p total pregnancy weight gain was independently related to major weight retention ( > or = 4 kg ) at three years postpartum ( odds ratio 1.34 , 95 % confidence intervals 1.03 - 1.74 ; p = 0.02 ) . CONCLUSION a high body mass index before pregnancy is not associated with increased risk of retaining more weight after pregnancy . On the other h and , total pregnancy weight gain was the most important determinant of weight retention at three years postpartum in this population of Iranian women",
"Background Postpartum weight retention affects many women and increases the risk of becoming overweight . The research objective was to study modifiable factors contributing to weight change at one year postpartum . Methods In this prospect i ve cohort , postpartum behavior , such as physical activity , sedentary behavior , sleep , and intake of total energy , total fat and saturated fatty acids of 118 Dutch women were assessed in 2003/2004 by self-report at 6 weeks , 6 and 12 months postpartum . Mean postpartum scores were computed for the behavioral measures . In linear regression models it was determined which factors were associated with average weight change from before pregnancy to one year postpartum . Furthermore , factors associated with substantial postpartum weight retention ( ≥ 5 kg ) were also studied in logistic regression models . Results At one year postpartum , the average weight of participants had increased by 0.9 kg ( SD 4.4 ) . Moreover , 20 % of the women retained ≥ 5 kg . Women who perceived themselves more physically active than others were almost ten times less likely to retain ≥ 5 kg than women who perceived themselves equally active ( OR = 0.11 , 95%CI : 0.02 - 0.66 ) . Exceeding the guideline for saturated fatty acid intake ( OR = 3.40 , 95%CI : 1.04 - 11.11 ) , total gestational weight gain ( OR = 1.14/kg , 95%CI : 1.01 - 1.27 ) , and not having completed post high school education ( OR = 5.13 , 95%CI : 1.66 - 15.90 ) increased the odds of retaining ≥ 5 kg . Conclusions Since one in five women had substantial weight retention postpartum , effective interventions for the prevention of weight retention are much needed . Future studies should evaluate whether interventions focusing on the identified modifiable postpartum factors are successful in reducing weight retention after childbirth",
"Postpartum weight retention plays an important role in the pathway leading to obesity among women of childbearing age . The objective of this study was to examine predictors of moderate ( 1 - 10 pounds ) and high ( > 10 pounds ) postpartum weight retention using data from a prospect i ve pregnancy cohort that followed women into the postpartum period ; n = 688 and 550 women at 3 and 12 months , respectively . Analysis included descriptive statistics and predictive modeling using log-binomial techniques . The average weight retained at 3 and 12 months postpartum in this population was 9.4 lb ( s.d . = 11.4 ) and 5.7 lb ( s.d . = 13.2 ) , respectively . At 3 months postpartum , prepregnancy weight , gestational weight gain , and hours slept during the night were associated with moderate or high weight retention , whereas having an infant hospitalized after going home and scoring in the upper 75th percentile of the Eating Attitudes Test ( EAT ) were associated only with high weight retention . At 12 months postpartum , prepregnancy weight , gestational weight gain , and maternal education were associated with moderate weight retention ; and gestational weight gain , maternal age , race , employment status , and having an infant hospitalized at birth were associated with high weight retention . The results of this study illustrate the importance of prepregnancy weight and gestational weight gain in predicting postpartum weight retention . Furthermore , given the lack of successful intervention studies that exist to date to help women lose weight in the postpartum period , the results of this study may help to inform future interventions that focus on such aspects as hours of sleep , dealing with stress associated with a hospitalized infant , and non clinical eating disorder symptomatology"
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OBJECTIVES To the best of our knowledge , no systematic review and meta- analysis has evaluated the cholesterol-lowering effects of intermittent fasting ( IF ) and energy-restricted diets ( ERD ) compared with control groups . The aim of this review and meta- analysis was to summarize the effects of controlled clinical trials examining the influence of IF and ERD on lipid profiles . METHODS A systematic review of four independent data bases ( PubMed / Medline , Scopus , Web of Science and Google Scholar ) was performed to identify clinical trials reporting the effects of IF or ERD , relative to non-diet controls , on lipid profiles in humans . A r and om-effects model , employing the method of DerSimonian and Laird , was used to evaluate effect sizes , and results were expressed as weighted mean difference ( WMD ) and 95 % confidence intervals ( CIs ) . Heterogeneity between studies was calculated using Higgins I2 , with values ≥50 % considered to represent high heterogeneity . Subgroup analyses were performed to examine the influence of intervention type , baseline lipid concentrations , degree of energy deficit , sex , health status , and intervention duration . RESULTS For the outcomes of low-density lipoprotein cholesterol ( LDL-C ) , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , and triacylglycerols ( TG ) , there were 34 , 33 , 35 , and 33 studies meeting all inclusion criteria , respectively . Overall , results from the r and om-effects model indicated that IF and ERD interventions result ed significant changes in TC ( WMD , -6.93 mg/dL ; 95 % CI , -10.18 to -3.67 ; P 78.2 % ) , LDL-C ( WMD , -6.16 mg/dL ; 95 % CI , -8.42 to -3.90 ; P ˂ 0.001 ; I2 = 52 % ) , and TG concentrations ( WMD , -6.46 mg/dL ; 95 % CI , -10.64 to -2.27 ; P = 0.002 ; I2 = 61 % ) . HDL-C concentrations did not change significantly after IF or ERD ( WMD , 0.50 mg/dL ; 95 % CI , -0.69 to 1.70 ; P = 0.411 ; I2 = 80 % ) . Subgroup analyses indicated potentially differential effects between subgroups for one or more lipid parameters in the majority of analyses . CONCLUSIONS Relative to a non-diet control , IF and ERD are effective for the improvement of circulating TC , LDL-C , and TG concentrations , but have no meaningful effects on HDL-C concentration . These effects are influenced by several factors that may inform clinical practice and future research . The present results suggest that these dietary practice s are a means of enhancing the lipid profile in humans
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"BACKGROUND & AIMS Indirect comparisons suggest that alternate-day fasting ( ADF ) may produce greater improvements in body composition , fat distribution , and /or the adipokine profile compared to daily calorie restriction ( CR ) , but this has not been tested directly . In a pre-planned secondary analysis of a r and omized controlled trial , we compared changes in the VAT : SAT ratio , FFM : total mass ratio , and the adipokine profile between ADF and CR . METHODS Overweight and obese participants ( n = 100 ) were r and omized to 1 ) ADF ( alternating every 24-h between consuming 25 % or 125 % of energy needs ) ; 2 ) CR ( consuming 75 % of needs every day ) ; or 3 ) control ( consuming 100 % of needs every day ) for 24 wk . RESULTS The VAT : SAT ratio did not change in any group . The FFM : total mass ratio increased in both ADF ( 0.03 ± 0.00 ) and CR ( 0.03 ± 0.01 ) compared to the control group ( P groups . Circulating leptin decreased in both the ADF group ( -18 ± 6 % ) and CR group ( -31 ± 10 % ) relative to the control group ( P groups . Circulating levels of adiponectin , resistin , IL-6 , and TNF-α did not change in either intervention group relative to the control group . CONCLUSION ADF and CR similarly improve the FFM : total mass ratio and reduce leptin after a 24-wk intervention . TRIAL REGISTRATION Clinical trials.gov , number NCT00960505",
"ABSTRACT Background : There are no investigations regarding the effects of consuming low-energy-dense diets rich in multiple functional foods on weight-loss maintenance , inflammatory markers , and cardiovascular disease ( CVD ) risk factors simultaneously . Method : This r and omized controlled trial design was conducted on 90 men and women who were under a previous weight loss diet . Three months of intervention with recruitment at Allzahra Hospital , Isfahan , Iran , was done . Intervention was conducted following achieving 7–11 kg weight loss . Participants were encouraged to consumed these three : an isocaloric control diet ( 50 % of energy from carbohydrate , 35 % from fat , 15 % from protein ) , a low-glycemic-index diet ( LE ) ( 60 % from carbohydrate , 25 % from fat , and 15 % from protein ) , and a low-glycemic-index diet rich in multiple functional foods ( LE + FF ) ( 60 % from carbohydrate , 25 % from fat , and 15 % from protein ) . Fasting blood glucose , serum insulin level , lipid profiles , inflammatory markers , adiponectin , systolic and diastolic blood pressure , and anthropometric measurements were assessed using st and ard guidelines . Results : The percent changes of weight , waist , and body mass index ( BMI ) , systolic and diastolic blood pressure , malondialdehyde ( MDA ) , high-sensitivity C-reactive protein ( hs-CRP ) , tumor necrosis factor ( TNF ) α , total cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglyceride , and fasting blood glucose ( FBS ) were substantially more decreased in the LE + FF group compared to the LE and control groups ( p ≤ 0.03 ) . Percent change of adiponectin among the LE + FF group was significantly more enhanced ( 7.29 ± 0.10 ) compared with the LE group ( 1.28 ± 0.20 ) ( p = 0.001 ) . Significantly more increment in the percent change of total antioxidant capacity ( TAC ) ( 6.91 ± 0.10 ) was obtained among the LE + FF group compared to the LE group ( 1.79 ± 0.04 ) . Conclusions : This study provides established evidence supporting the beneficial effects of a low-energy-dense diet rich in multiple functional foods diet on improving weight-loss maintenance , inflammation , and cardiovascular risk factors ",
"Background : Little is known about the effects of a low energy dense diet on weight maintenance and cardiovascular risks following a recent weight reduction . Therefore , we assessed if weight maintenance , lipid profiles , and glycemic control differ between low energy density ( LED ) diet and usual diet consumers following a recent weight reduction . Material s and Methods : In this r and omized controlled clinical trial study in a parallel design , we recruited 70 patients with the history of weight reduction in the recent 1 year . LED diet contained 30 % fat , 15 % protein , and 55 % carbohydrate was administered to the test group , and a usual diet including 35 % fat , 15 % protein , and 50 % carbohydrate was prescribed to the control group for 7 months . Dietary intake was assessed by using 3 days food records . Biochemical markers and anthropometric measures were done according to the st and ard protocol . Results : Weight reduced in LED diet consumers compared to usual diet consumers ( −0.3 ± 0.2 vs. 1.3 ± 0.4 % , P = 0.002 ) . The results was the same regarding waist circumference ( −0.4 ± 0.2 vs. 0.3 ± 0.1 % , P = 0.004 ) . Fasting blood sugar also decreased in LED diet group ( −9.5 ± 0.8 vs. 0.4 ± 1.0 % , P = 0.0001 ) . LED diet group had a drop in percent change of their total cholesterol ( −0.4 ± 0.5 vs. 2.05 ± 0.4 % , P = 0.04 ) and low-density lipoprotein-cholesterol ( 4.8 ± 0.9 vs. −0.3 ± 0.9 % , P = 0.002 ) . Conclusion : Our findings confirmed beneficial effects of LED diet on attenuating weight regain in subjects with history of recent weight reduction . It might be derived from higher consumption of fruits , vegetables , and fiber among LED diet than usual diet consumers",
"A periodic fasting diet improves markers of metabolic dysfunction , particularly in people already at risk . Fasting : More than a fad Mice that fast periodically are healthier , metabolically speaking . To explore whether fasting can help people as well , Wei et al. studied 71 people who either consumed a fasting-mimicking diet for 5 days each month for 3 months or maintained their normal diet for 3 months and then switched to the fasting schedule . The fasting-like diet reduced body weight and body fat , lowered blood pressure , and decreased the hormone IGF-1 , which has been implicated in aging and disease . A post hoc analysis replicated these results and also showed that fasting decreased BMI , glucose , triglycerides , cholesterol , and C-reactive protein ( a marker for inflammation ) . These effects were generally larger in the subjects who were at greater risk of disease at the start of the study . A larger study is needed to replicate these results , but they raise the possibility that fasting may be a practical road to a healthy metabolic system . Calorie restriction or changes in dietary composition can enhance healthy aging , but the inability of most subjects to adhere to chronic and extreme diets , as well as potentially adverse effects , limits their application . We r and omized 100 generally healthy participants from the United States into two study arms and tested the effects of a fasting-mimicking diet (FMD)—low in calories , sugars , and protein but high in unsaturated fats — on markers/risk factors associated with aging and age-related diseases . We compared subjects who followed 3 months of an unrestricted diet to subjects who consumed the FMD for 5 consecutive days per month for 3 months . Three FMD cycles reduced body weight , trunk , and total body fat ; lowered blood pressure ; and decreased insulin-like growth factor 1 ( IGF-1 ) . No serious adverse effects were reported . After 3 months , control diet subjects were crossed over to the FMD program , result ing in a total of 71 subjects completing three FMD cycles . A post hoc analysis of subjects from both FMD arms showed that body mass index , blood pressure , fasting glucose , IGF-1 , triglycerides , total and low-density lipoprotein cholesterol , and C-reactive protein were more beneficially affected in participants at risk for disease than in subjects who were not at risk . Thus , cycles of a 5-day FMD are safe , feasible , and effective in reducing markers/risk factors for aging and age-related diseases . Larger studies in patients with diagnosed diseases or selected on the basis of risk factors are warranted to confirm the effect of the FMD on disease prevention and treatment",
"Nutritional intervention for weight loss is one of the treatment options for obstructive sleep apnoea ( OSA ) in patients with overweight or obesity . However , the effects of moderate energy restriction on OSA severity are not yet known . The present study aim ed to evaluate the effects of moderate energy restriction on OSA severity and CVD risk factors in obese patients with OSA . In this 16-week r and omised clinical trial , twenty-one obese subjects aged 20 - 55 years and presenting an apnoea/hypopnoea index (AHI)≥5 events/h were r and omised into two groups : the energy restriction group ( ERG ) and the control group ( CG ) . The ERG was instructed to follow an energy-restricted diet -3347·2 kJ/d ( -800 kcal/d ) and the CG was advised not to change their food intake . At the beginning and at the end of the study , participants underwent evaluation of the following : OSA ( Watch-PAT200 ® ) , nutritional parameters , blood pressure , sympathetic activity , inflammatory biomarkers , metabolic profile and endothelial function . The ERG ( n 11 ) , compared with the CG ( n 10 ) , had a significantly greater reduction in body weight ( Cohen 's d=-1·19 ; P ( Cohen 's d=-0·95 ; P=0·04 ) and in plasma concentrations of adrenaline ( Cohen 's d=-1·02 ; P=0·04 ) as well as a significantly greater increase in minimum O2 saturation ( Cohen 's d=1·08 ; P=0·03 ) . Although energy restriction was not associated with significant improvements in CVD risk factors , medium-to-large effect sizes were observed , suggesting that the statistically non-significant difference between groups may be due to the small sample size . This study suggests that in obese patients with OSA , moderate energy restriction is able to reduce the parameters of OSA severity and sympathetic activity ",
"Abstract Overweight and obesity lead to changes in adipose tissue such as inflammation and reduced insulin sensitivity . The aim of this study was to assess how altered energy balance by reduced food intake or enhanced physical activity affect these processes . We studied sedentary subjects with overweight/obesity in two intervention studies , each lasting 12 weeks affecting energy balance either by energy restriction ( ~20 % reduced intake of energy from food ) in one group , or by enhanced energy expenditure due to physical exercise ( combined endurance‐ and strength‐training ) in the other group . We monitored mRNA expression by microarray and mRNA sequencing from adipose tissue biopsies . We also measured several plasma parameters as well as fat distribution with magnetic resonance imaging and spectroscopy . Comparison of microarray and mRNA sequencing showed strong correlations , which were also confirmed using RT‐PCR . In the energy restricted subjects ( body weight reduced by 5 % during a 12 weeks intervention ) , there were clear signs of enhanced lipolysis as monitored by mRNA in adipose tissue as well as plasma concentration of free‐fatty acids . This increase was strongly related to increased expression of markers for M1‐like macrophages in adipose tissue . In the exercising subjects ( glucose infusion rate increased by 29 % during a 12‐week intervention ) , there was a marked reduction in the expression of markers of M2‐like macrophages and T cells , suggesting that physical exercise was especially important for reducing inflammation in adipose tissue with insignificant reduction in total body weight . Our data indicate that energy restriction and physical exercise affect energy‐related pathways as well as inflammatory processes in different ways , probably related to macrophages in adipose tissue",
"Background Alternate day fasting ( ADF ; ad libitum “ feed day ” , alternated with 25 % energy intake “ fast day ” ) , is effective for weight loss and cardio-protection in obese individuals . Whether these effects occur in normal weight and overweight individuals remains unknown . This study examined the effect of ADF on body weight and coronary heart disease risk in non-obese subjects . Methods Thirty-two subjects ( BMI 20–29.9 kg/m2 ) were r and omized to either an ADF group or a control group for 12 weeks . Results Body weight decreased ( P ADF group , relative to the control group , by week 12 . Fat mass was reduced ( P fat free mass did not change , versus controls . Triacylglycerol concentrations decreased ( 20 ± 8 % , P and LDL particle size increased ( 4 ± 1 Å , P ADF group relative to controls . CRP decreased ( 13 ± 17 % , P 12 . Plasma adiponectin increased ( 6 ± 10 % , P controls by the end of the study . LDL cholesterol , HDL cholesterol , homocysteine and resistin concentrations remained unchanged after 12 weeks of treatment . Conclusion These findings suggest that ADF is effective for weight loss and cardio-protection in normal weight and overweight adults , though further research implementing larger sample sizes is required before solid conclusion can be reached",
"Dietary energy restriction ( DER ) reduces risk of spontaneous mammary cancer in rodents . In humans , DER in premenopausal years seems to reduce risk of postmenopausal breast cancer . Markers of DER are required to develop acceptable DER regimens for breast cancer prevention . We therefore examined markers of DER in the breast , adipose tissue , and serum . Nineteen overweight or obese women at moderately increased risk of breast cancer ( lifetime risk , 1 in 6 to 1 in 3 ) ages between 35 and 45 were r and omly allocated to DER [ liquid diet , 3,656 kJ/d ( 864 kcal/d ) ; n = 10 ] or asked to continue their normal eating patterns ( n = 9 ) for one menstrual cycle . Biopsies of the breast and abdominal fat were taken before and after the intervention . RNA was extracted from whole tissues and breast epithelium ( by laser capture microdissection ) and hybridized to Affymetrix GeneChips . Longitudinal plasma and urine sample s were collected before and after intervention , and metabolic profiles were generated using gas chromatography-mass spectrometry . DER was associated with significant reductions in weight [ −7.0 ( ±2.3 ) kg ] and in alterations of serum biomarkers of breast cancer risk ( insulin , leptin , total and low-density lipoprotein cholesterol , and triglycerides ) . In both abdominal and breast tissues , as well as isolated breast epithelial cells , genes involved in glycolytic and lipid synthesis pathways ( including stearoyl-CoA desaturase , fatty acid desaturase , and aldolase C ) were significantly down-regulated . We conclude that reduced expressions of genes in the lipid metabolism and glycolytic pathways are detectable in breast tissue following DER , and these may represent targets for DER mimetics as effective chemoprophylactic agents",
"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",
"Consecutive survivors of a myocardial infa rct ion from the Southern Hospital , below 70 years of age , were r and omized into a Control group ( n = 276 ) and a Treatment group ( n = 279 ) . The latter was openly prescribed the combination of clofibrate and nicotinic acid for serum lipid lowering . Each patient should remain in the study for 5 years and be seen regularly every 4 months at a special IHD outpatient clinic within the hospital . The concentration of serum cholesterol and triglyceride was lowered by 13 % and 19 % , respectively , in the Treatment group compared to the Control group . Total mortality was 82 cases in the Control group and 61 in the Treatment group , a 26 % reduction ( p less than 0.05 ) . For patients above 60 years of age in the Treatment group the reduction in mortality was 28 % ( p less than 0.05 ) . IHD mortality was reduced by 36 % ( p less than 0.01 ) in the Treatment group compared to the Control group . The beneficial effect of the serum lipid lowering treatment was related to the serum triglyceride concentration in two ways . First , it only occurred in patients with a triglyceride level greater than 1.5 mmol/l ( n = 216 ) . Secondly , it was most pronounced in the 44 % of the treated patients who had a lowering of the serum triglyceride by 30 % or more , and in this subgroup the reduction of IHD mortality was 60 % ( p less than 0.01 ) . For serum cholesterol there were no such relations . The difference between serum triglycerides and cholesterol concerning these relations to the treatment outcome may be due to the fact that hypertriglyceridaemia was the most common hyperlipidaemia among our patients , occurring in 50 % , while hypercholesterolaemia only occurred in 13 % . Caution should be exercised in the interpretation of the results as the trial was not blind . However , the fact that the decrease in IHD deaths was directly related to the degree of serum triglyceride lowering indicates that it was the drug effect on serum lipids that was responsible for the beneficial effect of the treatment",
"Oxidative stress is higher in obese diabetic than in non-diabetic subjects . This pilot study evaluates oxidative stress during short-term administration of a very low calorie diet in obese persons . Nine obese Type 2 diabetic patients ( age 55+/-5 years , BMI 35.9+/-1.9 kg/m2 ) and nine obese non-diabetic control subjects ( age 52+/-6 years , BMI 37.3+/-2.1 kg/m2 ) were treated by a very low calorie diet ( 600 kcal daily ) during 8 days stay in the hospital . Serum cholesterol , triglycerides , non-esterified fatty acids ( NEFA ) , beta-hydroxybutyrate ( B-HB ) , ascorbic acid ( AA ) , alpha-tocopherol ( AT ) , plasma malondialdehyde ( MDA ) and superoxide dismutase ( SOD ) activity in erythrocytes were measured before and on day 3 and 8 of very low calorie diet administration . A decrease of serum cholesterol and triglyceride concentrations on day 8 was associated with a significant increase of NEFA ( 0.30+/-0.13 vs. 0.47+/-0.11 micromol/l , p plasma MDA and serum AT together with an increase of SOD activity and AA concentration ( p SOD activity ( p NEFA or B-HB and SOD activity ( p very low calorie diet administration decreases oxidative stress in obese non-diabetic but only partly in diabetic persons . Diabetes mellitus causes a greater resistance to the effects of a low calorie diet on oxidative stress",
"Alternate day fasting ( ADF ) with a low-fat ( LF ) diet increases low-density lipoprotein ( LDL ) particle size . Whether these beneficial effects can be reproduced by a high-fat ( HF ) ADF diet is unclear . This study compared an ADF – HF to an ADF – LF diet on plasma lipids , LDL size and high-density lipoprotein ( HDL ) size . Thirty-five obese subjects were r and omized to an ADF – HF or ADF – LF diet for 10 weeks . Body weight decreased ( P – HF and ADF – LF group , respectively . LDL cholesterol was reduced ( P – LF . LDL particle size increased ( P . The proportion of small LDL particles decreased ( P – HF and ADF – LF groups , respectively . HDL cholesterol and HDL size remained unchanged . Thus , our results suggest that the ADF – HF diet is equally as effective as the ADF – LF diet in improving LDL particle size and distribution",
"BACKGROUND AND AIMS Decreasing energy intake relative to energy expenditure is the indisputable tenet of weight loss . In addition to caloric restriction modification of the type of dietary fat may provide further benefits . The aim of the present study was to examine the effect of energy restriction alone and with dietary fat modification on weight loss and adiposity , as well as on risk factors for obesity related disease . METHODS AND RESULTS One-hundred and fifty overweight men and women were r and omized into a 3month controlled trial with four low fat ( 30 % energy ) dietary arms : ( 1 ) isocaloric ( LF ) ; ( 2 ) isocaloric with 10 % polyunsaturated fatty acids ( LF-PUFA ) ; ( 3 ) low calorie ( LF-LC ) ( -2MJ ) ; ( 4 ) low calorie with 10 % PUFA ( LF-PUFA-LC ) . Primary outcomes were changes in body weight and body fat and secondary outcomes were changes in fasting levels of leptin , insulin , glucose , lipids and erythrocyte fatty acids . Changes in dietary intake were assessed using 3day food records . One-hundred and twenty-two participants entered the study and 95 completed the study . All groups lost weight and body fat ( P lost more weight ( P=0.026 for diet effect ) . All groups reduced total cholesterol levels ( P triacylglycerol levels ( P=0.056 diet effect ) . HDL increased with LF-LC and LF-PUFA but not with LF-PUFA-LC ( 0.042 diet effect ) . The LF and LF-LC groups reported greater dietary fat reductions than the two PUFA groups ( P=0.043 ) . CONCLUSION Energy restriction has the most potent effect on weight loss and lipids , but fat modification is also beneficial when energy restriction is more modest",
"OBJECTIVE The aim of the study was to evaluate whether intermittent fasting ( IF ) is an effective preventive measure , and whether it is feasible for healthy volunteers under every day conditions . METHODS A nonr and omized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk , and a subsequent 4-mo follow-up . Outcomes were assessed at baseline , after 8 wk , and after 6 mo . Volunteers who were not interested in fasting served as a control group . Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days , whereas the control group maintained their habitual nutrition throughout the whole period . Outcomes included changes of metabolic parameters ( insulin , glucose , insulin resistance , insulin-like growth factor-1 , brain-derived neurotropic factor , lipids , liver enzymes , hemoglobin A1c ) and coagulation markers ; bioelectrical impedance analysis ; body mass index ; abdominal girth ; blood pressure ; general quality of life ( five-item World Health Organization Well-Being Index [ WHO-5 ] question naire ) , as well as mood and anxiety ( Hospital Anxiety and Depression Scale [ HADS ] , Profile of Mood States , Flourishing-Scale , visual analog scale , Likert scales ) . The intervention consisted of a fasting day , which was repeated every week for 8 wk , with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day . A per- protocol analysis was performed . P Thirty-six volunteers were included ; 22 allocated themselves to the fasting group , and 14 to the control group . Thirty-three data sets were included in the final analysis . Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo , no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo , all in favor of the fasting group . However , none of the between-group differences were clinical ly relevant . CONCLUSIONS We did not find any clinical ly relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers . Further clinical research in this field is warranted to further analyze mechanisms and effects of IF",
"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",
"This pilot r and omised controlled study evaluated the effects of a nutrient-supported intermittent energy restriction nutrition programme to prevent weight gain in healthy overweight adults during the 6-week winter holiday period between Thanksgiving and New Year . For 52 d , twenty-two overweight adults ( mean age 41·0 years , BMI 27·3 kg/m2 ) were assigned to either the nutrition programme ( n 10 ; two fasting days of 730 kcal/d ( 3050 kJ/d ) of balanced shake and dietary supplements to support weight management efforts , followed by 5 d of habitual diet ) or a control group ( n 12 ; habitual diet ) . A significant weight loss from baseline ( pre-holiday 10 d before Thanksgiving ) to day 52 ( post-holiday 3 January ) was observed in the nutrition programme ( 75·0 ( sd 9·8 ) v. 76·3 ( sd 9·8 ) kg ; P did not significantly change in the control group and there was no between-group difference . Increases from baseline in fasting insulin ( 42·9 % ; P = 0·0256 ) , up date d homoeostasis model assessment ( HOMA2 ) ( 43 % ; P = 0·025 ) , LDL-cholesterol ( 8·4 % ; P = 0·0426 ) and total cholesterol ( 7·1 % ; P = 0·0154 ) levels were also reported in the control group . In the nutrition programme group , baseline HDL-cholesterol and TAG levels measured after two fasting days increased ( 13 % ; P = 0·0245 ) and decreased ( 22·8 % ; P = 0·0416 ) , respectively . There was no significant change in HOMA2 . Between-group differences in changes in insulin levels ( P = 0·0227 ) , total cholesterol : HDL-cholesterol ratio ( P = 0·0419 ) and HOMA2 ( P = 0·0210 ) were significant . Overall compliance rate was 98 % and no severe adverse events were reported . These preliminary findings suggest that this intermittent energy restriction intervention might support weight management efforts and help promote metabolic health during the winter holiday season",
"Background : Weight loss is the cornerstone of NAFLD management , but weight maintenance is difficult . Some studies have suggested that n-3 polyunsaturated fatty acid ( n-3 PUFA ) might have beneficial effects in NAFLD . We aim to compare the effects of a low-energy diet with n-3 PUFA supplementation on liver enzymes , body composition , and cardiometabolic risk factors in NAFLD . Material s and Methods : The study was a r and omized controlled trial conducted in Urmia in Iran from October 2016 to May 2017 . One hundred and fourteen eligible patients were r and omly assigned to one of the three following groups : low-energy diet group , n-3 PUFA supplementation ( fish oil ) group ( 1500 mg/d ) , or control group for 12 weeks . Liver enzymes , lipid profile , insulin resistance , and body composition were assessed before and after the intervention . Results : One hundred and four patients completed the study . All groups lost weight , but the reductions were greater in the diet group ( −2.97 ± 2.79 kg , P = 0.001 ) . The diet group had significant decreases in fat mass compared to other groups . Insulin resistance , total cholesterol , and low-density lipoprotein cholesterol significantly decreased only in the diet group , and patients who lost weight ≥4 % showed significantly larger decreases in serum liver enzymes . N-3 PUFA had no beneficial effects on the study outcomes . Conclusion : We found that 1500 mg/d n-3 PUFA supplied for 12 weeks , in contrast to 3.40 ± 2.98 % weight loss , does not improve liver enzymes , body composition , and cardiometabolic risk factors in NAFLD patients",
"ABSTRACT Background A very limited amount of research has examined intermittent fasting ( IF ) programs , such as time-restricted feeding ( TRF ) , in active population s. Objective Our objective was to examine the effects of TRF , with or without β-hydroxy β-methylbutyrate ( HMB ) supplementation , during resistance training ( RT ) . Methods This study employed a r and omized , placebo-controlled , reduced factorial design and was double-blind with respect to supplementation in TRF groups . Resistance-trained females were r and omly assigned to a control diet ( CD ) , TRF , or TRF plus 3 g/d HMB ( TRFHMB ) . TRF groups consumed all calories between 1200 h and 2000 h , whereas the CD group ate regularly from breakfast until the end of the day . All groups completed 8 wk of supervised RT and consumed supplemental whey protein . Body composition , muscular performance , dietary intake , physical activity , and physiological variables were assessed . Data were analyzed prior to unblinding using mixed models and both intention-to-treat ( ITT ) and per protocol ( PP ) frameworks . Results Forty participants were included in ITT , and 24 were included in PP . Energy and protein intake ( 1.6 g/kg/d ) did not differ between groups despite different feeding duration s ( TRF and TRFHMB : ∼7.5 h/d ; CD : ∼13 h/d ) . Comparable fat-free mass ( FFM ) accretion ( + 2 % to 3 % relative to baseline ) and skeletal muscle hypertrophy occurred in all groups . Differential effects on fat mass ( CD : + 2 % ; TRF : −2 % to −4 % ; TRFHMB : −4 % to −7 % ) were statistically significant in the PP analysis , but not ITT . Muscular performance improved without differences between groups . No changes in physiological variables occurred in any group , and minimal side effects were reported . Conclusions IF , in the form of TRF , did not attenuate RT adaptations in resistance-trained females . Similar FFM accretion , skeletal muscle hypertrophy , and muscular performance improvements can be achieved with dramatically different feeding programs that contain similar energy and protein content during RT . Supplemental HMB during fasting periods of TRF did not definitively improve outcomes . This study was prospect ively registered at clinical trials.gov as NCT03404271"
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Urinary iodine concentration ( UIC ( μg/ml ) from spot urine sample s collected from school-aged children is used to determine the iodine status of population s. Some studies further extrapolate UIC to represent daily iodine intake , based on the assumption that children pass approximately 1 L urine over 24-h , but this has never been assessed in population studies . Therefore , the present review aim ed to collate and produce an estimate of the average 24-h urine volume of children and adolescents ( > 1 year and from published studies . EBSCOHOST and EMBASE data bases were search ed to identify studies which reported the mean 24-h urinary volume of healthy children ( > 1 year and The overall mean ( 95 % CI ) estimate of 24-h urine volume was determined using a r and om effects model , broken down by age group . Of the 44 studies identified , a meta- analysis of 27 studies , with at least one criterion for assessing the completeness of urine collection s , indicated that the mean urine volume of 2–19 year olds was 773 ( 654 , 893 ) ( 95 % CI ) mL/24-h . When broken down by age group , mean ( 95 % CI ) 24-h urine volume was 531 mL/day ( 454 , 607 ) for 2–5 year olds , 771 mL/day ( 734 , 808 ) for 6–12 year olds , and 1067 mL/day ( 855 , 1279 ) for 13–19 year olds . These results demonstrate that the average urine volume of children aged 2–12 years is less than 1 L , therefore , misclassification of iodine intakes may occur when urine volumes fall below or above 1 L. Future studies utilizing spot urine sample s to assess iodine status should consider this when extrapolating UIC to represent iodine intakes of a population
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"Purpose : The Farm Family Exposure Study was initiated to characterize pesticide exposure to farm family members around the time of one pesticide application in a manner that will facilitate exposure assessment in epidemiologic studies of pesticides . Methods : A sample of farm families with children was recruited by r and omly selecting farmers from lists of licensed pesticide applicators in Minnesota and South Carolina . Eligible families were selected from among those who planned to apply one of three chemicals , glyphosate , 2,4-D , or chlorpyrifos , as part of their normal operations . The applicator , spouse , and all children in the family ages 4–17 years were included in the study . The applicator and spouse completed self-administered question naires addressing demographics , farming practice s and potential exposures to them and their children . Field observers documented the application , recorded application practice s , equipment , potential exposures , and the presence of children or spouses in the immediate vicinity of pesticide activities . All study participants were asked to collect each urine void for 5 days , 1 day before through 3 days after the application . Pesticides were measured in 24-h composite urine sample s with a one part per billion limit of detection . Results : Of 11,164 applicators screened , 994 families met the inclusion criteria . Of these , 95 families were enrolled . Enrollees were similar in most characteristics to their peers who were not participants in the study . In total , there were 106 applications , 10 of which involved more than one chemical . This result ed in urinary data for 48 farmers and spouses and their 79 children for glyphosate , 34 farmers and spouses and their 50 children for chlorpyrifos , and 34 farmers and spouses and their 53 children for 2,4-D. Compliance with the 24-h urine collection was particularly good for the adult participants . There were more missing sample s for children than for adults , but overall compliance was high . Conclusion : The Farm Family Exposure Study should provide insights about pesticide exposure under real world conditions and thereby facilitate improved exposure assessment in epidemiologic studies of agricultural population",
"Our overall aim is to monitor iodine supply in a prospect i ve study before and after the September 1998 increase of salt iodide content in Switzerl and . Because iodide is supplied by alimentation , we moreover wondered whether urinary iodine concentration ( UI ) is governed by circadian rhythmicity . Forty-two subjects ( 18 males and 24 females , including 13 children ) collected 3023 urine spots between May 1996 and May 1998 , at a rate of three to five sample s per month , at any time of the day . The results show that circadian rhythmicity of UI in adults and children was found independent of the individual subject , age , gender , and season . Lowest UI levels were found between 8 - 11 h. A curve increasing progressively between 12 and 24 h was obtained . UI returned to base-line levels between 21 and 22 h in children only . UI peaks occurred 4 - 5 h after main meals ; children 's peaks occurred later than that of adults . Although the existence of a circadian rhythm of UI is probably universal , its profile , however , depends on alimentation . Because nadir of UI is represented by morning spots , this might seem an appropriate collecting period . In view of the significant circadian rhythmicity of UI , studies with restriction of sampling time to morning hours , for example , can not be directly compared with studies in which urine is sample d all over the day",
"As there is no homeostatic mechanism for maintaining circulating fluoride ( F ) in the human body , the concentration may decrease and increase again when intake is interrupted and re-started . The present study prospect ively evaluated this process in children exposed to F intake from water and toothpaste , using F in urine as a biomarker . Eleven children from Ibiá , Brazil ( with sub-optimally fluori date d water supply ) aged two to four years who regularly used fluori date d toothpaste ( 1,100 ppm F ) took part in the study . Twenty-four-hour urine was collected at baseline ( Day 0 , F exposure from water and toothpaste ) as well as after the interruption of fluoride intake from water and dentifrice ( Days 1 to 28 ) ( F interruption ) and after fluoride intake from these sources had been re-established ( Days 29 to 34 ) ( F re-exposure ) . Urinary volume was measured , fluoride concentration was determined and the amount of fluoride excreted was calculated and expressed in mg F/day . Urinary fluoride excretion ( UFE ) during the periods of fluoride exposure , interruption and re-exposure was analyzed using the Wilcoxon test . Mean UFE was 0.25 mg F/day ( SD : 0.15 ) at baseline , dropped to a mean of 0.14 mg F/day during F interruption ( SD : 0.07 ; range : 0.11 to 0.17 mg F/day ) and rose to 0.21 ( SD : 0.09 ) and 0.19 ( SD : 0.08 ) following F re-exposure . The difference between baseline UFE and the period of F interruption was statistically significant ( p 0.05 ) . The findings suggest that circulating F in the body of young children rapidly decreases in the first 24 hours and again increases very fast after discontinuation and re-exposure of F from water and toothpaste",
"The use of discretionary salt , which is salt added during cooking and at the table , as a suitable vehicle for iodine intake was assessed by measuring salt consumption using the lithium-marker technique in rural areas of Guatemala and Benin . In both countries , we studied boys aged 6 - 12 y and their mothers . Subjects used lithium-labeled salt after all unlabeled salt was removed from their households . In Guatemala , 24-h urine sample s for 9 mother-son pairs were collected at baseline and on days 7 , 8 , and 9 during the use of lithium-labeled salt . Total maternal salt intake averaged 5.2 + /- 1.7 g/d ( mean + /- SD ) , of which 77 + /- 24 % came from discretionary sources , whereas Guatemalan boys consumed 1.8 + /- 0.6 g salt/d , of which 72 + /- 12 % came from discretionary sources . In Benin , urine collection from 13 mother-son pairs took place at baseline and on days 5 and 7 . Beninese mothers had a total salt intake of 9.0 + /- 2.9 g/d and their sons had an intake of 5.7 + /- 2.8 g/d ; discretionary salt contributed 52 + /- 14 % and 50 + /- 13 % , respectively , of total salt consumed . Therefore , fortification of household salt appears to be an appropriate method of controlling iodine deficiency in both countries , although fortification of other salt sources could be considered in Benin",
"BACKGROUND Iodine is required for the production of thyroid hormones , which are necessary for normal brain development and cognition . Although several r and omized trials examined the effect of iodine supplementation on cognitive performance in schoolchildren , the results were equivocal . OBJECTIVE We aim ed to ascertain whether providing iodized oil to iodine-deficient children would affect their cognitive and motor performance . DESIGN In a double-blind intervention trial , 10 - 12-y-old children ( n = 310 ) in primary schools in rural southeastern Albania were r and omly assigned to receive 400 mg I ( as oral iodized oil ) or placebo . We measured urinary iodine ( UI ) , thyroid-stimulating hormone ( TSH ) , and total thyroxine ( TT4 ) concentrations and thyroid gl and volume ( by ultrasound ) . The children were given a battery of 7 cognitive and motor tests , which included measures of information processing , working memory , visual problem solving , visual search , and fine motor skills . Thyroid ultrasound and the biochemical and psychological tests were repeated after 24 wk . RESULTS At baseline , the children 's median UI concentration was 43 microg/L ; 87 % were goitrous , and nearly one-third had low concentrations of circulating TT4 . Treatment with iodine markedly improved iodine and thyroid status : at 24 wk , median UI in the treated group was 172 microg/L , mean TT4 was approximately 40 % higher , and the prevalence of hypothyroxinemia was placebo , iodine treatment significantly improved performance on 4 of 7 tests : rapid target marking , symbol search , rapid object naming , and Raven 's Coloured Progressive Matrices ( P Information processing , fine motor skills , and visual problem solving are improved by iodine repletion in moderately iodine-deficient schoolchildren",
"Knowledge of levels of fluoride ingestion and excretion is important in planning optimum fluoride therapy for young children . In previous literature , it has been assumed that only about one-third of ingested fluoride is excreted in young children . The aims of the present study were ( a ) to measure total fluoride intake , urinary fluoride excretion and fluoride balance , and ( b ) to investigate the effect of air temperature on fluoride intake and urinary fluoride excretion , in young children . Children ( 4 years old ) living in a city , a small town and rural areas of Fars province , Iran , where drinking water contained 0.30 - 0.39 mg F/l , were invited to participate . Selection of subjects was by r and om sampling of kindergartens or health centres . The children were surveyed twice , once in summer and once in winter . Diet was obtained by 3 d diaries with interview . Sample s of most foods and drinks were analysed for fluoride content . Ingestion of fluoride from toothpaste was estimated for each child . Each child 's urine was collected over 24 h and analysed for fluoride content . Seventy-eight of the 116 volunteers completed all aspects of the study , which was conducted in 1995 - 6 . For all children , the mean fluoride ingestion from diet was 0.390 ( SD 0.122 ) mg/d or 0.028 ( SD 0.008 ) mg/kg body weight per d. Fluoride ingestion from diet was higher in summer and higher in rural areas . The mean ingestion of fluoride from all sources was 0.426 ( SD 0.126 ) mg/d and the mean fluoride urinary excretion was 0.339 ( SD 0.100 ) mg/d . The difference between ingestion and urinary excretion was + 0.087 ( SD 0.143 ) mg , equivalent to 80 % excretion . Faecal excretion was not estimated . The results indicate fluoride retention at 4 years to be much lower than previously assumed",
"Although the median urinary iodine concentration ( UIC ) is a good indicator of iodine status in population s , there is no established biomarker for individual iodine status . If the UIC were to be used to assess individuals , it is unclear how many repeat urine collection s would be needed and if the collection s should be spot sample s or 24-h sample s. In a prospect i ve , longitudinal , 15-mo study , healthy Swiss women ( n = 22 ) aged 52 - 77 y collected repeated 24-h urine sample s ( total n = 341 ) and corresponding fasting , second-void , morning spot urine sample s ( n = 177 ) . From the UIC in spot sample s , 24-h urinary iodine excretion ( UIE ) was extrapolated based on the age- and sex-adjusted iodine : creatinine ratio . Measured UIE in 24-h sample s , estimated 24-h UIE , and UIC in spot sample s were ( geometric mean ± SD ) 103 ± 28 μg/24 h , 86 ± 33 μg/24 h , and 68 ± 28 μg/L , respectively , with no seasonal differences . Intra-individual variation ( mean CV ) was comparable for measured UIE ( 32 % ) and estimated UIE ( 33 % ) . The CV tended to be higher for the spot UIC ( 38 % ) than for the estimated 24-h UIE ( 33 % ) ( P = 0.12 ) . In this population , 10 spot urine sample s or 24-h urine sample s were needed to assess individual iodine status with 20 % precision . Spot sample s would likely be preferable because of their ease of collection . However , the large number of repeated urine sample s needed to estimate individual iodine status is a major limitation and emphasizes the need for further investigation of more practical biomarkers of individual iodine status",
"BACKGROUND The effects of severe iodine deficiency during critical periods of brain development are well documented . There is little known about the consequences of milder forms of iodine deficiency on neurodevelopment . OBJECTIVE The objective was to determine whether supplementing mildly iodine-deficient children with iodine improves cognition . DESIGN A r and omized , placebo-controlled , double-blind trial was conducted in 184 children aged 10 - 13 y in Dunedin , New Zeal and . Children were r and omly assigned to receive a daily tablet containing either 150 microg I or placebo for 28 wk . Biochemical , anthropometric , and dietary data were collected from each child at baseline and after 28 wk . Cognitive performance was assessed through 4 subtests from the Wechsler Intelligence Scale for Children . RESULTS At baseline , children were mildly iodine deficient [ median urinary iodine concentration ( UIC ) : 63 microg/L ; thyroglobulin concentration : 16.4 microg/L ] . After 28 wk , iodine status improved in the supplemented group ( UIC : 145 microg/L ; thyroglobulin : 8.5 microg/L ) , whereas the placebo group remained iodine deficient ( UIC : 81 microg/L ; thyroglobulin : 11.6 microg/L ) . Iodine supplementation significantly improved scores for 2 of the 4 cognitive subtests [ picture concepts ( P = 0.023 ) and matrix reasoning ( P = 0.040 ) ] but not for letter-number sequencing ( P = 0.480 ) or symbol search ( P = 0.608 ) . The overall cognitive score of the iodine-supplemented group was 0.19 SDs higher than that of the placebo group ( P = 0.011 ) . CONCLUSIONS Iodine supplementation improved perceptual reasoning in mildly iodine-deficient children and suggests that mild iodine deficiency could prevent children from attaining their full intellectual potential . The trial was registered with the Australia New Zeal and Clinical Trials Register as ACTRN12608000222347",
"Objective To determine whether an education programme targeted at schoolchildren could lower salt intake in children and their families . Design Cluster r and omised controlled trial , with schools r and omly assigned to either the intervention or control group . Setting 28 primary schools in urban Changzhi , northern China . Participants 279 children in grade 5 of primary school , with mean age of 10.1 ; 553 adult family members ( mean age 43.8 ) . Intervention Children in the intervention group were educated on the harmful effects of salt and how to reduce salt intake within the schools ’ usual health education lessons . Children then delivered the salt reduction message to their families . The intervention lasted for one school term ( about 3.5 months ) . Main outcome measures The primary outcome was the difference between the groups in the change in salt intake ( as measured by 24 hour urinary sodium excretion ) from baseline to the end of the trial . The secondary outcome was the difference between the two groups in the change in blood pressure . Results At baseline , the mean salt intake in children was 7.3 ( SE 0.3 ) g/day in the intervention group and 6.8 ( SE 0.3 ) g/day in the control group . In adult family members the salt intakes were 12.6 ( SE 0.4 ) and 11.3 ( SE 0.4 ) g/day , respectively . During the study there was a reduction in salt intake in the intervention group , whereas in the control group salt intake increased . The mean effect on salt intake for intervention versus control group was −1.9 g/day ( 95 % confidence interval −2.6 to −1.3 g/day ; P mean effect on systolic blood pressure was −0.8 mm Hg ( −3.0 to 1.5 mm Hg ; P=0.51 ) in children and −2.3 mm Hg ( −4.5 to −0.04 mm Hg ; P programme delivered to primary school children as part of the usual curriculum is effective in lowering salt intake in children and their families . This offers a novel and important approach to reducing salt intake in a population in which most of the salt in the diet is added by consumers . Trial registration Clinical Trials.gov NCT01821144",
"CONTEXT Diet can impact on bone strength via metabolic shifts in acid-base status . In contrast to the strongly diet-dependent biomarker urinary potential renal acid load ( uPRAL ) , the amount of renally excreted citrate integrates nutritional and systemic influences on acid-base homeostasis with high citrate indicating prevailing alkalization . OBJECTIVE To examine the association between urinary citrate excretion and bone strength as well as long-term fracture risk . DESIGN AND PARTICIPANTS Prospect i ve cross-sectional analysis ; 231 healthy children ( 6 - 18 y ) of the Dortmund Nutritional and Anthropometric Longitudinally Design ed Study were included , with at least 2 urine collection s available during the 4 years preceding peripheral quantitative computed tomography ( pQCT ) of the nondominant proximal forearm . uPRAL , urinary citrate , and urinary nitrogen excretion were quantified in 857 24-hour urine sample s. Data on overall fracture incidence were collected within a 15-year follow-up after pQCT measurement . MAIN OUTCOME MEASURES Parameters of bone quality and geometry ( pQCT ) as well as long-term fracture incidence . RESULTS After controlling for confounders , especially forearm length , muscle area , and urinary nitrogen ( biomarker of protein intake ) , urinary citrate excretion was positively associated with various parameters of bone quality and geometry ( P Fracture risk in adult females , but not in males , was inversely associated with urinary citrate and positively with uPRAL ( P < .05 ) . CONCLUSIONS Although urinary citrate has to be confirmed as an integrated noninvasive biomarker of systemic acid-base status in further studies , our results substantiate dietary and metabolic acidity as potentially adverse for bone health in the long run from childhood onward",
"Effectiveness of 0.5 mg fluoride ( F ) milk ingestion in preventing caries has been termed only ‘ moderate ’ . In this 3-arm partial cross-over intervention , 32 children aged 6–7 years in a non-F area were recruited and urinary F excretion ( UFE ) measured before and after ingestion of 0.5 or 0.9 mg F milk . Maintaining customary dietary and oral hygiene habits , children underwent a 2-week ‘ wash-in ’ with non-F milk , providing a 24-hour urine sample on day 4 of non-F ( baseline ) and F milk ingestion containing either ( i ) 0.5 mg or ( ii ) 0.9 mg F ( intervention ) . A comparative group of thirteen 6- to 7-year-olds living in fluori date d areas provided a 24-hour urine sample on day 4 of daily non-F milk ingestion , following a 2-week non-F milk wash-in . Valid urine sample s were analysed for F and UFE estimated from corrected 24-hour urine volume and F concentration . For the 24 test children providing 2 valid urine sample s , mean ( 95 % CI ) change in corrected 24-hour UFE was 0.130 ( 0.049 , 0.211 ) and 0.153 ( 0.062 , 0.245 ) mg/day for 0.5 mg ( p , mean ( SD ) corrected 24-hour UFE was 0.437 ( 0.153 ) mg/day and 0.420 ( 0.188 ) mg/day for the 0.5 and 0.9 mg F groups , respectively , which were lower than the WHO provisional st and ards ( 0.48–0.60 mg F/day ) . F milk consumption significantly increased UFE ; however , the F content of 0.5 and 0.9 mg F milk may be too low to achieve WHO provisional UFE st and ards concomitant with optimal F exposure in children aged ≥6 years ",
"Objective : To evaluate the effect of tamarind ( Tamarindus indicus ) ingestion on excretion of fluoride in school children . Design : R and omized , diet-control study .Subject : Twenty healthy boys were included and 18 of them completed the study . Interventions : Each subject consumed 10 g tamarind daily with lunch for 18 days at the social welfare boys ' hostel . The nutrient composition of the daily diet was constant throughout the experimental period . Results : Tamarind intake led to significant increase ( P the excretion of fluoride in 24 h urine ( 4.8±0.22 mg/day ) as compared to excretion on control diet ( 3.5±0.22 mg/day ) . However , excretion of magnesium and zinc decreased significantly ( 7.11±1.48 mg of Mg and 252.88±12.84 µg of Zn per day on tamarind diet as compared to 23.39±3.68 mg of Mg and 331.78±35.31 µg Zn per day on control diet ) . Excretion of calcium and phosphorous were not significantly different while creatinine excretion decreased with tamarind intake ( 225.66±81 mg creatinine/day with tamarind and 294.5±78.76 mg creatinine/day without tamarind ) . Conclusion : Tamarind intake is likely to help in delaying progression of fluorosis by enhancing urinary excretion of fluoride . Sponsorship : National Institute of Nutrition , Hyderabad , India ( ICMR )",
"BACKGROUND Emerging evidence suggests a relationship between sodium ( Na ) intake and obesity risk . The aim of this study was to investigate the link between 24-hour ( 24-h ) urinary Na excretion and adiposity measures in a sample of Iranian children and adolescents . METHODS This cross-sectional study was performed among 374 healthy individuals aged 11 - 18 years old . R and om cluster sampling method was used to select the participants from 4 districts in Isfahan , Iran . Na excretion was estimated using a 24-h urinary sample . Creatinine ( Cr ) level was used to confirm the completeness of sample s. Anthropometric measures including weight , height and waist circumference ( WC ) were obtained based on st and ard protocol s. RESULTS The odds ratio ( OR ) for overweight/obesity in subjects with the highest tertile of Na excretion compared with the lowest tertile was 8.01 [ 95 % confidence interval ( CI ) 4.20 - 15.3 ] in crude model and 8.33 ( 95 % CI 4.14 - 16.8 ) after adjusting for potential confounders . The association was independent of intake of energy and sugar-sweetened beverages ( SSBs ) . The OR for abdominal obesity in the highest tertile of Na excretion compared with the lowest tertile was 9.12 ( 95 % CI 4.78- 17.4 ) in crude model and 9.75 ( 95 % CI 4.88 - 19.5 ) after controlling for potential confounders . The association was independent of energy intake or SSBs consumption . CONCLUSION Our study showed a positive association between Na excretion and obesity among children and adolescents . Further investigation through longitudinal studies using a more representative sample of children and adolescents is suggested to determine whether this is a causal relationship",
"The aim of this study was to establish methodology for a survey of the iodine and selenium status of New Zeal and residents , more specifically to investigate the correlation between fasting or r and om casual urine sample s and 24 hour urines for iodine and selenium excretion . Sixty-two ( 31 M , 31 F ) adults collected casual , fasting and 24 hour urine sample s for analysis of iodide , selenium and creatinine . Plasma and serum sample s were collected for analysis of selenium and glutathione peroxidase activity . Results indicated that fasting urine sample s , but not casual urines , may give a reasonable estimate of urinary output of iodine and selenium on a population basis , but that 24 hour urines are necessary for diagnosis of iodine deficiency in an individual and for research purpose s. The results for iodine also give no support for expressing iodine as the iodide-creatinine ratio , although there was some indication that the selenium-creatinine ratio might be useful . Significant correlations between total daily excretion of selenium and iodine and also for urinary concentrations of the two trace elements in fasting and in 24 hour urine specimens may reflect a relationship of selenium and iodine to body size which may have implication s for dietary requirements of these trace elements . Alternatively the correlations may reflect a relationship between dietary intake of the two trace elements in a country in which food concentrations are low , and this needs further investigation",
"The relationship between blood pressure and the 24-hour urinary excretion of four cations ( Ca , Mg , K , Na ) was investigated in a r and om sample of 688 inhabitants of two Belgian towns . In 160 youths aged 10 - 19 years , systolic/diastolic blood pressure averaged 118 + /- 12.6/65 + /- 8.6 mmHg ( mean + /- st and ard deviation ) and the urinary excretion of the four urinary cations was broadly similar in both sexes . Adjusting for body weight removed the strong relationship between blood pressure and age , but a positive relationship between systolic pressure and pulse rate emerged . The only association between blood pressure and a urinary constituent was with calcium excretion , and this correlation was no longer apparent after adjusting for weight . In 528 adults aged greater than or equal to 20 years , systolic/diastolic pressure averaged 130 + /- 14.4/77 + /- 9.8 ( p less than 0.001 ) higher in male than in female subjects . In these adults , both systolic and diastolic pressure were strongly and independently correlated with age and body weight . Systolic pressure in women was also significantly and positively related to pulse rate ( r = + 0.20 ; p less than 0.001 ) . After adjusting for age and body weight , systolic and diastolic pressure in men were significantly and negatively correlated ( p less than 0.001 and p less than 0.01 , respectively ) with urinary potassium excretion . Diastolic pressure in men was weakly but positively correlated with calcium excretion ( p less than 0.05 after adjusting for body weight , age and urinary potassium excretion ) . The present study indicates that urinary potassium is a consistent and negative predictor of both systolic and diastolic pressure in adult men , whose diastolic pressure was also weakly and positively associated with urinary calcium . In youths and female subjects , the single 24-hour urinary excretion of the four cations did not contribute to the prediction of blood pressure",
"The 24-hour urinary excretion of sodium , potassium , calcium , and magnesium and their relationship to arterial blood pressure were investigated from December 1983 to May 1984 in a 10 % r and om sample ( n = 666 ) of urban Bantu of Kinshasa , Zaïre . In youths aged 10 - 19 years , blood pressure averaged 109/60 mmHg , and the 24-hour urinary excretion of sodium , potassium , calcium , and magnesium averaged 84 mmol , 30 mmol , 483 mumol , and 2 mmol , respectively . After adjustment for age and body weight , a weak positive association became apparent between diastolic pressure and the urinary sodium to potassium ratio in girls and all youths . In adults aged greater than or equal to 20 years , blood pressure averaged 124/72 mmHg , and the 24-hour urinary excretion of sodium , potassium , calcium , and magnesium averaged 87 mmol , 33 mmol , 828 mumol , and 1.88 mmol , respectively . After adjustment for sex , age , body weight , and pulse rate in all adults , systolic pressure was significantly and positively correlated with urinary sodium excretion and negatively correlated with urinary potassium excretion , while diastolic pressure was weakly associated with urinary calcium excretion . In women , an independent and significant association was also observed between systolic pressure and 24-hour urinary sodium . When instead of the 24-hour urinary excretion of sodium and potassium , the sodium to potassium ratio was considered as an independent variable in multiple regression analysis , both systolic and diastolic pressure were independently and positively related to the sodium to potassium ratio in all adults . These results indicate that in this urban Bantu population , age and body weight are the major predictors of systolic pressure in youths and the major predictors of both systolic and diastolic pressure in adults . The sodium to potassium ratio did contribute to the prediction of blood pressure in girls and when , in youths as well as in adults , both sexes were considered together . Urinary calcium was associated with diastolic pressure only in all adults",
"OBJECTIVES 1 ) To investigate the amount of citrate and tartrate in aloe gel , and in the urine of healthy normal children , before and after consuming fresh aloe gel . 2 ) To evaluate the changes in the chemical composition of urine among subjects after taking aloe gel . 3 ) To determine the value of consuming aloe gel for prevention of renal stone formation . DESIGN Experimental study . MATERIAL AND METHOD Thirteen healthy boys between 9 and 13 years of age were enrolled ( with informed permission ) in the clinical trial . Subjects ingested 100 g of fresh prepared aloe gel twice a day for seven consecutive days . The 24-hour urine was collected one day prior to taking the gel ( Day 0 ) , Days 2 and 5 of consumption , and Day 8 ( one day after completion ) . The authors determined the urine volume , osmolality , potassium , sodium , phosphate , calcium , magnesium , uric acid , citrate , tartrate , oxalate , Permissible Increment in Calcium ( PI Ca ) , Permissible Increment in Oxalate ( PI Ox ) , Concentration Product Ratio of Calcium Phosphate ( CPR CaPO4 ) and the citrate per creatinine ratio . RESULTS The citrate and tartrate concentration in 100 g of fresh aloe gel was 96.3 and 158.9 mg , respectively . The 24-hr urine volume and urinary citrate excretion were significantly increased ( p PI Ca and the PI Ox were also significantly increased ( p Aloe vera gel contains 96.3 milligrams of citrate and 158.9 milligrams of tartrate and were in the mid-range among Thai fruits . Changes in chemical compositions of urine after aloe gel consumption shows potential for preventing kidney stone formation among children",
"CONTEXT Whether adrenarche impacts on pubertal development is controversial . OBJECTIVE The objective of the study was to examine the associations of adrenal and rogen ( AA ) secretion with early and late pubertal markers , independent of potential influences of dietary animal protein intake . DESIGN AND PARTICIPANTS This was a prospect i ve cohort study of healthy free-living Caucasian children ( n = 109 ) who provided both 24-h urine sample s and 3-d weighed dietary records 1 and 2 yr before the biological age at take-off of the pubertal growth spurt ( ATO ) . MEASUREMENTS Twenty-four-hour excretion rates of and rogen ( C19 ) metabolites quantified by gas chromatography-mass spectrometry were measured . MAIN OUTCOMES ATO , age at peak height velocity ( APHV ) , age at menarche/voice break , duration of pubertal growth acceleration , and ages at Tanner stage 2 for breast ( girls ) and genital ( boys ) development ( B2-G2 ) and pubic hair ( PH2 ) . RESULTS Higher adrenarchal C19 steroids predicted earlier ages at Tanner stage 2 for pubic hair ( P pubertal growth acceleration period ( P = 0.001 ) , independently of animal protein intake . Children with a higher AA secretion had a 1.5-yr earlier beginning of pubarche and a 0.8-yr earlier beginning of B2-G2 than those with a lower AA excretion . Furthermore , animal protein intake was independently negatively associated with ATO and APHV ( P age at menarche/voice break ( P = 0.07 ) . CONCLUSION A higher animal protein intake may be involved in an earlier attainment of ATO and APHV , whereas a more intensive adrenarchal process may precipitate a shorter pubertal growth spurt and a notably earlier onset of breast and genital development in girls and boys , respectively",
"Purpose To measure the iodine status and iodine intake of New Zeal and adults 18–64 years of age following m and atory fortification of bread with iodine . Methods A cross-sectional survey of NZ adults living in Dunedin and Wellington during February – November 2012 . Three hundred and one men and women aged 18–64 years r and omly selected from the New Zeal and Electoral Roll completed a 24-h urine collection , a demographic and iodine-specific food frequency question naire ( FFQ ) , and had height and weight measured . Urine collection s were analysed for iodine and reported as median urinary iodine concentration ( UIC ) µg/L and median urinary iodine excretion ( UIE ) µg/day . The FFQ was used to estimate iodine intake with and without discretionary iodised salt use . Results The median UIC for all adults was 73 µg/L , indicative of mild iodine deficiency . The mean urinary volume was 2.0 L. As an estimate of iodine intake , the median UIE was 127 µg/day . Estimated iodine intake , using the FFQ which included discretionary iodised salt use , was 132 µg/day . Iodine intakes were associated with UIC ( P = 0.040 ) and UIE ( P = 0.003 ) , but not with bread iodine intake and iodised salt use . Conclusion Using the WHO/UNICEF/ICCIDD target for iodine sufficiency ( a UIC of > 100 µg/L ) based on school-aged children with a mean urinary volume of 1.0 L , the iodine status of NZ adults does not reach adequate levels ( 73 µg/L ) . A more realistic parameter in a population with a higher urinary volume excretion ( 2.0 L ) is the UIE . A median UIE of 127 µg/day suggests that the iodine status of NZ adults is now likely to be adequate",
"The use of creatinine as a check on the completeness of 24-h urine collection s is based on the assumption that excretion per kg body mass is constant . In a study of eight volunteers maintained on uniform diets the within-subject coefficient of variation ( CV ) in daily 24-h creatinine excretion was only 4 per cent under conditions in which the completeness of collection s was assured . Cooked meat contains creatine and creatinine and an addition of 260 g/d cooked meat to the diet of four volunteers on a metabolic diet increased urine creatinine excretion by 23 per cent . A further source of variation in urine creatinine is the completeness of the collection itself . A new marker , PABA , was used to check the completeness of 24-h urine collection s in eight subjects studied for 28 d whilst eating their normal diets . The within-subject CV of 9 per cent for 24-h creatinine excretion was not significantly different from that of 13 per cent for overall urinary N. In 122 complete 24-h urine specimens collected from a r and omly selected population , the CV in creatinine excretion was 18 per cent . Twenty-one urine sample s were incomplete , of which only 3 would have been detected on the basis of low creatinine by conventional st and ards . Of 39 hospital patients asked to collect 24-h urine sample s , 12 provided incomplete sample s , of which only 4 had low creatinine excretion . It is concluded that PABA is a more sensitive and reliable verification of the completeness of 24-h urine collection s than creatinine",
"The objective of this study was to compare serum calcium levels , dietary calcium intake , and urinary calcium excretion between junior high students with high-normal and low-normal blood pressure . The study was conducted in 11- to 14-year-old children recruited after blood pressure screening of 5th to 8th grade Minneapolis and St. Paul Public School students . Comparisons were made between a group of 243 children selected from the upper 15 percentiles of the blood pressure distribution ( high-normal group ) and 40 children r and omly selected from the lowest 10 % of the blood pressure distribution ( low-normal group ) . Blood sample s were obtained from the participants at clinic visits conducted after school . Calcium measurements were based on the principle that serum calcium is found in three forms : 1 ) an ionized fraction ; 2 ) a fraction complexed with organic anions such as citrate , phosphate , and lactate ; and 3 ) a protein-bound fraction . Dietary calcium intake was determined from food diaries , and urinary electrolytes were determined in 24-h urine collection s. Serum total calcium levels were not significantly different between groups . However , serum ultrafilterable , true ionized , ionized normalized for pH , and complexed calcium levels were significantly greater in the low-normal group . There was no significant difference in 24-h intake of calcium or other nutrients between the groups . The low-normal group excreted significantly more calcium than the high-normal group , but there were no significant differences in sodium , potassium , or chloride excretion . This report of the relation between calcium and blood pressure represents the first study in children or adolescents to include serum , dietary , and urine data . ( ABSTRACT TRUNCATED AT 250 WORDS",
"To assess the daily iodine intake in a population study , we have compared the validity and degree of reliability of the urine iodide/creatinine ratios and iodide concentrations of casual sample s as a representative index of daily urine iodide excretion . The morning urine sample s were obtained from apparently healthy 2,956 men and 1,182 women residing in Sapporo , Japan , and urine iodide was measured by an iodide selective electrode . The iodide/creatinine ratios was higher in women than in men , increasing more steeply with age in women than in men , due to a concomitant decrease in the urine creatinine level with age . The iodide concentration showed no age-related change . Similarly the daily urine iodide excretion measured in 22 control subjects by collecting 24-h urine specimens did not vary with age , while the iodide/creatinine ratio of these subjects increased with age . The correlation coefficient(r ) of the iodide concentration with daily iodide excretion in the 95 observations of the 22 subjects was 0.832 ( P iodide/creatinine ratio with daily iodide excretion ( 0.699 , P iodide concentration in morning urine sample s in the population ( n = 4,138 ) was 9.0 - 70.3 mumol/L with a mean of 27.1 mumol/L. ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND The goal of eliminating iodine deficiency worldwide was successfully achieved in China after the implementation of a m and atory universal salt iodization program for the last 16 years . Thus , China has been assessed as a country with more than adequate iodine levels . This survey aim ed to investigate the current iodine status in China and the effects of an increased iodine intake on the spectrum and prevalence of thyroid disorders . METHODS A total of 15,008 adult subjects from 10 cities in eastern and central China were investigated . Serum thyrotropin ( TSH ) , thyroid peroxidase antibodies ( TPOAb ) , thyroglobulin antibodies ( TgAb ) , and urine iodine concentration ( UIC ) were measured , and an ultrasonography of the thyroid was performed in all subjects . Free thyroxine ( fT4 ) and free triiodothyronine ( fT3 ) levels were only measured if the serum TSH was outside the normal range . RESULTS The median UIC values were 197 μg/L in school-age children ( SAC ) and 205 μg/L in a cohort population . Six cities were classified as regions with adequate iodine intake ( AII ) , and four cities as regions with more than adequate iodine intake ( MTAII ) , according to median SAC UIC . The prevalence of clinical hypothyroidism , sub clinical hypothyroidism , and positive thyroid antibodies was significantly higher in MTAII cities than it was in AII cities . Moreover , the prevalence of clinical hyperthyroidism ( 1.1 % vs. 0.8 % , p = 0.033 ) and Graves ' disease ( 0.8 % vs. 0.5 % , p = 0.019 ) also significantly increased in MTAII cities . Compared with a five-year prospect i ve study conducted in 1999 , the prevalence of goiter significantly decreased ( 2.9 % vs. 5.02 % , p = 0.001 ) , but there was a significant increase in thyroid nodules ( 12.8 % vs. 2.78 % , p = 0.001 ) . The prevalence of sub clinical hypothyroidism ( 16.7 % vs. 3.22 % ) , positive TPOAb ( 11.5 % vs. 9.81 % ) , and positive TgAb ( 12.6 % vs. 9.09 % ) significantly increased , while no changes were seen in clinical hyperthyroidism , sub clinical hyperthyroidism , or Graves ' disease . CONCLUSION The goal of eliminating iodine deficiency has been successfully achieved in China . However , the prevalence and spectrum of thyroid disorders has increased , reflecting possible adverse effects of increased iodine intake"
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Increasing evidence indicates a relationship between cannabis use and psychosis risk . Specific factors , such as determinants of cannabis use or the genetic profile of cannabis users , appear to moderate this association . The present systematic review presents a detailed and up-to- date literature overview on factors that influence the relationship between cannabis use and psychosis risk . A systematic search was performed according to the PRISMA guidelines in MEDLINE and Embase , and 56 studies were included . The results show that , in particular , frequent cannabis use , especially daily use , and the consumption of high-potency cannabis are associated with a higher risk of developing psychosis . Moreover , several genotypes moderate the impact of cannabis use on psychosis risk , particularly those involved in the dopamine function , such as AKT1 . Finally , cannabis use is associated with an earlier psychosis onset and increased risk of transition in individuals at a clinical high risk of psychosis . These findings indicate that changing cannabis use behavior could be a harm reduction strategy employed to lower the risk of developing psychosis . Future research should aim to further develop specific biomarkers and genetic profiles for psychosis , thereby contributing to the identification of individuals at the highest risk of developing a psychotic disorder
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"Background Observational associations between cannabis and schizophrenia are well documented , but ascertaining causation is more challenging . We used Mendelian r and omization ( MR ) , utilizing publicly available data as a method for ascertaining causation from observational data . Method We performed bi-directional two- sample MR using summary -level genome-wide data from the International Cannabis Consortium ( ICC ) and the Psychiatric Genomics Consortium ( PGC2 ) . Single nucleotide polymorphisms ( SNPs ) associated with cannabis initiation ( p ) and schizophrenia ( p 5 × 10−8 ) were combined using an inverse-variance-weighted fixed-effects approach . We also used height and education genome-wide association study data , representing negative and positive control analyses . Results There was some evidence consistent with a causal effect of cannabis initiation on risk of schizophrenia [ odds ratio ( OR ) 1.04 per doubling odds of cannabis initiation , 95 % confidence interval ( CI ) 1.01–1.07 , p = 0.019 ] . There was strong evidence consistent with a causal effect of schizophrenia risk on likelihood of cannabis initiation ( OR 1.10 per doubling of the odds of schizophrenia , 95 % CI 1.05–1.14 , p = 2.64 × 10−5 ) . Findings were as predicted for the negative control ( height : OR 1.00 , 95 % CI 0.99–1.01 , p = 0.90 ) but weaker than predicted for the positive control ( years in education : OR 0.99 , 95 % CI 0.97–1.00 , p = 0.066 ) analyses . Conclusions Our results provide some that cannabis initiation increases the risk of schizophrenia , although the size of the causal estimate is small . We find stronger evidence that schizophrenia risk predicts cannabis initiation , possibly as genetic instruments for schizophrenia are stronger than for cannabis initiation",
"OBJECTIVE Despite the controversy surrounding the possible causal link between cannabis use and the onset of schizophrenia ( SZ ) , data seeking to eluci date the effect of cannabis use disorders ( CUDs ) on the clinical presentation of SZ have produced mixed results . Although several studies have suggested that CUD in patients with SZ may be associated with variation in cognitive function , clinical presentation and course of illness , the effects have been inconsistent . METHODS We retrospectively ascertained a large cohort ( N=455 ) of SZ patients with either no history of a CUD ( CUD- ; N=280 ) or a history of CUD ( CUD+ ; N=175 ) . The groups were initially compared on key demographic variables including sex , race , age , age at onset of SZ , parental socioeconomic status , premorbid IQ , education level and global assessment of functioning . Covarying for any observed differences in demographic variables , we then compared groups on lifetime measures of psychotic symptoms as well as a brief battery of neurocognitive tests . RESULTS Compared to the CUD- group the CUD+ group demonstrated significantly better performance on measures of processing speed ( Trail Making Tests A and B ) , verbal fluency ( animal naming ) and verbal learning and memory ( California Verbal Learning Test ) . Moreover , the CUD+ group had better GAF scores than the CUD group . CONCLUSIONS Collectively , these findings suggest that SZ patients with comorbid CUD may represent a higher functioning subgroup of SZ . Future prospect i ve studies are needed to eluci date the nature of this relationship",
"Cannabidiol is a component of marijuana that does not activate cannabinoid receptors , but moderately inhibits the degradation of the endocannabinoid an and amide . We previously reported that an elevation of an and amide levels in cerebrospinal fluid inversely correlated to psychotic symptoms . Furthermore , enhanced an and amide signaling let to a lower transition rate from initial prodromal states into frank psychosis as well as postponed transition . In our translational approach , we performed a double-blind , r and omized clinical trial of cannabidiol vs amisulpride , a potent antipsychotic , in acute schizophrenia to evaluate the clinical relevance of our initial findings . Either treatment was safe and led to significant clinical improvement , but cannabidiol displayed a markedly superior side-effect profile . Moreover , cannabidiol treatment was accompanied by a significant increase in serum an and amide levels , which was significantly associated with clinical improvement . The results suggest that inhibition of an and amide deactivation may contribute to the antipsychotic effects of cannabidiol potentially representing a completely new mechanism in the treatment of schizophrenia",
"OBJECTIVE Research in both animals and humans indicates that cannabidiol ( CBD ) has antipsychotic properties . The authors assessed the safety and effectiveness of CBD in patients with schizophrenia . METHOD In an exploratory double-blind parallel-group trial , patients with schizophrenia were r and omized in a 1:1 ratio to receive CBD ( 1000 mg/day ; N=43 ) or placebo ( N=45 ) alongside their existing antipsychotic medication . Participants were assessed before and after treatment using the Positive and Negative Syndrome Scale ( PANSS ) , the Brief Assessment of Cognition in Schizophrenia ( BACS ) , the Global Assessment of Functioning scale ( GAF ) , and the improvement and severity scales of the Clinical Global Impressions Scale ( CGI-I and CGI-S ) . RESULTS After 6 weeks of treatment , compared with the placebo group , the CBD group had lower levels of positive psychotic symptoms ( PANSS : treatment difference=-1.4 , 95 % CI=-2.5 , -0.2 ) and were more likely to have been rated as improved ( CGI-I : treatment difference=-0.5 , 95 % CI=-0.8 , -0.1 ) and as not severely unwell ( CGI-S : treatment difference=-0.3 , 95 % CI=-0.5 , 0.0 ) by the treating clinician . Patients who received CBD also showed greater improvements that fell short of statistical significance in cognitive performance ( BACS : treatment difference=1.31 , 95 % CI=-0.10 , 2.72 ) and in overall functioning ( GAF : treatment difference=3.0 , 95 % CI=-0.4 , 6.4 ) . CBD was well tolerated , and rates of adverse events were similar between the CBD and placebo groups . CONCLUSIONS These findings suggest that CBD has beneficial effects in patients with schizophrenia . As CBD 's effects do not appear to depend on dopamine receptor antagonism , this agent may represent a new class of treatment for the disorder",
"Observational studies have suggested that psychometric psychosis liability and a functional polymorphism in the catechol-O-methyltransferase ( COMT Val158Met ) gene moderate the psychosis-inducing effect of cannabis . To replicate and extend this finding , a double-blind , placebo-controlled cross-over design was used in which patients with a psychotic disorder ( n=30 ) , relatives of patients with a psychotic disorder ( n=12 ) , and healthy controls ( n=32 ) were exposed to Δ-9-tetrahydrocannabinol ( Δ-9-THC , the principal component of cannabis ) or placebo , followed by cognitive assessment and assessment of current psychotic experiences . Previous expression of psychometric psychosis liability was also assessed . Models of current psychotic experiences and cognition were examined with multilevel r and om regression analyses to assess ( i ) main effects of genotype and condition , ( ii ) interactions between condition and genotype , and ( iii ) three-way interactions between condition , genotype , and psychometric psychosis liability . Carriers of the Val allele were most sensitive to Δ-9-THC-induced psychotic experiences , but this was conditional on prior evidence of psychometric psychosis liability . Δ-9-THC impacted negatively on cognitive measures . Carriers of the Val allele were also more sensitive to Δ-9-THC-induced memory and attention impairments compared to carriers of the Met allele . Experimental effects of Δ-9-THC on cognition and psychosis are moderated by COMT Val158Met genotype , but the effects may in part be conditional on the additional presence of pre-existing psychosis liability . The association between cannabis and psychosis may represent higher order gene – environment and gene – gene interactions",
"BACKGROUND Cannabis use is associated with an increased risk of developing a psychotic disorder but the temporal relationship between cannabis use and onset of illness is unclear . The objective of this study was to assess prospect ively the influence of cannabis use on transition to psychosis in people at ultra-high risk ( UHR ) for the disorder . METHOD Lifetime and continued cannabis use was assessed in a consecutively ascertained sample of 182 people ( 104 male , 78 female ) at UHR for psychosis . Individuals were then followed clinical ly for 2 years to determine their clinical outcomes . RESULTS Lifetime cannabis use was reported by 134 individuals ( 73.6 % ) . However , most of these individuals had stopped using cannabis before clinical presentation ( n=98 , 73.1 % ) , usually because of adverse effects . Among lifetime users , frequent use , early-onset use and continued use after presentation were all associated with an increase in transition to psychosis . Transition to psychosis was highest among those who started using cannabis before the age of 15 years and went on to use frequently ( frequent early-onset use : 25 % ; infrequent or late-onset use : 5 % ; χ(2)1=10.971 , p=0.001 ) . However , within the whole sample , cannabis users were no more likely to develop psychosis than those who had never used cannabis ( cannabis use : 12.7 % ; no use : 18.8 % ; χ(2)1=1.061 , p=0.303 ) . CONCLUSIONS In people at UHR for psychosis , lifetime cannabis use was common but not related to outcome . Among cannabis users , frequent use , early-onset use and continued use after clinical presentation were associated with transition to psychosis ",
"Recent advances in the underst and ing of brain cannabinoid receptor function have renewed interest in the association between cannabinoid compounds and psychosis . In a 3-day , double-blind , r and omized , and counterbalanced study , the behavioral , cognitive , and endocrine effects of 0 , 2.5 , and 5 mg intravenous delta-9-tetrahydrocannabinol ( Δ-9-THC ) were characterized in 22 healthy individuals , who had been exposed to cannabis but had never been diagnosed with a cannabis abuse disorder . Prospect i ve safety data at 1 , 3 , and 6 months post study was also collected . Δ-9-THC ( 1 ) produced schizophrenia-like positive and negative symptoms ; ( 2 ) altered perception ; ( 3 ) increased anxiety ; ( 4 ) produced euphoria ; ( 5 ) disrupted immediate and delayed word recall , sparing recognition recall ; ( 6 ) impaired performance on tests of distractibility , verbal fluency , and working memory ( 7 ) did not impair orientation ; ( 8) increased plasma cortisol . These data indicate that Δ-9-THC produces a broad range of transient symptoms , behaviors , and cognitive deficits in healthy individuals that resemble some aspects of endogenous psychoses . These data warrant further study of whether brain cannabinoid receptor function contributes to the pathophysiology of psychotic disorders",
"CONTEXT Cannabis sativa use can impair verbal learning , provoke acute psychosis , and increase the risk of schizophrenia . It is unclear where C. sativa acts in the human brain to modulate verbal learning and to induce psychotic symptoms . OBJECTIVES To investigate the effects of 2 main psychoactive constituents of C. sativa , Delta9-tetrahydrocannabinol ( Delta9-THC ) and cannabidiol , on regional brain function during verbal paired associate learning . DESIGN Subjects were studied on 3 separate occasions using a block design functional magnetic resonance imaging paradigm while performing a verbal paired associate learning task . Each imaging session was preceded by the ingestion of Delta9-THC ( 10 mg ) , cannabidiol ( 600 mg ) , or placebo in a double-blind , r and omized , placebo-controlled , repeated- measures , within-subject design . SETTING University research center . PARTICIPANTS Fifteen healthy , native English-speaking , right-h and ed men of white race/ethnicity who had used C. sativa 15 times or less and had minimal exposure to other illicit drugs in their lifetime . MAIN OUTCOME MEASURES Regional brain activation ( blood oxygen level-dependent response ) , performance in a verbal learning task , and objective and subjective ratings of psychotic symptoms , anxiety , intoxication , and sedation . RESULTS Delta9-Tetrahydrocannabinol increased psychotic symptoms and levels of anxiety , intoxication , and sedation , whereas no significant effect was noted on these parameters following administration of cannabidiol . Performance in the verbal learning task was not significantly modulated by either drug . Administration of Delta9-THC augmented activation in the parahippocampal gyrus during blocks 2 and 3 such that the normal linear decrement in activation across repeated encoding blocks was no longer evident . Delta9-Tetrahydrocannabinol also attenuated the normal time-dependent change in ventrostriatal activation during retrieval of word pairs , which was directly correlated with concurrently induced psychotic symptoms . In contrast , administration of cannabidiol had no such effect . CONCLUSION The modulation of mediotemporal and ventrostriatal function by Delta9-THC may underlie the effects of C. sativa on verbal learning and psychotic symptoms , respectively",
"Cannabis use is observationally associated with an increased risk of schizophrenia , but whether the relationship is causal is not known . Using a genetic approach , we took 10 independent genetic variants previously identified to associate with cannabis use in 32 330 individuals to determine the nature of the association between cannabis use and risk of schizophrenia . Genetic variants were employed as instruments to recapitulate a r and omized controlled trial involving two groups ( cannabis users vs nonusers ) to estimate the causal effect of cannabis use on risk of schizophrenia in 34 241 cases and 45 604 controls from predominantly European descent . Genetically-derived estimates were compared with a meta- analysis of observational studies reporting ever use of cannabis and risk of schizophrenia or related disorders . Based on the genetic approach , use of cannabis was associated with increased risk of schizophrenia ( odds ratio ( OR ) of schizophrenia for users vs nonusers of cannabis : 1.37 ; 95 % confidence interval ( CI ) , 1.09–1.67 ; P-value=0.007 ) . The corresponding estimate from observational analysis was 1.43 ( 95 % CI , 1.19–1.67 ; P-value for heterogeneity = 0.76 ) . The genetic markers did not show evidence of pleiotropic effects and accounting for tobacco exposure did not alter the association ( OR of schizophrenia for users vs nonusers of cannabis , adjusted for ever vs never smoker : 1.41 ; 95 % CI , 1.09–1.83 ) . This adds to the substantial evidence base that has previously identified cannabis use to associate with increased risk of schizophrenia , by suggesting that the relationship is causal . Such robust evidence may inform public health messages about cannabis use , especially regarding its potential mental health consequences",
"Clinical and laboratory studies link alcohol and other drug use to the occurrence of psychotic experiences , but epidemiologic evidence has been lacking . In this study , the quantitative relationships between alcohol or other drug use and psychotic experiences were examined by analysis of prospect i ve data from 4994 adult household residents sample d in a multisite survey of mental disorders in the population , the NIMH Epidemiologic Catchment Area Program . After control for sociodemographic factors and preexisting psychiatric conditions , the risk for onset of self-reported delusions or hallucinations was observed to be greater for daily users of marijuana or cocaine and for users of anxiolytics or sympathomimetics compared with nonusers . After control for daily cocaine use and alcohol disorder , the risk of onset of psychotic experiences for daily users of marijuana was double that for nonusers . Alcohol disorder in men was associated with eightfold risk and in women with threefold risk . Baseline depressive episodes , manic episodes , agoraphobia , and obsessive-compulsive disorder also were associated with increased risk of onset of psychotic experiences",
"Psychosis is a heterogeneous psychiatric condition for which a multitude of risk and protective factors have been suggested . This umbrella review aim ed to classify the strength of evidence for the associations between each factor and psychotic disorders whilst controlling for several biases . The Web of Knowledge data base was search ed to identify systematic review s and meta-analyses of observational studies which examined associations between socio-demographic , parental , perinatal , later factors or antecedents and psychotic disorders , and which included a comparison group of healthy controls , published from 1965 to January 31 , 2017 . The literature search and data extraction followed PRISMA and MOOSE guidelines . The association between each factor and ICD or DSM diagnoses of non-organic psychotic disorders was grade d into convincing , highly suggestive , suggestive , weak , or non-significant according to a st and ardized classification based on : number of psychotic cases , r and om-effects p value , largest study 95 % confidence interval , heterogeneity between studies , 95 % prediction interval , small study effect , and excess significance bias . In order to assess evidence for temporality of association , we also conducted sensitivity analyses restricted to data from prospect i ve studies . Fifty-five meta-analyses or systematic review s were included in the umbrella review , corresponding to 683 individual studies and 170 putative risk or protective factors for psychotic disorders . Only the ultra-high-risk state for psychosis ( odds ratio , OR=9.32 , 95 % CI : 4.91 - 17.72 ) and Black-Caribbean ethnicity in Engl and ( OR=4.87 , 95 % CI : 3.96 - 6.00 ) showed convincing evidence of association . Six factors were highly suggestive ( ethnic minority in low ethnic density area , second generation immigrants , trait anhedonia , premorbid IQ , minor physical anomalies , and olfactory identification ability ) , and nine were suggestive ( urbanicity , ethnic minority in high ethnic density area , first generation immigrants , North-African immigrants in Europe , winter/spring season of birth in Northern hemisphere , childhood social withdrawal , childhood trauma , Toxoplasma gondii IgG , and non-right h and edness ) . When only prospect i ve studies were considered , the evidence was convincing for ultra-high-risk state and suggestive for urbanicity only . In summary , this umbrella review found several factors to be associated with psychotic disorders with different levels of evidence . These risk or protective factors represent a starting point for further etiopathological research and for the improvement of the prediction of psychosis",
"Papers pp 1195 , 1199 The strongest evidence that cannabis use may be a risk factor for later psychosis comes from a Swedish cohort study which found that heavy cannabis use at age 18 increased the risk of later schizophrenia sixfold . 1 2 This study could not establish whether adolescent cannabis use was a consequence of pre-existing psychotic symptoms rather than a cause . We present the first prospect i ve longitudinal study of adolescent cannabis use as a risk factor for adult schizophreniform disorder , taking into account childhood psychotic symptoms3 antedating cannabis use . View this table : Association between cannabis use in adolescence and schizophrenia and depressive symptoms and disorders at age 26 ( n=759 ) , controlling for childhood psychotic symptoms and use of other drugs in adolescence The Dunedin multidisciplinary health and development study ( a study of a general population birth cohort of 1037 individuals born in Dunedin , New Zeal and , in 1972 - 3)4 has a 96 % follow up rate at age 26 . It obtained information on psychotic symptoms at age 11 and drug use at ages 15 and 18 from self reports and assessed",
"Cannabis use is a heritable trait that has been associated with adverse mental health outcomes . In the largest genome-wide association study ( GWAS ) for lifetime cannabis use to date ( N = 184,765 ) , we identified eight genome-wide significant independent single nucleotide polymorphisms in six regions . All measured genetic variants combined explained 11 % of the variance . Gene-based tests revealed 35 significant genes in 16 regions , and S-PrediXcan analyses showed that 21 genes had different expression levels for cannabis users versus nonusers . The strongest finding across the different analyses was CADM2 , which has been associated with substance use and risk-taking . Significant genetic correlations were found with 14 of 25 tested substance use and mental health – related traits , including smoking , alcohol use , schizophrenia and risk-taking . Mendelian r and omization analysis showed evidence for a causal positive influence of schizophrenia risk on cannabis use . Overall , our study provides new insights into the etiology of cannabis use and its relation with mental health . A GWAS of lifetime cannabis use reveals new risk loci , shows that cannabis use has genetic overlap with smoking and alcohol use , and indicates that the likelihood of initiating cannabis use is causally influenced by schizophrenia",
"Abstract Aims We tested the age‐varying associations of cannabis use ( CU ) frequency and disorder ( CUD ) with psychotic , depressive and anxiety symptoms in adolescent and adult sample s. Moderating effects of early onset ( ≤ 15 years ) and sex were tested . Design Time‐varying effect models were used to assess the significance of concurrent associations between CU and CUD and symptoms of psychosis , depression and anxiety at each age . Setting and Participants Adolescent data ( V‐HYS ; n = 662 ) were collected from a r and omly recruited sample of adolescents in Victoria , British Columbia , Canada during a 10‐year period ( 2003–13 ) . Adult cross‐sectional data ( NESARC‐III ; n = 36 309 ) were collected from a representative sample from the United States ( 2012–13 ) . Measurements Mental health symptoms were assessed using self‐report measures of diagnostic symptoms . CU was based on frequency of past‐year use . Past‐year CUD was based on DSM‐5 criteria . Findings For youth in the V‐HYS , CU was associated with psychotic symptoms following age 22 [ b = 0.13 , 95 % confidence interval ( CI ) = 0.002 , 0.25 ] , with depressive symptoms from ages 16–19 and following age 25 ( b = 0.17 , 95 % CI = 0.003 , 0.34 ) , but not with anxiety symptoms . CUD was associated with psychotic symptoms following age 23 ( b = 0.51 , 95 % CI = 0.01 , 1.01 ) , depressive symptoms at ages 19–20 and following age 25 ( b = 0.71 , 95 % CI = 0.001 , 1.42 ) and anxiety symptoms ages 26–27 only . For adults in the NESARC‐III , CU was associated with mental health symptoms at most ages [ e.g. psychotic symptoms ; age 18 ( b = 0.22 , 95 % CI = 0.10 , 0.33 ) to age 65 ( b = 0.36 , 95 % CI = 0.16 , 0.56 ) ] . CUD was associated with all mental health symptoms across most ages [ e.g. depressive symptoms ; age 18 ( b = 0.96 , 95 % CI = 0.19 , 1.73 ) to age 61 ( b = 1.11 , 95 % CI = 0.01 , 2.21 ) ] . Interactions with sex show stronger associations for females than males in young adulthood [ e.g. V‐HYS : CUD × sex interaction on psychotic symptoms significant after age 26 ( b = 1.12 , 95 % CI = 0.02 , 2.21 ) ] . Findings were not moderated by early‐onset CU . Conclusions Significant associations between cannabis use ( CU ) frequency and disorder ( CUD ) and psychotic and depressive symptoms in late adolescence and young adulthood extend across adulthood , and include anxiety"
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Objective The aim of this study was to evaluate the clinical efficacy and safety outcomes of the treatment with cryoballoon ( CB ) compared to the treatment with traditional irrigated radiofrequency ablation ( RF ) for pulmonary vein isolation ( PVI ) in patients with paroxysmal atrial fibrillation ( pAF ) and refractory to antiarrhythmic drug therapy ( AAD ) . Design We conducted a systemic review to find and include more than two r and omized controlled trials ( RCTs ) with at least 20 patients in each of the CB and RF groups . Thereafter , we performed a meta- analysis to compare the treatment with CB and RF in primary outcomes including 1 year free from AF , complications and re-ablation procedures . Additionally , we evaluated procedure time and fluoroscopy duration in both groups . Risk of bias in the individual studies and across studies was assessed using Cochrane methods . Data extraction and synthesis Two review ers extracted study data and assessed risk of bias . Primary outcome data were extracted from the time point 1 year after the procedure . The r and om-effects model was used to calculate the odds ratio with 95 % confidence interval . Data sources Data sources utilized were PubMed and CENTRAL data bases up to 16 June 2016 . Eligibility criteria for selecting studies Included studies were RCTs in adults with pAF and refractory to AAD in which CB therapy , including 1st and 2nd generation CB , was compared to the traditional irrigated RF therapy . Clinical outcomes assessed in each RCT were 1 year AF-free survival , complication rates , re-ablations , fluoroscopy time and procedure time . Results The systematic review identified four r and omized controlled trials that reported on comparative clinical outcomes involving 1284 patients . Our meta- analysis demonstrated that CB ablation had a non-significant higher success rate than RF therapy ( OR 1.13 ; 95 % CI 0.72–1.77 ) . However , our study showed a relatively higher rate of complications in the CB group ( OR 1.20 ; 95 % CI 0.58–2.52 ) . Furthermore , CB treatment was associated with a non-significant , shorter procedure time and marginally prolonged fluoroscopy time in comparison to RF treatment . Conclusion Our systemic review and meta- analysis revealed further evidence that cryoballoon ablation is an equally effective alternative procedure to the st and ard radiofrequency treatment with a slightly , non-significant higher freedom from AF 1 year after the ablation and a shorter procedure time
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"Introduction Pulmonary vein isolation ( PVI ) is an effective therapy for paroxysmal atrial fibrillation ( AF ) , but it has limitations . The two most significant recent advances have centred on the integration of real-time quantitative assessment of catheter contact force into focal radio frequency ( RF ) ablation catheters and the development of dedicated ablation tools capable of achieving PVI with a single ablation lesion ( A rct ic Front cryoballoon , Medtronic , Minneapolis , MN , USA ) . Although each of these holds promise for improving the clinical success of catheter ablation of AF , there has not been a rigorous comparison of these advanced ablation technologies . Moreover , the optimal duration of cryoablation ( freezing time ) has not been determined . Methods and analysis Patients undergoing an initial PVI procedure for paroxysmal AF will be recruited . Patients will be r and omised 1:1:1 between contact-force irrigated RF ablation , short duration cryoballoon ablation ( 2 min applications ) and st and ard duration cryoballoon ablation ( 4 min applications ) . The primary outcome is time to first documented AF recurrence on implantable loop recorder . With a sample size of 111 per group and a two-sided 0.025 significance level ( to account for the two main comparisons ) , the study will have 80 % power ( using a log-rank test ) to detect a difference of 20 % between contact force RF catheter ablation and either of the two cryoballoon ablation groups . Factoring in a 4 % loss to follow-up , 116 patients per group should be r and omised and followed for a year ( total study population of 348 ) . Ethics and dissemination The study was approved by the University of British Columbia Office of Research ( Services ) Ethics Clinical Research Ethics Board . Results of the study will be su bmi tted for publication in a peer- review ed journal . Trial registration number NCT01913522 ; Pre-",
"Background — There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency ( RF ) and cryoballoon catheter ( CB ) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation . Methods and Results — In a prospect i ve , noninferiority study , 315 patients were r and omly assigned to RF ( n=159 ) or CB ( n=156 ) ablation . The primary end point was freedom from atrial arrhythmia with absence of persistent complications . Patients were largely comparable between groups with more vascular disease in the RF group ( 8.2 % versus 2.6 % for CB ; P=0.028 ) . The primary end point at 12 months was achieved by 70.7 % with RF and 73.6 % with CB ( multiple procedure success ) , including 31 redo procedures in each group ( 19.5 % of RF versus 19.9 % of CB ; P=0.933 ) . For the intention-to-treat population , noninferiority of CB was revealed for the predefined inferiority margin ( risk difference , 0.029 ; 95 % confidence interval , −0.074 to 0.132 ; P Rates at 6 months were 63.1 % and 64.1 % for the RF and CB groups ( single procedure success ) , and noninferiority was confirmed ( risk difference , 0.010 ; 95 % confidence interval , −0.097 to 0.116 ; P=0.002 ) . Periprocedural complications for the index procedure were more frequent in the CB group ( 5.0 % RF , 12.2 % CB ; P=0.022 ) with a significant difference in phrenic nerve palsies ( 0 % RF , 5.8 % CB ; P=0.002 ) . Conclusion — This large , prospect i ve , r and omized , controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00774566",
"BACKGROUND Catheter ablation is an established treatment for atrial fibrillation ( AF ) . Cryoballoon ablation ( CBA ) has emerged as an alternative to radiofrequency ablation ( RFA ) . However , there are few data comparing these modalities for treatment of paroxysmal AF ( pAF ) in the U.S. POPULATION The purpose of this study was to compare procedural times , safety , and efficacy of CBA against RFA . METHODS A single-center prospect i ve cohort study evaluated patients who underwent catheter ablation for pAF using CBA or RFA between January 1 , 2010 and October 31 , 2013 . Patients with prior ablation and those without rhythm follow-up for at least 3 months were excluded . The primary end point was freedom from AF , atrial flutter , and atrial tachycardia ( FFAF ) > 30 seconds after a 3-month blanking period without requirement for antiarrhythmic drugs . We also compared rates of successful pulmonary vein isolation ( PVI ) , fluoroscopy and procedure times , and major complication rates . RESULTS A total of 201 patients were included ( CBA = 101 , RFA = 100 ) . The rate of successful PVI was 99.3 % in CBA versus 97.4 % in RFA ( P = 0.08 ) . Procedure times were shorter with CBA ( 192.9 ± 44.0 minutes vs 283.7 ± 78.0 minutes , P total fluoroscopy times ( 46.0 ± 22.4 minutes vs 73.0 ± 30.1 minutes , P 0.001 ) . Overall complication rates were equivalent ; however , fewer cardiac perforations occurred with CBA ( 0 % vs 4 % , P = 0.042 ) . The 1-year FFAF rates were 60.3 % for CBA and 61.1 % for RFA ( log rank P = 0.93 ) . CONCLUSION CBA was associated with equivalent 1-year FFAF rate as RFA for pAF . Procedure and fluoroscopy times were shorter for CBA and fewer cardiac perforations occurred",
"Background —Radiofrequency catheter ablation ( RFA ) has emerged as an important treatment strategy for atrial fibrillation ( AF ) . The potential cost-effectiveness of RFA for AF , relative to antiarrhythmic drug ( AAD ) therapy , has not been fully explored from a US perspective . Methods and Results —We constructed a Markov disease simulation model for a hypothetical cohort of patients with drug-refractory paroxysmal AF , treated either with RFA with/without AAD or AAD alone . Costs and quality -adjusted life-years were projected over 5 years . Model inputs were drawn from published clinical trial and registry data , from new registry and trial data analysis , and from data prospect ively collected from patients with AF treated with RFA at our institution . We assumed no benefit from ablation on stroke , heart failure or death , but did estimate changes in quality -adjusted life expectancy using data from several AF cohorts . In the base case scenario , cumulative costs with the RFA and AAD strategies were $ 26 584 and $ 19 898 , respectively . Over 5 years , quality -adjusted life expectancy was 3.51 quality -adjusted life-years with RFA versus 3.38 for the AAD group . The incremental cost-effectiveness ratio for RFA versus AAD was thus $ 51 431 per quality -adjusted life-year . Model results were most sensitive to time horizon , the relative utility weights of successful ablation versus unsuccessful drug therapy , and to the cost of an ablation procedure . Conclusions —RFA with/without AAD for symptomatic , drug-refractory paroxysmal AF appears to be reasonably cost-effective compared with AAD therapy alone from the perspective of the US health care system , based on improved quality of life and avoidance of future health care costs",
"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",
"R and omized , controlled trials have become the gold st and ard of medical knowledge . Yet their scientific and political history offers lessons about the complexity of medicine and disease and the economic and political forces shaping the production and circulation of knowledge",
"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 )",
"INTRODUCTION Catheter ablation of paroxysmal AF using the Cryoballoon ( CRYO ) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation ( RFCA ) , but r and omized data are lacking . Pilot data suggested a high success rate with a combined approach ( COMBINED ) using wide encirclement with RFCA followed by 2 CRYO applications to each vein . We compared these 3 strategies in a r and omized controlled trial . METHODS AND RESULTS Patients undergoing first time paroxysmal AF ablation were r and omized to RFCA , CRYO , or COMBINED . Patients were followed up at 3 , 6 , and 12 months with 7 days of ambulatory ECG monitoring . Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure . A total of 237 patients were r and omized . Success at 1 year was achieved in 47 % in the RFCA group , 67 % in the CRYO group , and 76 % in the COMBINED group ( P RFCA vs. CRYO , P Procedure time was 211 ( IQR 174 - 256 ) minutes for RFCA compared to 167 ( 136 - 202 ) minutes for CRYO and 278 ( 243 - 327 ) minutes for COMBINED ( P CRYO and results in a higher single procedure success rate than conventional point by point RFCA . The COMBINED approach was not superior to CRYO alone",
"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",
"This article discusses the history and development of r and omized clinical trial methodology , the reasons for its status and authority as a method of therapeutic evaluation , and the continuing role of clinical judgement in design ing , interpreting , and applying the findings of trials",
"BACKGROUND Results from r and omized trials design ed to compare cryoenergy with radiofrequency for pulmonary vein ( PV ) isolation are lacking . OBJECTIVE To compare the efficacy of a simplified strategy for PV cryoablation ( group C ) vs PV isolation with open-irrigated radiofrequency catheters ( group R ) . METHODS Fifty patients with paroxysmal atrial fibrillation ( AF ) and 4 independent PVs received a Reveal XT implantable cardiac monitor and were r and omized to group C or group R. In group C , PV ablation was done with a single A rct ic Front balloon ( 23 or 28 mm ) per patient and two 300-second applications per PV . No further applications were delivered to close residual conduction gaps . In group R , bidirectional PV conduction block was pursued with Lasso and Navistar ThermoCool catheters and the CARTO system . The primary end point was the proportion of patients remaining free from AF recurrences ≥2 minutes without taking antiarrhythmic drugs 12 months after ablation . RESULTS The primary end point was met by 12 ( 48 % ) patients in group C and 25 ( 68 % ) patients in group R ( odds ratio 0.43 ; P = .05 ) . This difference disappeared after adjustment for acute procedural outcome . In patients for whom all 4 PVs were blocked at the end of the procedure , there was no difference between group C and group R in the primary end point ( 67 % vs 68 % ; P = .94 ) . CONCLUSIONS The efficacy of the simplified strategy for PV cryoablation tested in this study is inferior to PV isolation using open-irrigated radiofrequency catheters with electrophysiological and electroanatomical guidance . Complete PV conduction block is critical to the success of AF ablation",
"BACKGROUND Experimental data suggest that use of cryoablation in pulmonary vein isolation ( PVI ) is associated with less cell damage and less thrombus formation compared to radiofrequency ( RF ) energy . OBJECTIVE The purpose of this study was to test the hypothesis that cryoablation significantly reduces markers of cell damage , platelet activation , and inflammation in patients undergoing PVI for treatment of atrial fibrillation ( AF ) . METHODS Sixty patients with symptomatic drug-resistant AF ( age 56 ± 9 years , 48 males , 38 with paroxysmal AF ) were r and omly assigned to undergo PVI using either an open irrigated-tip RF catheter or a cryoballoon . Markers of cell damage ( high-sensitive troponin T [ hs-TnT ] , microparticles ) , platelet activation ( platelet reactivity by aggregometry , expression of platelet surface proteins P-selectin and activated glycoprotein [ GP ] IIb/IIIa ) , and inflammatory response ( high-sensitive C-reactive protein [ hs-CRP ] ) were determined before and up to 48 hours after the procedure . RESULTS PVI result ed in a significant rise in hs-TnT , microparticles , markers of platelet activation , and hs-CRP over time , with distinct temporal patterns for each parameter . However , after Bonferroni correction for repeated measurements , no significant differences were noted in these parameters between patients treated with cryoablation or RF energy . Procedural time was significantly shorter in patients treated with cryoballoon ( 177 ± 30 minutes vs 200 ± 46 minutes , P = .03 ) , with no differences in fluoroscopic time , periprocedural complications , or success rate . CONCLUSION Cryoablation and RF energy result in a comparable rise of markers of cell damage , platelet activation and inflammatory response . The data do not support the concept of an improved safety profile for cryoablation in PVI",
"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",
"BACKGROUND Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation . Radiofrequency ablation is the most common method , and cryoballoon ablation is the second most frequently used technology . METHODS We conducted a multicenter , r and omized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation . The primary efficacy end point in a time-to-event analysis was the first documented clinical failure ( recurrence of atrial fibrillation , occurrence of atrial flutter or atrial tachycardia , use of antiarrhythmic drugs , or repeat ablation ) following a 90-day period after the index ablation . The noninferiority margin was prespecified as a hazard ratio of 1.43 . The primary safety end point was a composite of death , cerebrovascular events , or serious treatment-related adverse events . RESULTS A total of 762 patients underwent r and omization ( 378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation ) . The mean duration of follow-up was 1.5 years . The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 34.6 % and 35.9 % , respectively ; hazard ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.76 to 1.22 ; P primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 10.2 % and 12.8 % , respectively ; hazard ratio , 0.78 ; 95 % CI , 0.52 to 1.18 ; P=0.24 ) . CONCLUSIONS In this r and omized trial , cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation , and there was no significant difference between the two methods with regard to overall safety . ( Funded by Medtronic ; FIRE AND ICE Clinical Trials.gov number , NCT01490814 . )"
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BACKGROUND Bradycardia [ resting heart rate below 60 beats per minute ( b.p.m . ) ] can be caused by conditions affecting the natural pacemakers of the heart , such as sick sinus syndrome ( SSS ) and atrioventricular ( AV ) blocks . People suffering from bradycardia may present with palpitations , exercise intolerance and fainting . The only effective treatment for patients suffering from symptomatic bradycardia is implantation of a permanent pacemaker . OBJECTIVE To appraise the clinical effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber atrial pacemakers for treating symptomatic bradycardia in people with SSS and no evidence of AV block . DATA SOURCES All data bases ( MEDLINE , EMBASE , Cochrane Central Register of Controlled Trials , Health Technology Assessment data base , NHS Economic Evaluations Data base ) were search ed from inception to June 2014 . METHODS A systematic review of the clinical and economic literature was carried out in accordance with the general principles published by the Centre for Review s and Dissemination . R and omised controlled trials ( RCTs ) evaluating dual-chamber and single-chamber atrial pacemakers and economic evaluations were included . Pairwise meta- analysis was carried out . A de novo economic model was developed . RESULTS Of 493 references , six RCTs were included in the review . The results were predominantly influenced by the largest trial DANPACE . Dual-chamber pacing was associated with a statistically significant reduction in reoperation [ odds ratio ( OR ) 0.48 , 95 % confidence interval ( CI ) 0.36 to 0.63 ] compared with single-chamber atrial pacing . The difference is primarily because of the development of AV block requiring up grade to a dual-chamber device . The risk of paroxysmal atrial fibrillation was also reduced with dual-chamber pacing compared with single-chamber atrial pacing ( OR 0.75 , 95 % CI 0.59 to 0.96 ) . No statistically significant difference was found between the pacing modes for mortality , heart failure , stroke , chronic atrial fibrillation or quality of life . However , the risk of developing heart failure may vary with age and device . The de novo economic model shows that dual-chamber pacemakers are more expensive and more effective than single-chamber atrial devices , result ing in a base-case incremental cost-effectiveness ratio ( ICER ) of £ 6506 . The ICER remains below £ 20,000 in probabilistic sensitivity analysis , structural sensitivity analysis and most scenario analyses and one-way sensitivity analyses . The risk of heart failure may have an impact on the decision to use dual-chamber or single-chamber atrial pacemakers . Results from an analysis based on age ( > 75 years or ≤ 75 years ) and risk of heart failure indicate that dual-chamber pacemakers dominate single-chamber atrial pacemakers ( i.e. are less expensive and more effective ) in older patients , whereas dual-chamber pacemakers are dominated by ( i.e. more expensive and less effective ) single-chamber atrial pacemakers in younger patients . However , these results are based on a subgroup analysis and should be treated with caution . CONCLUSIONS In patients with SSS without evidence of impaired AV conduction , dual-chamber pacemakers appear to be cost-effective compared with single-chamber atrial pacemakers . The risk of developing a complete AV block and the lack of tools to identify patients at high risk of developing the condition argue for the implantation of a dual-chamber pacemaker programmed to minimise unnecessary ventricular pacing . However , considerations have to be made around the risk of developing heart failure , which may depend on age and device . STUDY REGISTRATION This study is registered as PROSPERO CRD42013006708 . FUNDING The National Institute for Health Research Health Technology Assessment programme
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"BACKGROUND In a previous study of 225 patients with sick-sinus syndrome r and omised to either single-chamber atrial pacing ( n=110 ) or single-chamber ventricular pacing ( n=115 ) , we found that after a mean follow-up of 3.3 years , atrial pacing was associated with significantly less atrial fibrillation and thromboembolism whereas there was no significant difference in mortality and heart failure between the two groups . We aim ed to find out whether this beneficial effect of atrial pacing is maintained during extended follow-up of up to 8 years . METHODS Follow-up visits for all patients were at 3 months , 12 months , then once a year at which patients had a physical examination , ECG recording , and pacemaker check-up . Endpoints were mortality , cardiovascular death , atrial fibrillation , thromboembolic events , heart failure , and atrioventricular block . Data was analysed on Dec 31 , 1996 . FINDINGS At long-term follow-up , 39 patients from the atrial group had died versus 57 from the ventricular group ( relative risk 0.66 [ 95 % CI 0.44 - 0.99 ] ; p=0.045 ) . 19 patients from the atrial group and 39 patients from the ventricular group died from a cardiovascular cause ( 0.47 [ 0.27 - 0.82 ] ; p=0.0065 ) . The cumulative incidences of atrial fibrillation and chronic atrial fibrillation were also significantly lower in the atrial group than in the ventricular group ( 0.54 [ 0.33 - 0.89 ] , p=0.012 and 0.35 [ 0.16 - 0.76 ] , p=0.004 , respectively ) . Thromboembolic events occurred in 13 patients in the atrial group and 26 in the ventricular group ( 0.47 [ 0.24 - 0.92 ] , p=0.023 ) . Heart failure was less severe in the atrial group than in the ventricular group ( p freedom from thromboembolic events ( 0.47 [ 0.24 - 0.92 ] , p=0.028 ) and survival from cardiovascular death ( 0.52 [ 0.30 - 0.91 ] , p=0.022 ) , but no longer with overall survival ( 0.71 [ 0.46 - 1.08 ] , p=0.11 ) or chronic atrial fibrillation ( 0.45 [ 0.20 - 1.05 ] , p=0.063 ) . Atrioventricular block occurred in four patients in the atrial group ( 0.6 % annual risk ) . INTERPRETATION The beneficial effect of atrial pacing found in our previous study is enhanced substantially over time . Patients with sick-sinus syndrome should be treated with an atrial rather than ventricular-pacing system because after long-term follow-up , atrial pacing is associated with a significantly higher survival , less atrial fibrillation , fewer thromboembolic complications , less heart failure , and a low-risk of atrioventricular block",
"Reproducibility and validity are prerequisites for a useful clinical scale . We therefore prospect ively tested the reproducibility and validity of the New York Heart Association criteria and the Canadian Cardiovascular Society criteria for the assessment of cardiac functional class and compared these criteria with a new Specific Activity Scale based on the metabolic costs of specific activities . The New York Heart Association estimates made by two physicians had a reproducibility of only 56 % , and only 51 % of the estimates agreed with treadmill exercise performance . Functional estimates based on the Canadian Cardiovascular Society criteria were significantly more reproducible ( 73 % ) , but not significantly more valid . The Specific Activity Scale was as reproducible as the Canadian Cardiovascular Society criteria , and its 68 % validity was significantly higher than the validities of the other systems . The easily administered Specific Activity Scale was equally reproducible and valid when used by a nonphysician . It was especially better than the other systems for the evaluation of true class II patients and was significantly less likely to underestimate treadmill performance . Although no set of questions can perfectly predict exercise tolerance , the Specific Activity Scale deserves wider prospect i ve testing",
"BACKGROUND Both \" physiologic \" ( dual-chamber or atrial only ) or ventricular-pacing-only permanent pacemakers provide chronotropic competence , with unknown health-related quality of life ( QOL ) differences between these options . The QOL studies within the Canadian Trial of Physiologic Pacing were performed to assess whether QOL differences exist in patients r and omized to these 2 pacing modes . METHODS Two QOL protocol s were performed : 1 ) a sub study of 269 patients with detailed QOL measures ( The Medical Outcomes Study , Short-Form [ SF-36 ] , the Pacemaker Syndrome Scale , an activity scale , and a pacemaker-specific scale ) at baseline and 6 months after implantation ; and 2 ) a parent study assessment of QOL in 1721 patients with a 12-item QOL instrument package ( SF-6 , \" ladder of life , \" and pacemaker syndrome scale ) given 6 months after implantation only . RESULTS In the sub study , pacing was associated with an average significant ( P QOL across all domains ( SF-36 : 38 + /- 9 to 41 + /- 11 for physical scores , 47 + /- 11 to 52 + /- 9 for mental health scores , both P pacemaker-specific scales . There were no significant differences in the absolute or relative improvement in QOL between assigned pacing modes . The parent study similarly showed no differences in QOL between pacing modalities . Presyncope occurred in 31 % of patients in the physiological pacing group , compared with 38 % of the patients in the ventricular pacing group ( P heart rate QOL scores between the 2 assigned pacing modes . CONCLUSION In this largest r and omized assessment of QOL in patients with pacemakers , with the instruments used , there was no significant health-related QOL difference seen between \" physiologic \" pacing and ventricular pacing",
"Objective To determine the rate of late complications following first implantation or elective unit replacement of a permanent pacemaker system . Design Analysis of pacemaker data and complications prospect ively acquired on a computerised data base . Complications were studied over an 11 year period from January 1984 to December 1994 . Setting Tertiary referral cardiothoracic centre . Patients Records of 2621 patients were analysed retrospectively . Main outcome measures Complications requiring repeat procedures occurring more than six weeks after pacemaker implantation or elective unit replacement . Results The overall rate of late complications was significantly lower after first implantation of a permanent pacemaker ( 34 cases , complication rate 1.4 % , 95 % confidence interval 0.9 % to 1.9 % ) than after elective unit replacement ( 16 cases , complication rate 6.5 % ( 3.3 % to 9.7 % ) . There were 20 cases of erosion , 18 infections , five electrode problems , and seven miscellaneous problems . Complications were more common with inexperienced operators ( 18.9 % ( 6.0 % to 31.8 % ) ) than with experienced operators ( 0.9 % ( 0.3 % to 1.5 % ) ) . Conclusions The incidence of late complications following pacemaker implantation is low and compares favourably with early complication rates . The majority are caused by erosion and infection . Patients who have undergone elective unit replacement are at particular risk",
"The hemodynamic effects of two different pacing modes -- rate adaptive atrial ( AAIR ) versus dual chamber ( DDDR ) pacing -- were assessed in 12 patients with DDDR pacemakers during upright bicycle exercise first-pass radionuclide angiography using a multiwire gamma camera with tantalum-178 as a tracer . All patients had sinus node disease with intact AV conduction . Patients exercised to the same heart rate in r and om order in these two different pacing modes , AAIR and DDDR with AV delay ( of 100 msec ) selected to maintain 100 % ventricular capture . Cardiac output increased significantly above baseline values during exercise in both pacing modes : 154 + /- 41 % ( mean + /- SEM , P = 0.002 ) with AAIR , versus 95 + /- 24 % ( P = 0.004 ) with DDDR ( P = NS between the two modes ) . The peak filling rate , likewise , increased in both pacing modes ( 2.3 + /- 0.21 end-diastolic volumes/sec to 3.8 + /- 0.31 end-diastolic volumes/sec in AAIR [ P = 0.0004 ] and 2.2 + /- 0.18 end-diastolic volumes/sec to 3.4 + /- 0.27 end-diastolic volumes/sec in DDDR [ P = 0.0008 ] ) . LV ejection fraction was normal at rest ( 60 + /- 4 % , SEM ) and did not significantly change with submaximal exercise in either pacing mode ( both 56 % , P = NS ) . No significant changes in end-diastolic volume or stroke volume indexes occurred with exercise in either pacing mode . Our study demonstrates that in patients with normal resting LV function , AAIR and DDDR pacing are equally effective in attaining appropriate increases in cardiac output and LV filling during exercise",
"Pacemakers are frequently implanted , yet accurate prospect i ve data on implant complications are limited . Elderly patients may be at increased risk of implant complications and are increasingly being referred for pacemaker implantation . The purpose of the present analysis was to define the incidence and possible predictors of serious complications of dual chamber permanent pacemaker implantation in the elderly . Therefore , we sought to prospect ively identify the incidence and predictors of pacemaker implant complications in a large multicenter trial involving patients receiving a dual chamber pacemaker . The Pacemaker Selection in the Elderly ( PASE ) study was a prospect i ve trial design ed to evaluate quality of life in dual chamber pacemaker recipients age 65 years or older r and omized to DDDR versus VVIR programming . In addition to being age 65 years or older , patients enrolled in this study were in normal sinus rhythm , and had st and ard indications for permanent pacemaker implantation . All patients received dual chamber pacemakers and were r and omized to DDDR versus VVIR pacing . Pacemaker implant complications were collected on st and ardized forms which were completed at pacemaker implantation and during follow-up appointments . In this study of 407 patients , there were 26 complications occurring in 25 patients ( 6.1 % ) . The most frequent complication was lead dislodgment which occurred in 9 patients . This was followed by pneumothorax ( 8 patients ) and cardiac perforations ( 4 patients ) . In 18 patients ( 4.4 % ) repeat surgical procedures ( including chest tubes ) were required . Complications were noted prior to discharge in only 18 patients . There were no significant predictors of overall complications . Pneumothorax was more frequent in patients ≤75 years old , and was observed only in patients with subclavian venous access . In conclusion , complications from pacemaker implantation in the elderly are seen in 6.1 % of patients and 4.4 % of patients require a repeat surgical procedure . Other than advanced age and lower weight predicting for pneumothorax , there are no significant clinical predictors of",
"Background —Some current pacing systems can automatically detect and record atrial tachyarrhythmias that may be asymptomatic . We prospect ively studied a 312-patient ( pt ) subgroup of MOST ( MOde Selection Trial ) , a 2010-patient , 6-year r and omized trial of DDDR versus VVIR pacing in sinus node dysfunction ( SND ) . The purpose of the study was to correlate atrial high rate events ( AHREs ) detected by pacemaker diagnostics with clinical outcomes . Methods and Results —Pacemakers were programmed to log an AHRE when the atrial rate was > 220 bpm for 10 consecutive beats . Analysis was confined to patients with at least 1 AHRE duration exceeding 5 minutes . The 312 patients were median age 74 years , 55 % female , and 60 % had a history of SVT . 160 of 312 ( 51.3 % ) patients enrolled had at least 1 AHRE > 5 minutes duration over median follow-up of 27 months . Cox proportional hazards analysis assessed the relationship of AHREs with clinical events , adjusting for prognostic variables and baseline covariates . The presence of any AHRE was an independent predictor of the following : total mortality ( hazard ratio AHRE versus no AHRE and 95 % confidence intervals=2.48 [ 1.25 , 4.91 ] , P = 0.0092 ) ; death or nonfatal stroke ( 2.79 [ 1.51 , 5.15 ] , P = 0.0011 ) ; and atrial fibrillation ( 5.93 [ 2.88 , 12.2 ] , P = 0.0001 ) . There was no significant effect of pacing mode on the presence or absence of AHREs . Conclusions —AHRE detected by pacemakers in patients with SND identify patients that are more than twice as likely to die or have a stroke , and 6 times as likely to develop atrial fibrillation as similar patients without AHRE",
"OBJECTIVES We evaluated the incidence , predictors , and treatment of pacemaker syndrome in patients with sinus node dysfunction treated with ventricular-based ( VVIR ) pacing in the Mode Selection Trial ( MOST ) . BACKGROUND Pacemaker syndrome , or intolerance to VVIR pacing , consists of cardiovascular signs and symptoms induced by VVIR pacing . METHODS The definition of pacemaker syndrome required that a patient with single-chamber VVIR pacing develop either congestive signs and symptoms associated with retro grade conduction during VVIR pacing or a > or=20 mm Hg reduction of systolic blood pressure during VVIR pacing , associated with reproducible symptoms of weakness , lightheadedness , or syncope . RESULTS Of 996 patients r and omized to VVIR pacing , 182 ( 18.3 % ) met criteria for pacemaker syndrome in follow-up . Pacemaker syndrome occurred early in most patients ( 13.8 % at 6 months , 16.0 % at 1 year , increasing to 19.7 % at 4 years ) . Baseline univariate predictors of pacemaker syndrome included a lower sinus rate and higher programmed pacemaker rate . Previous heart failure , ejection fraction , and drop in systolic blood pressure with VVIR pacing at implantation did not predict the development of pacemaker syndrome . Post-implantation predictors of pacemaker syndrome were a higher percentage of paced beats , higher programmed low rate , and slower underlying spontaneous sinus rate . Quality of life decreased at the time of diagnosis of pacemaker syndrome and improved with reprogramming to atrial-based pacing . CONCLUSIONS Severe pacemaker syndrome developed in nearly 20 % of VVIR-paced patients and improved with reprogramming to the dual-chamber pacing mode . Because prediction of pacemaker syndrome is difficult , the only way to prevent pacemaker syndrome is to implant atrial-based pacemakers in all patients",
"Background —Compared with single-chamber ventricular pacing , dual-chamber pacing can reduce adverse events and , as a result , improve quality of life in patients paced for sick sinus syndrome . It is not clear , however , how these benefits compare with the increased cost of dual-chamber pacemakers . Methods and Results —We used 4-year data from a 2010-patient , r and omized trial to estimate the incremental cost-effectiveness of dual-chamber pacing compared with ventricular pacing and then projected these findings over the patients ’ lifetimes by using a Markov model that was calibrated to the first 5 years of in-trial data . To assess the stability of the findings , we performed 1000 bootstrap analyses and multiple sensitivity analyses . During the first 4 years of the trial , dual-chamber pacemakers increased quality -adjusted life expectancy by 0.013 year per subject at an incremental cost-effectiveness ratio of $ 53 000 per quality -adjusted year of life gained . Over a lifetime , dual-chamber pacing was projected to increase quality -adjusted life expectancy by 0.14 year with an incremental cost-effectiveness ratio of ≈$6800 per quality -adjusted year of life gained . In bootstrap analyses , dual-chamber pacing was cost-effective in 91.9 % of simulations at a threshold of $ 50 000 per quality -adjusted year of life and in 93.2 % of simulations at a threshold of $ 100 000 . Its cost-effectiveness ratio was also below this threshold in numerous sensitivity analyses that varied key estimates . Conclusions —For patients with sick sinus syndrome requiring pacing , dual-chamber pacing increases quality -adjusted life expectancy at a cost that is generally considered acceptable",
"Background Dual‐chamber ( DDDR ) pacing preserves AV synchrony and may reduce heart failure ( HF ) and atrial fibrillation ( AF ) compared with ventricular ( VVIR ) pacing in sinus node dysfunction ( SND ) . However , DDDR pacing often results in prolonged QRS duration s ( QRSd ) as the result of right ventricular stimulation , and ventricular desynchronization may result . The effect of pacing‐induced ventricular desynchronization in patients with normal baseline QRSd is unknown . Methods and Results Baseline QRSd was obtained from 12‐lead ECGs before pacemaker implantation in MOST , a 2010‐patient , 6‐year , r and omized trial of DDDR versus VVIR pacing in SND . Cumulative percent ventricular paced ( Cum%VP ) was determined from stored pacemaker data . Baseline QRSd 1339 patients ( 707 DDDR , 632 VVIR ) . Cum%VP was greater in DDDR versus VVIR ( 90 % versus 58 % , P=0.001 ) . Cox models demonstrated that the time‐dependent covariate Cum%VP was a strong predictor of HF hospitalization in DDDR ( hazard ratio [ HR ] , 2.99 [ 95 % CI , 1.15 to 7.75 ] for Cum%VP > 40 % ) and VVIR ( HR 2.56 [ 95 % CI , 1.48 to 4.43 ] for Cum%VP > 80 % ) . The risk of AF increased linearly with Cum%VP from 0 % to 85 % in both groups ( DDDR , HR 1.36 [ 95 % CI , 1.09 , 1.69 ] ; VVIR , HR 1.21 [ 95 % CI 1.02 , 1.43 ] , for each 25 % increase in Cum%VP ) . Model results were unaffected by adjustment for known baseline predictors of HF hospitalization and AF . Conclusions Ventricular desynchronization imposed by ventricular pacing even when AV synchrony is preserved increases the risk of HF hospitalization and AF in SND with normal baseline QRSd . ( Circulation . 2003;107:2932‐2937 .",
"ACCF : American College of Cardiology Foundation ACCP : American College of Chest Physicians ACS : acute coronary syndrome ACT : Atrial arrhythmia Conversion Trial ADONIS : American – Australian – African trial with DronedarONe In atrial fibrillation or flutter for the maintenance of Sinus rhythm AF : atrial fibrillation AHA : American Heart Association AND ROMEDA : ANtiarrhythmic trial with DROnedarone in Moderate-to-severe congestive heart failure Evaluating morbidity DecreAse APHRS : Asia Pacific Heart Rhythm Society aPTT : activated partial thromboplastin time ARB : angiotensin-receptor blocker ARISTOTLE : Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation ATHENA : A placebo-controlled , double-blind , parallel arm Trial to assess the efficacy of dronedarone 400 mg b.i.d . for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter ATRIA : AnTicoagulation and Risk factors In Atrial fibrillation AVERROES : Apixaban VErsus acetylsalicylic acid ( ASA ) to Reduce the Rate Of Embolic Stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment AVRO : A prospect i ve , r and omized , double-blind , Active-controlled , superiority study of Vernakalant vs. amiodarone in Recent Onset atrial fibrillation b.i.d : bis in die ( twice daily ) b.p.m . : beats per minute CABANA : Catheter ABlation vs . ANtiarrhythmic drug therapy for Atrial fibrillation CABG : coronary artery bypass graft CAP : Continued Access to Protect AF CHA2DS2-VASc : Congestive heart failure or left ventricular dysfunction Hypertension , Age ≥75 ( doubled ) , Diabetes , Stroke (doubled)-Vascular disease , Age 65–74 , Sex category ( female ) CHADS2 : Congestive heart failure , Hypertension , Age ≥75 , Diabetes , Stroke ( doubled ) CI : confidence interval CRAFT : Controlled R and omized Atrial Fibrillation Trial CrCl : creatinine clearance DAFNE : Dronedarone Atrial FibrillatioN study after Electrical cardioversion DIONYSOS : R and omized Double blind trIal to evaluate efficacy and safety of drOnedarone ( 400 mg b.i.d . ) vs . amiodaroNe ( 600 mg q.d . for 28 daYS , then 200 mg qd thereafter ) for at least 6 mOnths for the maintenance of Sinus rhythm in patients with atrial fibrillation EAST : Early treatment of Atrial fibrillation for Stroke prevention Trial EHRA : European Heart Rhythm Association ECG : electrocardiogram EMA : European Medicines Agency ERATO : Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation EURIDIS : EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm FAST : atrial Fibrillation catheter Ablation vs . Surgical ablation Treatment FDA : Food and Drug Administration Flec-SL : Flecainide Short-Long trial HAS-BLED : Hypertension , Abnormal renal/liver function , Stroke , Bleeding history or predisposition , Labile INR , Elderly , Drugs/alcohol concomitantly HF-PEF : heart failure with preserved ejection fraction HF-REF : heart failure with reduced ejection fraction HR : hazard ratio HRS : Heart Rhythm Society ICH : intracranial haemorrhage INR : international normalized ratio i.v . : intravenous J-RHYTHM : Japanese RHYTHM management trial for atrial fibrillation LAA : left atrial appendage LoE : level of evidence LVEF : left ventricular ejection fraction MANTRA-PAF : Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation NICE : National Institute for Health and Clinical Excellence NOAC : novel oral anticoagulant NSAID : non-steroidal anti-inflammatory drug NYHA : New York Heart Association OAC : oral anticoagulant or oral anticoagulation o.d . : omni die ( every day ) PALLAS : Permanent Atrial fibriLLAtion outcome Study using dronedarone on top of st and ard therapy PCI : percutaneous coronary intervention PREVAIL : Prospect i ve R and omized EVAluation of the LAA closure device In patients with atrial fibrillation v s. Long-term warfarin therapy PROTECT AF : WATCHMAN LAA system for embolic PROTECTion in patients with Atrial Fibrillation PT : prothrombin time RAAFT : Radio frequency Ablation Atrial Fibrillation Trial RE-LY : R and omized Evaluation of Long-term anticoagulant therapY with dabigatran etexilate ROCKET-AF : Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in atrial fibrillation RRR : relative risk reduction TE : thromboembolism TIA : transient ischaemic attack t.i.d . : ter in die ( three times daily ) TOE : transoesophageal echocardiogram TTR : time in therapeutic range VKA : vitamin K antagonist Guidelines summarize and evaluate all currently available evidence on a particular issue with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition , taking into account the impact on",
"BACKGROUND Evidence suggests that physiologic pacing ( dual-chamber or atrial ) may be superior to single-chamber ( ventricular ) pacing because it is associated with lower risks of atrial fibrillation , stroke , and death . These benefits have not been evaluated in a large , r and omized , controlled trial . METHODS At 32 Canadian centers , patients without chronic atrial fibrillation who were scheduled for a first implantation of a pacemaker to treat symptomatic bradycardia were eligible for enrollment . We r and omly assigned patients to receive either a ventricular pacemaker or a physiologic pacemaker and followed them for an average of three years . The primary outcome was stroke or death due to cardiovascular causes . Secondary outcomes were death from any cause , atrial fibrillation , and hospitalization for heart failure . RESULTS A total of 1474 patients were r and omly assigned to receive a ventricular pacemaker and 1094 to receive a physiologic pacemaker . The annual rate of stroke or death due to cardiovascular causes was 5.5 percent with ventricular pacing , as compared with 4.9 percent with physiologic pacing ( reduction in relative risk , 9.4 percent ; 95 percent confidence interval , -10.5 to 25.7 percent [ the negative value indicates an increase in risk ] ; P=0.33 ) . The annual rate of atrial fibrillation was significantly lower among the patients in the physiologic-pacing group ( 5.3 percent ) than among those in the ventricular-pacing group ( 6.6 percent ) , for a reduction in relative risk of 18.0 percent ( 95 percent confidence interval , 0.3 to 32.6 percent ; P=0.05 ) . The effect on the rate of atrial fibrillation was not apparent until two years after implantation . The observed annual rates of death from all causes and of hospitalization for heart failure were lower among the patients with a physiologic pacemaker than among those with a ventricular pacemaker , but not significantly so ( annual rates of death , 6.6 percent with ventricular pacing and 6.3 percent with physiologic pacing ; annual rates of hospitalization for heart failure , 3.5 percent and 3.1 percent , respectively ) . There were significantly more perioperative complications with physiologic pacing than with ventricular pacing ( 9.0 percent vs. 3.8 percent , P Physiologic pacing provides little benefit over ventricular pacing for the prevention of stroke or death due to cardiovascular causes",
"BACKGROUND Dual-chamber pacemakers restore AV synchrony compared with ventricular pacemakers , but the effects on health-related quality of life ( QOL ) are uncertain . OBJECTIVES The purpose of this study was to assess the effect of pacemaker implantation , clinical factors , and pacing mode on QOL . METHODS The Mode Selection Trial ( MOST ) r and omized 2,010 patients with sinus node dysfunction to rate-modulated right ventricular ( VVIR ) or dual-chamber ( DDDR ) pacing . A longitudinal analysis of serial QOL measures ( Short Form-36 [ SF-36 ] , Specific Activity Scale , and time trade-off utility ) was performed . In patients who crossed over from VVIR to DDDR because of severe pacemaker syndrome , the last known QOL prior to crossover was carried forward . RESULTS Pacemaker implantation result ed in substantial improvement in almost all QOL measures . Subjects 75 years or older experienced significantly less improvement in functional status and physical component summary scores than did younger subjects . In longitudinal analyses of the effect of pacing mode on QOL , significant improvement in three SF-36 subscales was observed with DDDR pacing compared with VVIR pacing : role physical [ 62.8 points ( 95 % confidence interval [ CI ] 60.2 , 65.5 ) vs 56.4 ( 95 % CI 53.7 , 59.1 ) ] , role emotional [ 85.0 ( 95 % CI 82.9 , 87.0 ) vs 81.9 ( 95 % CI 79.9 , 84.0 ) ] , and vitality [ 51.8 ( 95 % CI 50.3 , 53.3 ) vs 49.3 ( 95 % CI 47.8 , 50.7 ) ] , but not in other SF-36 subscales , the Specific Activity Scale , or utilities . The gains in QOL were larger than the declines associated with 1 year of aging but smaller than those associated with heart failure . CONCLUSION Pacemaker implantation improved health-related QOL . The mode selected was associated with much smaller , but significant , improvements in several domains , particularly role physical function",
"OBJECTIVE --To evaluate the incidence of intraoperative and early postoperative complications ( up to two months after implant ) of endocardial permanent pacemaker insertion in all patients under-going a first implant at a referral centre . METHODS -- Prospect i ve evaluation of all endocardial pacemaker implantation procedures performed from April 1992 to January 1994 carried out by completion of st and ard audit form at implant . Patients ' demographic data , medical history , details of pacemaker hardware used , and any complications were noted . Follow up information was also collected prospect ively onto st and ard forms at pacemaker outpatient clinic . SETTING --United Kingdom tertiary referral cardiothoracic centre . PATIENTS --1088 consecutive patients underwent implantation of their first endocardial permanent pacemaker from April 1992 to January 1994 . Implant and follow up data were available for 1059 ( 97.3 % ) patients at analysis . The median ( range ) age was 77 years ( 16 - 99 ) ; 51.2 % were male . RESULTS --Dual chamber units were implanted in 54.1 % of patients , single chamber atrial in 5.2 % , and ventricular in 40.7 % . A temporary pacing lead was present at implant in 22.9 % of patients . Most ( 93.6 % ) implants were performed via the subclavian vein . Immediate complications were rare : eight ( 0.8 % ) patients developed pneumothorax requiring medical treatment and 11 ( 1.0 % ) an insignificant pneumothorax . There was no significant difference in the pneumothorax rate for dual chamber ( DDD ) compared with single chamber systems . Arterial puncture without sequelae was documented in 2.7 % of attempts at subclavian vein cannulation . A total of 35 patients ( 3.3 % ) required reoperation ; the reoperation rate for dual chamber ( 3.5 % ) was similar to that for single chamber ( 3.1 % ) systems . Electrode displacement ( n = 15 , 1.4 % ) was the most common reason for reoperation . Atrial lead displacement ( n = 10 , 1.6 % of atrial leads ) was significantly more common than ventricular lead displacement ( n = 5 , 0.5 % of ventricular leads , P = 0.047 ) . There was no difference in electrode displacement rates for dual ( 1.6 % ) compared with single ( 1.2 % ) chamber systems . Pacemaker pocket infection led to reoperation in 10 patients ( six dual , four single chamber , P = not significant ) and was significantly more common in patients who had a temporary pacing lead in place at implant ( 2.9 % ) than in those who did not ( 0.4 % , P = 0.0014 ) . Five patients ( 0.5 % ) required reoperation for generator erosion ( two dual , three single chamber , P = not significant ) . and a further five for drainage of haematoma or a serous fluid collection ( three dual , two single chamber , P = not significant ) . Complications that did not require reoperation were also rare . Undersensing occurred in 10 patients ( 0.9 % ) . Atrial undersensing ( n = 8) was significantly more common than ventricular undersensing ( n = 2 , P = 0.017 ) . All patients were successfully treated by reprogramming of sensitivity . Superficial wound infection was treated successfully with antibiotics in nine patients ( six dual , three single chamber , P = not significant ) . Three patients with DDD generators developed sustained atrial fibrillation : two required reprogramming to VVI mode and one required cardioversion . CONCLUSIONS --Permanent pacing in a large tertiary referral centre with experienced operators carries a low risk . Infection rates are low , patients who undergo temporary pacing before implantation . Lead displacement and undersensing are more likely to occur with atrial than ventricular leads . The overall complication rate for dual chamber pacing , however , is no higher than for single chamber pacing",
"BACKGROUND Dual-chamber ( atrioventricular ) and single-chamber ( ventricular ) pacing are alternative treatment approaches for sinus-node dysfunction that causes clinical ly significant bradycardia . However , it is unknown which type of pacing results in the better outcome . METHODS We r and omly assigned a total of 2010 patients with sinus-node dysfunction to dual-chamber pacing ( 1014 patients ) or ventricular pacing ( 996 patients ) and followed them for a median of 33.1 months . The primary end point was death from any cause or nonfatal stroke . Secondary end points included the composite of death , stroke , or hospitalization for heart failure ; atrial fibrillation ; heart-failure score ; the pacemaker syndrome ; and the quality of life . RESULTS The incidence of the primary end point did not differ significantly between the dual-chamber group ( 21.5 percent ) and the ventricular-paced group ( 23.0 percent , P=0.48 ) . In patients assigned to dual-chamber pacing , the risk of atrial fibrillation was lower ( hazard ratio , 0.79 ; 95 percent confidence interval , 0.66 to 0.94 ; P=0.008 ) , and heart-failure scores were better ( P rates of hospitalization for heart failure and of death , stroke , or hospitalization for heart failure were not significant in unadjusted analyses but became marginally significant in adjusted analyses . Dual-chamber pacing result ed in a small but measurable increase in the quality of life , as compared with ventricular pacing . CONCLUSIONS In sinus-node dysfunction , dual-chamber pacing does not improve stroke-free survival , as compared with ventricular pacing . However , dual-chamber pacing reduces the risk of atrial fibrillation , reduces signs and symptoms of heart failure , and slightly improves the quality of life . Overall , dual-chamber pacing offers significant improvement as compared with ventricular pacing",
"INTRODUCTION Permanent pacemakers are capable of increasing heart rate in response to physical activity by a variety of sensors including accelerometers , piezoelectric crystals , or blended sensors . The impact of these different physiologic sensors on cardiovascular events and quality of life is not known . METHODS Of 2,010 patients r and omized in the Mode Selection Trial , 1,245 patients were selected with the most commonly used pacemakers with these three sensors . Clinical characteristics and quality of life were compared between groups at baseline , 3 months , and then yearly . RESULTS There were 449 patients with an accelerometer sensor device , 682 with a piezoelectric sensor , and 114 with a blended sensor . The groups were similar in terms of age ( mean 74 years ) , gender , and cardiac risk factors but differences existed in weight , heart rate , mitral regurgitation , revascularization history , and drug therapy . The median ventricular pacing frequency was 80 % ( 25th , 75th percentiles 42 , 97 ) . After a median follow-up of 33.1 months , the risk of death , heart failure hospitalization , atrial fibrillation , and the combined endpoint of mortality and stroke was not significantly different between the sensor types , after adjustment for baseline differences . Quality of life analyses demonstrated that patients with blended sensors had significantly worse ( P than did patients with the other two sensor systems . Moreover , patients receiving blended sensors had the poorest absolute scores , without reaching statistical significance , on 9 of 13 quality of life measures after adjusting for differences in the groups . CONCLUSION We found no significant differences among the three most utilized sensors in clinical endpoints . Those patients who received blended sensors had worse physical function quality of life scores . However , clinical selection of the most sophisticated sensor for the most ill patients can not be excluded as an explanation of these results",
"OBJECTIVES Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies . Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice . This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies . METHODS The task force was appointed with the advice and consent of the Board of Directors of ISPOR . Members were experienced developers or users of models , worked in academia and industry , and came from several countries in North America and Europe . The task force met on three occasions , conducted frequent correspondence and exchanges of drafts by electronic mail , and solicited comments on three drafts from a core group of external review ers and more broadly from the membership of ISPOR . RESULTS Criteria for assessing the quality of models fell into three areas : model structure , data used as inputs to models , and model validation . Several major themes cut across these areas . Models and their results should be represented as aids to decision making , not as statements of scientific fact ; therefore , it is inappropriate to dem and that models be vali date d prospect ively before use . However , model assumptions regarding causal structure and parameter estimates should be continually assessed against data , and models should be revised accordingly . Structural assumptions and parameter estimates should be reported clearly and explicitly , and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses . CONCLUSIONS Model-based evaluations are a valuable re source for health-care decision makers . It is the responsibility of model developers to conduct modeling studies according to the best practicable st and ards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built",
"Background —Expectations that reestablishing and maintaining sinus rhythm in patients with atrial fibrillation might improve survival were disproved in the Atrial Fibrillation Follow-up Investigation of Rhythm Management ( AFFIRM ) study . This report describes the cause-specific modes of death in the AFFIRM treatment groups . Methods and Results —All deaths in patients enrolled in AFFIRM underwent blinded review by the AFFIRM Events Committee , and a mode of death was assigned . In AFFIRM , 2033 patients were r and omized to a rhythm-control strategy and 2027 patients to a rate-control strategy . During a mean follow-up of 3.5 years , there were 356 deaths in the rhythm-control patients and 310 deaths in the rate-control patients ( P = 0.07 ) . In the rhythm-control group , 129 patients ( 9 % ) died of a cardiac cause , and in the rate-control group , 130 patients ( 10 % ) died ( P = 0.95 ) . Both groups had similar rates of arrhythmic and nonarrhythmic cardiac deaths . The numbers of vascular deaths were similar in the 2 groups : 35 ( 3 % ) in the rhythm-control group and 37 ( 3 % ) in the rate-control group ( P = 0.82 ) . There were no differences in the rates of ischemic stroke and central nervous system hemorrhage . In the rhythm-control group , there were 169 noncardiovascular deaths ( 47.5 % of the total number of deaths ) , whereas in the rate-control arm , there were 113 noncardiovascular deaths ( 36.5 % of the total number of deaths ) ( P = 0.0008 ) . Differences in noncardiovascular death rates were due to pulmonary and cancer-related deaths . Conclusions —Management of atrial fibrillation with a rhythm-control strategy conferred no advantage over a rate-control strategy in cardiac or vascular mortality and may be associated with an increased noncardiovascular death rate",
"AIMS In patients with sick sinus syndrome , bradycardia can be treated with a single-lead pacemaker or a dual-chamber pacemaker . Previous trials have revealed that pacing modes preserving atrio-ventricular synchrony are superior to single-lead ventricular pacing , but it remains unclear if there is any difference between single-lead atrial pacing ( AAIR ) and dual-chamber pacing ( DDDR ) . METHODS AND RESULTS We r and omly assigned 1415 patients referred for first pacemaker implantation to AAIR ( n = 707 ) or DDDR ( n = 708 ) pacing and followed them for a mean of 5.4 ± 2.6 years . The primary outcome was death from any cause . Secondary outcomes included paroxysmal and chronic atrial fibrillation , stroke , heart failure , and need for pacemaker reoperation . In the AAIR group , 209 patients ( 29.6 % ) died during follow-up vs. 193 patients ( 27.3 % ) in the DDDR group , hazard ratio ( HR ) 1.06 , 95 % confidence interval ( CI ) 0.88 - 1.29 , P = 0.53 . Paroxysmal atrial fibrillation was observed in 201 patients ( 28.4 % ) in the AAIR group vs. 163 patients ( 23.0 % ) in the DDDR group , HR 1.27 , 95 % CI 1.03 - 1.56 , P = 0.024 . A total of 240 patients underwent one or more pacemaker reoperations during follow-up , 156 ( 22.1 % ) in the AAIR group vs. 84 ( 11.9 % ) in the DDDR group ( HR 1.99 , 95 % CI 1.53 - 2.59 , P did not differ between treatment groups . CONCLUSION In patients with sick sinus syndrome , there is no statistically significant difference in death from any cause between AAIR pacing and DDDR pacing . AAIR pacing is associated with a higher incidence of paroxysmal atrial fibrillation and a two-fold increased risk of pacemaker reoperation . These findings support the routine use of DDDR pacing in these patients . CLINICAL TRIAL REGISTRATION URL http://www . clinical trials.gov . Unique identifier : NCT00236158",
"Objective : To analyse the occurrence of atrial fibrillation ( AF ) and thromboembolism in a r and omised comparison of rate adaptive single chamber atrial pacing ( AAIR ) and dual chamber pacing ( DDDR ) in patients with sick sinus syndrome and normal atrioventricular ( AV ) conduction , in which left atrial dilatation and decreased left ventricular fractional shortening had been observed in the DDDR group . Methods : 177 consecutive patients with sick sinus syndrome ( mean ( SD ) age 74 ( 9 ) years , 104 women ) were r and omly assigned to treatment with one of three pacemakers : AAIR ( n = 54 ) , DDDR with a short rate adaptive AV delay ( n = 60 ) ( DDDR-s ) ; or DDDR with a fixed long AV delay ( n = 63 ) ( DDDR-l ) . Analysis was intention to treat . Results : Mean follow up was 2.9 ( 1.1 ) years . AF at one or more ambulatory visits was significantly less common in the AAIR group ( 4 ( 7.4 % ) v 14 ( 23.3 % ) in the DDDR-s group v 11 ( 17.5 % ) in the DDDR-l group ; p = 0.03 , log rank test ) . The risk of developing AF in the AAIR group compared with the DDDR-s group was significantly decreased after adjustment for brady-tachy syndrome in a Cox regression analysis ( relative risk 0.27 , 95 % confidence interval ( CI ) 0.09 to 0.83 , p = 0.02 ) . The benefit of AAIR was highest among patients with brady-tachy syndrome . Brady-tachy syndrome and a thromboembolic event before pacemaker implantation were independent predictors of thromboembolism during follow up ( relative risk 7.5 , 95 % CI 1.6 to 36.2 , p = 0.01 , and relative risk 4.7 , 95 % CI 1.2 to 17.9 , p = 0.02 , respectively ) . Conclusions : During a mean follow up of 2.9 years AAIR was associated with significantly less AF . The beneficial effect of AAIR was still significant after adjustment for brady-tachy syndrome . Brady-tachy syndrome was associated with an increased risk of thromboembolism",
"AIMS Previous studies indicate that ventricular pacing may precipitate heart failure ( HF ) . We investigated occurrence of HF during long-term follow-up among patients with sick sinus syndrome ( SSS ) r and omized to AAIR or DDDR pacing . Furthermore , we investigated effects of percentage of ventricular pacing ( % VP ) and pacing site in the ventricle . METHODS AND RESULTS We analysed data from 1415 patients r and omized to AAIR ( n = 707 ) or DDDR pacing ( n = 708 ) . Ventricular pacing leads were recorded as located in either an apical or a non-apical position . The % VP and HF hospitalizations were recorded during follow-up . Patients were classified with new HF , if in New York Heart Association ( NYHA ) functional class IV or if presence of ≥2 of : oedema ; dyspnoea ; NYHA functional class III . Mean follow-up was 5.4 ± 2.4 years . Heart failure hospitalizations did not differ between groups . In the AAIR group , 170 of the 707 ( 26 % ) patients developed HF vs. 169 of the 708 ( 26 % ) patients in the DDDR group , hazard rate ratio ( HR ) 1.00 , 95 % confidence interval ( CI ) 0.79 - 1.22 , P = 0.87 . In DDDR patients , 146 of the 512 patients ( 29 % ) with ventricular leads in an apical position developed HF vs. 28 of the 161 patients ( 17 % ) with the leads in a non-apical position , HR 0.67 , CI 0.45 - 1.00 , P = 0.05 . After adjustments this difference was non-significant . The incidence of HF was not associated with % VP ( P = 0.57 ) . CONCLUSION In patients with SSS , HF was not associated with pacing mode , % VP , or ventricular lead localization . This suggests that DDDR pacing is safe in patients with SSS without precipitating HF",
"OBJECTIVES A r and omized trial was done to compare single-chamber atrial ( AAI ) and dual-chamber ( DDD ) pacing in patients with sick sinus syndrome ( SSS ) . Primary end points were changes in left atrial ( LA ) size and left ventricular ( LV ) size and function as measured by M-mode echocardiography . BACKGROUND In patients with SSS and normal atrioventricular conduction , it is still not clear whether the optimal pacing mode is AAI or DDD pacing . METHODS A total of 177 consecutive patients ( mean age 74 + /- 9 years , 73 men ) were r and omized to treatment with one of three rate-adaptive ( R ) pacemakers : AAIR ( n = 54 ) , DDDR with a short atrioventricular delay ( n = 60 ) ( DDDR-s ) , or DDDR with a fixed long atrioventricular delay ( n = 63 ) ( DDDR-l ) . Before pacemaker implantation and at each follow-up , M-mode echocardiography was done to measure LA and LV diameters . Left ventricular fractional shortening ( LVFS ) was calculated . Analysis was on an intention-to-treat basis . RESULTS Mean follow-up was 2.9 + /- 1.1 years . In the AAIR group , no significant changes were observed in LA or LV diameters or LVFS from baseline to last follow-up . In both DDDR groups , LA diameter increased significantly ( p LVFS decreased significantly ( p Atrial fibrillation was significantly less common in the AAIR group , 7.4 % versus 23.3 % in the DDDR-s group versus 17.5 % in the DDDR-l group ( p = 0.03 , log-rank test ) . Mortality , thromboembolism , and congestive heart failure did not differ between groups . CONCLUSIONS During a mean follow-up of 2.9 + /- 1.1 years , DDDR pacing causes increased LA diameter , and DDDR pacing with a short atrioventricular delay also causes decreased LVFS . No changes occur in LA or LV diameters or LVFS during AAIR pacing . Atrial fibrillation is significantly less common during AAIR pacing",
"In 19 patients paced and medicated for bradycardia tachycardia syndrome ( BTS ) , AAIR and DDDR pacing were compared with regard to quality of life ( QoL ) , atrial tachyarrhythmia ( AFib ) , exercise tolerance , and left ventricular (LV)function . Patients had a PQ interval In DDDR mode , AV delay was optimized using the aortic time velocity integral . After 3 months , QoL was assessed by question naires , patients were investigated by 24-hour Holter , cardiopulmonary exercise testing ( CPX ) was performed , and LV function was determined by echocardiography . QoL was similar in all dimensions , except dizziness , showing a significantly lower prevalence in AAIR mode . The incidence of AFib was 12 episodes in 2 patients with AAIR versus 22 episodes in 7 patients with DDDR pacing ( P = 0.072 ) . In AAIR mode , 164 events of second and third degree AV block were detected in 7 patients ( 37 % ) with pauses between 1 and 4 seconds . During CPX , exercise duration and work load were higher in AAIR than in DDDR mode ( 423+/-127 vs 402+/-102 s and 103+/-31 vs 96+/-27 Watt , P Oxygen consumption ( VO2 ) , was similar in both modes . During echocardiography , only deceleration of early diastolic flow velocity and early diastolic closure rate of the anterior mitral valve leaflet were higher in DDD than in AAI pacing ( 5.16+/-1.35 vs 3.56+/-0.95 m/s2 and 69.2+/-23 vs 54.1+/-26 mm/s , P DDDR , 8 patients chose AAIR . Hence , AAIR and DDDR pacing seem to be equally effective in BTS patients . In view of a considerable rate of high degree AV block during AAIR pacing , DDDR mode should be preferred for safety reasons",
"OBJECTIVES The purpose of this study was to determine the cost-effectiveness of physiologic pacemakers . BACKGROUND The Canadian Trial of Physiologic Pacing ( CTOPP ) was a large r and omized trial that evaluated the efficacy of physiologic pacing compared with ventricular pacing . CTOPP also included a prospect i ve cost-effectiveness sub study . METHODS Re source usage and costs were collected from a subset of 472 patients ( of 1,094 ) who received a physiologic pacemaker and 586 ( of 1,474 ) who received a ventricular pacemaker . Costs included initial pacemaker implantation and all health care follow-up costs over a follow-up of 5.2 years . Costs are reported in 2004 Canadian dollars ( 1 Canadian dollar = 0.76 US dollars ) , with adjustments for censoring . Incremental cost-effectiveness was estimated as the ratio of the difference ( treatment-control ) in mean cost to the difference in life expectancy ( mean survival ) , with costs and effects discounted at 3 % per year . RESULTS Over a mean follow-up of 3.1 years , physiologic pacing was associated with a gain of 0.01 life-years . This benefit increases to 0.25 life-years in the subgroup of patients with an intrinsic ( unpaced ) heart rate Physiologic pacing was more expensive than ventricular ( 16,833 Canadian dollars vs 13,857 US dollars ) , largely because of the increased cost of dual-chamber devices . Among all sub study patients , the incremental cost-effectiveness of physiologic pacing is 297,600 Canadian dollars per life-year gained ; however , this value falls to 16,343 Canadian dollars in patients with an intrinsic heart rate > 60 . CONCLUSIONS In the short term , a strategy of routine implantation of physiologic pacemakers is not cost-effective by currently accepted st and ards . The selective use of these devices in patients likely to be pacemaker dependent appears to be cost-effective . Further studies with longer follow-up and which consider the benefit of reducing nonfatal cardiac events would be valuable",
"AIMS To describe current evidence of the frequency , contents , and involved professionals of the routine follow-up visits in patients who have received a pacemaker ( PM ) . METHODS AND RESULTS The multicentre FOLLOWPACE study prospect ively collected data during implantation and follow-up of 1526 patients who received a PM for the first time . A total of 4914 follow-up visits were studied . Mean follow-up was 394 days with a mean of 3.2 visits per patient . At all follow-up visits , the battery condition was tested in > 93 % , the stimulation threshold in > 91 % , and sensing in > 87 % . The pacemaker parameters as stimulation and sensing thresholds , lead impedances , and percentages of pacing remained stable over time , but these values did depend on the lead location , lead fixation , and pulse duration . The majority of PM (re-)programming was performed during implantation and /or shortly before hospital discharge ( 50 % ) . PM re-programming during follow-up was most frequently performed by the PM technician alone ( 95 % ) . CONCLUSION Crucial PM parameters are regularly checked . Re-programming of PM parameters declined during the first year after PM implantation . The majority of PM checks were carried out by the PM technician , indicating the major influence of the allied professional on the quality and safety of the pacing therapy",
"AIMS Despite an annual rise in the numbers of patients receiving their first pacemaker ( PM ) , the risks of the implantation procedure remains unclear . The purpose of this prospect i ve study is to estimate the incidence of in-hospital events after first PM implantation and to determine the predictors of these events . METHODS AND RESULTS Patients with conventional pacing diagnosis were included in the Dutch multicentre FOLLOWPACE PM registry that prospect ively documented patients ' prognosis and quality of life , and PM events after first implantation . From these registry characteristics , implantation data and in-hospital findings were analysed as potential predictors for events in a sample of 1198 patients . In 111 patients studied , at least one serious in-hospital event occurred ( incidence 10.1 % , 95%CI : 8.9 - 12.3 ) . Six variables , i.e. a lower body mass index , presence of heart failure in medical history , main indication for implantation , vena subclavia use for venous access , active atrial lead fixation , and the implantation of a dual chamber system , were found to be independent predictors of events after first PM implantation . The overall multivariable model yielded an ROC area of 0.65 ( 95%CI : 0.60 - 0.70 ) . CONCLUSION This large prospect i ve multicentre study identified six variables as independent predictors for serious in-hospital events after first implantation . This may assist the implanting cardiologist and surgeon to identify patients at higher risk , during and immediately after PM implantation",
"BACKGROUND Health value or utility is the abstract ed magnitude of a person 's preference for quality and quantity of life . It reflects how much lifetime with the patient 's current health condition a patient is willing to exchange for a life in excellent health . Health values are used in cost-effectiveness analysis as a means of calculating quality -adjusted years of life . OBJECTIVE This study assessed the health values of elderly patients before and after pacemaker implantation . METHODS We prospect ively examined 398 patients from the Pacemaker Selection in the Elderly study , in which patients were r and omized to either VVIR or DDDR mode . Health values were estimated with the time tradeoff method before implantation and at 3 , 9 , and 18 months after implantation . RESULTS The mean age of patients was 76 + /- 6 years ; 234 patients ( 59 % ) were male . At baseline , patients were , on average , willing to exchange 5 years of current health for approximately 4 years in perfect health ( value 0.76 + /- 0.06 ) . There was no difference in baseline health values with implant diagnosis ( sinus node dysfunction n = 172 , 0.72 , atrioventricular block n = 227 , 0.75 , other diagnoses n = 39 , 0.78 , P = not significant ) . The overall improvement in health values at 3 months after pacemaker implantation was 0.165 + /- 0.4 ( P = .0001 ) . The improvement in health values was independent of pacing mode ( P = .6 ) . The time tradeoff score was modestly correlated with other measurements of health-related quality of life . The change in time tradeoff score with time was not influenced by demographic characteristics such as age and sex , diagnoses , pacing mode , employment status , or history of angina . Patients with a lower functional class at enrollment ( III or IV on the Specific Activity Scale ) demonstrated an absolute improvement of 23 % in their health values , whereas patients in class I or II improved only by 12 % , ( P = .03 ) . CONCLUSIONS Permanent pacemaker implantation for st and ard indications improves health values and descriptive health status measures . The values reported here may be used as a means of calculating the cost-effectiveness of different pacing modalities",
"AIMS Increasing evidence from r and omized trials and experimental studies indicates that right ventricular ( RV ) pacing may induce congestive heart failure . We studied regional left ventricular ( LV ) dyssynchrony and global LV function in 50 consecutive patients with sick sinus syndrome ( SSS ) r and omized to either atrial pacing [ AAI(R ) ] or dual chamber RV-pacing [ DDD(R ) ] . METHODS AND RESULTS Fifty consecutive patients were r and omized to AAI(R ) or DDD(R)-pacing . Tissue-Doppler imaging was used to quantify LV dyssynchrony in terms of number of segments with delayed longitudinal contraction ( DLC ) . Left ventricular ejection fraction ( LVEF ) was measured using three-dimensional echocardiography . Dyssynchrony was more pronounced in the DDD(R)-group than in the AAI(R)-group at the 12 months follow-up ( P dyssynchrony in the DDD(R)-group from baseline to the 12 months follow-up ( 1.3 + /- 1 to 2.1 + /- 1 segments displaying DLC per patient ) , P LVEF , NYHA or NT-proBNP was observed between AAI(R)- and DDD(R)-mode after 12 months of pacing although LVEF decreased significantly in the DDD(R)-group from baseline ( 63.1 + /- 8 % ) to the 12 months follow-up ( 59.3 + /- 8 % , P LVEF remained unchanged in the AAI(R)-group ( 61.5 + /- 11 % at baseline vs. 62.3 + /- 7 % after 12 months , NS . CONCLUSION In patients with SSS , DDD(R)-pacing but not AAI(R)-pacing induces significant LV desynchronization and reduction of LVEF",
"AIMS Atrioventricular synchronous pacing exerts beneficial effects , including reduction of left ventricular outflow tract gradients , in patients with hypertrophic obstructive cardiomyopathy . The Pacing in Cardiomyopathy study was initiated to explore the effects of pacing in a double-blind r and omized crossover fashion . The aims were to ascertain the beneficial effects of pacing in a controlled study and to rule out a placebo effect by pacing . This paper deals with the outcome of pacing on quality of life during 1 year of follow-up . METHODS Quality of life was evaluated with the Karolinska question naire , vali date d for patients paced for bradyarrhythmias and ischaemic heart disease . Drug-refractory patients with hypertrophic obstructive cardiomyopathy were recruited for the study and after a temporary pacing procedure implanted with permanent pacemakers . Patients were r and omized to two study arms defining the sequence of pacemaker programming . In one arm the pacemaker was inactive , in the other active . After 3 months the pacemaker was reprogrammed to the alternate mode and a further 3 months followed . After this period subsequent pacemaker programming corresponded to the mode preferred by the patient . A last assessment was made 1 year after baseline examinations . RESULTS Eighty patients completed the first crossover period and 75 completed the full 1 year of follow-up . Active pacing induced significant quality of life improvements , in the order of 9 - 44 % , regardless of programming sequence . Discontinuation of pacing after a first active period result ed in the return of symptoms . Fourteen patients requested early reprogramming after having been programmed to inactive pacing after a first period of active pacing . Seventy-six patients preferred active pacing after the crossover period . A further 6 months of pacing induced progressive improvement in symptoms already favourably influenced . CONCLUSION Atrioventricular synchronous pacing has a profound beneficial effect on most domains of quality of life in patients with hypertrophic obstructive cardiomyopathy refractory to drug treatment",
"The incidence and clinical predictors of the development of intolerance to VVIR pacing have not been extensively studied in prospect i ve long-term r and omized trials comparing different pacing modes . The frequency and clinical factors predicting intolerance to ventricular pacing are controversial . The Pacemaker Selection in the Elderly ( PASE ) Trial enrolled 407 patients aged > /=65 years in a 30-month , single-blind , r and omized , controlled comparison of quality of life and clinical outcomes with ventricular pacing and dual-chamber pacing in patients undergoing dual-chamber pacemaker implantation for st and ard clinical ly accepted indications . We review ed the clinical , hemodynamic , and electrophysiologic variables at the time of pacemaker implantation in 204 patients enrolled in the PASE trial and r and omized to the VVIR mode , some of whom subsequently required crossover ( reprogramming ) to DDDR pacing . During a median follow-up of 555 days , 53 patients ( 26 % ) crossed over from VVIR to DDDR pacing . A decrease in systolic blood pressure during ventricular pacing at the time of pacemaker implantation ( p = 0.001 ) , use of beta blockers at the time of r and omization ( p = 0.01 ) , and nonischemic cardiomyopathy ( p = 0.04 ) were the only variables that predicted crossover in the Cox multivariate regression model . After reprogramming to the dual-chamber mode , patients showed improvement in all aspects of quality of life , with significant improvements in physical and emotional role . The high incidence of crossover from VVIR to DDDR pacing along with significant improvements in quality of life after crossover to DDDR pacing strongly favors dual-chamber pacing compared with single-chamber ventricular pacing in elderly patients requiring permanent pacing",
"In patients with sick-sinus syndrome , single-chamber atrial pacing has been reported , in retrospective studies , to be associated with lower frequencies of atrial fibrillation , thromboembolism , heart failure , and mortality than ventricular pacing ; although single-chamber ventricular pacing is most commonly used . We did a prospect i ve r and omised trial in 225 consecutive patients ( 142 women , 83 men ; mean age 76 years ) with the sick-sinus syndrome , r and omised to atrial ( n = 110 ) or ventricular ( n = 115 ) pacing and followed for up to 5 years ( mean 40 [ SD 18 ] months ) . During follow-up , the frequency of atrial fibrillation was higher in the ventricular group , except at the first follow-up at 3 months . Thromboembolic events ( stroke or peripheral arterial embolus ) occurred in 20 patients in the ventricular group and in 6 patients in the atrial group ( p = 0.0083 ) . 25 patients died in the ventricular group compared with 21 in the atrial group ( p = 0.74 ) . Heart failure estimated by the New York Heart Association classification and by the daily doses of diuretics did not differ between the two groups . Atrioventricular block occurred in 2 patients in the atrial group . Patients with sick-sinus syndrome should be treated with atrial pacing rather than ventricular pacing because atrial pacing is associated with lower frequencies of atrial fibrillation , thromboembolic complications , and a low risk of atrioventricular block",
"BACKGROUND In the Mode Selection Trial ( MOST ) of 2,010 patients with sinus node dysfunction , dual-chamber-paced patients had less atrial fibrillation ( AF ) and heart failure and had slightly improved health-related quality of life ( QOL ) compared with rate modulated right ventricular-paced patients . Our objective was to assess the impact of AF on QOL within MOST . METHODS We analyzed serial QOL measures ( Short Form-36 , Specific Activity Scale , time trade-off ) in 3 groups : ( 1 ) those without AF ; ( 2 ) those with paroxysmal AF ( PAF ) , but not chronic AF ( CAF ) ; and ( 3 ) those with CAF . We carried forward the last known QOL before crossover for all subsequent time points in patients r and omized to rate modulated right ventricular pacing who crossed over to dual-chamber pacing for severe pacemaker syndrome . RESULTS Three hundred seventeen patients ( 15.8 % ) had AF in the year after implantation , 206 patients within 3 months ( 191 PAF , 15 CAF ) , and another 159 ( 124 PAF , 35 CAF ) between 3 and 12 months . There were no significant differences among groups in individual Short Form-36 subscales or time trade-off scores at 12 months as compared with baseline or 3 months . Cardiovascular health status was better at 12 months as compared with baseline or 3 months in those without AF . CONCLUSIONS Atrial fibrillation after pacemaker implantation in elderly patients with sick sinus syndrome was not a major determinant of QOL . However , there was a trend toward better cardiovascular functional status in patients without AF",
"An atrial-based pacing mode is superior to ventricular constant rate dem and pacing ( VVI ) mode in patients with sick sinus syndrome ( SSS ) by providing both rate adaptation and atrioventricular ( AV ) synchrony . The use of a non-atrial sensor to overcome chronotropic incompetence and preserve normal intrinsic AV conduction in pacemaker therapy for SSS was investigated in 15 consecutive patients ( mean age 66 + /- 2 years ) . All had intact AV conduction ( ante grade conduction capacity > 100 beats.min-1 and an atrial paced to intrinsic R interval of DDDR pacemakers capable of being programmed into atrial rate adaptive ( AAIR ) , dual chamber rate adaptive ( DDDR ) and ventricular rate adaptive ( VVIR ) modes were used . Beginning with an acute study , arterial pressure was invasively assessed in each pacing mode during physiological stresses and low level exercise . In the ambulatory phase , the incidence of ventricular pacing and arrhythmias ( Holter recording ) , diurnal blood pressure changes ( ambulatory blood pressure recording ) , and symptom and quality of life level ( question naires and interviews ) were compared . Despite similar heart rate changes during acute physiological stresses , a higher blood pressure was recorded during AAIR or DDDR pacing compared with VVIR pacing . Systolic blood pressure over 24 h was lower in the VVIR mode ( 122 + /- 5 mmHg ) than AAIR/DDDR pacing ( 129 + /- 6/128 + /- 6 mmHg , P frequency of atrial and ventricular ectopics , with two patients developing paroxysmal atrial fibrillation . Ventricular pacing was used in a higher percentage in the DDDR compared with the VVIR mode ( 64 + /- 11 and 39 + /- 7 % , P palpitations , a lower level of general well being and depression . Despite the use of a sensor to overcome chronotropic incompetence , VVIR pacing is a less satisfactory pacing mode for SSS . Although AAIR/DDDR pacing may achieve similar haemodynamic and clinical status , in patients with intact AV conduction , AAIR pacing may be preferable by avoiding an abnormal ventricular activation pattern",
"BACKGROUND There are two approaches to the treatment of atrial fibrillation : one is cardioversion and treatment with antiarrhythmic drugs to maintain sinus rhythm , and the other is the use of rate-controlling drugs , allowing atrial fibrillation to persist . In both approaches , the use of anticoagulant drugs is recommended . METHODS We conducted a r and omized , multicenter comparison of these two treatment strategies in patients with atrial fibrillation and a high risk of stroke or death . The primary end point was overall mortality . RESULTS A total of 4060 patients ( mean [ + /-SD ] age , 69.7+/-9.0 years ) were enrolled in the study ; 70.8 percent had a history of hypertension , and 38.2 percent had coronary artery disease . Of the 3311 patients with echocardiograms , the left atrium was enlarged in 64.7 percent and left ventricular function was depressed in 26.0 percent . There were 356 deaths among the patients assigned to rhythm-control therapy and 310 deaths among those assigned to rate-control therapy ( mortality at five years , 23.8 percent and 21.3 percent , respectively ; hazard ratio , 1.15 [ 95 percent confidence interval , 0.99 to 1.34 ] ; P=0.08 ) . More patients in the rhythm-control group than in the rate-control group were hospitalized , and there were more adverse drug effects in the rhythm-control group as well . In both groups , the majority of strokes occurred after warfarin had been stopped or when the international normalized ratio was subtherapeutic . CONCLUSIONS Management of atrial fibrillation with the rhythm-control strategy offers no survival advantage over the rate-control strategy , and there are potential advantages , such as a lower risk of adverse drug effects , with the rate-control strategy . Anticoagulation should be continued in this group of high-risk patients",
"BACKGROUND St and ard clinical practice permits the use of either single-chamber ventricular pacemakers or dual-chamber pacemakers for most patients who require cardiac pacing . Ventricular pacemakers are less expensive , but dual-chamber pacemakers are believed to be more physiologic . However , it is not known whether either type of pacemaker results in superior clinical outcomes . METHODS The Pacemaker Selection in the Elderly study was a 30-month , single-blind , r and omized , controlled comparison of ventricular pacing and dual-chamber pacing in 407 patients 65 years of age or older in 29 centers . Patients received a dual-chamber pacemaker that had been r and omly programmed to either ventricular pacing or dual-chamber pacing . The primary end point was health-related quality of life as measured by the 36-item Medical Outcomes Study Short-Form General Health Survey . RESULT The average age of the patients was 76 years ( range , 65 to 96 ) , and 60 percent were men . Quality of life improved significantly after pacemaker implantation ( P quality of life or prespecified clinical outcomes ( including cardiovascular events or death ) . However , 53 patients assigned to ventricular pacing ( 26 percent ) were crossed over to dual-chamber pacing because of symptoms related to the pacemaker syndrome . Patients with sinus-node dysfunction , but not those with atrioventricular block , had moderately better quality of life and cardiovascular functional status with dual-chamber pacing than with ventricular pacing . Trends of borderline statistical significance in clinical end points favoring dual-chamber pacing were observed in patients with sinus-node dysfunction , but not in those with atrioventricular block . CONCLUSION The implantation of a permanent pacemaker improves health-related quality of life . However , the quality -of-life benefits associated with dual-chamber pacing as compared with ventricular pacing are observed principally in the subgroup of patients with sinus-node dysfunction",
"OBJECTIVES This study examined the effect of physiologic pacing on the development of chronic atrial fibrillation ( CAF ) in the Canadian Trial Of Physiologic Pacing ( CTOPP ) . BACKGROUND The role of physiologic pacing to prevent CAF remains unclear . Small r and omized studies have suggested a benefit for patients with sick sinus syndrome . No data from a large r and omized trial are available . METHODS The CTOPP r and omized patients undergoing first pacemaker implant to ventricular-based or physiologic pacing ( AAI or DDD ) . Patients who were prospect ively found to have persistent atrial fibrillation ( AF ) lasting greater than or equal to one week were defined as having CAF . Kaplan-Meier plots for the development of CAF were compared by log-rank test . The effect of baseline variables on the benefit of physiologic pacing was evaluated by Cox proportional hazards modeling . RESULTS Physiologic pacing reduced the development of CAF by 27.1 % , from 3.84 % per year to 2.8 % per year ( p = 0.016 ) . Three clinical factors predicted the development of CAF : age > or = 74 years ( p = 0.057 ) , sinoatrial ( SA ) node disease ( p Physiologic pacing reduces the annual rate of development of chronic AF in patients undergoing first pacemaker implant . Age > or = 74 years , SA node disease and prior AF predicted the development of CAF . Patients with structurally normal hearts appear to derive greatest benefits",
"AIMS The recent Danish Multicentre R and omized Trial on Single-Lead Atrial ( AAIR ) Pacing versus Dual-Chamber ( DDDR ) Pacing in Sick Sinus Syndrome ( DANPACE ) suggested DDDR pacing as st and ard care . However , previous findings supported the routine use of AAIR pacing . This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome . METHODS AND RESULTS A decision-analytical model based on patient-level data from three r and omized trials was design ed from the Danish healthcare system 's perspective . The main outcomes were lifetime costs , quality -adjusted lifeyears ( QALYs ) , and net monetary benefit . Quality -adjusted lifeyears were calculated by utilizing community-based preferences . Costs were calculated by utilizing the extensive data on re source consumption , from the DANPACE trial . Data were pooled and adjusted for baseline differences . Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay ( WTP ) threshold of £ 20,000/QALY , and most analyses using a WTP of £ 30,000/QALY . When pooling the data and adjusting for baseline differences , Monte Carlo simulations revealed a 51 - 71 % probability of DDDR pacing being cost-effective at a WTP of £ 20,000/QALY , and a 42 - 58 % probability at a WTP of £ 30,000/QALY . Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity . The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged . CONCLUSION Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients"
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Supplemental Digital Content is available in the text . Background : Coconut oil is high in saturated fat and may , therefore , raise serum cholesterol concentrations , but beneficial effects on other cardiovascular risk factors have also been suggested . Therefore , we conducted a systematic review of the effect of coconut oil consumption on blood lipids and other cardiovascular risk factors compared with other cooking oils using data from clinical trials . Methods : We search ed PubMed , SCOPUS , Cochrane Registry , and Web of Science through June 2019 . We selected trials that compared the effects of coconut oil consumption with other fats that lasted at least 2 weeks . Two review ers independently screened articles , extracted data , and assessed the study quality according to the PRISMA guidelines ( Preferred Reporting Items for Systematic Review s and Meta-Analyses ) . The main outcomes included low-density lipoprotein cholesterol ( LDL-cholesterol ) , high-density lipoprotein cholesterol ( HDL-cholesterol ) , total cholesterol , triglycerides , measures of body fatness , markers of inflammation , and glycemia . Data were pooled using r and om-effects meta- analysis . Results : 16 articles were included in the meta- analysis . Results were available from all trials on blood lipids , 8 trials on body weight , 5 trials on percentage body fat , 4 trials on waist circumference , 4 trials on fasting plasma glucose , and 5 trials on C-reactive protein . Coconut oil consumption significantly increased LDL-cholesterol by 10.47 mg/dL ( 95 % CI : 3.01 , 17.94 ; I2 = 84 % , N=16 ) and HDL-cholesterol by 4.00 mg/dL ( 95 % CI : 2.26 , 5.73 ; I2 = 72 % , N=16 ) as compared with nontropical vegetable oils . These effects remained significant after excluding nonr and omized trials , or trials of poor quality ( Jadad score Coconut oil consumption did not significantly affect markers of glycemia , inflammation , and adiposity as compared with nontropical vegetable oils . Conclusions : Coconut oil consumption results in significantly higher LDL-cholesterol than nontropical vegetable oils . This should inform choices about coconut oil consumption
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"The effects of dietary supplementation with coconut oil on the biochemical and anthropometric profiles of women presenting waist circumferences ( WC ) > 88 cm ( abdominal obesity ) were investigated . The r and omised , double-blind , clinical trial involved 40 women aged 20–40 years . Groups received daily dietary supplements comprising 30 mL of either soy bean oil ( group S ; n = 20 ) or coconut oil ( group C ; n = 20 ) over a 12-week period , during which all subjects were instructed to follow a balanced hypocaloric diet and to walk for 50 min per day . Data were collected 1 week before ( T1 ) and 1 week after ( T2 ) dietary intervention . Energy intake and amount of carbohydrate ingested by both groups diminished over the trial , whereas the consumption of protein and fibre increased and lipid ingestion remained unchanged . At T1 there were no differences in biochemical or anthropometric characteristics between the groups , whereas at T2 group C presented a higher level of HDL ( 48.7 ± 2.4 vs. 45.00 ± 5.6 ; P = 0.01 ) and a lower LDL : HDL ratio ( 2.41 ± 0.8 vs. 3.1 ± 0.8 ; P = 0.04 ) . Reductions in BMI were observed in both groups at T2 ( P reduction in WC ( P = 0.005 ) . Group S presented an increase ( P 0.05 ) in total cholesterol , LDL and LDL : HDL ratio , whilst HDL diminished ( P = 0.03 ) . Such alterations were not observed in group C. It appears that dietetic supplementation with coconut oil does not cause dyslipidemia and seems to promote a reduction in abdominal obesity ",
"Introduction High dietary saturated fat intake is associated with higher blood concentrations of low-density lipoprotein cholesterol ( LDL-C ) , an established risk factor for coronary heart disease . However , there is increasing interest in whether various dietary oils or fats with different fatty acid profiles such as extra virgin coconut oil may have different metabolic effects but trials have reported inconsistent results . We aim ed to compare changes in blood lipid profile , weight , fat distribution and metabolic markers after four weeks consumption of 50 g daily of one of three different dietary fats , extra virgin coconut oil , butter or extra virgin olive oil , in healthy men and women in the general population . Design R and omised clinical trial conducted over June and July 2017 . Setting General community in Cambridgeshire , UK . Participants Volunteer adults were recruited by the British Broadcasting Corporation through their websites . Eligibility criteria were men and women aged 50–75 years , with no known history of cancer , cardiovascular disease or diabetes , not on lipid lowering medication , no contraindications to a high-fat diet and willingness to be r and omised to consume one of the three dietary fats for 4 weeks . Of 160 individuals initially expressing an interest and assessed for eligibility , 96 were r and omised to one of three interventions ; 2 individuals subsequently withdrew and 94 men and women attended a baseline assessment . Their mean age was 60 years , 67 % were women and 98 % were European Caucasian . Of these , 91 men and women attended a follow-up assessment 4 weeks later . Intervention Participants were r and omised to extra virgin coconut oil , extra virgin olive oil or unsalted butter and asked to consume 50 g daily of one of these fats for 4 weeks , which they could incorporate into their usual diet or consume as a supplement . Main outcomes and measures The primary outcome was change in serum LDL-C ; secondary outcomes were change in total and high-density lipoprotein cholesterol ( TC and HDL-C ) , TC/HDL-C ratio and non-HDL-C ; change in weight , body mass index ( BMI ) , waist circumference , per cent body fat , systolic and diastolic blood pressure , fasting plasma glucose and C reactive protein . Results LDL-C concentrations were significantly increased on butter compared with coconut oil ( + 0.42 , 95 % CI 0.19 to 0.65 mmol/L , P of LDL-C in coconut oil compared with olive oil ( −0.04 , 95 % CI −0.27 to 0.19 mmol/L , P=0.74 ) . Coconut oil significantly increased HDL-C compared with butter ( + 0.18 , 95 % CI 0.06 to 0.30 mmol/L ) or olive oil ( + 0.16 , 95 % CI 0.03 to 0.28 mmol/L ) . Butter significantly increased TC/HDL-C ratio and non-HDL-C compared with coconut oil but coconut oil did not significantly differ from olive oil for TC/HDL-C and non-HDL-C. There were no significant differences in changes in weight , BMI , central adiposity , fasting blood glucose , systolic or diastolic blood pressure among any of the three intervention groups . Conclusions and relevance Two different dietary fats ( butter and coconut oil ) which are predominantly saturated fats , appear to have different effects on blood lipids compared with olive oil , a predominantly monounsaturated fat with coconut oil more comparable to olive oil with respect to LDL-C. The effects of different dietary fats on lipid profiles , metabolic markers and health outcomes may vary not just according to the general classification of their main component fatty acids as saturated or unsaturated but possibly according to different profiles in individual fatty acids , processing methods as well as the foods in which they are consumed or dietary patterns . These findings do not alter current dietary recommendations to reduce saturated fat intake in general but highlight the need for further elucidation of the more nuanced relationships between different dietary fats and health . Trial registration number NCT03105947 ; Results",
"This study 's purpose was to evaluate the fasting human plasma lipid and lipoprotein responses to dietary beef fat ( BF ) by comparison with coconut oil ( CO ) and safflower oil ( SO ) , fats customarily classified as saturated and polyunsaturated . Nineteen free-living normolipidemic men aged 25.6 + /- 3.5 yr consumed central ly-prepared lunches and dinners of common foods having 35 % fat calories , 60 % of which was the test fat . The test fats were isocalorically substituted , and each fed for five weeks in r and om sequences with intervening five weeks of habitual diets . Plasma total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , and low-density lipoprotein cholesterol ( LDL-C ) concentrations among individuals follows the same relative rank regardless of diet . Triglycerides ( TG ) concentrations among individuals also maintain their relative rank regardless of diet but in a different order from that of the cholesterols . Plasma TC , HDL-C , and LDL-C responses to BF were significantly lower and TG higher than to CO . As compared to SO , BF produced equivalent levels of TG , HDL-C , and LDL-C and marginally higher TC . Thus , the customary consideration of BF as \" saturated \" and grouping it with CO appears unwarranted",
"The purpose of this study was to evaluate the fatty acid composition of chylomicron triglycerides isolated from subjects fed liquid-formula diets containing 40 % of total energy as medium- ( C8:0 and C10:0 ) or long-chain ( C16-C18 ) triglycerides ( MCT , LCT ) for 6 d. Medium-chain fatty acids ( MCFA ) comprised 8 % of total chylomicron triglyceride fatty acids after the first MCT meal . After 6 d of continued MCT feeding , chylomicron triglyceride MCFA content increased to 13 % . When subjects were fed the LCT ( soybean oil ) diet , C16:0 , C18:1 , and C18:2 comprised nearly 90 % of the chylomicron triglyceride fatty acids . The mass of triglyceride transported in chylomicrons isolated from subjects fed the MCT diet was approximately 20 % of that found when subjects consumed the LCT diet . We conclude that although total triglyceride production during MCT ingestion is low , the chylomicron triglycerides that are synthesized contain significant amounts of MCFA",
"The effects of lauric acid ( C12:0 ) on plasma lipids and lipoproteins were compared with the effects of palmitic acid ( C16:0 ) and oleic acid ( C18:1 ) in a metabolic-diet study of 14 men by using liquid-formula diets fed for 3 wk each in r and om order . Lauric acid was supplied in a synthetic high-lauric oil , palmitic acid was provided by palm oil and oleic acid in oleic-rich sunflower seed oil . The high-lauric oil result ed in higher concentrations of plasma total cholesterol ( 4.94 + /- 0.75 mmol/L [ mean + /- SE ] ) and LDL cholesterol ( 3.70 + /- 0.57 mmol/L ) when compared with high-oleic sunflower oil ( 4.44 + /- 0.54 and 3.31 + /- 0.44 mmol/L , respectively ) , but did not raise total and LDL cholesterol concentrations as much as did palm oil ( 5.17 + /- 0.65 and 3.93 + /- 0.51 mmol/L , respectively ) . No differences were noted in plasma triglycerides or HDL cholesterol . Lauric acid raises total and LDL cholesterol concentrations compared with oleic acid , but is not as potent for increasing cholesterol concentrations as is palmitic acid",
"The present paper reports the influence on plasma lipids of isoenergetic diets containing 30 % of energy as fat , with a polyunsaturated : saturated fat ratio of 4.00 or 0.25 , consumed for 8 weeks by twenty-five young normolipidaemic males . Approximately 70 % of the fat energy was provided by the test fats : soya-bean fat and coconut fat . During the soya-bean-fat-eating period the total plasma cholesterol level fell significantly compared with baseline values ( P less than 0.001 ) and during the coconut-fat-eating phase total plasma cholesterol level increased significantly compared with the soya-bean-eating period ( P less than 0.001 ) . On the soya-bean-fat diet , high-density-lipoprotein (HDL)-cholesterol decreased by 15 % ( range 6 - 35 % ) and plasma triacylglycerols decreased by 25 % ( range 13 - 37 % ) . Results of the present study show that even when the proportion of total fat in the diet is low , a high intake of linoleic acid lowers both total plasma cholesterol and HDL-cholesterol , while a high intake of saturated fat elevates both these lipid fractions . Application of regression formulas to the present findings indicates that short-chain saturated fatty acids have a neutral effect on serum cholesterol",
"Background / objectives : Effects of high-protein diets that are rich in saturated fats on cell adhesion molecules , thrombogenicity and other nonlipid markers of atherosclerosis in humans have not been firmly established . We aim to investigate the effects of high-protein Malaysian diets prepared separately with virgin olive oil ( OO ) , palm olein ( PO ) and coconut oil ( CO ) on cell adhesion molecules , lipid inflammatory mediators and thromobogenicity indices in healthy adults . Methods : A r and omized cross-over intervention with three dietary sequences , using virgin OO , PO and CO as test fats , was carried out for 5 weeks on each group consisting of 45 men and women . These test fats were incorporated separately at two-thirds of 30 % fat calories into high-protein Malaysian diets . Results : For fasting and nonfasting blood sample s , no significant differences were observed on the effects of the three test-fat diets on thrombaxane B2 ( TXB2 ) , TXB2/PGF1α ratios and soluble intracellular and vascular cell adhesion molecules . The OO diet induced significantly lower ( P compared with the other two test diets , whereas PGF1α concentrations were significantly higher ( P the thrombogenicity indices — cellular adhesion molecules , thromboxane B2 ( TXB2 ) and TXB2/prostacyclin ( PGF1α ) ratios . However , the OO diet lowered plasma proinflammatory LTB4 , whereas the PO diet raised the antiaggregatory plasma PGF1α in healthy Malaysian adults . This trial was registered at clinical trials.gov as NCT 00941837",
"OBJECTIVE A mutant soybean line ( A16 ) low in linolenic acid content ( 2 % of oil by weight ) was developed to increase oil oxidative stability . It was unknown whether serum lipid and lipoprotein concentrations in humans would be affected should A16 soybean oil ( A16 oil ) replace commercial soybean oil in diets . This study was conducted to examine the hypothesis that in free-living normolipidemic women , the consumption of A16 oil at approximately 10 % of energy intake ( en% ) would not affect serum lipids and lipoproteins differently than would the consumption of the same amount of a commercial soybean oil with 7 % of linolenic acid content . DESIGN Fifteen free-living female college students consumed the soybean oil daily with regular meals for 9 weeks in different orders , with each test oil being eaten for 3 weeks . During the study , 13 en% was provided by each test oil and a total of 35 en% was from dietary fat . Serum concentrations of total cholesterol , high-density lipoprotein cholesterol ( HDL cholesterol ) , low-density lipoprotein cholesterol ( LDL cholesterol ) and triacylglycerides ( TAG ) were measured . Serum total fatty acid patterns were analyzed as well . RESULTS Each of the three test oils decreased serum total cholesterol , LDL cholesterol and TAG concentrations from the baseline values . The feeding of A16 and commercial soybean oils decreased serum HDL cholesterol significantly compared with coconut oil ( p serum myristic acid significantly more than did either soybean oil ( p Serum arachidonic acid concentrations were significantly greater with A16 consumption than with commercial soybean oil consumption ( p A16 and commercial soybean oils both diminished serum HDL cholesterol . Although the fatty acid composition differed between the two soybean oils , A16 oil and commercial oil had similar effects on serum concentrations of lipoproteins and lipids . With increased oxidative stability , A16 oil is a good alternative to commercial soybean oil",
"This r and omized crossover study compared the impact of virgin coconut oil ( VCO ) to safflower oil ( SO ) on body composition and cardiovascular risk factors . Twelve postmenopausal women ( 58.8 ± 3.7 year ) consumed 30 mL VCO or SO for 28 days , with a 28-day washout . Anthropometrics included body weight and hip and waist circumference . Fat percent for total body , and roid and gynoid , fat mass , and lean mass were measured using dual-energy X-ray absorptiometry . Women maintained their typical diet recording 28 days of food records during the study . Results were analyzed with SPSS v24 with significance at P ≤ .05 . Comparisons are reported as paired t-test since no intervention sequence effect was observed . VCO significantly raised total cholesterol , TC ( + 18.2 ± 22.8 mg/dL ) , low-density lipoprotein ( + 13.5 ± 16.0 mg/dL ) , and high-density lipoprotein , HDL ( + 6.6 ± 7.5 mg/dL ) . SO did not significantly change lipid values . TC and HDL were significantly different between test oils . The TC/HDL ratio change showed a neutral effect of both VCO and SO . One person had adverse reactions to VCO and increased inflammation . VCO decreased IL-1β for each person who had a detected sample . The impact of VCO and SO on other cytokines varied on an individual basis . This was the first study evaluating the impact of VCO on body composition in Caucasian postmenopausal women living in the United States . Results are suggestive that individuals wishing to use coconut oil in their diets can do so safely , but more studies need to be conducted with larger sample sizes , diverse population s , and more specific clinical markers such as particle size",
"Background and rationale Coronary artery disease ( CAD ) and its pathological atherosclerotic process are closely related to lipids . Lipids levels are in turn influenced by dietary oils and fats . Saturated fatty acids increase the risk for atherosclerosis by increasing the cholesterol level . This study was conducted to investigate the impact of cooking oil media ( coconut oil and sunflower oil ) on lipid profile , antioxidant mechanism , and endothelial function in patients with established CAD . Design and methods In a single center r and omized study in India , patients with stable CAD on st and ard medical care were assigned to receive coconut oil ( Group I ) or sunflower oil ( Group II ) as cooking media for 2 years . Anthropometric measurements , serum , lipids , Lipoprotein a , apo B/A-1 ratio , antioxidants , flow-mediated vasodilation , and cardiovascular events were assessed at 3 months , 6 months , 1 year , and 2 years . Results Hundred patients in each arm completed 2 years with 98 % follow-up . There was no statistically significant difference in the anthropometric , biochemical , vascular function , and in cardiovascular events after 2 years . Conclusion Coconut oil even though rich in saturated fatty acids in comparison to sunflower oil when used as cooking oil media over a period of 2 years did not change the lipid-related cardiovascular risk factors and events in those receiving st and ard medical care",
"STUDY OBJECTIVE A validation study was conducted first to test assumptions about the effect of saturated and unsaturated dietary fat supplements . The second study was conducted to determine the effect on blood cholesterol levels of saturated and unsaturated fat supplements in patients who followed a low-fat diet and were administered lovastatin . DESIGN R and omized , crossover design , with three periods in the first study and four in the second study , each lasting 6 weeks . SETTING Cholesterol Research Center . PATIENTS The first study evaluated adults with total cholesterol levels between 200 and 280 mg/dl ( 5.172 and 7.241 mmol/L ) . The second study included adults with low-density lipoprotein ( LDL ) cholesterol levels above 160 mg/dl ( 4.138 mmol/L ) . INTERVENTIONS Fat supplements with either coconut or canola oil were delivered to patients in oatmeal-raisin cookies . MEASUREMENTS AND MAIN RESULTS In the validation study , patients ' mean prer and omization total cholesterol level of 222 mg/dl was reduced to 213 mg/dl with canola oil and increased to 233 mg/dl with coconut oil cookies ( p = 0.0038 ) . In the second study the mean prer and omization total cholesterol level of 214 mg/dl was decreased to 199 mg/dl with canola oil and to 208 mg/dl with coconut oil cookies ( p = 0.2342 ) . The LDL cholesterol levels changed in a similar fashion in both studies . CONCLUSIONS Changes in total and LDL cholesterol levels in the validation study were expected based on established effects of saturated and unsaturated fatty acids , but changes in these levels in lovastatin-cookie study were not expected . They could have occurred because lovastatin reversed the effect of saturated fats and enhanced the effect of unsaturated fats . Alternatively , they may have been due to enhanced bioavailability of lovastatin when administered with a high-fat diet . These findings must be confirmed",
"BACKGROUND Dietary fat type is known to modulate the plasma lipid profile , but its effects on plasma homocysteine and inflammatory markers are unclear . OBJECTIVE We investigated the effects of high-protein Malaysian diets prepared with palm olein , coconut oil ( CO ) , or virgin olive oil on plasma homocysteine and selected markers of inflammation and cardiovascular disease ( CVD ) in healthy adults . DESIGN A r and omized-crossover intervention with 3 dietary sequences of 5 wk each was conducted in 45 healthy subjects . The 3 test fats , namely palmitic acid (16:0)-rich palm olein ( PO ) , lauric and myristic acid ( 12:0 + 14:0)-rich CO , and oleic acid (18:1)-rich virgin olive oil ( OO ) , were incorporated at two-thirds of 30 % fat calories into high-protein Malaysian diets . RESULTS No significant differences were observed in the effects of the 3 diets on plasma total homocysteine ( tHcy ) and the inflammatory markers TNF-α , IL-1β , IL-6 , and IL-8 , high-sensitivity C-reactive protein , and interferon-γ . Diets prepared with PO and OO had comparable nonhypercholesterolemic effects ; the postpr and ial total cholesterol for both diets and all fasting lipid indexes for the OO diet were significantly lower ( P decrease postpr and ial lipoprotein(a ) . CONCLUSION Diets that were rich in saturated fatty acids prepared with either PO or CO , and an OO diet that was high in oleic acid , did not alter postpr and ial or fasting plasma concentrations of tHcy and selected inflammatory markers . This trial was registered at clinical trials.gov as NCT00941837",
"A small-scale preliminary cross-over study was conducted to investigate the effects of supercritical CO(2)-extracted sea buckthorn berry oil ( SBO ) on some risk factors of cardiovascular disease . Special features of the oil are high proportions of palmitic ( 16:0 ) , oleic ( 18:1n-9 ) , palmitoleic ( 16:1n-7 ) , linoleic ( 18:2n-6 ) , and alpha-linolenic ( 18:3n-3 ) acids as well as vitamin E , carotenoids , and sterols . Twelve healthy normolipidemic men were recruited and each volunteer consumed SBO and fractionated coconut oil ( control ) 5 g per day for a period of 4 weeks in a r and om order ( wash-out 4 - 8 weeks ) . Phospholipid fatty acids , plasma lipids , and glucose were unaffected by SBO supplementation . Instead , a clear decrease in the rate of adenosine-5'-diphosphate-induced platelet aggregation and maximum aggregation were found . This suggested the beneficial effects of SBO on blood clotting , but further studies on the dose-response effects are needed to assess the practical use of SBO supplements",
"Fatty acid ( FA ) composition is a determinant of the physiological effects of dietary oils . This study investigated the effects of vegetable oil supplementation with different FA compositions on anthropometric and biochemical parameters in obese women on a hypocaloric diet with lifestyle modifications . Seventy-five women ( body mass index , BMI , 30–39.9kg/m2 ) were r and omized based on 8-week oil supplementation into four experimental groups : the coconut oil group ( CoG , n = 18 ) , the safflower oil group ( SafG , n = 19 ) , the chia oil group ( ChG , n = 19 ) , and the soybean oil placebo group ( PG , n = 19 ) . Pre- and post-supplementation weight , anthropometric parameters , and body fat ( % BF ) , and lean mass percentages ( % LM ) were evaluated , along with biochemical parameters related to lipid and glycidemic profiles . In the anthropometric evaluation , the CoG showed greater weight loss ( Δ% = −8.54 ± 2.38 ) , and reduced BMI ( absolute variation , Δabs = −2.86 ± 0.79 ) , waist circumference ( Δabs = −6.61 ± 0.85 ) , waist-to-height ratio ( Δabs = −0.041 ± 0.006 ) , conicity index ( Δabs = −0.03 ± 0.016 ) , and % BF ( Δabs = −2.78 ± 0.46 ) , but increased % LM ( Δabs = 2.61 ± 1.40 ) ( p higher reduction in biochemical parameters of glycemia ( Δabs = −24.71 ± 8.13 ) and glycated hemoglobin ( Δabs = −0.86 ± 0.28 ) ( p higher reduction in cholesterol ( Δabs = −45.36 ± 0.94 ) , low-density lipoprotein cholesterol ( LDLc ; Δabs = −42.53 ± 22.65 ) , and triglycerides ( Δabs = −49.74 ± 26.3 ) , but an increase in high-density lipoprotein cholesterol ( HDLc ; abs = 3.73 ± 1.24 , p = 0.007 ) . Coconut oil had a more pronounced effect on abdominal adiposity and glycidic profile , whereas chia oil had a higher effect on improving the lipid profile . Indeed , supplementation with different fatty acid compositions result ed in specific responses",
"ABSTRACT Background Few trials have examined the effects of coconut oil consumption in comparison with polyunsaturated fatty acid – rich oils such as corn oil . Objective This trial assessed the effects of consuming foods made with corn oil compared with coconut oil on lipids , glucose homeostasis , and inflammation . Methods This was a preliminary r and omized crossover study of men ( n = 12 ) and women ( n = 13 ) with a mean age of 45.2 y , mean body mass index ( in kg/m2 ) of 27.7 , fasting LDL cholesterol ≥115 mg/dL and Subjects consumed muffins and rolls providing 4 tablespoons ( ∼54 g ) per day of corn oil or coconut oil as part of their habitual diets for 4 wk , with a 3-wk washout between conditions . Fasting plasma lipids and high-sensitivity C-reactive protein ( hs-CRP ) and glucose metabolism were assessed via an intravenous glucose tolerance test at baseline and 15 and 29 d of treatment . Responses were compared between treatments by ANCOVA . Results Median baseline concentrations of LDL cholesterol , non-HDL cholesterol , total cholesterol ( total-C ) , HDL cholesterol , total-C : HDL cholesterol , and TGs were 123 , 144 , 188 , 46.0 , 4.21 , and 92.5 mg/dL , respectively . Changes from baseline for corn oil and coconut oil conditions , respectively , were : LDL cholesterol ( primary outcome ; −2.7 % compared with + 4.6 % ) , non-HDL cholesterol ( −3.0 % compared with + 5.8 % ) , total-C ( −0.5 % compared with + 7.1 % ) , HDL cholesterol ( + 5.4 % compared with + 6.5 % ) , total-C : HDL cholesterol ( −4.3 % compared with −3.3 % ) , and TGs ( −2.1 % compared with + 6.0 % ) . Non-HDL cholesterol responses were significantly different between corn and coconut oil conditions ( P = 0.034 ) ; differences between conditions in total-C and LDL cholesterol approached significance ( both P = 0.06 ) . Responses for hs-CRP and carbohydrate homeostasis parameters did not differ significantly between diet conditions . Conclusions When incorporated into the habitual diet , consumption of foods providing ∼54 g of corn oil/d produced a more favorable plasma lipid profile than did coconut oil in adults with elevated cholesterol . This trial was registered at clinical trials.gov as NCT03202654"
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4116de2c-06ff-11f0-808a-c43d1ab1c353
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AIMS Thromboembolic risk stratification schemes and clinical guidelines for atrial fibrillation ( AF ) regard risk as independent of classification into paroxysmal ( PAF ) and non-paroxysmal atrial fibrillation ( NPAF ) . The aim of the current study was to conduct a systematic review evaluating the impact of AF type on thromboembolism , bleeding , and mortality . METHODS AND RESULTS PubMed was search ed through 27 November 2014 for r and omized controlled trials , cohort studies , and case series reporting prospect ively collected clinical outcomes stratified by AF type . The incidence of thromboembolism , mortality , and bleeding was extracted . Atrial fibrillation clinical outcome data were extracted from 12 studies containing 99 996 patients . The unadjusted risk ratio ( RR ) for thromboembolism in NPAF vs. PAF was 1.355 ( 95 % CI : 1.169 - 1.571 , P overall multivariable adjusted hazard ratio ( HR ) for thromboembolism was 1.384 ( 95 % CI : 1.191 - 1.608 , P unadjusted RR for all-cause mortality was 1.462 ( 95 % CI : 1.255 - 1.703 , P Multivariable adjusted HR for all-cause mortality was 1.217 ( 95 % CI : 1.085 - 1.365 , P Rates of bleeding were similar , with unadjusted RR 1.00 ( 95 % CI : 0.919 - 1.087 , P = 0.994 ) and adjusted HR 1.025 ( 95 % CI : 0.898 - 1.170 , P = 0.715 ) . CONCLUSION Non-paroxysmal atrial fibrillation is associated with a highly significant increase in thromboembolism and death . These data suggest the need for new therapies to prevent AF progression and further studies to explore the integration of AF type into models of thromboembolic risk
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"Aim Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) . We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation . Methods and results Patients r and omized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = 14 264 ) were grouped by baseline AF category : paroxysmal or persistent . Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) . Of 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF . Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P patients with paroxysmal AF . In patients r and omized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) . Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) . Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) . Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) . Conclusion In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF",
"OBJECTIVE This study was performed to characterize the risk of stroke in elderly patients with recurrent intermittent atrial fibrillation ( AF ) . BACKGROUND Although intermittent AF is common , relatively little is known about the attendant risk of stroke . METHODS A longitudinal cohort study was performed comparing 460 participants with intermittent AF with 1,552 with sustained AF treated with aspirin in the Stroke Prevention in Atrial Fibrillation studies and followed for a mean of two years . Independent risk factors for ischemic stroke were identified by multivariate analysis . RESULTS Patients with intermittent AF were , on average , younger ( 66 vs. 70 years , p women ( 37 % vs. 26 % p heart failure ( 11 % vs. 21 % , p annualized rate of ischemic stroke was similar for those with intermittent ( 3.2 % ) and sustained AF ( 3.3 % ) . In patients with intermittent AF , independent predictors of ischemic stroke were advancing age ( relative risk [ RR ] = 2.1 per decade , p hypertension ( RR = 3.4 , p = 0.003 ) and prior stroke ( RR = 4.1 , p = 0.01 ) . Of those with intermittent AF predicted to be high risk ( 24 % ) , the observed stroke rate was 7.8 % per year ( 95 % confidence interval 4.5 to 14 ) . CONCLUSIONS In this large cohort of AF patients given aspirin , those with intermittent AF had stroke rates similar to patients with sustained AF and similar stroke risk factors . Many elderly patients with recurrent intermittent AF have substantial rates of stroke and likely benefit from anticoagulation . High-risk patients with intermittent AF can be identified using the same clinical criteria that apply to patients with sustained AF",
"Background Few data on the thromboembolic ( TE ) risk of paroxysmal and persistent atrial fibrillation ( AF ) are available . This study aim ed to assess the incidence of TE events in paroxysmal and persistent AF . Methods We performed a subset post hoc analysis of 771 patients with paroxysmal and 463 with persistent AF enrolled in the multicenter , prospect i ve , r and omized , double-blind , placebo-controlled GISSI-AF trial - comparing the efficacy of valsartan versus placebo in preventing AF recurrences – where the choice of antithrombotic treatment was left to the judgment of the referring physician . TE and major outcome events were central ly vali date d. AF recurrences were detected by frequent clinic visits and a transtelephonic monitoring device with weekly and symptomatic transmissions . Results Eighty-five percent of patients had a history of hypertension , and the 7.7 % had heart failure , left ventricular dysfunction , or both . The mean CHADS2 score was 1.41±0.84 . TE and major bleeding events were observed at a low incidence among the overall population at 1-year follow-up ( 0.97 % and 0.81 % , respectively ) . The univariate and multivariable analyses revealed no statistically significant differences in the incidence of TE , major bleeding events or mortality in paroxysmal and persistent AF patients . TE events were more common among women than men ( p=0.02 ) . The follow-up examination showed under- or overtreatment with warfarin in many patients , according to guideline suggestions . Warfarin was more frequently prescribed to patients with persistent AF ( p ) . AF recurrences were noninvasively detected in 632 ( 51.2 % ) patients . In patients without AF recurrences , the TE event rate was 0.5 % versus 1.74 % , 1.28 % , and 1.18 % for those with only symptomatic , only asymptomatic or both symptomatic and asymptomatic AF recurrences , respectively , but the difference was not statistically significant , even after adjusting for warfarin treatment and the CHADS2 score ( HR 2.93 ; CI 95 % ; 0.8 - 10.9 ; p=0.11 ) . Conclusions TE and major bleeding events showed a very low incidence in the GISSI-AF trial population , despite under- or overtreatment with warfarin in many patients . TE events had a similar rate in paroxysmal and persistent AF.Trial registration Trial registration number :",
"AIMS To test the hypothesis that stroke and systemic embolic events ( SEE ) in the stroke prevention using an oral thrombin inhibitor in atrial fibrillation ( SPORTIF ) III and V trials are different between paroxysmal and persistent atrial fibrillation ( AF ) . METHODS Data analysis from two cohorts of patients enrolled in the prospect i ve SPORTIF III and V clinical trials ( n = 7329 ) ; 836 subjects ( 11.4 % ) with paroxysmal AF [ mean age 70.1 years ( SD = 9.5 ) ] were compared with 6493 subjects with persistent AF for this ancillary study . RESULTS The annual event rates for stroke/SEE are 1.73 % for persistent AF and 0.93 % for paroxysmal AF . In a multivariate analysis , after adjusting for stroke risk factors , gender and aspirin usage , the differences remained statistically significant with a higher hazard ratio ( HR ) for stroke/SEE in persistent AF [ vs. paroxysmal AF , HR 1.87 , 95 % confidence interval ( CI ) 1.04 - 3.36 ; P = 0.037 ] . In ' high risk ' patients ( with > or=2 stroke risk factors ) annual event rates for stroke/SEE were 2.08 % for persistent AF and 1.27 % for paroxysmal AF ( adjusted HR = 1.68 , 95 % CI 0.91 - 3.1 , P = 0.098 ) . Elderly patients had annual event rates for stroke/SEE of 2.38 % for persistent AF and 1.13 % for paroxysmal AF ( adjusted HR = 2.27 , 95 % CI 0.92 - 5.59 , P = 0.075 ) . Vitamin K antagonist (VKA)-naive paroxysmal AF patients had a 1.89%/year stroke/SEE rate , compared with 0.61 % for previous VKA takers ( HR = 0.33 , 95 % CI 0.11 - 1.01 , P = 0.052 ) . CONCLUSION In this large clinical trial cohort of anticoagulated AF patients , those with paroxysmal AF had stroke rates which were lower than for patients with persistent AF , although both groups had broadly similar stroke risk factors . Subjects with paroxysmal AF at ' high risk ' had stroke/SEE rates that were not significantly different to persistent AF subjects",
"BACKGROUND Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects . The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known . METHODS We conducted a r and omized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) . The primary efficacy end point was stroke or systemic embolism . Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period . The principal safety end point was major bleeding . RESULTS The annualized rate of the primary end point during treatment was 1.50 % with warfarin ( median time in the therapeutic range , 68.4 % ) , as compared with 1.18 % with high-dose edoxaban ( hazard ratio , 0.79 ; 97.5 % confidence interval [ CI ] , 0.63 to 0.99 ; P edoxaban ( hazard ratio , 1.07 ; 97.5 % CI , 0.87 to 1.31 ; P=0.005 for noninferiority ) . In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , 0.87 ; 97.5 % CI , 0.73 to 1.04 ; P=0.08 ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , 1.13 ; 97.5 % CI , 0.96 to 1.34 ; P=0.10 ) . The annualized rate of major bleeding was 3.43 % with warfarin versus 2.75 % with high-dose edoxaban ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.91 ; P edoxaban ( hazard ratio , 0.47 ; 95 % CI , 0.41 to 0.55 ; P corresponding annualized rates of death from cardiovascular causes were 3.17 % versus 2.74 % ( hazard ratio , 0.86 ; 95 % CI , 0.77 to 0.97 ; P=0.01 ) , and 2.71 % ( hazard ratio , 0.85 ; 95 % CI , 0.76 to 0.96 ; P=0.008 ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were 4.43 % versus 3.85 % ( hazard ratio , 0.87 ; 95 % CI , 0.78 to 0.96 ; P=0.005 ) , and 4.23 % ( hazard ratio , 0.95 ; 95 % CI , 0.86 to 1.05 ; P=0.32 ) . CONCLUSIONS Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes . ( Funded by Daiichi Sankyo Pharma Development ; ENGAGE AF-TIMI 48 Clinical Trials.gov number , NCT00781391 . )",
"INTRODUCTION Paroxysmal atrial fibrillation ( AF ) may progress to persistent AF . We studied the clinical correlates and the effect of rhythm-control strategy on AF progression . METHODS RecordAF was a worldwide prospect i ve survey of AF management . Consecutive eligible patients with recent-onset AF were included and allocated to rate or rhythm control according to patient/physician choice . A total of 2,137 patients were followed up for 12 months . Atrial fibrillation progression was defined as a change from paroxysmal to persistent/permanent AF . RESULTS Progression of AF occurred in 318 patients ( 15 % ) after 1 year . Patients with AF progression were older ; had a higher diastolic blood pressure ; and more often had a history of coronary artery disease , stroke or transient ischemic attack , hypertension , or heart failure . Patients treated with rhythm control were less likely to show progression than those treated only with rate control ( 164/1542 [ 11 % ] vs 154/595 [ 26 % ] , P history of heart failure ( odds ratio [ OR ] 2.2 , 95 % CI 1.7 - 2.9 , P history of hypertension ( OR 1.5 , 95 % CI 1.1 - 2.0 , P = .01 ) , and rate control rather than rhythm control ( OR 3.2 , 95 % CI 2.5 - 4.1 , P AF progression . The propensity score-adjusted OR of AF progression in patients with rate rather than rhythm control was 3.3 ( 95 % CI 2.4 - 4.6 , P AF progression , rhythm control is associated with lower risk of AF progression",
"AIMS It is uncertain whether the benefit from apixaban varies by type and duration of atrial fibrillation ( AF ) . METHODS AND RESULTS A total of 18 201 patients with AF [ 2786 ( 15.3 % ) with paroxysmal and 15 412 ( 84.7 % ) with persistent or permanent ] were r and omized to apixaban or warfarin . In this pre-specified secondary analysis , we compared outcomes and treatment effect of apixaban vs. warfarin by AF type and duration . The primary efficacy endpoint was a composite of ischaemic or haemorrhagic stroke or systemic embolism . The secondary efficacy endpoint was all-cause mortality . There was a consistent reduction in stroke or systemic embolism ( P for interaction = 0.71 ) , all-cause mortality ( P for interaction = 0.75 ) , and major bleeding ( P for interaction = 0.50 ) with apixaban compared with warfarin for both AF types . Apixaban was superior to warfarin in all studied endpoints , regardless of AF duration at study entry ( P for all interactions > 0.13 ) . The rate of stroke or systemic embolism was significantly higher in patients with persistent or permanent AF than patients with paroxysmal AF ( 1.52 vs. 0.98 % ; P = 0.003 , adjusted P = 0.015 ) . There was also a trend towards higher mortality in patients with persistent or permanent AF ( 3.90 vs. 2.81 % ; P = 0.0002 , adjusted P = 0.066 ) . CONCLUSION The risks of stroke , mortality , and major bleeding were lower with apixaban than warfarin regardless of AF type and duration . Although the risk of stroke or systemic embolism was lower in paroxysmal than persistent or permanent AF , apixaban is an attractive alternative to warfarin in patients with AF and at least one other risk factor for stroke , regardless of the type or duration of AF"
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4116de72-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND One potential solution to limited healthcare access in low and middle income countries ( LMIC ) is task-shifting- the training of non-physician healthcare workers ( NPHWs ) to perform tasks traditionally undertaken by physicians . The aim of this paper is to conduct a systematic review of studies involving task-shifting for the management of non-communicable disease ( NCD ) in LMIC . METHODS A search strategy with the following terms " task-shifting " , " non-physician healthcare workers " , " community healthcare worker " , " hypertension " , " diabetes " , " cardiovascular disease " , " mental health " , " depression " , " chronic obstructive pulmonary disease " , " respiratory disease " , " cancer " was conducted using Medline via Pubmed and the Cochrane library . Two review ers independently review ed the data bases and extracted the data . FINDINGS Our search generated 7176 articles of which 22 were included in the review . Seven studies were r and omised controlled trials and 15 were observational studies . Tasks performed by NPHWs included screening for NCDs and providing primary health care . The majority of studies showed improved health outcomes when compared with usual healthcare , including reductions in blood pressure , increased uptake of medications and lower depression scores . Factors such as training of NPHWs , provision of algorithms and protocol s for screening , treatment and drug titration were the main enablers of the task-shifting intervention . The main barriers identified were restrictions on prescribing medications and availability of medicines . Only two studies described cost-effective analyses , both of which demonstrated that task-shifting was cost-effective . CONCLUSIONS Task-shifting from physicians to NPHWs , if accompanied by health system re-structuring is a potentially effective and affordable strategy for improving access to healthcare for NCDs . Since the majority of study design s review ed were of inadequate quality , future research methods should include robust evaluations of such strategies
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"A r and omized intervention trial is in progress in Kerala , India , to evaluate the effectiveness of oral visual inspection by trained health workers ( HWs ) in the prevention of oral cancer . Fourteen health workers with college graduation as the basic qualification were trained in oral visual inspection to identify oral cancers and precancers among the participants of the screening trial and to refer them for further confirmation and management . The aim of the present study was to evaluate the reproducibility and validity of the screening test provided by the health worker against the reference oral visual findings of three physicians . A total of 2069 subjects who had already been examined were re-examined by the health workers and physicians . The sensitivity and the specificity of the oral visual inspection were 94.3 % and 99.3 % respectively . There was moderate agreement between the findings of the initial and the repeat mouth examinations carried out by the health workers , which were on average 6 months apart . There was almost perfect agreement ( kappa = 0.85 ) between the findings of the health workers and the physicians in identifying the different types of oral precancerous lesions . The findings of our study indicate that it is possible to train re source persons to perform the oral cancer screening test as accurately as doctors , although experience appears to be a crucial component of health workers ' accuracy . The efficacy of such an approach to reduce the incidence of and mortality from oral cancer , however , remains to be proven",
"Objectives : The study aims to investigate the efficacy of screening by low-cost technology in down-staging and reduction of mortality due to breast and cervix cancer . Methods : The present trial is a community-based , cluster r and omised controlled cohort study on screening for breast and cervix cancers ( clinical breast examination and visual inspection of the cervix after application of 4 % acetic acid ) . Univariate and multivariate logistic regression analyses are conducted to identify the predictors of compliance to referral among screen-positive women and to treatment among cancer cases . Results : The compliance to diagnostic investigations is 73 % among screen-positive women referred for breast cancer and 79 % among women referred for cervix cancer . Younger women , women working in service or being self-employed , school level-educated women , mother tongue Marathi , participation in screening in all 3 rounds and women referred as screen positive for cervix cancer had higher compliance to diagnostic investigations . The compliance to treatment completion is higher in women diagnosed with breast cancer , at 95 % , compared to 86 % for cervix cancers and 81 % for cervix pre-cancers . Conclusions : Good compliance rates along with a proper system of referral , further investigations , confirmation of diagnosis and treatment as demonstrated in this trial are crucial for successful screening programmes",
"Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy ( ART ) from doctors to other health workers is scarce . We aim ed to assess the effects on mortality , viral suppression , and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Exp and Treatment and Care for HIV ( STRETCH ) programme , which provides educational outreach training of nurses to initiate and represcribe ART , and to de central ise care . Methods We undertook a pragmatic , parallel , cluster-r and omised trial in South Africa between Jan 28 , 2008 , and June 30 , 2010 . We r and omly assigned 31 primary -care ART clinics to implement the STRETCH programme ( intervention group ) or to continue with st and ard care ( control group ) . The ratio of r and omisation depended on how many clinics were in each of nine strata . Two cohorts were enrolled : eligible patients in cohort 1 were adults ( aged ≥16 years ) with CD4 counts of 350 cells per μL or less who were not receiving ART ; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment . The primary outcome in cohort 1 was time to death ( superiority analysis ) . The primary outcome in cohort 2 was the proportion with undetectable viral loads ( ) 12 months after enrolment ( equivalence analysis , prespecified difference 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group , and 3862 in cohort 1 and 3202 in cohort 2 were in the control group . Median follow-up was 16·3 months ( IQR 12·2–18·0 ) in cohort 1 and 18·0 months ( 18·0–18·0 ) in cohort 2 . In cohort 1 , 997 ( 20 % ) of 4943 patients analysed in the intervention group and 747 ( 19 % ) of 3862 in the control group with known vital status at the end of the trial had died . Time to death did not differ ( hazard ratio [ HR ] 0·94 , 95 % CI 0·76–1·15 ) . In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL , mortality was slightly lower in the intervention group than in the control group ( 0·73 , 0·54–1.00 ; p=0·052 ) , but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less ( 0·94 , 0·76–1·15 ; p=0·577 ) . In cohort 2 , viral load suppression 12 months after enrolment was equivalent in intervention ( 2156 [ 71 % ] of 3029 patients ) and control groups ( 2230 [ 70 % ] of 3202 ; risk difference 1·1 % , 95 % CI −2·4 to 4·6 ) . Interpretation Expansion of primary -care nurses ' roles to include ART initiation and represcription can be done safely , and improve health outcomes and quality of care , but might not reduce time to ART or mortality . Funding UK Medical Research Council , Development Cooperation Irel and , and Canadian International Development Agency",
"OBJECTIVE To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary -care setting s in Goa , India . METHODS Cost-utility and cost-effectiveness analyses based on generalized linear models were performed within a trial set in 24 public and private primary -care facilities . Subjects were r and omly assigned to an intervention or a control arm . Eligible subjects in the intervention arm were given psycho-education , case management , interpersonal psychotherapy and /or antidepressants by lay health workers . Subjects in the control arm were treated by physicians . The use of health-care re sources , the disability of each subject and degree of psychiatric morbidity , as measured by the Revised Clinical Interview Schedule , were determined at 2 , 6 and 12 months . FINDINGS Complete data , from all three follow-ups , were collected from 1243 ( 75.4 % ) and 938 ( 81.7 % ) of the subjects enrolled in the study facilities from the public and private sectors , respectively . Within the public facilities , subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm . Time costs were also significantly lower in the intervention arm than in the control arm , whereas health system costs in the two arms were similar . Within the private facilities , however , the effectiveness and costs recorded in the two arms were similar . CONCLUSION Within public primary -care facilities in Goa , the use of lay health workers in the care of subjects with common mental disorders was not only cost-effective but also cost-saving",
"This paper has been corrected post-publication in deviation from print and in accordance with a correction printed in the February 2012 issue of the Journal . Background Depressive and anxiety disorders ( common mental disorders ) are the most common psychiatric condition encountered in primary healthcare . Aims To test the effectiveness of an intervention led by lay health counsellors in primary care setting s ( the MANAS intervention ) to improve the outcomes of people with common mental disorders . Method Twenty-four primary care facilities ( 12 public , 12 private ) in Goa ( India ) were r and omised to provide either collaborative stepped care or enhanced usual care to adults who screened positive for common mental disorders . Participants were assessed at 2 , 6 and 12 months for presence of ICD-10 common mental disorders , the severity of symptoms of depression and anxiety , suicidal behaviour and disability levels . All analyses were intention to treat and carried out separately for private and public facilities and adjusted for the design . The trial has been registered with clinical trials.gov ( NCT00446407 ) . Results A total of 2796 participants were recruited . In public facilities , the intervention was consistently associated with strong beneficial effects over the 12 months on all outcomes . There was a 30 % decrease in the prevalence of common mental disorders among those with baseline ICD-10 diagnoses ( risk ratio ( RR ) = 0.70 , 95 % CI 0.53–0.92 ) ; and a similar effect among the subgroup of participants with depression ( RR = 0.76 , 95 % CI 0.59–0.98 ) . Suicide attempts/plans showed a 36 % reduction over 12 months ( RR = 0.64 , 95 % CI 0.42–0.98 ) among baseline ICD-10 cases . Strong effects were observed on days out of work and psychological morbidity , and modest effects on overall disability . In contrast , there was little evidence of impact of the intervention on any outcome among participants attending private facilities . Conclusions Trained lay counsellors working within a collaborative-care model can reduce prevalence of common mental disorders , suicidal behaviour , psychological morbidity and disability days among those attending public primary care facilities",
"Summary Background The treatment of perinatal depression is a public-health priority because of its high prevalence and association with disability and poor infant development . We integrated a cognitive behaviour therapy-based intervention into the routine work of community-based primary health workers in rural Pakistan and assessed the effect of this intervention on maternal depression and infant outcomes . Methods We r and omly assigned 40 Union Council clusters in rural Rawalpindi , Pakistan , in equal numbers to intervention or control . Married women ( aged 16–45 years ) in their third trimester of pregnancy with perinatal depression were eligible to participate . In the intervention group , primary health workers were trained to deliver the psychological intervention , whereas in the control group untrained health workers made an equal number of visits to the depressed mothers . The primary outcomes were infant weight and height at 6 months and 12 months , and secondary outcome was maternal depression . The interviewers were unaware of what group the participants were assigned to . Analysis was by intention to treat . The study is registered as IS RCT N65316374 . Findings The number of clusters per group was 20 , with 463 mothers in the intervention group and 440 in the control group . At 6 months , 97 ( 23 % ) of 418 and 211 ( 53 % ) of 400 mothers in the intervention and control groups , respectively , met the criteria for major depression ( adjusted odds ratio ( OR ) 0·22 , 95 % CI 0·14 to 0·36 , p The differences in weight-for-age and height-for-age Z scores for infants in the two groups were not significant at 6 months ( −0·83 vs −0·86 , p=0·7 and −2·03 vs −2·16 , p=0·3 , respectively ) or 12 months ( −0·64 vs −0·8 , p=0·3 and −1·10 vs −1·36 , p=0·07 , respectively ) . Interpretation This psychological intervention delivered by community-based primary health workers has the potential to be integrated into health systems in re source -poor setting s. Funding Wellcome Trust",
"OBJECTIVE To evaluate oral cancer screening by visual inspection . METHODS A cluster r and omized controlled trial was initiated in Triv and rum district , Kerala , India . Of 13 population clusters , seven were r and omly allocated to three rounds of screening between 1996 and 2004 , while st and ard care was provided in six ( control arm ) . An activity-based approach was employed to calculate costs associated with various components of the screening trial . Information on the re sources used and on clinical events in each trial arm was derived from trial data bases . Total costs for each cluster were estimated in 2004 United States dollars ( US$ ) . The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals ( i.e. tobacco or alcohol users ) . FINDINGS The proportion of oral cancers detected at an early stage ( i.e. stage I or II ) was higher in the intervention arm than the control arm ( 42 % versus 24 % , respectively ) . The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals . Oral cancer screening by visual inspection was performed for under US$ 6 per person . CONCLUSION The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population . Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-re source setting",
"OBJECTIVE To compare the effects of low-level facility-based interventions on patient retention rates for cardiovascular ( CV ) disease in an environment of task shifting and nurse-led care in rural health districts in Central Cameroon . METHODS This study is an open-label , three-arm , cluster-r and omised trial in nurse-led facilities . All three groups implemented a treatment contract . The control group ( group 1 ) had no additional intervention , group 2 received the incentive of 1 month of free treatment every forth month of regularly respected visits , and group 3 received reminder letters in case of a missed follow-up visit . The primary outcome was patient retention at 1 year . Secondary outcomes were adherence to follow-up visit schemes and changes in blood pressure ( BP ) and blood glucose levels . Patients ' monthly spending for drugs and transport was calculated retrospectively . RESULTS A total of 33 centres and 221 patients were included . After 1 year , 109 patients ( 49.3 % ) remained in the programme . Retention rates in groups 2 and 3 were 60 % and 65 % , respectively , against 29 % in the control group . The differences between the intervention groups and the control group were significant ( P differences in BP or fasting plasma glucose trends between retained patients in the study groups . Average monthly cost to patients for antihypertensive medication was € 1.1 ± 0.9 and for diabetics € 1.2 ± 1.1 . Transport costs to the centres were on average € 1.1 ± 1.0 for hypertensive patients and € 1.1 ± 1.6 for patients with diabetes . CONCLUSIONS Low-cost interventions suited to an environment of task shifting and nurse-led care and needing minimal additional re sources can significantly improve retention rates in CV disease management in rural Africa . The combination of a treatment contract and reminder letters in case of missed appointments was an effective measure to retain patients in care",
"BACKGROUND Oral cancer is common in men from developing countries , and is increased by tobacco and alcohol use . We aim ed to assess the effect of visual screening on oral cancer mortality in a cluster-r and omised controlled trial in India . METHODS Of the 13 clusters chosen for the study , seven were r and omised to three rounds of oral visual inspection by trained health workers at 3-year intervals and six to a control group during 1996 - 2004 , in Triv and rum district , Kerala , India . Healthy participants aged 35 years and older were eligible for the study . Screen-positive people were referred for clinical examination by doctors , biopsy , and treatment . Outcome measures were survival , case fatality , and oral cancer mortality . Oral cancer mortality in the study groups was analysed and compared by use of cluster analysis . Analysis was by intention to treat . FINDINGS Of the 96,517 eligible participants in the intervention group , 87,655 ( 91 % ) were screened at least once , 53,312 ( 55 % ) twice , and 29,102 ( 30 % ) three times . Of the 5145 individuals who screened positive , 3218 ( 63 % ) complied with referral . 95,356 eligible participants in the control group received st and ard care . 205 oral cancer cases and 77 oral cancer deaths were recorded in the intervention group compared with 158 cases and 87 deaths in the control group ( mortality rate ratio 0.79 [ 95 % CI 0.51 - 1.22 ] ) . 70 oral cancer deaths took place in users of tobacco or alcohol , or both , in the intervention group , compared with 85 in controls ( 0.66 [ 0.45 - 0.95 ] ) . The mortality rate ratio was 0.57 ( 0.35 - 0.93 ) in male tobacco or alcohol users and 0.78 ( 0.43 - 1.42 ) in female users . INTERPRETATION : Oral visual screening can reduce mortality in high-risk individuals and has the potential of preventing at least 37,000 oral cancer deaths worldwide",
"Objectives : This study aims to investigate the efficacy of screening by low-cost technology in down-staging and reducing mortality due to breast and cervix cancer . Methods : The present trial is a community-based , cluster r and omised controlled cohort study on screening for breast and cervix cancers ( clinical breast examination and visual inspection of the cervix after application of 4 % acetic acid ) . Univariate and multivariate logistic regression analyses are conducted to identify the predictors of participation in screening . Results : The average compliance is 71.43 and 64.93 % for breast and cervix cancer screening , respectively , with the highest compliance in round 1 . At the end of 3 screening rounds , 94 and 84 % of the eligible women were screened at least once for breast and cervix cancer , respectively . Younger women , women from other than Hindu and Muslim communities , school level-educated women , women belonging to lower-income families , Marathi-speaking women , married women and women who had previously consulted for any breast or gynaecological complaints had higher compliance to participation in screening . Conclusions : Good compliance rates to screening have been demonstrated in the trial , reflecting acceptance of the study by the society , which has implication s while translating the trial into a programme",
"Cervix and Breast cancers are the most common cancers among women worldwide and extract a large toll in developing countries . In May 1998 , supported by a grant from the NCI ( US ) , the Tata Memorial Hospital , Mumbai , India , started a cluster-r and omized , controlled , screening-trial for cervix and breast cancer using trained primary health workers to provide health-education , visual-inspection of cervix ( with 4 % acetic acid-VIA ) and clinical breast examination ( CBE ) in the screening arm , and only health education in the control arm . Four rounds of screening at 2-year intervals will be followed by 8 years of monitoring for incidence and mortality from cervix and breast cancers . The methodology and interim results after three rounds of screening are presented here . Good r and omization was achieved between the screening ( n = 75360 ) and control arms ( n = 76178 ) . In the screening arm we see : High screening participation rates ; Low attrition ; Good compliance to diagnostic confirmation ; Significant downstaging ; Excellent treatment completion rate ; Improving case fatality ratios . The ever-screened and never-screened participants in the screening arm show significant differences with reference to the variables religion , language , age , education , occupation , income and health-seeking behavior for gynecological and breast-related complaints . During the same period , in the control arm we see excellent participation rate for health education ; Low attrition and a good number of symptomatic referrals for both cervix and breast",
"The value of screening by Clinical Examination of the Breast ( CBE ) as a means of reducing mortality from breast cancer ( BC ) is not established . The issue is relevant , as CBE may be a suitable option for countries in economic transition , where incidence rates are on the increase but limited re sources do not permit screening by mammography . Our aims were to assess whether mass screening by CBE carried out by trained para‐medical personnel is feasible in an urban population of a low‐income country , and its efficacy in reducing BC mortality . Our study was design ed as a r and omised controlled trial of the effect on BC mortality of 5 annual CBE carried out by trained nurses . The target population was women aged 35–64 years , resident in 12 municipalities of the National Capital Region of Manila , Philippines . The units of r and omization were the 202 health centres ( HC ) within the selected municipalities . During 1995 nurses and midwives were recruited and trained in performing CBE . The first round of screening took place in 1996–1997 . The intervention however showed a refractory attitude of the population with respect to clinical follow‐up and was discontinued after the completion of the first screening round . Cases of breast cancer occurring in the study population during 1996–1999 were identified by the 2 local population ‐based registries . In the single screening round 151,168 women were interviewed and offered CBE , 92 % accepted ( 138,392 ) , 3,479 were detected positive for a lump and referred for diagnosis . Of these only 1220 women ( 35 % ) completed diagnostic follow‐up , whereas 42.4 % actively refused further investigation even with home visits , and 22.5 % were not traced . Of 53 cases that occurred among screen‐positive women in the 2 years after CBE only 34 were diagnosed through the intervention . Eighty cases occurred among screen‐negative women . The test sensitivity for CBE repeated annually was 53.2 % . The actual sensitivity of the programme was 25.6 % and positive predictive value 1 % . Screen‐detected cases were non‐significantly less advanced than the others . Previous studies have shown that most breast cancer cases in the Philippines present at advanced stages and have an unfavourable outcome . Although CBE undertaken by health workers seems to offer a cost‐effective approach to reducing mortality , the sensitivity of the screening programme in the real context was low . Moreover , in this relatively well‐educated population , cultural and logistic barriers to seeking diagnosis and treatment persist and need to be addressed before any screening programme is introduced . © 2005 Wiley‐Liss ,",
"OBJECTIVE This study was primarily carried out to assess the feasibility of an adapted WHO CVD risk management package in a primary care setting . METHODS A community intervention trial was conducted in eight health posts located in rural , urban , and slum areas of northern India . After a 4 day training , eight health workers implemented the package among 1010 adults > or = 30 years of age from a r and omly chosen cluster of households . Locally adapted scenario 1 WHO protocol was used for the assessment of CVD risks . The health workers inquired about smoking , alcohol , diet , physical activity , symptoms of angina , and transient ischaemic attacks ; and measured systolic blood pressure ( SBP7 ) , height , and weight . Those with a risk were counseled and referred to a physician . Hypertensives were followed at 1 , 3 , and 5-month interval to reinforce risk prevention and adherence to treatment . In a 20 % r and om sub sample , in the study and control area before and after the intervention , WHO STEPS instrument was used to evaluate effectiveness of the package . FINDINGS After training , the knowledge of health workers regarding risk factors and symptoms of CVDs increased from 47 % to 92.5 % , and their performance in detection of risks was comparable to the investigator . All health workers could pay scheduled home visits regularly . They referred 279 ( 27.6 % ) individuals having raised systolic blood pressure ( SBP ) , and 74.5 % contacted the doctor . Significant decrease in mean SBP ( 8.8 mm Hg ) was observed during follow-up . Significantly higher reports of intention to quit tobacco ( 60.3 % vs 25.5 % ) and regular intake of anti-hypertensive medication ( 58.3 % vs 34.8 % ) were observed in the intervention area compared to the control area . CONCLUSION Adapted WHO CVD risk management package can be implemented through primary care system",
"A programme of antiepileptic treatment in a rural and semi-urban region in Kenya was assessed . Patients with generalised tonic-clonic seizures were treated according to one of two simple drug protocol s. Health workers screened cases reported by key informants in the community . From the 529 patients identified by health workers as having active seizures 302 patients aged 6 - 65 years were recruited by a psychiatrist for therapy with carbamazepine or phenobarbitone . Treatment was supervised largely by primary health workers , and the programme was monitored by a research team , which assessed the effectiveness of treatment . Of the 249 patients who completed the study , 53 % became seizure-free in the second 6 months of therapy , and another 26 % had substantially ( 50 % or more reduction ) fewer seizures than in the 6 months before therapy . The similarity of these findings to those obtained in newly diagnosed patients in the developed world , the low drop-out rate , the low rate of withdrawal due to adverse effects , and the acceptable compliance with therapy indicate that health workers can monitor therapy adequately . Most patients had had several years of delay before starting therapy for their epilepsy , yet they responded well -- a finding that does not support the suggestion that the disorder becomes intractable if not treated early"
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Background Hypertension increases with increasing age . Optimal treatment of hypertension is important to reduce cardiovascular disease . Recent guidelines for hypertension have made recommendations for older adults but are supported by evidence that includes younger individuals . This systematic review evaluates the benefits and harms of antihypertensive agents in adults aged ≥65 years . Methods We search ed MEDLINE and Clinical Trials.gov for studies from 1996 to 2014 . Eligible studies included participants aged ≥65 years with hypertension . Eligible studies had clearly defined treatment assignments , blood pressure ( BP ) targets , and evaluated endpoints of cardiovascular morbidity , mortality , and /or harms of antihypertensive medications . We abstract ed study characteristics , cardiovascular benefits , and harms . Results Thirty-one articles met the inclusion criteria . Most studies compared different antihypertensive agents and /or placebo groups . These studies consistently demonstrated reduced cardiovascular morbidity and mortality compared with no treatment . Seven studies examined optimal BP targets . Strict control [ systolic BP ( SBP ) mmHg ] was not consistently better than mild control ( SBP Mild SBP control benefitted subjects in all age ranges over 65 years . Few studies assessed and explicitly reported harms . Conclusions In this review , older adults with hypertension had decreased cardiovascular morbidity and mortality with antihypertensives compared with no treatment . Strict control was not consistently better than mild control in older adults . There was enormous heterogeneity in these studies , and reporting of harms stratified by age is lacking . The current evidence is insufficient to determine the safest , most beneficial hypertension regimen in older adults
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"BACKGROUND Treatment of hypertension with diuretics , beta-blockers , or both leads to improved outcomes . It has been postulated that agents that inhibit the renin-angiotensin system confer benefit beyond the reduction of blood pressure alone . We compared the outcomes in older subjects with hypertension who were treated with angiotensin-converting-enzyme ( ACE ) inhibitors with the outcomes in those treated with diuretic agents . METHODS We conducted a prospect i ve , r and omized , open-label study with blinded assessment of end points in 6083 subjects with hypertension who were 65 to 84 years of age and received health care at 1594 family practice s. Subjects were followed for a median of 4.1 years , and the total numbers of cardiovascular events in the two treatment groups were compared with the use of multivariate proportional-hazards models . RESULTS At base line , the treatment groups were well matched in terms of age , sex , and blood pressure . By the end of the study , blood pressure had decreased to a similar extent in both groups ( a decrease of 26/12 mm Hg ) . There were 695 cardiovascular events or deaths from any cause in the ACE-inhibitor group ( 56.1 per 1000 patient-years ) and 736 cardiovascular events or deaths from any cause in the diuretic group ( 59.8 per 1000 patient-years ; the hazard ratio for a cardiovascular event or death with ACE-inhibitor treatment was 0.89 [ 95 percent confidence interval , 0.79 to 1.00 ] ; P=0.05 ) . Among male subjects , the hazard ratio was 0.83 ( 95 percent confidence interval , 0.71 to 0.97 ; P=0.02 ) ; among female subjects , the hazard ratio was 1.00 ( 95 percent confidence interval , 0.83 to 1.21 ; P=0.98 ) ; the P value for the interaction between sex and treatment-group assignment was 0.15 . The rates of nonfatal cardiovascular events and myocardial infa rct ions decreased with ACE-inhibitor treatment , whereas a similar number of strokes occurred in each group ( although there were more fatal strokes in the ACE-inhibitor group ) . CONCLUSIONS Initiation of antihypertensive treatment involving ACE inhibitors in older subjects , particularly men , appears to lead to better outcomes than treatment with diuretic agents , despite similar reductions of blood pressure",
"Whether the strict control of blood pressure ( BP ) of patients with hypertension who are aged 85 years or older is beneficial is unclear . The Japan ’s Benidipine Research on Antihypertensive Effects in the Elderly study is a prospect i ve , observational 3-year study to evaluate the safety and effectiveness of treatment with a calcium channel blocker benidipine in 8897 hypertensive patients aged 65 years or older as a post-marketing surveillance . We examined the relationship between the achieved BP and cardiovascular events ( i.e. , stroke , myocardial infa rct ion , and heart failure ) in a subgroup of 415 patients aged 85 years or older ( mean age 88 years ) . BP decreased significantly from 165 ± 14/84 ± 10 mmHg to 130 ± 11/71 ± 10 mmHg during treatment in patients with a treated systolic BP ( SBP ) ) and BP decreased significantly from 169 ± 16/86 ± 12 mmHg to 143 ± 13/75 ± 10 mmHg in those with a treated SBP ≥ 140 mmHg ( n = 185 ) . There was a nonsignificant trend toward a lower rate of cardiovascular events and higher rate of total death in patients with a treated SBP higher incidence of cardiovascular events . There was no significant difference in the incidence of adverse reactions between the controlled BP group ( 3.04 % ) and the less well controlled BP group ( 3.24 % ) . In conclusion , although this study was not powered for definitive conclusion , there was a nonsignificant trend toward a lower rate of cardiovascular events and higher total death in patients aged 85 years or older with a treated SBP < 140 mmHg",
"Objective To assess if very elderly people with hypertension obtain early benefit from antihypertensive treatment . Design One year open label active treatment extension of r and omised controlled trial ( Hypertension in the Very Elderly Trial ( HYVET ) ) . Setting Hospital and general practice based centres mainly in eastern and western Europe , China , and Tunisia . Participants People on double blind treatment at the end of HYVET were eligible to enter the extension . Interventions Participants on active blood pressure lowering treatment continued taking active drug ; those on placebo were given active blood pressure lowering treatment . The treatment regimen was as used in the main trial — indapamide SR 1.5 mg ( plus perindopril 2 - 4 mg if required)—with the same target blood pressure of less than 150/80 mm Hg . Main outcome measures The primary outcome was all stroke ; other outcomes included total mortality , cardiovascular mortality , and cardiovascular events . Results Of 1882 people eligible for entry to the extension , 1712 ( 91 % ) agreed to participate . During the extension period , 1682 patient years were accrued . By six months , the difference in blood pressure between the two groups was 1.2/0.7 mm Hg . Comparing people previously treated with active drug and those previously on placebo , no significant differences were seen for stroke ( n=13 ; hazard ratio 1.92 , 95 % confidence interval 0.59 to 6.22 ) or cardiovascular events ( n=25 ; 0.78 , 0.36 to 1.72 ) . Differences were seen for total mortality ( 47 deaths ; hazard ratio 0.48 , 0.26 to 0.87 ; P=0.02 ) and cardiovascular mortality ( 11 deaths ; 0.19 , 0.04 to 0.87 ; P=0.03 ) . Conclusion Very elderly patients with hypertension may gain immediate benefit from treatment . Sustained differences in reductions of total mortality and cardiovascular mortality reinforce the benefits and support the need for early and long term treatment . Trial registration Clinical trials NCT00122811",
"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 ",
"The Combination Therapy of Hypertension to Prevent Cardiovascular Events ( COPE ) trial demonstrated that the calcium-channel blocker benidipine-based combination therapies with an angiotensin-receptor blocker ( ARB ) , a β-blocker , or a thiazide diuretic ( thiazide ) were similarly effective in preventing cardiovascular events and achieving the target blood pressure ( BP ; efficacy and safety of these combination therapies in older ( ⩾65 years ) and younger ( In this sub- analysis of the COPE trial 3293 patients ( 1533⩾65 years old and 1760 assigned to receive benidipine-based therapy with an ARB , a β-blocker or a thiazide . In each group , the average BP did not differ among the three treatment groups . The incidence of the primary cardiovascular composite end point in the older group was higher than in the younger group ( 12.7 vs. 8.3 per 1000 person-years , P=0.023 ) . The primary composite cardiovascular end point , achievement ( % ) of target BP , and cardiovascular hard composite end points were similar among the three treatment groups . However , the hazard ratios and 95 % confidence intervals in older patients were 2.74 ( 1.08–6.96 ; β-blocker vs. thiazide , P=0.022 ) for fatal and non-fatal stroke , and 2.47 ( 1.03–5.91 ; β-blocker vs. ARB , P=0.043 ) for new-onset diabetes . Thus , benidipine combined with an ARB , a β-blocker , or a thiazide was similarly effective in preventing cardiovascular events and achieving the target BP in both older and younger hypertensive patients . Further studies will be necessary to evaluate the usefulness of benidipine combined with a β-blocker in terms of the incidence of stroke and new-onset diabetes in older patients",
"In this prospect i ve , r and omized , open-label , blinded end point study , we aim ed to establish whether strict blood pressure control ( moderate blood pressure control ( ≥140 mm Hg to cardiovascular mortality and morbidity in elderly patients with isolated systolic hypertension . We divided 3260 patients aged 70 to 84 years with isolated systolic hypertension ( sitting blood pressure 160 to 199 mm Hg ) into 2 groups , according to strict or moderate blood pressure treatment . A composite of cardiovascular events was evaluated for ≥2 years . The strict control ( 1545 patients ) and moderate control ( 1534 patients ) groups were well matched ( mean age : 76.1 years ; mean blood pressure : 169.5/81.5 mm Hg ) . Median follow-up was 3.07 years . At 3 years , blood pressure reached 136.6/74.8 mm Hg and 142.0/76.5 mm Hg , respectively . The blood pressure difference between the 2 groups was 5.4/1.7 mm Hg . The overall rate of the primary composite end point was 10.6 per 1000 patient-years in the strict control group and 12.0 per 1000 patient-years in the moderate control group ( hazard ratio : 0.89 ; [ 95 % CI : 0.60 to 1.34 ] ; P=0.38 ) . In summary , blood pressure targets of 140 mm Hg are safely achievable in relatively healthy patients ≥70 years of age with isolated systolic hypertension , although our trial was underpowered to definitively determine whether strict control was superior to less stringent blood pressure targets",
"A r and omized , double-blind , active-controlled , multicenter trial assigned 32,804 participants aged 55 years and older with hypertension and ≥ 1 other coronary heart disease risk factors to receive chlorthalidone ( n=15,002 ) , amlodipine ( n=8898 ) , or lisinopril ( n=8904 ) for 4 to 8 years , when double-blinded therapy was discontinued . Passive surveillance continued for a total follow-up of 8 to 13 years using national administrative data bases to ascertain deaths and hospitalizations . During the post-trial period , fatal outcomes and nonfatal outcomes were available for 98 % and 65 % of participants , respectively , due to lack of access to administrative data bases for the remainder . This paper assesses whether mortality and morbidity differences persisted or new differences developed during the extended follow-up . Primary outcome was cardiovascular mortality and secondary outcomes were mortality , stroke , coronary heart disease , heart failure , cardiovascular disease , and end-stage renal disease . For the post-trial period , data are not available on medications or blood pressure levels . No significant differences ( P in cardiovascular mortality for amlodipine ( hazard ratio [ HR ] , 1.00 ; 95 % confidence interval [ CI ] , 0.93 - 1.06 ) or lisinopril ( HR , 0.97 ; CI , 0.90 - 1.03 ) , each compared with chlorthalidone . The only significant differences in secondary outcomes were for heart failure , which was higher with amlodipine ( HR , 1.12 ; CI , 1.02 - 1.22 ) , and stroke mortality , which was higher with lisinopril ( HR , 1.20 ; CI , 1.01 - 1.41 ) , each compared with chlorthalidone . Similar to the previously reported in-trial result , there was a significant treatment-by-race interaction for cardiovascular disease for lisinopril vs chlorthalidone . Black participants had higher risk than non-black participants taking lisinopril compared with chlorthalidone . After accounting for multiple comparisons , none of these results were significant . These findings suggest that neither calcium channel blockers nor angiotensin-converting enzyme inhibitors are superior to diuretics for the long-term prevention of major cardiovascular complications of hypertension ",
"The achievement rate of blood pressure ( BP ) target and the relationship between on-treatment BP and development of cardiovascular events ( i.e. , stroke , myocardial infa rct ion , and heart failure ) were investigated in a total of 8,897 patients in the Japan 's Benidipine Research on Antihypertensive Effects in the Elderly ( J-BRAVE ) study , a prospect i ve , 3-year observational study of a calcium channel blocker-based treatment in hypertensive patients aged ≥65 years as a post-marketing surveillance . Blood pressure decreased significantly from 164.8 ± 14.1/88.2 ± 10.3 mmHg to 137.0 ± 13.5/75.6 ± 9.5 mmHg and the percentage of patients who achieved BP . The incidence of cardiovascular events was 7.54/1,000 patient-years . Subgroups of patients stratified by on-treatment systolic blood pressure ( SBP ) were analyzed . Baseline BP , body mass index ( BMI ) , the dose of benidipine , the mean number of anti-hypertensive drugs , and the incidence of cardiovascular events were higher in patients with on-treatment SBP ≥160 mmHg than in those with an SBP of patients aged 65 to 74 years ( n = 5,092 ) and patients aged ≥75 years ( n = 3,805 ) , the percentages of patients who achieved the BP target of respectively , and the incidence of cardiovascular events was higher in patients with on-treatment SBP ≥160 mmHg in both age subgroups . The results of the J-BRAVE study show that on-treatment SBP ≥160 mmHg is associated with a higher incidence of cardiovascular events in elderly hypertensive patients",
"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 ] . )",
"BACKGROUND The efficacy of new antihypertensive drugs has been question ed . We compared the effects of conventional and newer antihypertensive drugs on cardiovascular mortality and morbidity in elderly patients . METHODS We did a prospect i ve , r and omised trial in 6614 patients aged 70 - 84 years with hypertension ( blood pressure > or = 180 mm Hg systolic , > or = 105 mm Hg diastolic , or both ) . Patients were r and omly assigned conventional antihypertensive drugs ( atenolol 50 mg , metoprolol 100 mg , pindolol 5 mg , or hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily ) or newer drugs ( enalapril 10 mg or lisinopril 10 mg , or felodipine 2.5 mg or isradipine 2 - 5 mg daily ) . We assessed fatal stroke , fatal myocardial infa rct ion , and other fatal cardiovascular disease . Analysis was by intention to treat . FINDINGS Blood pressure was decreased similarly in all treatment groups . The primary combined endpoint of fatal stroke , fatal myocardial infa rct ion , and other fatal cardiovascular disease occurred in 221 of 2213 patients in the conventional drugs group ( 19.8 events per 1000 patient-years ) and in 438 of 4401 in the newer drugs group ( 19.8 per 1000 ; relative risk 0.99 [ 95 % CI 0.84 - 1.16 ] , p=0.89 ) . The combined endpoint of fatal and non-fatal stroke , fatal and non-fatal myocardial infa rct ion , and other cardiovascular mortality occurred in 460 patients taking conventional drugs and in 887 taking newer drugs ( 0.96 [ 0.86 - 1.08 ] , p=0.49 ) . INTERPRETATION Old and new antihypertensive drugs were similar in prevention of cardiovascular mortality or major events . Decrease in blood pressure was of major importance for the prevention of cardiovascular events",
"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",
"Abstract Background : In Japan , when pharmaceutical companies launch a new drug , they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14 - 4 ( re-examination ) of the Pharmaceutical Affairs Law at contracted medical institutions . We report the results of a long-term special survey that we conducted as a post-marketing survey . Objective : The results of a prospect i ve post-marketing survey that was conducted to assess the safety and efficacy of the b-adrenergic receptor antagonist ( β-blocker ) Artist ® tablets 10 mg , 20 mg ( carvedilol ) in patients with hypertension in Japan , were investigated in order to examine the safety and efficacy of the drug during long-term treatment ( 18 months ) . Patients : Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension . Methods : We performed this survey as a prospect i ve cohort study ( special survey ) utilizing a central ized registration method over 3 years ( starting from April 1994 ) , for an observation period of 18 months of carvedilol treatment . Results : Sixty-one medical institutions across Japan collected 380 case report forms of patients who received long-term administration of carvedilol , with 363 and 341 cases evaluated for safety and efficacy , respectively . The discontinuation rate was 7.2 % and the incidence of adverse drug reactions was 5.23 % ( 19 of 363 ) in the safety population . There was no significant change in fasting plasma glucose levels from baseline ( 118.1 ± 46.5mg/dL ) to after carvedilol treatment ( 114.6 ± 43.3 mg/dL ) [ n = 141 ; p = 0.310].In 341 evaluable patients in the efficacy population , decreases in both blood pressure and pulse rate were statistically significant at all assessment points in comparison with baseline data ( p hypertensive patients with diabetes mellitus , decreases in blood pressure were statistically significant at all assessment points in comparison with baseline data ( p that carvedilol exerted stable antihypertensive effects leading to favorable blood pressure control throughout long-term treatment , without showing any safety concerns . It was concluded that there were no clinical ly significant issues in terms of safety or efficacy with the long-term treatment of carvedilol in patients with hypertension",
"OBJECTIVES The aim of this study was to test the hypothesis that the angiotensin II type 1 receptor blocker ( ARB ) c and esartan can reduce the risk of stroke in elderly patients with isolated systolic hypertension ( ISH ) . BACKGROUND Isolated systolic hypertension is the predominant form of hypertension in the elderly , and stroke is the most common cardiovascular ( CV ) complication . METHODS In the Study on Cognition and Prognosis in the Elderly ( SCOPE ) , 4,964 patients age 70 to 89 years were r and omly assigned to double-blind c and esartan or placebo with open-label antihypertensive therapy ( mostly thiazide diuretics ) added as needed to control blood pressure . Of the 4,964 patients , 1,518 had ISH ( systolic blood pressure > 160 mm Hg and diastolic blood pressure . The present study is a predefined subgroup analysis of outcome results in the ISH patients . RESULTS Of the ISH patients , 754 were r and omized to the c and esartan group and 764 to the control group . Over the study period , blood pressure was reduced by 22/6 mm Hg in the c and esartan group and by 20/5 mm Hg in the control group ( difference between treatments 2/1 mm Hg ; p = 0.101 and 0.064 ) . A total of 20 fatal/non-fatal strokes occurred in the c and esartan group ( 7.2/1,000 patient-years ) and 35 in the control group ( 12.5/1,000 patient-years ) ; relative risk ( RR ) was 0.58 ( 95 % confidence interval 0.33 to 1.00 ) , that is , a RR reduction of 42 % ( p = 0.050 unadjusted , p = 0.049 adjusted for baseline risk ) . There were no marked or statistically significant differences between the treatment groups in other CV end points or all-cause mortality . CONCLUSIONS In elderly patients with ISH , antihypertensive treatment based on the ARB c and esartan result ed in a significant 42 % RR reduction in stroke in comparison with other antihypertensive treatment , despite little difference in blood pressure reduction",
"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",
"Objective : To compare the blood pressure‐lowering efficacy , the frequency of side effects and changes in laboratory values of three & bgr;‐blockers and a potassium‐sparing diuretic combination in elderly hypertensive patients . Design : The Swedish Trial in Old Patients with Hypertension ( STOP‐Hypertension ) was a prospect i ve , r and omized , double‐blind , multicentre trial comparing active antihypertensive treatment with placebo in patients aged 70‐84 years . Methods : The study group consisted of 1627 elderly hypertensive patients ( mean ± SD age 75.7 ± 3.7 years ; 37 % males , 63 % females ) . Supine and st and ing blood pressure , heart rate and side effects were recorded at each visit . Blood was drawn for routine analysis . The mean length of follow‐up was 25 months ( range 6‐65 ) . No patient was lost to follow‐up . Results : After 2‐months ' single‐drug therapy , all four active drugs were found to be equally effective in reducing diastolic blood pressure ( DBP ) . However , there were differences in their efficacy in reducing systolic blood pressure ( SBP ) ; the diuretic was significantly more effective than the & bgr;‐receptor blockers . The results of a series of multiple linear regression analyses showed that the observed differences in effect on SBP could not be explained by the different effects of the drugs on heart rate . More than two‐thirds of the patients were given supplementary treatment , most of them already by the 2‐month visit , after which there was no significant difference in blood pressure among the treatment regimens . The changes in laboratory values and in the prevalence of symptoms were minor for all four regimens . Conclusion : Metoprolol ( controlled release ) , atenolol , pindolol and the combination hydrochlorothiazide + amiloride were equally effective as single drugs in reducing DBP . There were differences in their efficacy in reducing SBP , the diuretic being more effective than the & bgr;‐blockers . After addition of supplementary treatment ( & bgr;‐blocker to diuretic , or vice versa ) there were no significant differences in blood pressure reduction among the groups . The changes in laboratory values and in the prevalence of symptoms were minor for all active treatment regimens . Thus , the satisfactory effect on cardiovascular morbidity and mortality was not impaired by low tolerability of the drugs",
"Objective : To perform a subgroup analysis on those patients in STOP‐Hypertension‐2 who had isolated systolic hypertension . Design and methods : The STOP‐Hypertension‐2 study evaluated cardiovascular mortality and morbidity in elderly hypertensives comparing treatment with conventional drugs ( diuretics , beta‐blockers ) with that of newer ones [ angiotensin‐converting enzyme ( ACE ) inhibitors , calcium antagonists ] . In all , 6614 elderly patients with hypertension ( mean age 76.0 years , range 70–84 years at baseline ) were included in STOP‐Hypertension‐2 . In the present subgroup analysis of STOP‐Hypertension‐2 , isolated systolic hypertension was defined as systolic blood pressure at least 160 mmHg and diastolic blood pressure below 95 mmHg , in accordance with the Syst‐Eur and Syst‐China study criteria . In total , 2280 patients in STOP‐Hypertension‐2 met these criteria . In the study , patients were r and omized to one of three treatment groups : “ conventional ” antihypertensive therapy with beta‐blockers or diuretics ( atenolol 50 mg , metoprolol 100 mg , pindolol 5 mg , or fixed‐ratio hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily ) ; ACE inhibitors ( enalapril 10 mg or lisinopril 10 mg daily ) ; or calcium antagonists ( felodipine 2.5 mg or isradipine 2.5 mg daily ) . Analysis was by intention to treat . Results : The blood pressure lowering effect in patients with systolic hypertension was similar with all three therapeutic regimens : 35/13 mmHg in the conventional group ( n = 717 ) , 34/12 mmHg in the ACE inhibitor group ( n = 724 ) , and 35/13 mmHg in the calcium antagonist group ( n = 708 ) . Prevention of cardiovascular mortality , the primary endpoint of the study , did not differ between the three treatment groups . All stroke events , i.e. fatal and non‐fatal stroke together , were significantly reduced by 25 % in the newer‐drugs group compared with the conventional group ( 95 % CI 0.58–0.97 ; p = 0.027 ) . This difference was attributable to reduction of non‐fatal stroke while fatal stroke events did not differ between groups . New cases of atrial fibrillation were significantly increased by 43 % ( 95 % CI 1.02–1.99 ; p = 0.037 ) on “ newer ” drugs compared with “ conventional ” therapy , mainly attributable to the calcium antagonists . There were no significant differences between the three treatment groups with respect to the risks of myocardial infa rct ion , sudden death or congestive heart failure . Conclusions : The analysis demonstrated that “ newer ” therapy ( ACE inhibitors/calcium antagonists ) was significantly better ( 25 % ) than “ conventional ” ( diuretics/beta‐blockers ) in preventing all stroke in elderly patients with isolated systolic hypertension",
"CONTEXT Antihypertensive therapy is well established to reduce hypertension-related morbidity and mortality , but the optimal first-step therapy is unknown . OBJECTIVE To determine whether treatment with a calcium channel blocker or an angiotensin-converting enzyme inhibitor lowers the incidence of coronary heart disease ( CHD ) or other cardiovascular disease ( CVD ) events vs treatment with a diuretic . DESIGN The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) , a r and omized , double-blind , active-controlled clinical trial conducted from February 1994 through March 2002 . SETTING AND PARTICIPANTS A total of 33 357 participants aged 55 years or older with hypertension and at least 1 other CHD risk factor from 623 North American centers . INTERVENTIONS Participants were r and omly assigned to receive chlorthalidone , 12.5 to 25 mg/d ( n = 15 255 ) ; amlodipine , 2.5 to 10 mg/d ( n = 9048 ) ; or lisinopril , 10 to 40 mg/d ( n = 9054 ) for planned follow-up of approximately 4 to 8 years . MAIN OUTCOME MEASURES The primary outcome was combined fatal CHD or nonfatal myocardial infa rct ion , analyzed by intent-to-treat . Secondary outcomes were all-cause mortality , stroke , combined CHD ( primary outcome , coronary revascularization , or angina with hospitalization ) , and combined CVD ( combined CHD , stroke , treated angina without hospitalization , heart failure [ HF ] , and peripheral arterial disease ) . RESULTS Mean follow-up was 4.9 years . The primary outcome occurred in 2956 participants , with no difference between treatments . Compared with chlorthalidone ( 6-year rate , 11.5 % ) , the relative risks ( RRs ) were 0.98 ( 95 % CI , 0.90 - 1.07 ) for amlodipine ( 6-year rate , 11.3 % ) and 0.99 ( 95 % CI , 0.91 - 1.08 ) for lisinopril ( 6-year rate , 11.4 % ) . Likewise , all-cause mortality did not differ between groups . Five-year systolic blood pressures were significantly higher in the amlodipine ( 0.8 mm Hg , P = .03 ) and lisinopril ( 2 mm Hg , P chlorthalidone , and 5-year diastolic blood pressure was significantly lower with amlodipine ( 0.8 mm Hg , P amlodipine vs chlorthalidone , secondary outcomes were similar except for a higher 6-year rate of HF with amlodipine ( 10.2 % vs 7.7 % ; RR , 1.38 ; 95 % CI , 1.25 - 1.52 ) . For lisinopril vs chlorthalidone , lisinopril had higher 6-year rates of combined CVD ( 33.3 % vs 30.9 % ; RR , 1.10 ; 95 % CI , 1.05 - 1.16 ) ; stroke ( 6.3 % vs 5.6 % ; RR , 1.15 ; 95 % CI , 1.02 - 1.30 ) ; and HF ( 8.7 % vs 7.7 % ; RR , 1.19 ; 95 % CI , 1.07 - 1.31 ) . CONCLUSION Thiazide-type diuretics are superior in preventing 1 or more major forms of CVD and are less expensive . They should be preferred for first-step antihypertensive therapy",
"The benefits of lowering a systolic blood pressure below 140 mmHg in elderly hypertension remain controversial . This study is a prospect i ve , r and omized , open-label study with blinded assessment of endpoints to compare the 2-year effect of strict treatment to maintain systolic blood pressure below 140 mmHg with that of mild treatment to maintain systolic blood pressure below 160 but at or above 140 mmHg in elderly hypertensive patients . Patients with essential hypertension ( 65–85 years old , with a pretreatment systolic blood pressure of above 160 mmHg ) were r and omly assigned to receive strict treatment ( n=2,212 ) or mild treatment ( n=2,206 ) . The baseline drug was efonidipine hydrochloride , a long-acting calcium antagonist . The primary endpoint was the combined incidence of cardiovascular disease and renal failure , and the secondary endpoints were total deaths and any safety problems . Although final blood pressures ( systolic/diastolic ) were significantly lower in the strict-treatment group compared with the mild-treatment group ( 135.9/74.8 vs. 145.6/78.1 mmHg ; p ) . Total deaths were 54 in the strict-treatment group vs. 42 in the mild-treatment group ( p=0.22 ) , and treatment was withdrawn because of adverse events in 36 patients in each group ( p=0.99 ) . An interaction between age and treatment for the primary endpoints ( p=0.03 ) was seen . Complex clinical features associated with aging seem to have obscured the difference in effect between the two treatments . Further studies are needed to assess the optimal treatment strategy for hypertension in the elderly",
"BACKGROUND Is cancer related to hypertension and blood pressure ? Do antihypertensive drugs promote cancer ? Do antihypertensive drugs protect against cancer ? We previously analysed the frequency of cardiovascular mortality and morbidity in elderly people who participated in the Swedish Trial in Old Patients with Hypertension 2 ( STOP-Hypertension-2 ) . We have also looked at the frequency of cancer in these patients . METHODS We r and omly assigned 6614 elderly patients with hypertension ( mean age 76 years , median time of follow-up 5.3 years ) to one of three treatment strategies : conventional drugs ( diuretics or b-blockers ) , calcium antagonists , or ACE inhibitors . We matched the patients to the Swedish Cancer Registry and compared our findings with expected values based on age , sex , and calendar-year-specific reference frequencies for the general Swedish population . We also compared the number of cancers between the three treatment groups . FINDINGS At baseline , 607 ( 9 % ) patients had previous malignant disease . Diagnoses were closely similar to the distribution of cancer types that might be seen in elderly patients . During follow-up , there were 625 new cases of cancer in 590 patients . The frequency of cancer did not differ significantly between the treatment strategies , including all cancers and those at individual sites . The st and ardised incidence ratios ( SIRs ) for all cancers were also close to unity : 0.92 ( 95 % CI 0.80 - 1.06 ) for conventional drugs , 0.96 ( 0.83 - 1.10 ) for calcium antagonists , and 0.99 ( 0.86 - 1.13 ) for ACE inhibitors . INTERPRETATIONS No difference in cancer risk was seen between patients r and omly assigned to conventional drugs , calcium antagonists , or ACE inhibitors . Thus , the general message to the practising physician is that more attention should be given to getting the blood pressure down than to the risk of cancer ",
"Background The benefits of treating hypertension in elderly diabetic patients , in terms of achieving reductions in cardiovascular morbidity and mortality , have been documented in several recent prospect i ve trials . There has , however , been some controversy regarding the effect of different antihypertensive drugs on the frequency of myocardial infa rct ion in this group of patients . Design STOP Hypertension-2 was a prospect i ve , r and omized , open trial with blinded endpoint evaluation . Methods We studied 6614 elderly patients aged 70–84 years ; 719 of them had diabetes mellitus at the start of the study ( mean age 75.8 years ) . Patients were r and omly assigned to one of three treatment strategies : conventional antihypertensive drugs ( diuretics or β-blockers ) , calcium antagonists , or angiotensin converting enzyme ( ACE ) inhibitors . Results Reduction in blood pressure was similar in the three treatment groups of diabetics . The prevention of cardiovascular mortality was also similar ; the frequency of this primary endpoint did not differ significantly between the three groups . There were , however , significantly fewer ( P = 0.025 ) myocardial infa rct ions during ACE inhibitor treatment ( n = 17 ) than during calcium antagonist treatment ( n = 32 ; relative risk 0.51 , 95 % confidence interval 0.28–0.92 ) ; but a ( non-significant ) tendency to more strokes during ACE inhibitor treatment ( n = 34 compared with n = 29 ; relative risk 1.16 , 95 % confidence interval 0.71–1.91 ) . Conclusion Treatment of hypertensive diabetic patients with conventional antihypertensive drugs ( diuretics , β-blockers , or both ) seemed to be as effective as treatment with newer drugs such as calcium antagonists or ACE inhibitors",
"BACKGROUND fractures may have serious implication s in an elderly individual , and fracture prevention may include a careful choice of medications . DESIGN the Hypertension in the Very Elderly Trial ( HYVET ) was a double-blind placebo-controlled trial of a thiazide-like diuretic ( indapamide 1.5 mg SR ) with the optional addition of the angiotensin-converting enzyme ( ACE ) inhibitor ( perindopril 2 - 4 mg ) . Fracture was a secondary end point of the trial . SETTING HYVET recruited participants from Eastern and Western Europe , China , Australasia , and Tunisia . SUBJECTS all participants were > or = 80 years of age and hypertensive . METHODS participants were r and omised to receive a thiazide-like diuretic ( indapamide 1.5 mg SR ) + /- ACE inhibitor ( perindopril 2 - 4 mg ) or matching placebos . Incident fractures were vali date d and analysed based on time to first fracture . RESULTS there were 3,845 participants in HYVET and a total 102 reported fractures ( 42 in the active and 60 in the placebo group ) . When taking only vali date d first fractures , 90 were included in the analyses ( 38 in the active and 52 in the placebo group ) . Cox proportional hazard regression , adjusted for key baseline risk factors , result ed in a point estimate of 0.58 ( 95 % CI 0.33 - 1.00 , P = 0.0498 ) . CONCLUSIONS despite the lowering of blood pressure , treatment with a thiazide-like diuretic and an ACE inhibitor does not increase and may decrease fracture rate",
"OBJECTIVE --To establish whether treatment with diuretic or beta blocker in hypertensive older adults reduces risk of stroke , coronary heart disease , and death . DESIGN --R and omised , placebo controlled , single blind trial . SETTING --226 general practice s in the MRC general practice research framework . SUBJECTS--4396 patients aged 65 - 74 r and omised to receive diuretic , beta blocker , or placebo . Patients had mean systolic pressures of 160 - 209 mm Hg and mean diastolic pressures less than 115 mm Hg during an eight week run in and were not taking antihypertensive treatment . INTERVENTION-- Patients were r and omised to atenolol 50 mg daily ; hydrochlorothiazide 25 mg or 50 mg plus amiloride 2.5 mg or 5 mg daily ; or placebo . The regimens were adjusted to achieve specified target pressures . Mean follow up was 5.8 years . MAIN OUTCOME MEASURES --Strokes , coronary events , and deaths from all causes . RESULTS --Both treatments reduced blood pressure below the level in the placebo group . Compared with the placebo group , actively treated subjects ( diuretic and beta blocker groups combined ) had a 25 % ( 95 % confidence interval 3 % to 42 % ) reduction in stroke ( p = 0.04 ) , 19 % ( -2 % to 36 % ) reduction in coronary events ( p = 0.08 ) , and 17 % ( 2 % to 29 % ) reduction in all cardiovascular events ( p = 0.03 ) . After adjusting for baseline characteristics the diuretic group had significantly reduced risks of stroke ( 31 % ( 3 % to 51 % ) p = 0.04 ) , coronary events ( 44 % ( 21 % to 60 % ) , p = 0.0009 ) , and all cardiovascular events ( 35 % ( 17 % to 49 % ) , p = 0.0005 ) compared with the placebo group . The beta blocker group showed no significant reductions in these end points . The reduction in strokes was mainly in non-smokers taking the diuretic . CONCLUSION --Hydrochlorothiazide and amiloride reduce the risk of stroke , coronary events , and all cardiovascular events in older hypertensive adults ",
"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",
"BACKGROUND It is unknown whether high-dose angiotensin II receptor blocker therapy or angiotensin II receptor blocker + calcium channel blocker combination therapy is better in elderly hypertensive patients with high cardiovascular risk . The objective of the study was to compare the efficacy of these treatments in elderly , high-risk Japanese hypertensive patients . METHODS The OlmeSartan and Calcium Antagonists R and omized ( OSCAR ) study was a multicenter , prospect i ve , r and omized , open-label , blinded-end point study of 1164 hypertensive patients aged 65 to 84 years with type 2 diabetes or cardiovascular disease . Patients with uncontrolled hypertension during treatment with olmesartan 20 mg/d were r and omly assigned to receive 40 mg/d olmesartan ( high-dose angiotensin II receptor blocker ) or a calcium channel blocker + 20 mg/d olmesartan ( angiotensin II receptor blocker + calcium channel blocker ) . The primary end point was a composite of cardiovascular events and noncardiovascular death . RESULTS During a 3-year follow-up , blood pressure was significantly lower in the angiotensin II receptor blocker + calcium channel blocker group than in the high-dose angiotensin II receptor blocker group . Mean blood pressure at 36 months was 135.0/74.3 mm Hg in the high-dose angiotensin II receptor blocker group and 132.6/72.6 mm Hg in the angiotensin II receptor blocker + calcium channel blocker group . More primary end points occurred in the high-dose angiotensin II receptor blocker group than in the angiotensin II receptor blocker + calcium channel blocker group ( 58 vs 48 events , hazard ratio [ HR ] , 1.31 , 95 % confidence interval , 0.89 - 1.92 ; P=.17 ) . In patients with cardiovascular disease at baseline , more primary events occurred in the high-dose angiotensin II receptor blocker group ( HR , 1.63 , P=.03 ) ; in contrast , fewer events were observed in the subgroup without cardiovascular disease ( HR , 0.52 , P=.14 ) . This treatment-by-subgroup interaction was significant ( P=.02 ) . CONCLUSION The angiotensin II receptor blocker and calcium channel blocker combination lowered blood pressure more than the high-dose angiotensin II receptor blocker and reduced the incidence of primary end points more than the high-dose angiotensin II receptor blocker in patients with cardiovascular disease . The addition of a second antihypertensive agent is more effective at lowering blood pressure than simply doubling the dose of an existing agent",
"ABCD : Appropriate Blood pressure Control in Diabetes ABI : ankle – brachial index ABPM : ambulatory blood pressure monitoring ACCESS : Acute C and esartan Cilexetil Therapy in Stroke Survival ACCOMPLISH : Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension ACCORD : Action to Control Cardiovascular Risk in Diabetes ACE : angiotensin-converting enzyme ACTIVE I : Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events ADVANCE : Action in Diabetes and Vascular Disease : Preterax and Diamicron-MR Controlled Evaluation AHEAD : Action for HEAlth in Diabetes ALLHAT : Antihypertensive and Lipid-Lowering Treatment to Prevent Heart ATtack ALTITUDE : ALiskiren Trial In Type 2 Diabetes Using Cardio-renal Endpoints ANTIPAF : ANgioTensin II Antagonist In Paroxysmal Atrial Fibrillation APOLLO : A R and omized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People ARB : angiotensin receptor blocker ARIC : Atherosclerosis Risk In Communities ARR : aldosterone renin ratio ASCOT : Anglo-Sc and inavian Cardiac Outcomes Trial ASCOT-LLA : Anglo-Sc and inavian Cardiac Outcomes Trial — Lipid Lowering Arm ASTRAL : Angioplasty and STenting for Renal Artery Lesions A-V : atrioventricular BB : beta-blocker BMI : body mass index BP : blood pressure BSA : body surface area CA : calcium antagonist CABG : coronary artery bypass graft CAPPP : CAPtopril Prevention Project CAPRAF : C And esartan in the Prevention of Relapsing Atrial Fibrillation CHD : coronary heart disease CHHIPS : Controlling Hypertension and Hypertension Immediately Post-Stroke CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease — EPIdemiology collaboration CONVINCE : Controlled ONset Verapamil INvestigation of CV Endpoints CT : computed tomography CV : cardiovascular CVD : cardiovascular disease D : diuretic DASH : Dietary Approaches to Stop Hypertension DBP : diastolic blood pressure DCCT : Diabetes Control and Complications Study DIRECT : DIabetic REtinopathy C and esartan Trials DM : diabetes mellitus DPP-4 : dipeptidyl peptidase 4 EAS : European Atherosclerosis Society EASD : European Association for the Study of Diabetes ECG : electrocardiogram EF : ejection fraction eGFR : estimated glomerular filtration rate ELSA : European Lacidipine Study on Atherosclerosis ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease EXPLOR : Amlodipine – Valsartan Combination Decreases Central Systolic Blood Pressure more Effectively than the Amlodipine – Atenolol Combination FDA : U.S. Food and Drug Administration FEVER : Felodipine EVent Reduction study GISSI-AF : Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation HbA1c : glycated haemoglobin HBPM : home blood pressure monitoring HOPE : Heart Outcomes Prevention Evaluation HOT : Hypertension Optimal Treatment HRT : hormone replacement therapy HT : hypertension HYVET : HYpertension in the Very Elderly Trial IMT : intima-media thickness I-PRESERVE : Irbesartan in Heart Failure with Preserved Systolic Function INTERHEART : Effect of Potentially Modifiable Risk Factors associated with Myocardial Infa rct ion in 52 Countries INVEST : INternational VErapamil SR/T Tr and olapril ISH : Isolated systolic hypertension JNC : Joint National Committee JUPITER : Justification for the Use of Statins in Primary Prevention : an Intervention Trial Evaluating Rosuvastatin LAVi : left atrial volume index LIFE : Losartan Intervention For Endpoint Reduction in Hypertensives LV : left ventricle/left ventricular LVH : left ventricular hypertrophy LVM : left ventricular mass MDRD : Modification of Diet in Renal Disease MRFIT : Multiple Risk Factor Intervention Trial MRI : magnetic resonance imaging NORDIL : The Nordic Diltiazem Intervention study OC : oral contraceptive OD : organ damage ONTARGET : ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial PAD : peripheral artery disease PATHS : Prevention And Treatment of Hypertension Study PCI : percutaneous coronary intervention PPAR : peroxisome proliferator-activated receptor PREVEND : Prevention of REnal and Vascular ENdstage Disease PROFESS : Prevention Regimen for Effectively Avoiding Secondary Strokes PROGRESS : Perindopril Protection Against Recurrent Stroke Study PWV : pulse wave velocity QALY : Quality adjusted life years RAA : renin-angiotensin-aldosterone RAS : renin-angiotensin system RCT : r and omized controlled trials RF : risk factor ROADMAP : R and omized Olmesartan And Diabetes MicroAlbuminuria Prevention SBP : systolic blood pressure SCAST : Angiotensin-Receptor Blocker C and esartan for Treatment of Acute STroke SCOPE : Study on COgnition and Prognosis in the Elderly SCORE : Systematic COronary Risk Evaluation SHEP : Systolic Hypertension in the Elderly Program STOP : Swedish Trials in Old Patients with Hypertension STOP-2 : The second Swedish Trial in Old Patients with Hypertension SYSTCHINA : SYSTolic Hypertension in the Elderly : Chinese trial SYSTEUR : SYSTolic Hypertension in Europe TIA : transient ischaemic attack TOHP : Trials Of Hypertension Prevention TRANSCEND : Telmisartan R and omised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease UKPDS : United Kingdom Prospect i ve Diabetes Study VADT : Veterans ' Affairs Diabetes Trial VALUE : Valsartan Antihypertensive Long-term Use Evaluation WHO : World Health Organization # # # 1.1 Principles The 2013 guidelines on hypertension of the European Society of Hypertension ( ESH ) and the European Society of Cardiology",
"Hypertension is the most common condition seen in primary care and leads to myocardial infa rct ion , stroke , renal failure , and death if not detected early and treated appropriately . Patients want to be assured that blood pressure ( BP ) treatment will reduce their disease burden , while clinicians want guidance on hypertension management using the best scientific evidence . This report takes a rigorous , evidence -based approach to recommend treatment thresholds , goals , and medications in the management of hypertension in adults . Evidence was drawn from r and omized controlled trials , which represent the gold st and ard for determining efficacy and effectiveness . Evidence quality and recommendations were grade d based on their effect on important outcomes . There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mm Hg ; however , there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal , or in those younger than 30 years for a diastolic goal , so the panel recommends a BP of less than 140/90 mm Hg for those groups based on expert opinion . The same thresholds and goals are recommended for hypertensive adults with diabetes or nondiabetic chronic kidney disease ( CKD ) as for the general hypertensive population younger than 60 years . There is moderate evidence to support initiating drug treatment with an angiotensin-converting enzyme inhibitor , angiotensin receptor blocker , calcium channel blocker , or thiazide-type diuretic in the nonblack hypertensive population , including those with diabetes . In the black hypertensive population , including those with diabetes , a calcium channel blocker or thiazide-type diuretic is recommended as initial therapy . There is moderate evidence to support initial or add-on antihypertensive therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in persons with CKD to improve kidney outcomes . Although this guideline provides evidence -based recommendations for the management of high BP and should meet the clinical needs of most patients , these recommendations are not a substitute for clinical judgment , and decisions about care must carefully consider and incorporate the clinical characteristics and circumstances of each individual patient"
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Urinary incontinence ( UI ) , the involuntary loss of urine , affects about 17 % of nonpregnant women ( 1 ) , and its prevalence increases with age , particularly after menopause . Incontinence may have a negative effect on a woman 's physical , psychological , and social well-being and may impose substantial lifestyle restrictions . The most common types of UI in women are stress , urgency , and mixed incontinence . Stress UI is the involuntary loss of urine with effort or physical exertion or on sneezing or coughing , urgency UI is associated with a sudden compulsion to urinate that is difficult to defer , and mixed UI has features of both types ( 2 ) . Nonpharmacologic and pharmacologic interventions are available to manage UI . Nonpharmacologic approaches mostly aim to strengthen the pelvic floor or change behaviors that influence bladder function , whereas pharmacologic treatments primarily address bladder and urethral sphincter function . We conducted a broad systematic review of the clinical effects and harms of all nonsurgical treatments for stress , urgency , and mixed UI in nonpregnant women . Although some causes of UI are amenable to surgery , we focused only on nonsurgical interventions . The review ( available at www.effectivehealthcare.ahrq.gov ) was commissioned by the Agency for Healthcare Research and Quality ( AHRQ ) and the Patient-Centered Outcomes Research Institute ( PCORI ) ( 3 ) . This article presents the network meta- analysis ( NMA ) that focuses on symptomatic cure and improvement outcomes ; the technical report presents details of other outcomes , including adverse events and quality of life ( 3 ) . Methods The Evidence -based Practice Center at Brown University used established systematic review methods , as outlined in the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Review s ( 4 ) . The review is registered with PROSPERO ( CRD42017069903 ) . Detailed descriptions of the review and NMA methods may be found in Supplement 1 and in the full report ( 3 ) . Supplement . Network Meta- analysis Model and Inconsistency Analysis Results ( Supplement 1 ) ; Literature Search Strategies ( Supplement 2 ) ; Network Meta- analysis Results ( Supplement 3 ) ; and Evidence Profile for Pharmacologic and Nonpharmacologic Interventions for UI ( Supplement 4 ) Data Sources and Search es We up date d a systematic review conducted in 2012 ( 5 ) and included all eligible studies from that earlier work . We search ed MEDLINE , the Cochrane Central Register of Controlled Trials ( Wiley ) , the Cochrane Data base of Systematic Review s ( Wiley ) , EMBASE ( Elsevier ) , CINAHL ( EBSCO ) , and PsycINFO ( American Psychological Association ) to identify relevant primary research studies published since 2011 . See Supplement 2 for search strategies . For the full report ( 3 ) , final search es were conducted on 4 December 2017 . We also included other eligible studies identified by AHRQ , PCORI , peer review ers , manufacturers , and other stakeholders . On 10 August 2018 , we performed an up date d search for r and omized controlled trials ( RCTs ) on MEDLINE , the U.S. Food and Drug Administration Web site , and Clinical Trials.gov . After 2 rounds of pilot screening were conducted for training purpose s , a team of 6 research ers independently double-screened all identified citations ( abstract s ) using Abstrackr ( http://abstrackr.cebm.brown.edu ) ; conflicts were resolved by group discussion . The full texts of all potentially relevant studies were rescreened in duplicate . Study Selection We included studies of adult women with stress , urgency , or mixed UI , excluding those who were pregnant , hospitalized , or institutionalized and those with UI due to urinary tract infection or neurogenic bladder ; however , we allowed up to 10 % of study participants to fall into any of the exclusion categories . We included comparisons of pharmacologic , nonpharmacologic ( nonsurgical ) , and placebo ( or sham or no ) treatments for stress , urgency , or mixed UI . Among eligible interventions , we included those that sometimes require minor surgery ( such as device implantation for sacral neuromodulation ) or might be performed in an office setting ( such as periurethral bulking and bladder onabotulinum toxin A [ BTX ] injection ) . Studies had to report categorical symptomatic cure ( for example , cured vs. not cured ) , improvement , or satisfaction after treatment ; quality -of-life score after treatment ; or adverse events related to treatment . This article focuses on the clinical outcomes of cure and improvement . As commonly understood , symptomatic cure means resolution of incontinence ; it does not imply permanent cure . We included RCTs with no minimum sample size and nonr and omized comparative studies with at least 50 women per intervention group . All studies had to have a minimum follow-up of 4 weeks . We included only peer- review ed publications and studies with complete results data in Clinical Trials.gov or available from the U.S. Food and Drug Administration . We included translatable studies in any language . Four studies , 2 in Russian and 2 in Persian , could not be translated and were excluded . The non-English studies included were published in Spanish ( 2 studies ) , French ( 1 study ) , and Chinese ( 1 study ) . Data Extraction and Quality Assessment Each new study was extracted and assessed for method ological quality by 1 method ologist . The extraction and assessment were review ed and confirmed by at least 1 other experienced method ologist . Disagreements were resolved by discussion among the team members . Studies were extracted into a customized form in the Systematic Review Data Repository ( https://srdr.ahrq.gov/projects/1153 ) . To assess quality , we used the Cochrane Risk of Bias Tool for RCTs ( 6 ) . For nonr and omized comparative studies , we evaluated outcome assessor blinding ; attrition bias ; group similarity at baseline ; adherence ; and whether groups were selected similarly , analyses were adjusted for differences between groups , and interventions were described adequately . We grade d strength of evidence ( SoE ) according to the AHRQ methods guide ( 7 ) . We assessed SoE for each outcome category for our main conclusion statements across all intervention categories . For each SoE assessment , we considered the number of studies , study design s , study limitations ( that is , risk of bias and overall method ological quality ) , directness of the comparisons ( in the network ) , consistency of study results , precision of any estimates of effect ( imprecise if the 95 % CI extended beyond both 0.80 and 1.25 ) , likelihood of reporting bias , other limitations , and overall findings across studies . On the basis of these assessment s , we assigned an SoE rating of high , moderate , or low or deemed the evidence insufficient to estimate an effect . Data Synthesis and Analysis Categorization of Interventions Where feasible , we used guidelines from the National Institute for Health and Care Excellence and the American Urological Association to categorize interventions ( 8 , 9 ) . First , we classified the 53 specific interventions for which there were any outcomes of interest ( including adverse events ) into 16 categories ( Table 1 ) . Then , we divided the categories further on the basis of whether they are recommended primarily for stress or urgency UI . Behavioral therapy is recommended for both stress and urgency UI and thus appeared in both categories . Neuromodulation is recommended primarily for urgency UI , but several RCTs evaluated it in women with stress UI ; thus , it also was included in both categories . Next , we stratified the interventions according to whether they are recommended as first- , second- , or third-line therapies ( 8 , 9 ) . Table 1 . Categories of Interventions Evaluated by Eligible Studies Network Meta- analysis We conducted frequentist ( maximum-likelihood ) pairwise comparisons and NMAs of odds ratios ( ORs ) with mixed-effects ( r and om intercepts and fixed intervention slopes ) or full r and om-effects ( r and om intercepts and slopes ) multilevel models within the generalized linear and latent mixed modeling framework . We assessed consistency qualitatively , deeming direct and indirect effects in agreement if they were in the same direction and if the CI of one included the point estimate of the other , and quantitatively , using a node-split approach ( 10 ) . Further details are provided in Supplement 1 . We conducted separate sets of NMAs for each UI outcome ( cure and improvement ) . Originally , we considered performing separate NMA sets for each UI type ( stress , urgency , and mixed ) ; however , many studies did not restrict their eligibility to women with a specific UI type , and very few studies reported specifically on women with mixed UI . Therefore , for each UI outcome , we ran an overall NMA that included all eligible studies regardless of UI type or line of therapy . Then , we summarized comparisons of interventions on the basis of whether they are used ( or recommended ) primarily for urgency or stress UI and whether they are first- and second-line therapies or third-line therapies ( 8 , 9 ) . We ran separate sets of NMAs for specific interventions and for intervention categories . The analyses are presented in the full report ( 3 ) . We ran separate NMAs of the subsets of studies that included only women with stress or urgency UI and compared these results with the overall analyses . Role of the Funding Source This topic was nominated and funded by PCORI for systematic review by an Evidence -based Practice Center in partnership with AHRQ . Program officers from AHRQ and PCORI provided comments on draft versions of the protocol and full evidence report ( 3 ) . Neither PCORI nor AHRQ participated directly in the literature search ; determination of study eligibility criteria ; data analysis or interpretation ; or preparation , review , or approval of the manuscript for publication . Results The 2018 search returned 7840 new citations , 7117 of which were excluded during abstract screening ( Figure 1 ) . Of the 723 abstract s accepted at the initial screening and retrieved for full-text review , 613 were found to be
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"Introduction and hypothesisOur goal was to compare the long-term efficacy of bladder training ( BT ) , pelvic floor muscle training ( PFMT ) , combined pelvic floor rehabilitation ( CPFR ) , and drug therapy ( DT ) in patients with urgency urinary incontinence ( UUI ) . Methods This multicenter single-blind r and omized controlled trial compared the efficacy of BT , PFMT , DT , and CPFR at baseline and 3- and 12-month follow-ups . Outcome measures included number of voids/24 h , number of UUI episodes , Quality of Life related to UUI ( QOL-rUI ) , urogynecologic visual analog scale , and self-reported function and disability . Results A significant improvement was found for all treatment groups at 3 and 12 months in urinary frequency , UUI episodes , QOL-rUI , and number of daily pads . Only CPFR showed a significant decrease of 4 voids/24 h and a significant increase in self-reported function . Conclusions The study demonstrated long-term benefits of DT , BT , PFMT , and CPFR in the treatment of UUI with a slight advantage for CPFR",
"The objective of this study was to evaluate the effectiveness of duloxetine in improving quality of life among women with stress and mixed urinary incontinence . The study included 451 women with self-reported stress incontinence episodes ( ≥1/week ) who were r and omized to duloxetine ( 40 mg BID ) or placebo in a double-blind , usual care design . Patients and physicians were allowed to titrate , augment , and /or discontinue treatment . Concomitant treatments were permitted . The primary outcome was the Incontinence Quality of Life Question naire ( I-QOL ) score , with assessment s at 3 , 6 , and 9 months . Other measures included the Patient Global Impression of Improvement ( PGI-I ) and adverse events . The adjusted mean change in I-QOL total score was greater in the duloxetine group than in the placebo group and at a level comparable to that found in previous clinical trials , but the difference between placebo and duloxetine was not statistically significant in the intent-to-treat , last observation carried forward ( LOCF ) analysis . The difference approached statistical significance in favor of duloxetine at 3 months ( p=0.07 ) . PGI-I ratings did not demonstrate significant superiority for duloxetine in LOCF analysis ; however , study completers taking duloxetine were significantly more likely to rate themselves as “ better ” ( 70.2 % ) than completers taking placebo ( 50.8 % , p mean I-QOL change scores were numerically higher for the duloxetine group than mean change scores for the placebo group , this difference was not statistically significant . Among women who completed the study on study drug , a significantly greater proportion of duloxetine women versus placebo women rated their condition to be better",
"Introduction The aim of this study was to examine the efficacy of transcutaneous electrical tibial nerve stimulation ( TTNS ) to treat urge urinary incontinence ( UUI ) in older women . Material and methods The study design was a r and omized clinical trial conducted on 51 elderly women ( > 60 years ) with UUI . All were treated with 12 weeks of bladder retraining and pelvic floor muscle exercises , and 25 were r and omly selected to receive TTNS in addition to the st and ard therapy . The cases were evaluated at the baseline and after the end of therapy by 3-day bladder diary , quality of life question naires ( QoL ) , and subjective response . Results Of the patients , 68.0 % in TTNS group reported cure or improvement vs. 34.6 % in the control group ( P = 0.017 ) . TTNS showed significant improvement in most areas of QoL and in UUI parameters when compared with the control group . Conclusion TTNS is efficacious to treat UUI in older women",
"CONTEXT Pelvic floor electrical stimulation ( PFES ) has been shown to be effective for stress incontinence . However , its role in a multicomponent behavioral training program has not been defined . OBJECTIVE To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence . DESIGN AND SETTING Prospect i ve r and omized controlled trial conducted from October 1 , 1995 , through May 1 , 2001 , at a university-based outpatient continence clinic in the United States . PATIENTS Volunteer sample of 200 ambulatory , nondemented , community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern ; stratified by race , type of incontinence ( stress only vs mixed ) , and severity ( frequency of episodes ) . INTERVENTIONS Patients were r and omly assigned to 8 weeks ( 4 visits ) of behavioral training , 8 weeks ( 4 visits ) of the behavioral training plus home PFES , or 8 weeks of self-administered behavioral treatment using a self-help booklet ( control condition ) . MAIN OUTCOME MEASURES Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries . Secondary outcomes were patient satisfaction and changes in quality of life . RESULTS Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6 % with behavioral training , 71.9 % with behavioral training plus PFES , and 52.5 % with the self-help booklet ( P = .005 ) . In comparison with the self-help booklet , behavioral training ( P = .02 ) and behavioral training plus PFES ( P = .002 ) were significantly more effective , but they were not significantly different from each other ( P = .60 ) . The PFES group had significantly better patient self-perception of outcome ( P satisfaction with progress ( P = .02 ) . Significant improvements were seen across all 3 groups on the Incontinence Impact Question naire but with no between-group differences . CONCLUSIONS Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence . A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs",
"We evaluated overactive bladder ( OAB ) symptoms and sexual and emotional health in sexually active women with OAB/urgency urinary incontinence ( UUI ) treated with tolterodine extended release ( ER ) . Sexually active women with OAB symptoms were r and omized to placebo or tolterodine ER . Five-day bladder diaries , Sexual Quality of Life Question naire — Female ( SQOL-F ) , Pelvic Organ Prolapse/Urinary Incontinence Sexual Question naire ( PISQ ) , and Hospital Anxiety and Depression Scale ( HAD ) were completed at baseline and week 12 . Tolterodine ER ( n = 201 ; mean ± SD age , 49 ± 12 years ) reduced UUI episodes ( P = 0.0029 ) , total ( P = 0.0006 ) and OAB ( P ( P = 0.0024 ) , and was associated with improvements in SQOL-F ( P = 0.004 ) , PISQ total ( P = 0.009 ) , and HAD Anxiety ( P = 0.03 ) scores versus placebo ( n = 210 ; mean ± SD age , 47 ± 12 years ) . OAB symptoms improved with tolterodine ER as did the scores of sexual health and anxiety measures in sexually active women with OAB",
"OBJECTIVE To evaluate the effect of a low‐intensity behavioral therapy program on urinary incontinence in older women . METHODS A r and omized clinical trial for community‐dwelling women at least 55 years reporting at least one urinary incontinent episode per week was conducted . Women were r and omly assigned to a behavioral therapy group ( n = 77 ) or a control group ( n = 75 ) . The treatment group had six weekly instructional sessions on bladder training and followed individualized voiding schedules . The control group received no instruction but kept urinary diaries for 6 weeks . After this period , the control group underwent the behavioral therapy protocol . Using per‐ protocol analyses , t and χ2 tests were used to compare the treatment and control groups , and paired t tests were used to evaluate the efficacy of behavioral therapy for all women ( treatment and control groups before and after behavioral therapy ) . RESULTS Women in the treatment group experienced a 50 % reduction in mean number of incontinent episodes recorded on a 7‐day urinary diary compared with a 15 % reduction for controls ( P = .001 ) . After behavioral therapy , all women had a 40 % decrease in mean weekly incontinent episodes ( P = .001 ) , which was maintained over 6 months ( P improved ( dry ) , 40 ( 41 % ) were at least 75 % improved , and 50 ( 52 % ) at least 50 % improved . There were no differences in treatment efficacy by type of incontinence ( stress , urge , mixed ) or group assignment ( treatment , control ) . CONCLUSION A low‐intensity behavioral therapy intervention for urinary incontinence was effective and should be considered as a first‐line treatment for urinary incontinence in older women",
"PURPOSE We evaluated the efficacy and safety of a once monthly oxybutynin vaginal ring in women with overactive bladder . MATERIAL S AND METHODS This r and omized , multicenter , double-blind , 12-week phase 2 study compared oxybutynin vaginal ring ( 4 or 6 mg daily ) to a placebo vaginal ring in women with well-defined overactive bladder symptoms . The primary efficacy variable was the change from baseline to week 12 in the total weekly number of incontinence episodes ( stress and urge ) . Safety was measured in terms of treatment emergent adverse events , laboratory , physical , gynecologic examinations , electrocardiogram and vital signs . RESULTS After a 3-week post-r and omization placebo run-in phase ( sample size 720 ) 445 women entered the treatment phase ( safety population ) . Of these women 323 met all 3 overactive bladder specific baseline characteristics of 10 or more urinary urge incontinence episodes weekly , urinary frequency 8 or more voids per 24 hours and voided volume 3 L or less per 24 hours ) ( analysis population ) . Women treated with 4 and 6 mg daily oxybutynin vaginal ring had significantly fewer incontinence episodes weekly ( p = 0.036 and p = 0.018 , respectively ) , lower daily urinary frequency ( p = 0.014 , p = 0.002 ) and a higher proportion had no incontinence episodes at week 12 ( p = 0.026 , p = 0.027 ) compared with placebo . The change in severity of urgency and voided volume was similar for all groups ( p > 0.05 ) . Except for a higher incidence of dry mouth and urinary tract infections that were not always culture confirmed , the oxybutynin vaginal ring was well tolerated and had a safety profile similar to that of the placebo vaginal ring . CONCLUSIONS The oxybutynin vaginal ring appears to be an effective and safe once monthly treatment option for women with overactive bladder characterized primarily by urinary urge incontinence that merits further evaluation in a phase 3 study",
"OBJECTIVE To determine the efficacy of intradetrusor injections of botulinum toxin A for non-neurogenic urinary urge incontinence . METHODS We conducted a six-month , r and omized , double-blind controlled trial involving women with urinary urge incontinence . Participants received intradetrusor injections of either botulinum toxin ( 100U in 10 mL ) via cystoscopy or a placebo control ( saline injection ) . The primary outcome was maximum bladder capacity at cystoscopy . Secondary outcomes included quality -of-life measures , 24-hour leakage rate , patients ' subjective assessment , and safety data . RESULTS There were 21 participants : 11 in the botulinum toxin ( treated ) group and 10 in the placebo ( control ) group . There were no significant differences between the groups at baseline . After six months the mean maximum bladder capacity at cystoscopy was 161.6 mL greater in the treated group than in the control group ( P = 0.018 ) . There were no differences in diary data or quality -of-life measures . The 24-hour pad test ( a measure of leakage ) after three months showed significant improvement in the treated group ( difference 272.12 g , P = 0.016 ) ; treated subjects also showed subjective benefit at three months ( difference 1.29 , P = 0.007 ) and at six months ( difference 1.16 , P = 0.01 ) . There was no significant difference in rates of urinary tract infection between groups . There was one serious adverse event ( a perioperative cardiac event ) in the botulinum toxin group . CONCLUSION Botulinum toxin increased bladder capacity at cystoscopy and reduced urinary incontinence on 24-hour pad testing in adult females with urinary urge incontinence . There was one adverse event in the group treated with botulinum toxin",
"The efficacy of bladder training was evaluated in a r and omized clinical trial involving 123 noninstitutionalized women 55 years and older with urinary incontinence . Subjects were urodynamically categorized as those with urethral sphincteric incompetence ( N = 88 ) and those with detrusor instability with or without concomitant sphincteric incompetence ( N = 35 ) . Bladder training reduced the number of incontinent episodes by 57 % ; the effect was similar for both urodynamic diagnostic groups . The quantity of fluid loss was reduced by 54 % . This was greater for patients with detrusor instability than for those without it . Diurnal and nocturnal voluntary micturitions were also reduced . The effect on nocturnal micturition , however , was not observed in subjects with unstable detrusor function . It is recommended that bladder training be considered as an initial step in treatment of women with urinary incontinence . Provided prior comprehensive clinical evaluation is done , it can be prescribed without the need for urodynamic characterization",
"PURPOSE In this clinical trial we evaluated the efficacy , safety and tolerability of a novel pressure attenuation device for the reduction or elimination of female stress urinary incontinence using a prospect i ve , r and omized , single-blind , multicenter design . MATERIAL S AND METHODS A total of 166 female patients with stress urinary incontinence were r and omized 2:1 to treatment with an intravesical pressure attenuation device ( 112 ) or sham procedure ( 54 ) . In the treatment arm the device was replaced every 90 days and in the sham arm device replacement was simulated every 90 days . The primary outcome measure was Stamey score improvement of 1 or more at 6 months . An additional outcome measure evaluated at 6 months was a composite score combining data from a provocative pad test and patient impression of symptom improvement . RESULTS In the treatment arm 40.9 % of women achieved the primary end point , compared to only 22.4 % in the sham arm ( p=0.046 in per protocol analysis ) . In an intent to treat analysis , 28.6 % of women in the treatment arm reached the primary end point vs 22.2 % of women in the sham arm ( p=0.455 ) . 50.8 % of women in the treatment arm reached the composite end point compared to 16.3 % of women in the control arm ( p total daily leakage events after 6 months from 4.4 per day to 2.5 per day ( 43.2 % ) in the treatment group vs 5.4 per day to 4.1 per day ( 24.1 % reduction ) in the control group ( p intravesical pressure attenuation device was safe and effective when evaluated by a composite end point . For those patients that can tolerate the device , the concept of pressure attenuation as a therapy for stress urinary incontinence is valid and feasible . Further modifications are anticipated for this device potentially result ing in improved outcomes",
"Twenty-nine postmenopausal women with slight to severe stress urinary incontinence and estrogen deficiency symptoms in the urogenital tract were treated with estriol , p.o . 4 mg once daily , and either phenylpropanolamine ( PPA ) , p.o . 50 mg twice daily , or placebo for periods of 6 weeks according to a r and omized double-blind crossover schedule . At urodynamic recordings the maximum urethral closure pressure increased by 22 % with combined treatment ( p less than 0.001 ) and an additional effect of PPA to estriol was shown ( p = 0.022 ) . The pressure transmission ratio increased , by about 15 % , with both treatments ( p less than 0.07 ) . The number of leakage episodes was reduced by 28 % with combined treatment ( p = 0.007 ) , but not with estriol alone ( p = 0.08 ) . Both combined treatment and estriol alone reduced significantly ( p less than 0.01 ) the urinary incontinence complaints . Twelve women ( 43 % ) preferred combined treatment , while 7 ( 25 % ) preferred estriol alone . In women with initially slight to very severe urine loss , combined treatment reduced also ( p = 0.02 ) the amount of urine loss , measured at a st and ardized physical stress test . Signs of estrogen deficiency in vulva , vagina and urethra were reduced , 75 % ( p less than 0.001 ) or 65 % ( p = 0.001 ) with estriol given in combination with PPA or alone . Maturation index of both urethral and vaginal epithelium displayed significant changes . It is concluded that the combined treatment , PPA + estriol , by affecting both the muscular and mucosal factor of the urethra , is more effective than estriol alone for treatment of female stress urinary incontinence in the postmenopausal ages",
"Importance Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence ( SUI ) , but evidence is limited . Objective To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI . Design , Setting , and Participants Multicenter , r and omized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015 , with data collection completed in December 2015 . Interventions Participants were r and omly assigned ( 1:1 ) to receive 18 sessions ( over 6 weeks ) of electroacupuncture involving the lumbosacral region ( n = 252 ) or sham electroacupuncture ( n = 252 ) with no skin penetration on sham acupoints . Main Outcomes and Measures The primary outcome was change from baseline to week 6 in the amount of urine leakage , measured by the 1-hour pad test . Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary ( 72-hour incontinence episodes ) . Results Among the 504 r and omized participants ( mean [ SD ] age , 55.3 [ 8.4 ] years ) , 482 completed the study . Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group . Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group . At week 6 , the electroacupuncture group had greater decrease in mean urine leakage ( −9.9 g ) than the sham electroacupuncture group ( −2.6 g ) with a mean difference of 7.4 g ( 95 % CI , 4.8 to 10.0 ; P in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 ( 95 % CI , 0.2 - 1.7 ; P = .01 ) , 2.0 episodes in weeks 15 to 18 ( 95 % CI , 1.3 - 2.7 ; P - 2.8 ; P . The incidence of treatment-related adverse events was 1.6 % in the electroacupuncture group and 2.0 % in the sham electroacupuncture group , and all events were classified as mild . Conclusions and Relevance Among women with stress urinary incontinence , treatment with electroacupuncture involving the lumbosacral region , compared with sham electroacupuncture , result ed in less urine leakage after 6 weeks . Further research is needed to underst and long-term efficacy and the mechanism of action of this intervention . Trial Registration clinical trials.gov Identifier : NCT01784172",
"The aim of the r and omised , double blind , placebo controlled study was to evaluate the efficacy , tolerability and safety of solifenacin , a once-daily M3 selective receptor antagonist , in patients with overactive bladder syndrome . Following a single blind 2-week placebo run in period , patients who complained from symptoms of OAB for at least 6 months , were r and omized to 4 weeks of solifenacin in 5 mg once daily doses or placebo . 171 patients were enrolled in the study and 157 patients completed the study . Patients with solifenacin had significantly improved micturitions per 24 hours after first week of treatment ( 1.75 + /- 0.63 vs. 2.64 + /- 0.48 , p mean number of urgency episodes per 24 hours had significantly decreased in patients with solifenacin compared to placebo after first week ( 5.75 + /- 1.43 vs. 6.65 + /- 0.65 , p Solifenacin was also significantly more effective than placebo in reducing the mean number of episodes of severe urgency from baseline to end point ( 5.83 + /- 1.16 vs. 6.48 + /- 0.50 , p placebo , episodes of urinary frequency were significanlty reduced after first week ( 0.3 vs. -0.5 , p solifenacin ( 0.19 vs. -0.15 , p Episodes of nocturia was significantly reduced in patients treated with solifenacin after first week ( 0.3 vs. -0.5 , p number of incontinence episodes was also significantly decreased in solifenacin group compared to placebo group after first week ( 1.06 + /- 0.57 vs. 2.74 + /- 0.47 , p adverse effects with solifenacin were dry mouth and constipation . Adverse effects were mild or moderate severity . The discontinuation rate owing to adverse effects was 4.5%-6.7 % with solifenacin and 3.8%-6.1 % with placebo , respectively . According to subjective estimation , significant improvement was achieved in 71 ( 92.21 % ) of patients treated with solifenacin and in 68 ( 85 % ) patients treated with placebo there was no change in OAB symptoms compared to baseline values . UDI score was significantly improved after solifenacin ( 22.26 + /- 5.91 vs. 29.61 + /- 8.45 , p IIQ score was significantly decreased in patients with solifenacin ( 36.25 + /- 10.34 vs. 46.86 + /- 6.81 , p solifenacin is a safe and effective treatment alternative for patients with overactive bladder symptoms",
"Abstract Objective : To evaluate short- and long-term safety and efficacy of duloxetine in women with predominant stress urinary incontinence ( SUI ) . Research design and methods : The study was a 6-week , double-blind , r and omised , parallel , placebo-controlled study followed by an uncontrolled open-label extension ( OLE ) run in 342 study centres in 16 European countries . Women with predominant SUI were r and omly assigned to placebo ( n = 1380 ) or duloxetine 40 mg twice daily ( n = 1378 ) for 6 weeks . Completers of the acute phase were enrolled in the OLE , which had a minimum duration of 6 weeks and ended , based on the approval status of duloxetine in the participating country . Clinical Trial Registry : www . clinical trials.gov ; NCT00190996 . Main outcome measures : The primary outcome measure was the change in incontinence episode frequency ( IEF ) over 6 weeks . Secondary outcome measures were the long-term maintenance of effect on IEF and Patient Global Impression of Improvement ( PGI-I ) , the short- and long-term impact on quality of life using the King ’s Health Question naire ( KHQ ) , and the long-term safety of duloxetine . Results : After 6 weeks , the decrease in weekly IEF was significantly greater with duloxetine treatment compared to placebo ( −50.0 vs. −29.9 % ; p decrease in IEF ) was significantly higher with duloxetine treatment than with placebo ( 50.6 vs. 31.2 % ; p ) . Duloxetine treatment was associated with improvements in weekly pad use ( −31.4 % ) , PGI-I ratings ( 63.6 % ) , and KHQ score ( −6.25 ) compared to placebo ( −12.5 % , 48.5 % and −3.13 , respectively , all p events were significantly more common during duloxetine treatment ( 48.3 % ) than placebo ( 33.3 % ) , ( p 2290 patients continuing into the OLE , 1165 ( 42.2 % ) completed the available duration , and 592 ( 21.5 % ) discontinued because of an adverse event ( percentages relative to total r and omised patients ) . Long-term efficacy in the OLE was assessed over a 72-week period and was maintained over that time . However , the results should be interpreted within the context that better responding patients are more likely to remain on duloxetine , while patients responding poorly are more likely to discontinue over time . Conclusions : Duloxetine seems to be an efficacious treatment with an acceptable safety profile for women with SUI . Achieved improvement is maintained over the longer term in those women who remain on therapy",
"Oxybutynin hydrochloride ( 3 mg ) was compared with placebo by r and omised , double-blind crossover trial in 53 females with idiopathic detrusor instability . Symptoms were cured or markedly improved in 60 % of patients on oxybutynin and 2.3 % on placebo . During the first treatment period , oxybutynin reduced the frequency of voiding by 35 % , compared with 9 % for placebo . Oxybutynin gave a significantly greater improvement than placebo in volume at the first desire to void ( 70 ml increase versus 7.7 ml ) , maximum filling-phase detrusor pressure ( 17 cm H2O reduction versus no benefit ) and cystometric capacity ( 104 ml increase versus 7.0 ml ) . A marked oxybutynin carry-over effect was seen during the second treatment period . Side effects from the 3 mg dose of oxybutynin caused 7.5 % of subjects to discontinue therapy",
"Objectives The primary objective of this cluster r and omised controlled trial was to compare the effectiveness of the three experimental continence promotion interventions against a control intervention on urinary symptom improvement in older women with untreated incontinence recruited from community organisations . A second objective was to determine whether changes in incontinence-related knowledge and new uptake of risk-modifying behaviours explain these improvements . Setting 71 community organisations across the UK . Participants 259 women aged 60 years and older with untreated incontinence entered the trial ; 88 % completed the 3-month follow-up . Interventions The three active interventions consisted of a single 60 min group workshop on ( 1 ) continence education ( 20 clusters , 64 women ) ; ( 2 ) evidence -based self-management ( 17 clusters , 70 women ) ; or ( 3 ) combined continence education and self-management ( 17 clusters , 61 women ) . The control intervention was a single 60 min educational group workshop on memory loss , polypharmacy and osteoporosis ( 17 clusters , 64 women ) . Primary and secondary outcome measures The primary outcome was self-reported improvement in incontinence 3 months postintervention at the level of the individual . The secondary outcome was change in the International Consultation on Incontinence Question naire ( ICIQ ) from baseline to 3-month follow-up . Changes in incontinence-related knowledge and behaviours were also assessed . Results The highest rate of urinary symptom improvement occurred in the combined intervention group ( 66 % vs 11 % of the control group , prevalence difference 55 % , 95 % CI 43 % to 67 % , intracluster correlation 0 ) . 30 % versus 6 % of participants reported significant improvement respectively ( prevalence difference 23 % , 95 % CI 10 % to 36 % , intracluster correlation 0 ) . The number-needed-to-treat was 2 to achieve any improvement in incontinence symptoms , and 5 to attain significant improvement . Compared to controls , participants in the combined intervention reported an adjusted mean 2.05 point ( 95 % CI 0.87 to 3.24 ) greater improvement on the ICIQ from baseline to 3-month follow-up . Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of improvement in all intervention arms . Conclusions Continence education combined with evidence -based self-management improves symptoms of incontinence among untreated older women . Community organisations represent an untapped vector for delivering effective continence promotion interventions . Trial registration Clinical Trials.gov ID number NCT01239836",
"PURPOSE To compare the effectiveness of pelvic floor exercises , electrical stimulation , vaginal cones , and no active treatment in women with urodynamic stress urinary incontinence . PATIENTS AND METHODS One hundred eighteen subjects were r and omly selected to recieve pelvic floor exercises ( n=31 ) , ES ( n=30 ) , vaginal cones ( n=27 ) , or no treatment ( untreated control ) ( n=30 ) . Women were evaluated before and after completion of six months of treatment by the pad test , quality of life question naire ( I-QOL ) , urodynamic test , voiding diary , and subjective response . RESULTS In the objective evaluation , we observed a statistically significant reduction in the pad test ( p=0.003 ) , in the number of stress urinary episodes ( p quality of life ( p pelvic floor exercises , electrical stimulation , and vaginal cones compared to the control group . No significant difference was found between groups in the urodynamic parameters . In the subjective evaluation , 58 % , 55 % , and 54 % of women who had used pelvic floor exercises , electrical stimulation , and vaginal cones , respectively , reported being satisfied after treatment . In the control group , only 21 % patients were satisfied with the treatment . CONCLUSION Based on this study , pelvic floor exercises , electrical stimulation , and vaginal cones are equally effective treatments and are far superior to no treatment in women with urodynamic stress urinary incontinence",
"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 : Despite significant differences in success rates between surgical and nonsurgical treatments for female stress urinary incontinence , a few cross‐sectional surveys showed that most patients still prefer the latter . We evaluated the efficacy of the under studied nonsurgical treatment using pulsed magnetic stimulation for female stress urinary incontinence . Material s and Methods : This r and omized , double‐blind , sham controlled study was performed in 120 female subjects at least 21 years old with stress urinary incontinence . Treatment involved pulsed magnetic stimulation for 2 sessions per week for 2 months ( 16 sessions ) . After 2 months , subjects could opt for 16 additional sessions regardless of initial r and omization . The primary response criterion was a 5‐point reduction in the ICIQ‐UI SF ( International Consultation on Incontinence Question naire for Urinary Incontinence‐Short Form ) score . Key secondary response criteria included objective and subjective cure , supplemented by other secondary criteria . Followups were performed at months 1 , 2 , 5 , 8 and 14 . Results : At 2 months 45 of 60 subjects ( 75 % ) in the active arm vs 13 of 60 ( 21.7 % ) in the sham arm were treatment responders ( p additional active pulsed magnetic stimulation . At 14 months , subjects who received 32 sessions of active pulsed magnetic stimulation had the highest percentage of treatment responders ( 18 of 24 or 75.0 % ) , followed by those who received 16 sessions ( 26 of 36 or 72.2 % and 28 of 41 or 68.3 % ) and those who did not receive any active pulsed magnetic stimulation ( 4 of 19 or 21.1 % ) ( p that pulsed magnetic stimulation is an attractive nonsurgical alternative for patients who do not want to undergo surgery",
"PURPOSE We tested whether individualized drug therapy enhanced with behavioral training would result in better outcomes than individualized drug therapy alone . MATERIAL S AND METHODS Participants were community dwelling women with urge predominant incontinence . Using a r and omized clinical trial design women were r and omized to 8 weeks ( 4 visits ) of drug therapy alone ( 32 ) or drug therapy plus behavioral training ( 32 ) . Drug therapy was individually titrated , extended release oxybutynin with proactive management of side effects . Behavioral training included pelvic floor muscle training and urge suppression techniques . The primary outcome measure was reduction in frequency of incontinence episodes on bladder diary at 8 weeks ( with followup at 6 and 12 months ) . Secondary outcomes included patient satisfaction , global perception of improvement , Urogenital Distress Inventory and Incontinence Impact Question naire . RESULTS In intent to treat analysis frequency of incontinence was reduced a mean of 88.5 % in the drug alone group and 78.3 % in the combined therapy group ( p = 0.16 ) . Outcomes were not significantly different between the groups in the analysis of completers ( 91.5 % vs 86.2 % , p = 0.34 ) , or in either analysis at 6 or 12 months . The groups also did not differ significantly on secondary outcomes at any point . Participants in the drug alone group tended to be taking higher doses of oxybutynin at 8 weeks but the final dose did not differ significantly between the groups . Based on a conditional power calculation the trial was stopped early for futility . CONCLUSIONS When drug therapy is implemented with frequent individualized dose titration , daily bladder diaries and careful management of side effects , initiating concurrent behavioral training does not enhance outcomes for urge incontinence in women",
"OBJECTIVES We previously reported high rates of urinary incontinence among gynecologic cancer survivors and aim ed to evaluate the effectiveness of a simple intervention for treatment of urinary incontinence in this population . METHODS We recruited 40 gynecologic cancer survivors who reported urinary incontinence on a vali date d question naire . Women were r and omized to either pelvic floor muscle training/behavioral therapy ( treatment group ) or usual care ( control group ) . The primary outcome measure , assessed at 12 weeks post intervention , was a 40 % difference in the vali date d Patient Global Impression of Improvement ( PGI-I ) score . Fisher 's exact test was used to identify differences between groups for frequency data ; two- sample t-test was conducted for continuous measurements . RESULTS Mean age of this cohort was 57 ( range : 37 - 79 ) . The majority of the survivors had uterine cancer ( 60 % ) , 18 % had received radiation therapy , 95 % had received surgical therapy , and 35 % had received chemotherapy . At three months , 80 % of the treatment and 40 % of the control group reported that their urinary incontinence was \" much better \" or \" very much better \" as evaluated by the Patient Global Impression of Improvement scale ( p=0.02 ) . Brink 's scores were significantly improved in the treatment group as compared to those of the controls ( p adherence was high ; the treatment group performed exercises with an average of 22 days/month . CONCLUSIONS Urinary incontinence negatively affects quality of life , and despite a high prevalence among gynecologic cancer survivors , it is often under-assessed and undertreated . We found a simple intervention that included pelvic floor muscle training and behavioral therapy , which significantly improved cancer survivor 's urinary incontinence",
"Objectives To assess the efficacy of an oestradiol‐releasing vaginal ring and oestriol pessaries in the alleviation of lower urinary tract symptoms occurring after the menopause",
"Many women in Japan have lived with urinary incontinence ( UI ) . These women are not willing to visit the hospital with their problem of incontinence . Even if the women consent to a hospital visit , continence education is often very limited and patients may immediately stop looking for further treatment . Programs of effective education are needed . The Continence Efficacy Intervention Program ( CEIP ) was developed for patients and was design ed to circumvent many of the obstacles common to stopping exercise . In this study , a r and omized trial was conducted to compare the effectiveness of this program to conventional intervention on exercise continuity . This report describes the study design , intervention program , and outcomes . Subjects were 48 women with stress urinary incontinence ( SUI ) : the mean age was 53.5 , the mean weight was 56.6 kg , and the average prevalent year was 6.5 years . The CEIP phone interviews improved exercise continuity and urine loss symptom . Findings suggest that this intervention program is effective and readily available to the community-residing women with SUI",
"The aim of this study was to assess the usefulness of pelvic floor exercises in the treatment of urinary incontinence in women and to analyse the factors which determine a successful outcome . The study involved 66 women who had reported ' genuine stress incontinence ' to their general practitioner . They were assigned at r and om to the treatment or control group . The treatment group received instructions in pelvic floor exercises from a general practitioner . The control group received no therapy . At the start of the trial the severity of the patients ' incontinence was assessed objective ly . This assessment was repeated after three months and patients were also asked for their own perception of whether their incontinence had improved . After the three months ' evaluation the patients in the control group were also given instructions in pelvic floor exercises . After another three months they were assessed in the same way . About 60 % of the patients in the treatment group were dry or mildly incontinent after three months compared with only one patient in the control group ; the mean weekly frequency of incontinence episodes fell from 17 to five in the treatment group but remained virtually unchanged in the control group ; and about 85 % of the women in the treatment group felt that their incontinence had improved or was cured compared with no one in the control group . These results were later corroborated by those for the control group . The most important factor in the success of the treatment was the patients ' motivation , as demonstrated by their adherence to the daily exercises . ( ABSTRACT TRUNCATED AT 250 WORDS",
"This study was a r and omized controlled trial to investigate the effect of treating women with stress or mixed urinary incontinence ( SUI or MUI ) by diaphragmatic , deep abdominal and pelvic floor muscle ( PFM ) retraining . Seventy women were r and omly allocated to the training ( n = 35 ) or control group ( n = 35 ) . Women in the training group received 8 individual clinical visits and followed a specific exercise program . Women in the control group performed self-monitored PFM exercises at home . The primary outcome measure was self-reported improvement . Secondary outcome measures were 20-min pad test , 3-day voiding diary , maximal vaginal squeeze pressure , holding time and quality of life . After a 4-month intervention period , more participants in the training group reported that they were cured or improved ( p cure/improved rate was above 90 % . Both amount of leakage and number of leaks were significantly lower in the training group ( p quality of life improved significantly in the training group than in the control group . Maximal vaginal squeeze pressure , however , decreased slightly in both groups . Coordinated retraining diaphragmatic , deep abdominal and PFM function could improve symptoms and quality of life . It may be an alternative management for women with SUI or MUI",
"Background This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI . Methods Taiwanese women with SUI were were r and omly assigned to placebo ( n = 61 ) or duloxetine 80 mg/day ( n = 60 ) in this double-blind , 8-week , placebo-controlled study . Outcome variables included : incontinence episode frequency ( IEF ) , Incontinence Quality of Life question naire ( I-QOL ) scores , and Patient Global Impression of Improvement rating ( PGI-I ) . Results Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women ( 69.98 % vs 42.56 % , P I-QOL scores were significant . There were significant differences in PGI-I rating . Treatment-emergent adverse events ( TEAEs ) were experienced by more duloxetine-treated than placebo-treated women ( 80.0 % vs 44.3 % ; P Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women ( 26.7 % vs 6.6 % ; P = .003 ) . Conclusion Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.Trial Registration Clinical Trials.gov Identifier :",
"Abstract Objective : To compare the effect of pelvic floor exercises , electrical stimulation , vaginal cones , and no treatment for genuine stress incontinence . Design : Stratified , single blind , r and omised controlled trial . Setting : Multicentre . Participants : 107 women with clinical ly and urodynamically proved genuine stress incontinence . Mean ( range ) age was 49.5 ( 24 - 70 ) years , and mean ( range ) duration of symptoms 10.8 ( 1 - 45 ) years . Interventions : Pelvic floor exercise ( n=25 ) comprised 8 - 12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week . The electrical stimulation group ( n=25 ) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day . The vaginal cones group ( n=27 ) used cones for 20 minutes a day . The untreated control group ( n=30 ) was offered the use of a continence guard . Muscle strength was measured by vaginal squeeze pressure once a month . Main outcome measures : Pad test with st and ardised bladder volume , and self report of severity . Results : Improvement in muscle strength was significantly greater ( P=0.03 ) after pelvic floor exercises ( 11.0 cm H2O ( 95 % confidence interval 7.7 to 14.3 ) before v 19.2 cm H2O ( 15.3 to 23.1 ) after ) than either electrical stimulation ( 14.8 cm H2O ( 10.9 to 18.7 ) v 18.6 cm H2O ( 13.3 to 23.9 ) ) or vaginal cones ( 11.8 cm H2O ( 8.5 to 15.1 ) v 15.4 cm H2O ( 11.1 to 19.7 ) ) . Reduction in leakage on pad test was greater in the exercise group ( −30.2 g ; −43.3 to 16.9 ) than in the electrical stimulation group ( −7.4 g ; −20.9 to 6.1 ) and the vaginal cones group ( −14.7 g ; −27.6 to −1.8 ) . On completion of the trial one participant in the control group , 14 in the pelvic floor exercise group , three in the electrical stimulation group , and two in the vaginal cones group no longer considered themselves as having a problem . Conclusion : Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence",
"PURPOSE We design ed an investigational study and placebo controlled trial to evaluate the potential efficacy of magnetic stimulation of the sacral roots for the treatment of stress incontinence . MATERIAL S AND METHODS A total of 75 patients with stress incontinence were studied . A 15 Hz . repetitive magnetic stimulation of the sacral roots with 50 % intensity output and duration of 5 seconds per minute was applied for 30 minutes . Urodynamic investigations under magnetic stimulation were performed in 13 patients to evaluate acute effects to lower urinary tract function . There were 62 women ( mean age 58 years ) enrolled in a placebo controlled study to investigate the short-term efficacy of magnetic stimulation . The number of leaks for 3 days , amount of urine loss on a pad test and quality of life score were evaluated before and 1 week after stimulation . RESULTS The urodynamic investigations revealed an apparent elevation of urethral closure pressure induced by stimulation ( mean 8.2 + /- 3.0 cm H2O , p = 0.0000004 ) and a significant increase in bladder capacity after stimulation ( mean 40.0 + /- 51.0 ml . , p = 0.0152 ) . In the placebo controlled study the number of leaks and amount of urine loss on a pad test significantly decreased more in the active than in the sham stimulation group ( p = 0.0023 and 0.0377 , respectively ) . The quality of life score significantly improved in the active stimulation group ( p = 0.0006 ) in contrast to no significant improvement in the sham stimulation group . The improvement rate in the active stimulation group was 74 % , which was significantly higher than the 32 % in the sham stimulation group ( p = 0.0009 ) . No adverse effects were noted in any patients . CONCLUSIONS These results suggest that magnetic stimulation of the sacral roots may be useful for the treatment of stress incontinence . Further studies are needed to evaluate the long-term efficacy of this potential treatment",
"To further assess , in a phase 3 study , treatment with duloxetine for women with stress urinary incontinence ( SUI ) in other geographical regions , including Argentina , Australia , Brazil , Finl and , Pol and , South Africa and Spain , as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women",
"Introduction and hypothesisWe assessed fesoterodine efficacy and tolerability in women with overactive bladder ( OAB ) . Methods This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB r and omized to placebo , fesoterodine 4 or 8 mg , or tolterodine extended release ( ER ) 4 mg ( in 1 trial ) for 12 weeks . Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12 . Results By weeks 2 and 12 , all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo . Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week . The most common adverse events were dry mouth and constipation , which were predominately mild or moderate . Conclusions Fesoterodine is efficacious and well tolerated in women with OAB",
"Purpose To assess the effects of the combination of pelvic floor rehabilitation and intravaginal estriol administration on stress urinary incontinence ( SUI ) , urogenital atrophy and recurrent urinary tract infections in postmenopausal women . Methods Two-hundred-six postmenopausal women with urogenital aging symptoms were enrolled in this prospect i ve r and omized controlled study . Patients were r and omly divided into two groups and each group consisted of 103 women . Subjects in the treatment group received intravaginal estriol ovules , such as 1 ovule ( 1 mg ) once daily for 2 weeks and then 2 ovules once weekly for a total of 6 months as maintenance therapy plus pelvic floor rehabilitation . Subjects in the control group received only intravaginal estriol in a similar regimen . We evaluated urogenital symptomatology , urine cultures , colposcopic findings , urethral cytologic findings , urethral pressure profiles and urethrocystometry before , as well as after 6 months of treatment . Results After therapy , the symptoms and signs of urogenital atrophy significantly improved in both groups . 61/83 ( 73.49 % ) of the treated patients , and only 10/103 ( 9.71 % ) of the control patients referred a subjective improvement of their incontinence . In the patients treated by combination therapy with estriol plus pelvic floor rehabilitation , we observed significant improvements of colposcopic findings , and there were statistically significant increases in mean maximum urethral pressure ( MUP ) , in mean urethral closure pressure ( MUCP ) , as well as in the abdominal pressure transmission ratio to the proximal urethra ( PTR ) . Conclusions Our results showed that combination therapy with estriol plus pelvic floor rehabilitation was effective and should be considered as a first-line treatment for symptoms of urogenital aging in postmenopausal women",
"PURPOSE We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence . MATERIAL S AND METHODS This institutional review board approved , multicenter registered trial r and omized women with refractory urge incontinence , detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio . Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence . The primary outcome measure was time to failure , as evidence d by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection , or changes in treatment ( initiation or increase ) at any time after injection . Safety data , including increased post-void residual volume , defined as more than 200 ml irrespective of symptoms , was obtained at specified time points . RESULTS Approximately 60 % of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement . The median duration of their responses was 373 days , significantly longer than the 62 days or less for placebo ( p botulinum toxin A group increased post-void residual urine ( 12 of 28 women or 43 % ) and urinary tract infection in those with increased post-void residual urine ( 9 of 12 or 75 % ) exceeded expected ranges . Further injections were stopped after 43 patients were r and omized , including 28 to botulinum toxin A and 15 to placebo . CONCLUSIONS Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder . However , a transient post-void residual urine increase was experienced in 43 % of patients . Botulinum toxin A for idiopathic overactive bladder is still under investigation",
"AIMS To test the None hypothesis that a novel disposable \" tampon like \" electrostimulation device ( Pelviva ( ® ) ) is no better than unsupervised pelvic floor muscle exercise for treatment of urinary incontinence in women . METHODS Pre/post-intervention assessor blinded , single center RCT . A total of 123 community dwelling self referred women with symptoms of stress , urge , or mixed incontinence were r and omly assigned to one of two 12-week duration treatments : Pelviva ( ® ) used for 30 min a day plus unsupervised pelvic floor muscle exercise or unsupervised exercises alone . Outcome measures included ICIQ-UI ( primary ) , ICIQ FLUTSex and global impression of severity and improvement ( secondary ) completed at recruitment , after 4 weeks of unsupervised exercise and immediately post-treatment . Diary of exercise frequency/type , overall impression , and usage of device was completed mid- and post-treatment . RESULTS Pelviva ( ® ) plus exercise produced significantly better outcome than unsupervised exercise alone : 5 points ( 45 % ) versus 1 point ( 10 % ) for ICIQ-UI ( P = 0.014 ) ; 67 % versus 33 % for leak frequency ( P = 0.005 ) ; 40 % versus 20 % for leak interference with life ( P = 0.018 ) . Incontinence was less bothersome during sex to a greater extent in the Pelviva ( ® ) group ( P = 0.026 ) . Women were enthusiastic about the device , found it comfortable/easy to use and experienced no adverse events . CONCLUSIONS The Pelviva ( ® ) device plus unsupervised exercise is more successful than unsupervised pelvic floor muscle exercise alone in treating urinary incontinence . The device is easy/comfortable to use , there are no apparent adverse incidents , and women can manage their incontinence in the privacy of their own home . The product will be launched 2013",
"PURPOSE We evaluated the effectiveness of periurethral autologous fat injection as treatment for female stress urinary incontinence . MATERIAL S AND METHODS Women with stress incontinence were r and omized in a double-blind fashion to receive periurethral injections of autologous fat ( treatment group ) or saline ( placebo group ) . After injection patients were evaluated monthly for 3 months by a vali date d st and ardized incontinence question naire , 1-hour pad test and cough test . Patients who remained incontinent were offered repeat injection using the same initial agent to a maximum of 3 injections . Every 3 months after injection patients were assessed by a st and ardized question naire , pad test , cough test and urodynamics . Those who did not qualify for repeat injection at 3 months were then followed 6 , 9 , 12 , 18 and 24 months or until failure . RESULTS Of the 68 women enrolled 35 received fat and 33 received saline injections . The groups were comparable in terms of baseline parameters . A total of 56 patients completed the study , including 27 in the fat and 29 in the placebo group , for a total of 189 injections ( 91 fat and 98 saline ) . At 3 months 6 of 27 ( 22.2 % ) and 6 of 29 ( 20.7 % ) women were cured or improved in the fat and saline groups , respectively . Complications included cystitis in 9 of 189 injections , urinary retention in 6 in the fat injection group , urge incontinence in 9 of 68 patients and pulmonary fat embolism result ing in death in 1 of 189 procedures . CONCLUSIONS In this study periurethral fat injection did not appear to be more efficacious than placebo for treating stress incontinence",
"Objective To investigate the effect of hormone replacement therapy on post‐menopausal urinary stress incontinence",
"OBJECTIVES To evaluate the effectiveness of pelvic floor muscle ( PFM ) and fitness exercises in reducing urine leakage in elderly women with stress urinary incontinence ( UI ) . DESIGN R and omized , crossover , follow-up trial . SETTING Urban community in Japan . PARTICIPANTS Seventy women aged 70 and older who reported urine leakage one or more times per month ; 35 were r and omly assigned to intervention and the other 35 to control . INTERVENTION The intervention group attended an exercise class aim ed at enhancing PFMs and fitness . Duration of the exercise was 60 minutes per session twice a week for 3 months . After 3 months of exercise , the intervention group was followed for 1 year . MEASUREMENTS Body mass index ( BMI ) , urine leakage , walking speed , and muscle strength were measured at baseline , after the intervention , and at follow-up . RESULTS In the intervention group , maximum walking speed and adductor muscle strength increased significantly after the intervention ; there were no significant changes in the control group . After 3 months of exercise , 54.5 % of the intervention group and 9.4 % of the control group reported being continent . Within the cured group of UI , a significantly higher proportion had decreased their BMI at 3 months ( P=.03 ) and increased walking speed at 3 ( P=.04 ) and 12 ( P=.047 ) months . CONCLUSION Decrease in BMI and increase in walking speed may contribute to the treatment of UI , although the data do not support a positive correlation between strengthening of adductor muscle and improvement of UI , which needs more research",
"OBJECTIVE The purpose of this study was to assess the efficacy and safety of duloxetine , a selective inhibitor of serotonin and norepinephrine reuptake , in the treatment of stress urinary incontinence . STUDY DESIGN A double-blind , r and omized , placebo-controlled study was conducted in 553 women aged 18 to 65 years with a predominant symptom of stress urinary incontinence . Subjects were r and omized to placebo ( n = 138 women ) or duloxetine at one of three doses ( 20 mg/d , n = 138 women ; 40 mg/d , n = 137 women ; or 80 mg/d , n = 140 women ) . Outcome variables that were assessed after 12 weeks of treatment included incontinence episode frequency recorded in a real-time diary and answers provided to the Patient Global Impression of Improvement scale and the Incontinence Quality of Life question naire . RESULTS Duloxetine was associated with significant and dose-dependent decreases in incontinence episode frequency that paralleled improvements that were observed in the Patient Global Impression of Improvement scale and the Incontinence Quality of Life question naire . The median incontinence episode frequency decrease with the use of the pooled diary analysis with placebo was 41 % compared with 54 % for duloxetine 20 mg per day ( P = .06 ) , 59 % for duloxetine 40 mg per day ( P = .002 ) , and 64 % for duloxetine 80 mg per day ( P or = 64 % reduction in incontinence episode frequency ( P or = 50 % reduction ( P = .001 vs placebo ) . These improvements were observed despite significant concurrent dose-dependent increases in the average voiding interval in the duloxetine groups compared with the placebo group . Similar statistically significant improvements were demonstrated in a subgroup of 163 subjects who had more severe stress urinary incontinence ( > or = 14 incontinence episode frequency per week ; 49%-64 % reduction in incontinence episode frequency in the duloxetine groups compared with 30 % in the placebo group ) . Discontinuation rates for adverse events were 5 % for placebo and 9 % , 12 % , and 15 % for duloxetine 20 , 40 , and 80 mg per day , respectively ( P = .04 ) . Nausea was the most common symptom that led to discontinuation . None of the adverse events that were reported were considered to be clinical ly severe . CONCLUSION This trial provides evidence for the efficacy and safety of duloxetine as a pharmacologic agent for the treatment of stress urinary incontinence",
"OBJECTIVES To determine the clinical ly relevant reference points for the Incontinence Quality of Life ( I-QOL ) question naire scores in women with stress urinary incontinence and compare them with the treatment effects observed with duloxetine and placebo . METHODS Using data from 1133 women with predominant stress urinary incontinence in two r and omized , placebo-controlled duloxetine studies , the within-treatment and between-treatment minimal clinical ly important differences ( MCIDs ) were obtained by anchoring the I-QOL scores to the vali date d Patient Global Impression of Improvement scale ( PGI-I ) . The within-treatment MCID ( mean I-QOL for women rating their condition \" a little better \" with treatment ) and between-treatment MCID ( difference in scores between the group ratings of \" no change \" and \" a little better \" ) were derived . The treatment effects were compared with these MCIDs . Real-time urinary diaries were completed , along with the I-QOL and PGI-I. RESULTS The within-treatment and between-treatment MCID for the I-QOL total score was 6.3 and 2.5 , respectively . The total and subscale scores had almost identical MCIDs . Duloxetine 80 mg significantly improved the I-QOL total and subscale scores . Treatment differences in the I-QOL scores exceeded the between-treatment MCID and the duloxetine I-QOL treatment effect exceeded the within-treatment MCID . The number of patients needed to treat to gain an additional I-QOL responder was 6.8 . CONCLUSIONS Improvements in I-QOL scores should be greater than the within-treatment MCID , and differences between two treatments should be greater than the between-treatment MCIDs , for statistically significant differences to be considered clinical ly meaningful . We propose 2.5 points as a reasonable guide for the I-QOL between-treatment MCID and 6.3 points for the within-treatment MCID",
"Clinical efficacy and adverse effects of oxybutynin and propantheline in the treatment of symptoms related to detrusor hyperactivity were studied in a r and omized , controlled , double-blind multicenter trial . Of 169 patients entered into the study 154 were evaluable for statistical analysis . Mean grade of improvement ( visual analogue scale ) was significantly higher with oxybutynin ( 58.2 % ) versus propantheline ( 44.7 % ) and placebo ( 43.4 % ) . Mean bladder volume at first involuntary cystometric contraction was significantly increased with oxybutynin ( + 57.0 ml . ) versus placebo ( -9.7 ml . ) . Mean maximum cystometric bladder capacity was also significantly increased with oxybutynin ( + 80.1 ml . ) versus placebo ( + 22.5 ml . ) . Rate of inquired possible adverse effects was significantly higher for oxybutynin ( 63 % ) versus propantheline ( 44 % ) and placebo ( 33 % ) . However , only 5 patients dropped out of the study because of adverse effects ( oxybutynin 2 and propantheline 3 ) . No serious or lasting adverse effects were encountered with dryness of the mouth being the major complaint . Oxybutynin has statistically significant effects on subjective symptoms and objective urodynamic parameters in patients with detrusor hyperactivity compared to propantheline",
"PURPOSE We determined whether a behavioral modification program ( BMP ) taught to groups of continent older women would decrease the incidence of urinary incontinence , increase pelvic muscle strength and improve voiding control . MATERIAL S AND METHODS We performed a r and omized , controlled trial comparing a BMP treatment group to a control , no treatment group in ambulatory , postmenopausal , continent women ( 0 to 5 days of incontinent episodes in the previous year ) 55 years and older who were followed for 12 months . Qualified volunteers from 4 Michigan counties were r and omly assigned to a control or a treatment group , consisting of a 2-hour classroom presentation on BMP followed 2 to 4 weeks later with individualized evaluation to test knowledge , adherence and skills in behavioral techniques , and brief reinforcement of the technique as needed . Followup was done by telephone and mail every 3 months except month 12 , when all participants underwent final clinical evaluation . Outcome measures were continence status , pelvic floor muscle strength and voiding frequency/intervoid interval . RESULTS A total of 195 control and 164 treated participants completed the study . Baseline data on the 2 groups were not statistically different . At 12 months the treatment group was statistically significantly better than the control group in continence status ( p = 0.01 ) , pelvic muscle strength ( pressure score p = 0.0003 and displacement score p improved voiding frequency ( p intervoid interval ( p BMP for preventing urinary incontinence in older women . It demonstrated feasibility and efficacy in improving continence status , pelvic muscle strength and voiding control as long as a year after treatment",
"Introduction and hypothesisAn intravaginal device ( Uresta ) is currently available for the treatment of stress urinary incontinence ( SUI ) . Case-series data on its effectiveness exist ; however , controlled data are lacking . The objective of this study is to determine the short-term efficacy of the Uresta device using a r and omized placebo controlled trial . The hypothesis is that the Uresta device might significantly reduce urinary loss . Methods A single blind r and omized controlled trial was conducted among women with urodynamic SUI recruited from a single urogynecology unit . Participants were r and omized to receive the Uresta device or a placebo vaginal silastic ring placed high in the vagina for the duration of a pad test . Pad tests were performed before and after device placement . The primary outcome was the achievement of a 50 % or greater reduction in pad weight after device placement , in a comparison of the two groups . Sample size calculation showed a need for 18 subjects per group . Fisher ’s exact test was used to analyze the primary outcome . Research Ethics Board approval was obtained . Results Eighteen subjects per group completed the study protocol . The percentage of patients who achieved the primary outcome was 66.7 % in the Uresta group and 22.2 % in the placebo group ( p = 0.01 ) . The baseline demographic data were similar in the two groups . There were no adverse events during the test period . Conclusions The Uresta intravaginal continence device significantly reduces the short-term objective measures of urine loss due to SUI . Further study to assess subjective outcomes and long-term patient satisfaction is required",
"PURPOSE In this study we determined the efficacy of functional magnetic stimulation ( FMS ) compared to placebo for treating women with mixed urinary incontinence ( MUI ) . MATERIAL S AND METHODS A total of 39 women with MUI were r and omly assigned to the FMS group ( 23 patients ) or to the placebo group ( 16 patients ) . FMS was applied continuously at 18.5 Hz day and night for 2 months . Conventional urodynamic studies were performed before and after stimulation . Outcome measures assessed were clinical ( daytime frequency , nocturia , pad use , pad weight ) and urodynamic variables ( first sensation of bladder filling , maximum cystometric capacity , maximum urethral closure pressure ) , and patient subjective assessment ( visual analogue scale ) . RESULTS After 2 months of FMS significant decreases in voiding frequency ( from 9.0 to 6.7 , p = 0.0002 ) , nocturia ( from 2.6 to 1.4 , p = 0.0007 ) and pad use ( from 3.9 to 2.2 , p = 0.007 ) were observed only in the FMS group . First sensation of bladder filling and maximum cystometric capacity increased significantly after stimulation compared with prestimulation levels only in the FMS group , p = 0.003 ( from 118 to 174 ml ) and p = 0.00004 ( from 267 to 396 ml ) , respectively . A total of 18 women ( 78.3 % ) reported an improvement in symptoms after FMS with an average success rate of 41.9 % . The success rate was significantly lower in the placebo group ( p = 0.021 ) at 22.9 % . CONCLUSIONS Functional magnetic stimulation was useful and safe for treating women with MUI",
"The aim of this study was to examine the efficacy of oxybutynin plus bladder training in the treatment of detrusor instability in frail elderly patients living independently in the community . It was a r and omized , double-blind , placebo-controlled parallel-group trial of oxybutynin in 57 elderly patients ( mean age 82.2 , SD 6.06 ) , with frequency and incontinence due to detrusor instability . After a 2-week run-in period patients received a bladder training and drug or placebo for the next 6 weeks . Outcome measures were changes in frequency and incontinence , recorded throughout on diary charts , and subjective evaluation of symptoms ( ' better'/'not better ' , and using a four-point scale ' cure ' to ' no change ' ) . Oxybutynin was superior to placebo in reducing daytime frequency [ 95 % confidence interval ( CI ) of difference in change in frequencies totalled over 14 days was -27.0 , -6.0 ; p = 0.003 ] and in producing subjective benefit ( at day 29 only ) , when 24/28 ( 86 % ) patients on oxybutynin described benefit compared with 16/29 ( 55 % ) on placebo ( p = 0.02 ) . There was no difference between the groups in reduction of incontinent episodes . The median dose of oxybutynin titrated for therapeutic effect was 5 mg/day , and for placebo 10 mg/day ( CI of difference 0.001 , 5.001 ; p = 0.05 ) . Side-effects reported were of similar frequency ( 50 % ) in the two groups . We conclude that oxybutynin with bladder training is superior to bladder training alone in reducing frequency due to detrusor instability in very elderly people living at home",
"PURPOSE The Overactive Bladder Innovative Therapy trial was a r and omized , multicenter , controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine . The reduction in overactive bladder symptoms along with global response assessment s was evaluated . MATERIAL S AND METHODS A total of 100 adults with urinary frequency were r and omized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine . Voiding diaries and an overactive bladder question naire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency , urinary urge incontinence episodes , voids causing waking , volume voided , urgency episodes and quality of life indices . Global response assessment s were completed by subjects and investigators after 12 weeks of therapy . RESULTS The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5 % reporting cure or improvement compared to 54.8 % of subjects on tolterodine ( p = 0.01 ) . Assessment s by investigators were similar but did not reach statistical significance ( p = 0.05 ) . After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency , urge urinary incontinence episodes , urge severity and nighttime voids , as well as for improvement in voided volume . There were no serious adverse events or device malfunctions . CONCLUSIONS This multicenter , r and omized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms , and with objective effectiveness comparable to that of pharmacotherapy . Percutaneous tibial nerve stimulation may be considered a clinical ly significant alternative therapy for overactive bladder",
"PURPOSE We evaluated the effect of weight loss on urinary incontinence ( UI ) in overweight and obese women . MATERIAL S AND METHODS A r and omized , controlled clinical trial was conducted among overweight and obese women experiencing at least 4 UI episodes per week . Women were r and omly assigned to a 3-month liquid diet weight reduction program ( 24 in the immediate intervention group ) or a wait-list delayed intervention group ( 24 in the wait-list control group ) . Participants in the wait-list control group began the weight reduction program in month 3 of the study . All women were followed for 6 months after completing the weight reduction program . Wilcoxon tests were used to compare intergroup differences in change in weekly UI episodes and quality of life scores . RESULTS A total of 48 women were r and omized and 40 were assessed 3 months after r and omization . Median ( with 25 % to 75 % interquartile range [ IQR ] ) baseline age was 52 years ( IQR 47 to 59 ) , weight was 97 kg ( IQR 87 to 106 ) and UI episodes were 21 weekly ( IQR 11 to 33 ) . Women in the immediate intervention group had a 16 kg ( IQR 9 to 20 ) weight reduction compared with 0 kg ( IQR -2 to 2 ) in the wait-list control group ( p weekly UI episodes compared with 15 % ( IQR -9 % to 25 % ) in the wait-list control group ( p quality of life scores . Stress ( p = 0.003 ) and urge ( p = 0.03 ) incontinent episodes decreased in the immediate intervention vs wait-list control group . Following the weight reduction program the wait-list control group experienced a similar median reduction in weekly UI episodes ( 71 % ) . Among all 40 women mean weekly UI episodes decreased 54 % ( 95 % CI 40 % to 69 % ) after weight reduction and the improvement was maintained for 6 months . CONCLUSIONS Weight reduction is an effective treatment for overweight and obese women with UI . Weight loss of 5 % to 10 % has an efficacy similar to that of other nonsurgical treatments and should be considered a first line therapy for incontinence",
"Importance Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information . Objective To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence . Design , Setting , and Participants Multicenter open-label r and omized trial ( February 2012-January 2015 ) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence . Interventions Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA ( n = 192 ) or sacral neuromodulation ( n = 189 ) . Main Outcomes and Measures Primary outcome , change from baseline mean number of daily urgency urinary incontinence episodes over 6 months , was measured with monthly 3-day diaries . Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Question naire Short Form ( SF ) ; range , 0 - 100 , higher scores indicating worse symptoms ; Overactive Bladder Satisfaction question naire ; range , 0 - 100 ; includes 5 subscales , higher scores indicating better satisfaction ; and adverse events . Results Of the 364 women ( mean [ SD ] age , 63.0 [ 11.6 ] years ) in the intention-to-treat population , 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group ( -3.9 vs -3.3 episodes per day ; mean difference , 0.63 ; 95 % CI , 0.13 to 1.14 ; P = .01 ) . Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Question naire SF for symptom bother ( -46.7 vs -38.6 ; mean difference , 8.1 ; 95 % CI , 3.0 to 13.3 ; P = .002 ) ; treatment satisfaction ( 67.7 vs 59.8 ; mean difference , 7.8 ; 95 % CI , 1.6 to 14.1 ; P = .01 ) and treatment endorsement ( 78.1 vs 67.6 ; mean difference ; 10.4 , 95 % CI , 4.3 to 16.5 ; P P = .36 ) , adverse effects ( 88.4 vs 85.1 ; mean difference , 3.3 ; 95 % CI , -1.9 to 8.5 ; P = .22 ) , and treatment preference ( 92.% vs 89 % ; risk difference , -3 % ; 95 % CI , -16 % to 10 % ; P = .49 ) . Urinary tract infections were more frequent in the onabotulinumtoxinA group ( 35 % vs 11 % ; risk difference , -23 % ; 95 % CI , -33 % to -13 % ; P The need for self-catheterization was 8 % and 2 % at 1 and 6 months in the onabotulinumtoxinA group . Neuromodulation device revisions and removals occurred in 3 % . Conclusions and Relevance Among women with refractory urgency urinary incontinence , treatment with onabotulinumtoxinA compared with sacral neuromodulation result ed in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance . In addition , it result ed in a higher risk of urinary tract infections and need for transient self-catheterizations",
"Our objective was to determine the efficacy of functional electrical stimulation as a st and -alone therapy for female stress incontinence . The study was conducted as a prospect i ve , double-blind , r and omized controlled trial using subjective and objective outcome criteria . Patients enrolled in this study had stress incontinence consistent with International Continence Society criteria . Patients with significant pelvic prolapse or detrusor instability were excluded . Patients underwent twice-daily treatment sessions for a total of 3 months . Results were analyzed for confounding variables between the treatment and control groups . Statistical analysis was performed utilizing Fisher 's exact test and the paired t-test . Of the 54 patients enrolled in this study , 44 completed the program . The dropout rate was similar for both the treatment and control groups . There was no statistically significant difference between the treatment and control groups with regard to age , gravity , parity , previous antiincontinence surgery , menopausal status , or previous hysterectomy . Objective success for the treatment group was 15 % and for the control group , 12.5 % ( NS ) . The subjective success for the treatment group was 25 % and for the control group , 29 % ( NS ) . There was no relationship demonstrated between age , parity , previous surgery , hysterectomy , or menopausal status and the successful treatment of genuine stress incontinence with functional electrical stimulation . In this patient population , functional electrical stimulation was no more effective at improving or eliminating the symptoms of genuine stress incontinence than was the daily retention of the control probe",
"OBJECTIVE To compare the effect of pelvic floor muscle training ( PFMT ) and watchful waiting on pelvic floor symptoms in women aged 55 years and over with symptomatic mild pelvic organ prolapse in primary care . DESIGN R and omised controlled trial in primary care . METHOD Women aged 55 years or over with symptomatic mild prolapse ( leading edge above the hymen ) were identified by screening . Women were r and omised to PFMT or watchful waiting . Primary outcome was change in bladder , bowel and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 ( PFDI-20 ) , three months after the start of treatment . Secondary outcomes were changes in condition specific and general quality of life , sexual function , degree of prolapse , pelvic floor muscle function , and patients ' perceived change of symptoms . RESULTS Of the 278 women who were r and omised to PFMT ( n=145 ) or watchful waiting ( n=142 ) , 250 ( 87 % ) completed follow-up . Participants in the PFMT group improved by 9.1 ( 95 % CI -15.4 to -2.8 ) points more on the PFDI-20 than did participants in the watchful waiting group ( p = 0.005 ) . Of women in the PFMT group , 57 % ( 82/145 ) reported an improvement of overall symptoms from the start of the study compared with 13 % ( 18/142 ) in the watchful waiting group ( p PFMT led to a significantly greater improvement in PFDI-20 score , the difference between groups was below the presumed level of clinical relevance ( 15 points ) . Nevertheless , 57 % of the participants in the PFMT group reported an overall improvement of symptoms",
"PURPOSE The effectiveness of intravaginal electrical stimulation was compared to st and ard therapy in the treatment of genuine stress urinary incontinence and detrusor instability . MATERIAL S AND METHODS A total of 57 women with urinary incontinence was evaluated with video urodynamics and voiding diaries before and after treatment . Of the women 18 with stress urinary incontinence were r and omized to electrical stimulation or Kegel exercise and 38 with detrusor instability were r and omized to anticholinergic therapy or electrical stimulation . RESULTS Of patients using electrical stimulation in the stress urinary incontinence group 66 % improved and 72 % of the patients with detrusor instability treated with electrical stimulation improved . These rates were not statistically significant when compared to traditional therapy . CONCLUSIONS Electrical stimulation is safe and at least as effective as properly performed Kegel and anticholinergic therapy in the treatment of stress urinary incontinence and detrusor instability",
"BACKGROUND Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence , but data directly comparing the two types of therapy are needed . METHODS We performed a double-blind , double-placebo-controlled , r and omized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period , as recorded in a diary . For a 6-month period , participants were r and omly assigned to daily oral anticholinergic medication ( solifenacin , 5 mg initially , with possible escalation to 10 mg and , if necessary , subsequent switch to trospium XR , 60 mg ) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo . The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period , as recorded in 3-day diaries su bmi tted monthly . Secondary outcomes included complete resolution of urgency urinary incontinence , quality of life , use of catheters , and adverse events . RESULTS Of 249 women who underwent r and omization , 247 were treated , and 241 had data available for the primary outcome analyses . The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months , from a baseline average of 5.0 per day , was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group ( P=0.81 ) . Complete resolution of urgency urinary incontinence was reported by 13 % and 27 % of the women , respectively ( P=0.003 ) . Quality of life improved in both groups , without significant between-group differences . The anticholinergic group had a higher rate of dry mouth ( 46 % vs. 31 % , P=0.02 ) but lower rates of catheter use at 2 months ( 0 % vs. 5 % , P=0.01 ) and urinary tract infections ( 13 % vs. 33 % , P anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence . The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections . ( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women 's Health ; Clinical Trials.gov number , NCT01166438 . )",
"Background . To evaluate the effectiveness of intravaginal electrical stimulation ( ES ) of the pelvic floor for urinary incontinence in elderly women , and to determine whether ES of the pelvic floor is a preferable treatment for urinary incontinence in elderly women",
"OBJECTIVE Our purpose was to determine the efficacy of transvaginal electrical stimulation in treating genuine stress incontinence . STUDY DESIGN This was a multicenter , prospect i ve , r and omized , double-blind , placebo-controlled 15-week trial comparing the use of an active pelvic floor stimulator with a sham device . Thirty-five women used an active unit and 17 control subjects used sham devices . Weekly and daily voiding diaries were recorded throughout the trial . Urodynamic testing , including pad test and subtracted cystometry , was done before and at the end of device use . Pelvic muscle strength was measured at baseline and at the end of the trial . Patients scored their symptoms on visual analog scales and completed quality -of-life question naires before and after therapy . RESULTS Significant improvements from baseline were found in patients using active devices but not in controls . Comparisons of changes from baseline between active-device and control patients showed that active-device patients had significantly greater improvement in weekly ( p = 0.009 ) and daily ( p = 0.04 ) leakage episodes , pad testing ( p = 0.005 ) , and vaginal muscle strength ( p = 0.02 ) when compared with control subjects . Significantly greater improvement was also found for both visual analog scores of urinary incontinence ( p = 0.007 ) and stress incontinence ( p = 0.02 ) , as well as for subjective reporting of frequency of urine loss ( p = 0.002 ) , and urine loss with sneezing , coughing , or laughing ( p = 0.02 ) , when compared with controls . Pad testing showed that stress incontinence was improved by at least 50 % in 62 % of patients using an active device compared with only 19 % of patients using sham devices ( p = 0.01 ) . Voiding diaries showed at least 50 % improvement in 48 % of active-device patients compared with 13 % of women using the sham device ( p = 0.02 ) . No irreversible adverse effects were noted in either group . CONCLUSIONS Transvaginal pelvic floor electrical stimulation was found to be a safe and effective therapy for genuine stress incontinence",
"OBJECTIVES To examine the efficacy and tolerability of antimuscarinic therapy in women with urge-predominant mixed incontinence . METHODS This was a double-blind , r and omized , placebo-controlled trial comprising 854 women with urge-predominant mixed incontinence , including urge incontinence ( five or more episodes per week ) , urinary frequency ( eight or more micturitions on average in 24 hours ) , and urgency in combination with stress incontinence . Women received 8 weeks of treatment with tolterodine tartrate extended-release ( ER ) 4 mg or placebo once daily . The outcome measures included urge incontinence episodes per week , stress incontinence episodes per week , micturition frequency per 24 hours , urgency episodes per 24 hours , volume voided per micturition , patient perception of bladder condition , and assessment of treatment benefit . RESULTS After 8 weeks , tolterodine ER produced a statistically significant decrease in the weekly urge incontinence episodes compared with placebo ( -12.3 versus -8.0 ; P variables improved significantly more with tolterodine ER . No difference was found between treatment groups regarding the change in the number of stress incontinence episodes . A significantly greater proportion of patients receiving tolterodine ER than those receiving placebo reported improvement in bladder condition ( 61 % versus 46 % ; P treatment benefit ( 76 % versus 55 % ; P tolterodine ER group had experienced statistically significant improvements compared with the placebo group in 9 of 10 quality -of-life domains . The frequency of adverse events was similar between treatment groups . CONCLUSIONS Tolterodine ER is an effective treatment of urge urinary incontinence , frequency , and urgency in women with concomitant stress urinary incontinence . The efficacy of tolterodine ER in reducing urge incontinence episodes was unaffected by the presence of stress incontinence . The results of this study support the first-line use of antimuscarinic therapy to treat the urge incontinence component of urge-predominant mixed incontinence",
"OBJECTIVES To determine the efficacy and safety of functional magnetic stimulation ( FMS ) produced by the Pulsegen device compared with placebo in the treatment of women with urinary incontinence . METHODS Fifty-five women with urinary incontinence were r and omly assigned to the active FMS group ( 30 patients ) or the placebo group ( 22 patients ) . Each patient in the active group received a Pulsegen device , which produced a pulsating magnetic field of B = 10 microT intensity and a frequency of 10 Hz . Patients were asked to wear the Pulsegen device day and night for 2 months . Clinical and urodynamic data were collected before and after FMS and analyzed using nonparametric statistics . RESULTS Compared with the placebo , the number of pads used was significantly lower ( P = 0.0031 ) after FMS , as was the pad weight ( P = 0.014 ) . In patients from the active group , a significant improvement in the power of the pelvic floor muscle contractions ( P = 0.0071 ) , as well as in the duration of the pelvic floor muscle contractions ( P = 0.038 ) , was observed . After FMS , a 56.3 % improvement in urinary incontinence symptoms was reported by patients in the active group , a significantly greater difference ( P = 0.00012 ) compared with the reported 26.3 % improvement in symptoms in the placebo group . CONCLUSIONS We believe that FMS represents a new method in the conservative treatment of urinary incontinence . Magnetic stimulation with the Pulsegen device is efficient and safe . It can be used at home and , because of its small size , wearing the device is not annoying for patients",
"OBJECTIVE To compare the difference in the clinical efficacy on mild and moderate female stress urinary incontinence ( FSUI ) between transcutaneous acupoint electrical stimulation and oral administration of midodrine hydrochloride tablets . METHODS Ninety cases of mild and moderate FSUI were r and omized into an observation group and a control group , 45 cases in each one . In the observation group , the transcutaneous acupoint electrical stimulation was applied to Ciliao ( BL 32 ) , Shenshu ( BL 23 ) , Zigong ( EX-CA 1 ) , Guanyuan ( CV 4 ) and Qihai ( CV 6 ) , once a day . In the control group , midodrine hydrochloride tablets were prescribed for oral administration , 2 . 5 mg per treatment , three times each day . The duration of treatment was 4 weeks . The score of international consultation on incontinence question naire-urinary incontinence short form ( ICI-Q-SF ) and leakage of urine in 1 h urinal pad test were observed before and after treatment in the patients of the two groups , and the efficacy was compared between the two groups . RESULTS The score of ICI-Q-SF and leakage of urine in urinal pad test after treatment were all improved apparently as compared with those before treatment in the two groups ( all P total effective rate was 86 . 7 % ( 39/45 ) in the observation group , which was better than 68 . 9 % ( 31/45 , P transcutaneous acupoint electrical stimulation achieves the better efficacy on FSUI as compared with the oral administration of midodrine hydrochloride tablets . This therapy effectively improves the patient 's urine control ability and reduces leakage of urine",
"OBJECTIVE : To estimate the effect of 2 years of treatment with ultralow-dose transdermal estradiol ( E2 ) on incontinence in postmenopausal women . METHODS : Ultra Low Dose Transdermal estRogen Assessment ( ULTRA ) was a multicenter , r and omized , double-blinded , placebo-controlled trial of unopposed ultralow-dose ( 0.014 mg/d ) transdermal E2 for prevention of osteoporosis in 417 postmenopausal women aged 60 to 80 years . Frequency of incontinence episodes was assessed at baseline and after 4 months and 2 years of treatment using a self-reported question naire . We used an intention-to-treat analysis to compare change in incontinence frequency , improved ( decreased 2 or more episodes per week ) , unchanged ( increased or decreased no more than 1 episode per week ) , or worsened ( increased 2 or more episodes per week ) between the E2 and placebo groups among women with and without at least weekly incontinence at baseline . RESULTS : At baseline , the prevalence of at least weekly incontinence was similar between E2 and placebo groups ( 43 % ) . After 2 years , there was no difference between groups in the proportions of women with incontinence at baseline whose incontinence improved , worsened , or was unchanged . The odds ratio for worsening incontinence in the E2 compared with placebo group was 1.35 ( 95 % confidence interval 0.75–2.42 . In women without incontinence at baseline , the odds of developing at least weekly incontinence after 2 years in the E2 compared with placebo group was not significant ( odds ratio 1.2 , 95 % confidence interval 0.7–2.2 ) . CONCLUSION : Two years of treatment with unopposed ultralow-dose transdermal E2 did not substantially change the frequency of incontinence symptoms or alter the risk of developing at least weekly incontinence . LEVEL OF EVIDENCE :",
"PURPOSE To compare pelvic muscle exercise to pharmacologic treatment of stress urinary incontinence , the most common cause of urine leakage reported by community-living elderly women . SUBJECTS Convenience sample of 157 community-living women , aged 55 to 90 years , after completion of a comprehensive diagnostic evaluation . METHODS Eighty-two subjects were r and omly assigned to the exercise protocol ( with a 34 % attrition rate ) . Pelvic muscle exercises were taught and monitored for 6 months . Phenylpropanolamine hydrochloride was given to the other group in a dose of 50 mg a day , increasing to 50 mg twice a day . MAIN RESULTS Treatment outcomes ( subjective improvement , self recorded frequency of wetting ) were equally satisfactory in both groups . The response to exercises was as good in 5 months as in 6 . It was also as good when the minimum recommended number of exercises per day was 80 as when it was 125 . CONCLUSIONS Among those completing the protocol , pelvic exercises were beneficial in reducing stress incontinence , and the benefit was comparable to that produced by phenylpropanolamine",
"BACKGROUND Urinary incontinence remains a hidden and inadequately treated problem in a high proportion of women . METHODS Ninety women 50 - 74 years of age were recruited to a population -based , r and omized , controlled clinical trial of conservative treatment for urinary incontinence , with delayed treatment for the control group . The study was performed in general practice in three north-Norwegian municipalities , in cooperation with two local departments of gynecology . Three patients were found protocol deviant and analysis was based on 87 patients . INTERVENTION Local estrogen , physiotherapy and electrostimulation combined with close follow-up . MAIN OUTCOME MEASURES 1 . Change in severity of incontinence from start of treatment ( index range 0 - 8 ) . 2 . Change in impact from start of treatment ( index range 0 - 4 ) . 3 . Quantitative measures in relation to micturition . 4 . Criteria based classification into cured , improved , unchanged , worse . RESULTS Treatment reduced severity ( index change 1.8 in the intervention group vs. 0.1 in the control group at six months ) and impact ( index change 0.8 vs. 0.0 ) of leakage . Almost one third of the patients did not complete all micturition tests , but in those who did , average number of wet episodes per 24 hours decreased with treatment , and so did average number of micturitions in urge and mixed incontinence . Forty-nine patients ( 56 % ) were cured or improved after one year . CONCLUSION Women 50 to 74 years of age with urinary incontinence may improve considerably through conservative treatment in general practice",
"OBJECTIVE To investigate the effects of the combination of pelvic floor muscle exercise ( PFME ) and estriol on postmenopausal stress incontinence ( SI ) . STUDY DESIGN Sixty-six patients with postmenopausal SI were r and omized to a group treated with a combination of estriol ( 1 mg/d ) and PFME ( group A , n = 32 ) and a group treated with PFME alone ( group B , n = 34 ) . Efficacy was evaluated every three months based on stress scores obtained from a urinary incontinence ( UI ) question naire . RESULTS A significant decrease in stress score was observed in mild and moderate UI patients in both groups three months after the commencement of therapy ( A and B , P therapeutic effect in group A was more prominent for up to 18 months in mild UI and for up to 12 months in moderate UI ( A vs. B , P cumulative morbidity rate in mild SI patients was significantly lower in group A ( 0 % ) than in group B ( 12 % , P estriol plus PFME was effective and is capable of serving as first-line treatment for mild SI",
"BACKGROUND Women with urge urinary incontinence are commonly treated with antimuscarinic medications , but many discontinue therapy . OBJECTIVE To determine whether combining antimuscarinic drug therapy with supervised behavioral training , compared with drug therapy alone , improves the ability of women with urge incontinence to achieve clinical ly important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy . DESIGN 2-stage , multicenter , r and omized clinical trial conducted from July 2004 to January 2006 . SETTING 9 university-affiliated outpatient clinics . PATIENTS 307 women with urge-predominant incontinence . INTERVENTION 10 weeks of open-label , extended-release tolterodine alone ( n = 153 ) or combined with behavioral training ( n = 154 ) , followed by discontinuation of therapy and follow-up at 8 months . MEASUREMENTS The primary outcome , measured at 8 months , was no receipt of drugs or other therapy for urge incontinence and a 70 % or greater reduction in frequency of incontinence episodes . Secondary outcomes were reduction in incontinence , self-reported satisfaction and improvement , and scores on vali date d question naires measuring symptom distress and bother and health-related quality of life . Study staff who performed outcome evaluations , but not participants and interventionists , were blinded to group assignment . RESULTS 237 participants completed the trial . According to life-table estimates , the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups ( 41 % in both groups ; difference , 0 percentage points [ 95 % CI , -12 to 12 percentage points ] ) . A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70 % or greater reduction in incontinence at 10 weeks ( 69 % vs. 58 % ; difference , 11 percentage points [ CI , -0.3 to 22.1 percentage points ] ) . Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Question naire ( both P patient satisfaction and perceived improvement but not health-related quality of life . Adverse events were uncommon ( 12 events in 6 participants [ 3 in each group ] ) . LIMITATIONS Behavioral therapy components ( daily bladder diary and recommendations for fluid management ) in the group receiving drug therapy alone may have attenuated between-group differences . Assigned treatment was completed by 68 % of participants , whereas 8-month outcome status was assessed on 77 % . CONCLUSION The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence . Combination therapy has a beneficial effect on patient satisfaction , perceived improvement , and reduction of other bladder symptoms",
"A total of 110 women who had reported urinary incontinence to their general practitioners were r and omly assigned to a treatment or control group . Treatment consisted of pelvic floor exercises in the case of stress incontinence and bladder training in the case of urge incontinence . The results were measured after 3 and 12 months by a research assistant on the basis of a constructed severity scale , an incontinence diary , and a comparison by the patients themselves of their previous and current conditions . After 3 months the control group were given the same treatment . After a further 3 and 12 months , they were assessed in exactly the same way as the treatment group . After 3 months about 60 % of the patients were either dry or only mildly incontinent ; the mean number of wet episodes had gone down from 20 to 7 , and 74 % of the women felt improved or cured . These results were later corroborated by the control group . After 12 months this successful outcome was improved slightly further . It may be concluded that the majority of women with incontinence can be successfully treated by the general practitioner . The effect of this treatment continues after one year",
"BACKGROUND Research using biofeedback as a treatment for sphincteric incontinence began with Kegel 's early studies using a perineometer and pelvic muscle exercises demonstrating a 90 % improvement in urine loss symptoms . More recent studies using varying combinations of biofeedback and pelvic muscle exercises found symptom reduction rates of 78 % to 90 % , but these studies lacked the rigor of a \" phase three , \" or r and omized controlled clinical trial . METHODS A r and omized controlled trial assessed the efficacy of biofeedback for older women for treatment of sphincteric incompetence . One hundred thirty-five community-dwelling women were r and omized in a single-blind trial to three groups : biofeedback , pelvic muscle exercise , or control . Incontinent episodes were monitored over 8 weeks of treatment and at 3 and 6 months thereafter . RESULTS The number of incontinent episodes decreased significantly in the biofeedback and pelvic muscle exercise subjects but not in the control subjects for all severity of incontinence frequency subgroups . Improvement was maintained within the moderate and severe symptom subgroups for both treatments for at least 6 months but declined in subjects with mild incontinence frequency . Pelvic muscle activity ( EMG ) was significantly correlated with decreases in incontinent episodes , and only the biofeedback subjects showed significant improvement in EMGs . CONCLUSIONS Biofeedback and pelvic muscle exercises are efficacious for sphincteric incompetence in older women . Benefits are maintained and improvement continues for at least 6 months postintervention . These therapies may be useful before considering invasive treatment",
"We investigated the effectiveness of pelvic floor muscle ( PFM ) exercises or biofeedback for the treatment of urinary stress incontinence ( USI ) . Fifty patients with USI were included in this r and omized , controlled , prospect i ve study . Twenty patients were taught PFM exercises via digital palpation and instructed to perform regularly as home program . The second group of 20 patients had PFM exercises via biofeedback three times a week for 2 months . The third group of 10 patients did not have any exercises . The patients were evaluated via pad test , perineometry , digital palpation based PFM strength , incontinence frequency , and visual analog scale based social activity index prior to and 8 weeks after the treatment . The first two groups had significant improvement in USI with respect to the control group ( p rise in PFM strength with perineometry of the biofeedback group was higher than in the digital palpation group after treatment ( p PFM exercises are effective for the treatment of USI ; the biofeedback method revealed better PFM strength results with respect to digital palpation",
"AIMS Evaluate duloxetine in the treatment of women with mixed urinary incontinence ( MUI ) . MATERIAL S AND METHODS 588 women , 19 - 85 years old with > or=4 incontinence episodes/week were r and omly assigned to duloxetine 80 mg/day ( N = 300 ) or placebo ( N = 288 ) . Patients were classified into three symptom subgroups : stress or urge predominant MUI ( SPMUI or UPMUI ) or balanced MUI ( BMUI ) based on their responses to the vali date d Stress/Urge Incontinence Question naire . Half the population was r and omly assigned to have urodynamics ; SPMUI , UPMUI , and BMUI condition diagnoses were based on signs , symptoms , and urodynamic observations . The primary outcome measure was the change in incontinence episode frequency ( IEF ) . Secondary outcome measures included the Incontinence Quality of Life ( I-QOL ) scores , the ICI Quality of Life ( ICIQ-SF ) score , and the Patient Global Impression of Improvement ( PGI-I ) rating . RESULTS At baseline , women with SPMUI averaged 15.9 IEF/week ( 61 % stress ) , those with UPMUI averaged 13.2 ( 70 % urge ) , and those with BMUI averaged 16.5 ( 52 % urge ) . Overall IEF decreases were significantly greater with duloxetine than placebo ( median percent reduction 60 % vs. 47 % , P UUI and SUI episodes were significantly decreased with duloxetine ( median SUI IEF reduction 59 % vs. 43 % , P = 0.001 ; UUI IEF reduction 58 % vs. 40 % , P Duloxetine IEF decreases were significantly greater for patients with SPMUI conditions and symptoms and for those with UPMUI conditions but not symptoms . Significant benefits were also demonstrated with duloxetine for improvements in I-QOL total score ( 11.5 points vs. 8.1 points , P = 0.002 ) , all three I-QOL subscale scores , and for the ICIQ-SF score ( -2.6 vs. -1.7 , P = 0.002 ) as well as for PGI-I ratings ( much/very much better 44.2 % vs. 27.3 % , P = 0.001 ) . CONCLUSION Duloxetine demonstrated significant efficacy in this population of women with MUI",
"Objectives : This community-based intervention to reduce urinary incontinence ( UI ) in elderly women used a small group educational approach . This article reports on change in episodes of incontinence and other urinary symptoms . Methods : Participants were r and omly assigned to intervention orwait control condition . This article is restricted to 49 intervention and 59 control participants with acceptable diaries . Results : There was a significant treatment effect for a number of incontinent episodes . In the intervention group , 61 % had a 50 % or greater reduction in episodes , with more than one third having 100 % reduction ; 38 % of the control group had a reduction of 50 % or greater . One year postprogram , 75 % of treated women reported subjective improvement . Therewas a reduction in frequency of daily , but not nocturnal , micturition . Discussion : This community-based intervention is an encouraging option for behavioral treatment of UI . Public health models may be particularly appropriate with moderate levels of urinary incontinence",
"PURPOSE In a pivotal trial we evaluated the effectiveness and safety of Macroplastique(R ) as minimally invasive endoscopic treatment for female stress urinary incontinence primarily due to intrinsic sphincter deficiency . MATERIAL S AND METHODS A total of 247 females with intrinsic sphincter deficiency were r and omized 1:1 and treated with a transurethral injection of Macroplastique or Contigen . The latter group served as the control . Repeat treatment was allowed after the 3-month followup . Effectiveness was determined 12 months after the last treatment using Stamey grade , pad weight and Urinary Incontinence Quality of Life Scale scores . Safety assessment was recorded throughout the study . RESULTS After 12 patients were excluded from study 122 patients received Macroplastique injection and 125 received Contigen injection . Mean patient age was 61 years and the average history of incontinence was 11.2 years . Of the patients 24 % had undergone prior incontinence surgery . At 12 months after treatment 61.5 % of patients who received Macroplastique and 48 % of controls had improved 1 Stamey grade . In the Macroplastique group the dry/cure rate was 36.9 % compared to 24.8 % in the control group ( p Macroplastique and control groups the 1-hour pad weight decrease was 25.4 and 22.8 ml from baseline ( p = 0.64 ) , and the mean improvement in Urinary Incontinence Quality of Life Scale score was 28.7 and 26.4 ( p = 0.49 ) , respectively . CONCLUSIONS Macroplastique injection was statistically more effective than Contigen for stress urinary incontinence primarily due to intrinsic sphincter deficiency with a 12.1 % cure rate difference . Macroplastique can be administered on an outpatient basis . It should be considered a primary or secondary treatment option for stress urinary incontinence",
"AIMS We assessed the effects of onabotulinumtoxinA ( BOTOX ® ) on clinical and urodynamic variables in patients with idiopathic overactive bladder ( OAB ) and urinary urgency incontinence ( UUI ) with or without detrusor overactivity ( DO ) , inadequately managed with anticholinergics . METHODS Three hundred thirteen patients with OAB were r and omized to double-blind intradetrusor injection with placebo ( n = 44 ) or 1 of 5 onabotulinumtoxinA doses ( 50 - 300 U ; n = 269 ) . Primary efficacy variable was change from baseline in UUI episodes/week at week 12 . Urodynamic assessment s at baseline and weeks 12 and 36 included maximum cystometric capacity ( MCC ) and volume at first involuntary detrusor contraction ( IDC ) . RESULTS 76.0 % of patients had baseline DO . Changes from baseline in MCC and volume at first IDC with onabotulinumtoxinA ≥100 U were superior to placebo at week 12 , generally decreasing by week 36 . Significant dose-dependent increases in MCC were observed for all onabotulinumtoxinA doses at week 12 , and for 150 , 200 , and 300 U at week 36 . Data suggested a dose-response relationship . At week 12 on diary , 15.9 % of placebo and 29.8 - 57.1 % of onabotulinumtoxinA 50 - 300 U recipients , respectively , did not demonstrate UUI . OnabotulinumtoxinA doses > 150 U were more commonly associated with post-void residual urine volumes > 200 ml . CONCLUSIONS Improvements in urodynamic parameters and clinical outcomes generally trended together following onabotulinumtoxinA treatment . This therapy improved key urodynamic parameters in patients with idiopathic OAB and UUI , with no differences in outcomes between those with and those without baseline DO . Therefore , successful idiopathic OAB treatment with onabotulinumtoxinA does not appear to be related to pretreatment finding of DO",
"OBJECTIVE To compare the efficacies of electrical pudendal nerve stimulation ( EPNS ) vs electromyogram biofeedback (BF)-assisted pelvic floor muscle training ( PFMT ) plus transvaginal electrical stimulation ( TES ) in treating female stress urinary incontinence ( SUI ) and to evaluate the posttreatment and long-term efficacies of EPNS for female SUI . MATERIAL S AND METHODS Forty-two female SUI patients were r and omized into groups I and II , 21 in each group . The two groups were treated by EPNS and BF-assisted PFMT plus TES , respectively , for comparison of their effects . Group III ( 196 patients ) were treated by EPNS for evaluation of its effects . To perform EPNS , long acupuncture needles were deeply inserted into four sacrococcygeal points and electrified to stimulate pudendal nerves . Outcome measures were stress test , 24-hour pad test , and a question naire to measure the severity of symptoms and quality of life in women with SUI . RESULTS After 4 weeks of treatment , the question naire score was lower and the therapeutic effect was better in group I ( question naire score 0 [ 0 , 6 ] and a ≥ 50 % symptom improvement rate of 85.7 % , respectively ) than in group II ( question naire score 9 [ 5.5 , 15.5 ] and a ≥ 50 % symptom improvement rate of 28.6 % ) ( both P complete resolution occurred in 94 cases ( 48.0 % ) , with a ≥ 50 % symptom improvement rate of 85.7 % , after 20.3 ± 16.8 sessions of treatment . At the mean follow-up of 52.9 months , complete resolution occurred in 32 ( 47.1 % ) of the 68 patients in group III who attained ≥50 % posttreatment improvement . CONCLUSION EPNS is more effective than BF-assisted PFMT plus TES in treating female SUI . It has good posttreatment and long-term effects on female SUI ",
"OBJECTIVES To determine whether combining behavioral urinary incontinence ( UI ) treatments with physical activity improves UI in frail older women . DESIGN Single-blind , two-arm pilot r and omized controlled trial . SETTING Senior apartments . PARTICIPANTS Frail women ( mean age 84.9 ± 6.4 ) without dementia ( n = 42 ) . INTERVENTION Twelve-week program of customized behavioral UI treatments : 150 minutes of weekly walking and twice weekly strength training classes . MEASUREMENTS UI was measured using 3-day bladder diaries , the International Consultation on Incontinence Question naire ( ICIQ ) , and UI global improvement questions . Toileting skills were measured using the Performance Oriented Timed Toileting Instrument ( POTTI ) and the Minnesota Toileting Skills Question naire ( MTSQ ) . Physical function was measured using the Short Physical Performance Battery . UI-related quality of life was measured using the Incontinence Impact Question naire and Urogenital Distress Inventory . RESULTS The treatment group reported a 50 % reduction in daily leaks using bladder diaries , and the control group reported no change ( P = .04 ) . Although there were no group differences in total ICIQ scores ( P = .66 ) , the treatment group reported significantly greater improvement on the ICIQ item for urine leakage ( P = .01 ) . More than 81 % of the treatment group and 36 % of the control group reported improvement in UI ( χ2 = 4.84 , P = .01 ) , with mean estimated percentage improvement of 65.3 ± 32.0 versus 34.1 ± 41.3 ( P = .03 ) . Although the difference was not statistically significant , treatment group participants improved their toileting skills , whereas those of the control group declined ( P = .42 POTTI , P = .11 MTSQ ) . Balance ( P = .33 ) and gait ( P = .24 ) improved more in the treatment group , whereas chair st and s improved more in the control group ( P = .14 ) . CONCLUSION UI may be improved in frail older women by combining behavioral strategies for UI with physical activity , but larger trails are needed to determine whether these findings can be replicated and sustained"
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BACKGROUND The precise age distribution and calculated stroke risk of screen-detected atrial fibrillation ( AF ) is not known . Therefore , it is not possible to determine the number needed to screen ( NNS ) to identify one treatable new AF case ( NNS-Rx ) ( i.e. , Class-1 oral anticoagulation [ OAC ] treatment recommendation ) in each age stratum . If the NNS-Rx is known for each age stratum , precise cost-effectiveness and sensitivity simulations can be performed based on the age distribution of the population /region to be screened . Such calculations are required by national authorities and organisations responsible for health system budgets to determine the best age cutoffs for screening programs and decide whether programs of screening should be funded . Therefore , we aim ed to determine the exact yield and calculated stroke-risk profile of screen-detected AF and NNS-Rx in 5-year age strata . METHODS AND FINDINGS A systematic review of Medline , Pubmed , and Embase was performed ( January 2007 to February 2018 ) , and AF-SCREEN international collaboration members were contacted to identify additional studies . Twenty-four eligible studies were identified that performed a single time point screen for AF in a general ambulant population , including people ≥65 years . Authors from eligible studies were invited to collaborate and share patient-level data . Statistical analysis was performed using r and om effects logistic regression for AF detection rate , and Poisson regression modelling for CHA2DS2-VASc scores . Nineteen studies ( 14 countries from a mix of low- to middle- and high-income countries ) collaborated , with 141,220 participants screened and 1,539 new AF cases . Pooled yield of screening was greater in males across all age strata . The age/sex-adjusted detection rate for screen-detected AF in ≥65-year-olds was 1.44 % ( 95 % CI , 1.13%-1.82 % ) and 0.41 % ( 95 % CI , 0.31%-0.53 % ) for . New AF detection rate increased progressively with age from 0.34 % ( the detection rate of AF . Mean CHA2DS2-VASc scores ( n = 1,369 ) increased with age from 1.1 ( People with screen-detected AF are at elevated calculated stroke risk : above age 65 , the majority have a Class-1 OAC recommendation for stroke prevention , and > 70 % have ≥1 additional stroke risk factor other than age/sex . Our data , based on the largest number of screen-detected AF collected to date , show the precise relationship between yield and estimated stroke risk profile with age , and strong dependence for NNS-RX on the age distribution of the population to be screened : essential information for precise cost-effectiveness calculations
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"OBJECTIVES To evaluate the cost-effectiveness of a national atrial fibrillation screening program in Irel and involving annual opportunistic pulse palpation of all those older than 65 years during general practitioner consultations , with an electrocardiogram being performed if an irregular pulse is detected . METHODS A probabilistic Markov model was used to simulate costs and clinical outcomes in a hypothetical cohort of men and women with and without screening over the course of 25 years , using a societal perspective . RESULTS Screening was associated with an incremental cost-effectiveness ratio of € 23,004/ quality -adjusted life-year compared with routine care . Nevertheless , if the relative risk of stroke and systematic embolism in screen-detected patients is more than 12 % lower than that in patients with atrial fibrillation identified through routine practice , then screening would not be considered cost-effective at a willingness-to-pay threshold of € 45,000/ quality -adjusted life-year . An analysis comparing alternative combinations of start age and screening interval found that less frequent screening with a later start age may be more cost-effective than an annual screening from age 65 years . CONCLUSIONS Annual opportunistic screening of men and women aged 65 years and older in primary care in Irel and is likely to be cost-effective using conventional willingness-to-pay thresholds , assuming that those detected through screening have a comparable stroke risk profile as those detected through routine practice . Raising the start age of screening or increasing the screening interval may improve the cost-effectiveness of a prospect i ve screening program",
"Objectives To assess whether screening improves the detection of atrial fibrillation ( cluster r and omisation ) and to compare systematic and opportunistic screening . Design Multicentred cluster r and omised controlled trial , with subsidiary trial embedded within the intervention arm . Setting 50 primary care centres in Engl and , with further individual r and omisation of patients in the intervention practice s. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practice s. Interventions Patients in intervention practice s were r and omly allocated to systematic screening ( invitation for electrocardiography ) or opportunistic screening ( pulse taking and invitation for electrocardiography if the pulse was irregular ) . Screening took place over 12 months in each practice from October 2001 to February 2003 . No active screening took place in control practice s. Main outcome measure Newly identified atrial fibrillation . Results The detection rate of new cases of atrial fibrillation was 1.63 % a year in the intervention practice s and 1.04 % in control practice s ( difference 0.59 % , 95 % confidence interval 0.20 % to 0.98 % ) . Systematic and opportunistic screening detected similar numbers of new cases ( 1.62 % v 1.64 % , difference 0.02 % , −0.5 % to 0.5 % ) . Conclusion Active screening for atrial fibrillation detects additional cases over current practice . The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography . Trial registration Current Controlled Trials IS RCT N19633732",
"INTRODUCTION AND OBJECTIVES Atrial fibrillation is associated with substantial morbidity and mortality and both its incidence and prevalence are high . Nevertheless , comprehensive data on this condition in Spain are lacking . The aim of this study was to estimate the prevalence of atrial fibrillation in Spain . METHODS A cross-sectional study was conducted in the general Spanish population older than 40 years . Two-stage r and om sampling was used , in which first-stage units were primary care physicians r and omly selected in every Spanish province and second-stage units were 20 r and omly selected persons drawn from each participating physician 's assigned population . The reported prevalence was st and ardized for the age and sex distribution of the Spanish population . The electrocardiogram recordings were read central ly . RESULTS Overall , 8343 individuals were evaluated . The mean age was 59.2 years ( 95 % confidence interval , 58.6 - 59.8 years ) , and 52.4 % of the participants were female . The overall age-adjusted prevalence of atrial fibrillation was 4.4 % ( 95 % confidence interval , 3.8 - 5.1 ) . Prevalence was similar in both sexes , men 4.4 % ( 3.6 - 5.2 ) and women 4.5 % ( 3.6 - 5.3 ) , rising with increasing age older than 60 years . In patients older than 80 years , the prevalence was 17.7 % ( 14.1 - 21.3 ) . In 10 % of patients an unknown atrial fibrillation was diagnosed . CONCLUSIONS The prevalence of atrial fibrillation in the general Spanish population older than 40 years is high , at 4.4 % . The prevalence is similar in both sexes and rises steeply above 60 years of age . It is estimated that there are over 1 million patients with atrial fibrillation in the Spanish population , of whom over 90,000 are undiagnosed",
"BACKGROUND One quarter of strokes are of unknown cause , and sub clinical atrial fibrillation may be a common etiologic factor . Pacemakers can detect sub clinical episodes of rapid atrial rate , which correlate with electrocardiographically documented atrial fibrillation . We evaluated whether sub clinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation . METHODS We enrolled 2580 patients , 65 years of age or older , with hypertension and no history of atrial fibrillation , in whom a pacemaker or defibrillator had recently been implanted . We monitored the patients for 3 months to detect sub clinical atrial tachyarrhythmias ( episodes of atrial rate > 190 beats per minute for more than 6 minutes ) and followed them for a mean of 2.5 years for the primary outcome of ischemic stroke or systemic embolism . Patients with pacemakers were r and omly assigned to receive or not to receive continuous atrial overdrive pacing . RESULTS By 3 months , sub clinical atrial tachyarrhythmias detected by implanted devices had occurred in 261 patients ( 10.1 % ) . Sub clinical atrial tachyarrhythmias were associated with an increased risk of clinical atrial fibrillation ( hazard ratio , 5.56 ; 95 % confidence interval [ CI ] , 3.78 to 8.17 ; P ischemic stroke or systemic embolism ( hazard ratio , 2.49 ; 95 % CI , 1.28 to 4.85 ; P=0.007 ) . Of 51 patients who had a primary outcome event , 11 had had sub clinical atrial tachyarrhythmias detected by 3 months , and none had had clinical atrial fibrillation by 3 months . The population attributable risk of stroke or systemic embolism associated with sub clinical atrial tachyarrhythmias was 13 % . Sub clinical atrial tachyarrhythmias remained predictive of the primary outcome after adjustment for predictors of stroke ( hazard ratio , 2.50 ; 95 % CI , 1.28 to 4.89 ; P=0.008 ) . Continuous atrial overdrive pacing did not prevent atrial fibrillation . CONCLUSIONS Sub clinical atrial tachyarrhythmias , without clinical atrial fibrillation , occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism . ( Funded by St. Jude Medical ; ASSERT Clinical Trials.gov number , NCT00256152 . )",
"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 / BACKGROUND This pilot study of a large population based r and omised screening trial investigated feasibility , acceptability , and relevance ( prevalence of clinical and sub clinical cardiovascular disease [ CVD ] and proportion receiving insufficient prevention ) of a multifaceted screening for CVD . METHODS In total , 2060 r and omly selected Danish men and women aged 65 - 74 years were offered ( i ) low dose non-contrast computed tomography to detect coronary artery calcification ( CAC ) and aortic/iliac aneurysms ; ( ii ) detection of atrial fibrillation ( AF ) ; ( iii ) brachial and ankle blood pressure measurements ; and ( iv ) blood levels of cholesterol and hemoglobin A1c . Web based self booking and data management was used to reduce the administrative burden . RESULTS Attendance rates were 64.9 % ( n = 678 ) and 63.0 % ( n = 640 ) for men and women , respectively . In total , 39.7 % received a recommendation for medical preventive actions . Prevalence of aneurysms was 12.4 % ( 95 % confidence interval [ CI ] 9.9 - 14.9 ) in men and 1.1 % ( 95 % CI 0.3 - 1.9 ) in women , respectively ( p A CAC score > 400 was found in 37.8 % of men and 11.3 % of women ( p in median CAC score with age ( p = .03 ) . Peripheral arterial disease was more prevalent in men ( 18.8 % , 95 % CI 15.8 - 21.8 ) than in women ( 11.2 % , 95 % CI 8.7 - 13.6 ) . No significant differences between the sexes were found with regard to newly discovered AF ( men 1.3 % , women 0.5 % ) , potential hypertension ( men 9.7 % , women 11.5 % ) , hypercholesterolemia ( men 0.9 % , women 1.1 % ) or diabetes mellitus ( men 2.1 % , women 1.3 % ) . CONCLUSION Owing to the higher prevalence of severe conditions , such as aneurysms and CAC ≥ 400 , screening for CVD seemed more prudent in men than women . The attendance rates were acceptable compared with other screening programs and the logistical structure of the screening program proved successful",
"Background : Asymptomatic atrial fibrillation ( AF ) is increasingly common in the aging population and implicated in many ischemic strokes . Earlier identification of AF with appropriate anticoagulation may decrease stroke morbidity and mortality . Methods : We conducted a r and omized controlled trial of AF screening using an AliveCor Kardia monitor attached to a WiFi-enabled iPod to obtain ECGs ( iECGs ) in ambulatory patients . Patients ≥65 years of age with a CHADS-VASc score ≥2 free from AF were r and omized to the iECG arm or routine care ( RC ) . iECG participants acquired iECGs twice weekly over 12 months ( plus additional iECGs if symptomatic ) onto a secure study server with overread by an automated AF detection algorithm and by a cardiac physiologist and /or consultant cardiologist . Time to diagnosis of AF was the primary outcome measure . The overall cost of the devices , ECG interpretation , and patient management were captured and used to generate the cost per AF diagnosis in iECG patients . Clinical events and patient attitudes/experience were also evaluated . Results : We studied 1001 patients ( 500 iECG , 501 RC ) who were 72.6±5.4 years of age ; 534 were female . Mean CHADS-VASc score was 3.0 ( heart failure , 1.4 % ; hypertension , 54 % ; diabetes mellitus , 30 % ; prior stroke/transient ischemic attack , 6.5 % ; arterial disease , 15.9 % ; all CHADS-VASc risk factors were evenly distributed between groups ) . Nineteen patients in the iECG group were diagnosed with AF over the 12-month study period versus 5 in the RC arm ( hazard ratio , 3.9 ; 95 % confidence interval=1.4–10.4 ; P=0.007 ) at a cost per AF diagnosis of $ 10 780 ( £ 8255 ) . There was a similar number of stroke/transient ischemic attack/systemic embolic events ( 6 versus 10 , iECG versus RC ; hazard ratio=0.61 ; 95 % confidence interval=0.22–1.69 ; P=0.34 ) . The majority of iECG patients were satisfied with the device , finding it easy to use without restricting activities or causing anxiety . Conclusions : Screening with twice-weekly single-lead iECG with remote interpretation in ambulatory patients ≥65 years of age at increased risk of stroke is significantly more likely to identify incident AF than RC over a 12-month period . This approach is also highly acceptable to this group of patients , supporting further evaluation in an appropriately powered , event-driven clinical trial . Clinical Trial Registration : URL : https://www.is rct n.com . Unique identifier : IS RCT N10709813",
"OBJECTIVES To determine the most cost-effective method of screening for atrial fibrillation ( AF ) in the population aged 65 years and over , as well as its prevalence and incidence in this age group . Also to evaluate the relative cost-effectiveness of different methods of recording and interpreting the electrocardiogram ( ECG ) within a screening programme . DESIGN Multicentred r and omised controlled trial . Purpose fully selected general practice s were r and omly allocated to 25 intervention practice s and 25 control practice s. SETTING Fifty primary care centres across the West Midl and s , UK . PARTICIPANTS Patients aged 65 years and over . INTERVENTIONS GPs and practice nurses in the intervention practice s received education on the importance of AF detection and ECG interpretation . Patients in the intervention practice s were r and omly allocated to systematic ( n = 5000 ) or opportunistic screening ( n = 5000 ) . Prospect i ve identification of pre-existing risk factors for AF within the screened population enabled comparison between targeted screening of people at higher risk of AF and total population screening . MAIN OUTCOME MEASURES AF detection rates in systematic ally screened and opportunistically screened population s in the intervention practice s were compared with AF detection rate in 5000 patients in the control practice s. The screening period was 12 months . RESULTS Baseline prevalence of AF was 7.2 % , with a higher prevalence in males ( 7.8 % ) and patients aged 75 years and over ( 10.3 % ) . The control population demonstrated higher baseline prevalence ( 7.9 % ) than either the systematic ( 6.9 % ) or opportunistic ( 6.9 % ) intervention population . In the control population 47 new cases were detected ( incidence 1.04 % per year ) . In the opportunistic arm 243 patients without a baseline diagnosis of AF were found to have an irregular pulse , with 177 having an ECG , yielding 31 new cases ( incidence 0.69 % per year ) . A further 44 cases were detected outside the screening programme ( overall incidence 1.64 % per year ) . In the systematic arm 2357 patients had an ECG yielding 52 new cases ( incidence 1.1 % per year ) . Of these , 31 were detected by targeted screening and a further 21 by total population screening . A further 22 cases were detected outside the screening programme ( overall incidence 1.62 % per year ) . In terms of ECG interpretation , computerised decision support software ( CDSS ) gave a sensitivity of 87.3 % , a specificity of 99.1 % and a positive predictive value ( PPV ) of 89.5 % compared with the gold st and ard ( cardiologist reporting ) . GPs and practice nurses performed less well . The only difference in performance between intervention population s and controls was that practice nurses from the control arm performed less well than with intervention practice nurses on interpretation of limb-lead ( PPV 38.8 % versus 20.8 % ) and single-lead ( PPV 37.7 % versus 24.0 % ) ECGs . The within-trial economic evaluation results showed the lowest incremental cost to be for the opportunistic arm , with an incremental cost-effectiveness ratio of 337 pounds Sterling for each additional case detected compared to the control arm . Opportunistic screening dominated both more intensive screening strategies . Model-based analyses showed small differences in cost and quality -adjusted life-years for different methods and intensities of screening , but annual opportunistic screening result ed in the lowest number of ischaemic strokes and greatest proportion of cases of AF diagnosed . Probabilistic sensitivity results indicated that there was a probability of approximately 60 % that screening from the age of 65 years was cost-effective in both men and women . CONCLUSIONS The results of the study indicated that in terms of a screening programme for atrial fibrillation in patients 65 and over , the only strategy that improved on routine practice was opportunistic screening , model-based analyses indicated that there was a probability of approximately 60 % of annual opportunistic screening being cost effective . It is suggested that the following topics are worthy of further investigation : the effect of the implementation of a screening programme for AF on the uptake and maintenance of anticoagulation in patients aged 65 years and over ; an evaluation of the role of CDSS in the diagnosis of cardiac arrythmias ; the best method for routinely detecting paroxysmal AF ; ways of improving healthcare professionals ' performance in ECG interpretation ; development of a robust economic model to incorporate data on new therapeutic agents for use as thromboprophylactic agents for patients with AF , and an evaluation of the relative risk of stroke for patients with incident as opposed to prevalent AF",
"OBJECTIVE The goal of this study was to assess the effectiveness of opportunistic screening through pulse palpation in the early detection of atrial fibrillation in subjects aged≥65 years versus detection through an active search for patients with symptoms and /or complications and sequelae associated . MATERIAL AND METHODS This was a cluster r and omized controlled trial performed in 48 primary care centers of the Spanish National Healthcare System . A total of 368 physicians and nurses were r and omized . The research ers in the experimental group ( EG ) performed opportunistic screening for auricular fibrillation , whereas the research ers in the control group ( CG ) actively search ed for symptomatic patients . An ECG was performed on patients found to have an irregular heartbeat to confirm the diagnosis of auricular fibrillation . RESULTS A total of 5,465 patients with a mean age of 75.61 years were recruited for the EG , and 1,525 patients with a mean age of 74.07 years were recruited for the CG . Of these , 58.6 % were female , without significant differences between groups . Pulse was irregular in 4.3 and 15.0 % of the patients in the EG and the CG , respectively ( P cases of atrial fibrillation were detected ( 2.3 % ) , 1.1 % in the EG and 6.7 % in the CG ( adjusted OR : 0.29 ; 95 % CI 0.18 - 0.45 ) . CONCLUSIONS Case finding for atrial fibrillation in patients aged≥65 years with symptoms or signs suggestive of atrial fibrillation is a more effective strategy than opportunistic screening through pulse palpation in asymptomatic patients . TRIAL REGISTRATION The trial is registered in Clinical Trials.gov ( NCT01291953 ; February 8 , 2011 )",
"Importance Opportunistic screening for atrial fibrillation ( AF ) is recommended , and improved methods of early identification could allow for the initiation of appropriate therapies to prevent the adverse health outcomes associated with AF . Objective To determine the effect of a self-applied wearable electrocardiogram ( ECG ) patch in detecting AF and the clinical consequences associated with such a detection strategy . Design , Setting , and Participants A direct-to-participant r and omized clinical trial and prospect i ve matched observational cohort study were conducted among members of a large national health plan . Recruitment began November 17 , 2015 , and was completed on October 4 , 2016 , and 1-year cl aims -based follow-up concluded in January 2018 . For the clinical trial , 2659 individuals were r and omized to active home-based monitoring to start immediately or delayed by 4 months . For the observational study , 2 deidentified age- , sex- and CHA2DS2-VASc – matched controls were selected for each actively monitored individual . Interventions The actively monitored cohort wore a self-applied continuous ECG monitoring patch at home during routine activities for up to 4 weeks , initiated either immediately after enrolling ( n = 1364 ) or delayed for 4 months after enrollment ( n = 1291 ) . Main Outcomes and Measures The primary end point was the incidence of a new diagnosis of AF at 4 months among those r and omized to immediate monitoring vs delayed monitoring . A secondary end point was new AF diagnosis at 1 year in the combined actively monitored groups vs matched observational controls . Other outcomes included new prescriptions for anticoagulants and health care utilization ( outpatient cardiology visits , primary care visits , or AF-related emergency department visits and hospitalizations ) at 1 year . Results The r and omized groups included 2659 participants ( mean [ SD ] age , 72.4 [ 7.3 ] years ; 38.6 % women ) , of whom 1738 ( 65.4 % ) completed active monitoring . The observational study comprised 5214 ( mean [ SD ] age , 73.7 [ 7.0 ] years ; 40.5 % women ; median CHA2DS2-VASc score , 3.0 ) , including 1738 actively monitored individuals from the r and omized trial and 3476 matched controls . In the r and omized study , new AF was identified by 4 months in 3.9 % ( 53/1366 ) of the immediate group vs 0.9 % ( 12/1293 ) in the delayed group ( absolute difference , 3.0 % [ 95 % CI , 1.8%-4.1 % ] ) . At 1 year , AF was newly diagnosed in 109 monitored ( 6.7 per 100 person-years ) and 81 unmonitored ( 2.6 per 100 person-years ; difference , 4.1 [ 95 % CI , 3.9 - 4.2 ] ) individuals . Active monitoring was associated with increased initiation of anticoagulants ( 5.7 vs 3.7 per 100 person-years ; difference , 2.0 [ 95 % CI , 1.9 - 2.2 ] ) , outpatient cardiology visits ( 33.5 vs 26.0 per 100 person-years ; difference , 7.5 [ 95 % CI , 7.2 - 7.9 ) , and primary care visits ( 83.5 vs 82.6 per 100 person-years ; difference , 0.9 [ 95 % CI , 0.4 - 1.5 ] ) . There was no difference in AF-related emergency department visits and hospitalizations ( 1.3 vs 1.4 per 100 person-years ; difference , 0.1 [ 95 % CI , −0.1 to 0 ] ) . Conclusions and Relevance Among individuals at high risk for AF , immediate monitoring with a home-based wearable ECG sensor patch , compared with delayed monitoring , result ed in a higher rate of AF diagnosis after 4 months . Monitored individuals , compared with nonmonitored controls , had higher rates of AF diagnosis , greater initiation of anticoagulants , but also increased health care re source utilization at 1 year . Trial Registration Clinical Trials.gov Identifier :",
"BACKGROUND Detection of undiagnosed or undertreated ( \" actionable \" ) atrial fibrillation could increase the use of appropriate oral anticoagulant therapy and reduce the risk of stroke . We sought to compare newer screening technologies with a pulse-check for the detection of atrial fibrillation and to determine whether the detection of actionable atrial fibrillation increases the use of oral anticoagulant agents . METHODS This prospect i ve multicentre cohort study involved 22 primary care clinics . We recruited participants aged 65 years and older who were attending routine appointments . Each participant underwent 3 methods of screening : a 30-second radial pulse-check ; single-lead electrocardiogram ; and screening by blood pressure machine with atrial fibrillation detection algorithms . Participants who received a positive result on 1 or more test underwent 12-lead electrocardiogram with or withour 24-hour Holter . Screening tests were compared using the McNemar test . Participants with confirmed atrial fibrillation received follow-up at 90 days . RESULTS The mean age of participants was 73.7 ( ± 6.9 ) years , and 53.4 % of participants were female . Of 2171 patients , we had data from all 3 screening tests for 2054 patients . Both single-lead electrocardiogram and the blood pressure device showed superior specificity compared with pulse-check ( p atrial fibrillation ( 0.7 % ) . By 90 days , 77 % of patients with actionable atrial fibrillation had started anticoagulant therapy . INTERPRETATION Newer screening technologies showed superior specificity compared with a pulse-check . Screening detected undiagnosed or undertreated atrial fibrillation in 0.7 % of participants , and 77 % started appropriate anticoagulant therapy . TRIAL REGISTRATION Clinical Trials.gov , no. NCT02262351",
"A number of r and omized controlled trials in atrial fibrillation ( AF ) conducted in the last century showed that vitamin K antagonists , ( VKAs ) , principally warfarin , were remarkably effective in stroke prevention , reducing stroke by 64 % and all-cause mortality by 26 % , figures rarely matched in treatments of other diseases . With the introduction of the non-VKA anticoagulants ( NOACs ) in the last 8 years , stroke reduction in the r and omized trials was similar to VKAs , but with less intracranial haemorrhage and a further 1 % absolute risk reduction in total mortality ; results confirmed in many ‘ real-life ’ studies using administrative or registry data . Many guidelines , including the first joint AHA/ACC/ESC guideline in 2001 , recommended oral anticoagulant ( OAC ) therapy for those with AF at elevated risk of stroke , as have subsequent joint and ESC guidelines and up date s in 2006 , 2010 , 2012 , and 2016 . But OAC uptake has been less than ideal for some time , hovering in the UK at 50 % of those for whom OAC was guideline recommended , in the 10 years from 2001 to 2011 . The data from the Swedish RIKS registry of > 94 000 strokes help identify the two major gaps in prevention of AF-related strokes , which represent 33 % of all ischaemic strokes ( Take home figure ) . In 9 % of all strokes , AF was not known prior to stroke : prevention would require screening to detect and treat unknown AF . In another 20 % , AF was known but patients were either on no antithrombotic therapy ( 8 % ) or on antiplatelet therapy alone ( 12 % ) , which is largely ineffective for AF thrombo-prophylaxis . Thus , up to 20 % of ischaemic strokes might be prevented if the evidence – practice gap of OAC prescription was eliminated . It is therefore very pleasing to see in this issue of the European Heart Journal that in the UK , OAC use in patients with elevated stroke risk has increased from antiplatelet therapy has reduced from 43 % to 16 % . This is a great success story , observed to some degree in many countries , but by no means uniformly , even within the same country . Trying to pinpoint the reason for this improvement is not easy . Success has many fathers , while failure is an orphan . Cowan and colleagues postulate that successive ESC and NICE guidelines , quality improvement incentivization programmes such as GRASP and QOF , or licensing and marketing of NOACs , accentuating their ease of use , could all have played a role , but it is difficult to determine which is the major one . ESC guidelines and their up date s were recommending OAC in 2001 , 2006 , and 2010 , and the GRASP quality initiative from 2009 , with little change in OAC uptake , while QOF did not commence until 2012 . It is instructive to look at our own UK data using a higher resolution temporal trend of OAC initiation within 90 days of incident AF ( Figure 1 ) . The graph plots total OAC initiations for patients with CHA2DS2-VASc > _ 2 . A rise in VKA OAC prescription was observed from early 2011 , when limited marketing preceded the availability of NOAC drugs , followed by an accentuated increase due to NOAC prescription accompanied by a plateau in VKA prescription . It is quite likely that at this time point , the availability and marketing of NOACs played a dominant role , with this influence increasing as additional NOACs became available . The final increase from 2013 to 2106 is probably a combination of all three factors : an effective national QOF quality framework , gradual percolation of guidelines and up date s , and continued marketing of NOACs . Ensuring that a high proportion of patients with AF are taking effective doses of OAC rather than aspirin requires first that OAC is offered by the physician and accepted by the patient , secondly that patients are adherent to taking the drugs as prescribed , achieving > 70 % time in the therapeutic international normalized ratio ( INR ) range for VKAs , and finally , that patients persist with taking OAC therapy long-term . There is a high non-persistence rate for OAC in the first 2 years after initiation , significantly greater for VKAs than"
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BACKGROUND Cryptogenic stroke is a stroke for which no cause is identified after st and ard diagnostic tests . Long-term implantable cardiac monitors may be better at diagnosing atrial fibrillation and provide an opportunity to reduce the risk of stroke recurrence with anticoagulants . OBJECTIVES The objectives were to assess the diagnostic test accuracy , clinical effectiveness and cost-effectiveness of three implantable monitors [ BioMonitor 2-AF ™ ( Biotronik SE & Co. KG , Berlin , Germany ) , Confirm Rx ™ ( Abbott Laboratories , Lake Bluff , IL , USA ) and Reveal LINQ ™ ( Medtronic plc , Minneapolis , MN , USA ) ] in patients who have had a cryptogenic stroke and for whom no atrial fibrillation is detected after 24 hours of external electrocardiographic monitoring . DATA SOURCES MEDLINE , EMBASE , The Cochrane Library , Data base of Abstract s of Review s of Effects and Health Technology Assessment data bases were search ed from inception until September 2018 . REVIEW METHODS A systematic review was undertaken . Two review ers agreed on studies for inclusion and performed quality assessment using the Cochrane Risk of Bias 2.0 tool . Results were discussed narratively because there were insufficient data for synthesis . A two-stage de novo economic model was developed : ( 1 ) a short-term patient flow model to identify cryptogenic stroke patients who have had atrial fibrillation detected and been prescribed anticoagulation treatment ( rather than remaining on antiplatelet treatment ) and ( 2 ) a long-term Markov model that captured the lifetime costs and benefits of patients on either anticoagulation or antiplatelet treatment . RESULTS One r and omised controlled trial , Cryptogenic Stroke and underlying Atrial Fibrillation ( CRYSTAL-AF ) ( Sanna T , Diener HC , Passman RS , Di Lazzaro V , Bernstein RA , Morillo CA , et al. Cryptogenic stroke and underlying atrial fibrillation . N Engl J Med 2014;370:2478 - 86 ) , was identified , and no diagnostic test accuracy study was identified . The CRYSTAL-AF trial compared the Reveal ™ XT ( a Reveal LINQ predecessor ) ( Medtronic plc ) monitor with st and ard of care monitoring . Twenty-six single-arm observational studies for the Reveal devices were also identified . The only data for BioMonitor 2-AF or Confirm Rx were from mixed population studies supplied by the companies . Atrial fibrillation detection in the CRYSTAL-AF trial was higher with the Reveal XT than with st and ard monitoring at all time points . By 36 months , atrial fibrillation was detected in 19 % of patients with an implantable cardiac monitor and in 2.3 % of patients receiving conventional follow-up . The 26 observational studies demonstrated that , even in a cryptogenic stroke population , atrial fibrillation detection rates are highly variable and most cases are asymptomatic ; therefore , they probably would not have been picked up without an implantable cardiac monitor . Device-related adverse events , such as pain and infection , were low in all studies . The de novo economic model produced incremental cost effectiveness ratios comparing implantable cardiac monitors with st and ard of care monitoring to detect atrial fibrillation in cryptogenic stroke patients based on data for the Reveal XT device , which can be related to Reveal LINQ . The BioMonitor 2-AF and Confirm RX were included in the analysis by making a strong assumption of equivalence with Reveal LINQ . The results indicate that implantable cardiac monitors could be considered cost-effective at a £ 20,000 - 30,000 threshold . When each device is compared incrementally , BioMonitor 2-AF dominates Reveal LINQ and Confirm RX . LIMITATIONS The cost-effectiveness analysis for implantable cardiac monitors is based on a strong assumption of clinical equivalence and should be interpreted with caution . CONCLUSIONS All three implantable cardiac monitors could be considered cost-effective at a £ 20,000 - 30,000 threshold , compared with st and ard of care monitoring , for cryptogenic stroke patients with no atrial fibrillation detected after 24 hours of external electrocardiographic monitoring ; however , further clinical studies are required to confirm their efficacy in cryptogenic stroke patients . STUDY REGISTRATION This study is registered as PROSPERO CRD42018109216 . 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 . 24 , No. 5 . See the NIHR Journals Library website for further project information
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"Background and Purpose — Many ischemic strokes or transient ischemic attacks are labeled cryptogenic but may have undetected atrial fibrillation ( AF ) . We sought to identify those most likely to have sub clinical AF . Methods — We prospect ively studied patients with cryptogenic stroke or transient ischemic attack aged ≥55 years in sinus rhythm , without known AF , enrolled in the intervention arm of the 30 Day Event Monitoring Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event ( EMBRACE ) trial . Participants underwent baseline 24-hour Holter ECG poststroke ; if AF was not detected , they were r and omly assigned to 30-day ECG monitoring with an AF auto-detect external loop recorder . Multivariable logistic regression assessed the association between baseline variables ( Holter-detected atrial premature beats [ APBs ] , runs of atrial tachycardia , age , and left atrial enlargement ) and subsequent AF detection . Results — Among 237 participants , the median baseline Holter APB count/24 h was 629 ( interquartile range , 142–1973 ) among those who subsequently had AF detected versus 45 ( interquartile range , 14–250 ) in those without AF ( P ) . APB count was the only significant predictor of AF detection by 30-day ECG ( P the probability of AF increased from older cryptogenic stroke or transient ischemic attack patients , the number of APBs on a routine 24-hour Holter ECG was a strong dose-dependent independent predictor of prevalent sub clinical AF . Those with frequent APBs have a high probability of AF and represent ideal c and i date s for prolonged ECG monitoring for AF detection . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00846924",
"Background —It is unknown if brief episodes of device-detected atrial fibrillation ( AF ) increase thromboembolic event ( TE ) risk . Methods and Results —TRENDS was a prospect i ve , observational study enrolling patients with ≥1 stroke risk factor ( heart failure , hypertension , age ≥65 years , diabetes , or prior TE ) receiving pacemakers or defibrillators that monitor atrial tachycardia (AT)/AF burden ( defined as the longest total AT/AF duration on any given day during the prior 30-day period ) . This time-varying exposure was up date d daily during follow-up and related to TE risk . Annualized TE rates were determined according to AT/AF burden subsets : zero , low ( Patients ( n=2486 ) had at least 30 days of device data for analysis . During a mean follow-up of 1.4 years , annualized TE risk ( including transient ischemic attacks ) was 1.1 % for zero , 1.1 % for low , and 2.4 % for high burden subsets of 30-day windows . Compared with zero burden , adjusted hazard ratios ( 95 % CIs ) in the low and high burden subsets were 0.98 ( 0.34 to 2.82 , P=0.97 ) and 2.20 ( 0.96 to 5.05 , P=0.06 ) , respectively . Conclusions —The TE rate was low compared with patients with traditional AF with similar risk profiles . The data suggest that TE risk is a quantitative function of AT/AF burden . AT/AF burden ≥5.5 hours on any of 30 prior days appeared to double TE risk . Additional studies are needed to more precisely investigate the relationship between stroke risk and AT/AF burden",
"Abstract Objectives . The aim of this study was to compare health-related quality of life ( HRQoL ) scores obtained from the instrument Short Form (SF)-36 through the so-called SF-6D utilities , and those obtained from 15D , in patients with ST-elevation myocardial infa rct ion ( STEMI ) , and to evaluate the consequences in estimation of quality adjusted life years ( QALYs ) . Design . This was a sub- study of the Norwegian District Treatment of STEMI , in which patients with STEMI treated with tenecteplase , were r and omized to early angioplasty or st and ard management ( n = 266 ) . HRQoL data were collected at all visits ( 0 , 1 , 3 , 7 and 12 months ) . All patients with complete data were included ( n = 248 ) . Results . The score range was 0.33–1.0 for SF-6D and 0.49–1.0 for 15D . Mean utility scores from 15D were higher and had different distribution compared to scores from SF-6D . Mean QALY for the whole group was higher using 15D than SF-6D ( 0.89 vs. 0.77 ) . The incremental number of QALYs with early angioplasty compared to st and ard treatment was 0.005 ( 95 % CI : − 0.018 to 0.028 ) using SF-6D , and 0.004 ( 95 % CI : − 0.010 to 0.018 ) using the 15D instrument . Conclusions . Choice of instrument may influence HRQoL scores , but not necessarily the gain in QALYs ",
"Background The impact of different types of extracranial bleeding events on health‐related quality of life and health‐state utility among patients with atrial fibrillation is not well understood . Methods and Results The ENGAGE AF‐TIMI 48 ( Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation – Thrombolysis in Myocardial Infa rct ion 48 ) Trial compared edoxaban with warfarin with respect to the prevention of stroke or systemic embolism in atrial fibrillation . Data from the EuroQol‐5D ( EQ‐5D‐3L ) question naire , prospect ively collected at 3‐month intervals for up to 48 months , were used to estimate the impact of different categories of bleeding events on health‐state utility over 12 months following the event . Longitudinal mixed‐effect models revealed that major gastrointestinal bleeds and major nongastrointestinal bleeds were associated with significant immediate decreases in utility scores ( −0.029 [ −0.044 to −0.014 ; P impacts on utility ( −0.010 [ −0.016 to −0.005 ] and −0.016 [ −0.024 to −0.008 ] ; P impacts on health‐state utility in patients with atrial fibrillation . Major bleeds were associated with relatively large immediate decreases in utility scores that gradually diminished over 12 months ; clinical ly relevant nonmajor and minor bleeds were associated with smaller immediate decreases in utility that persisted over 12 months . Clinical Trial Registration URL : https://www . clinical trials.gov/. Unique identifier : NCT00781391",
"BACKGROUND Atrial fibrillation ( AF ) is a major risk factor of stroke , but the association between AF and transient ischemic attack ( TIA ) is less clear . Despite this , patients with TIA are included in stroke trials . AIMS To determine the 1-year incidence of AF in TIA patients using an insertable cardiac monitor ( ICM ) ; second , to determine factors associated with incident AF in these patients . METHODS Prospect i ve cohort study of patients with TIA with normal st and ard electrocardiogram ( ECG ) and 72-hour Holter monitoring ( HM ) . Exclusion criteria were as follows : age 81 years ; prior AF/stroke ; ongoing oral anticoagulation therapy or contraindication for it ; significant carotid artery stenosis ; uncertain TIA diagnosis . Eligible patients received an ICM and were followed for 12 months . RESULTS From November 2013 to October 2015 , 809 patients were diagnosed with TIA . In total , 235 patients were eligible . Nine ( 3.8 % ) of these had AF on st and ard ECG or HM . Of the remaining patients , 121 refused ICM implantation . In total , 105 patients ( median age 65.4 years [ range 27.1 - 80.8 ] , 46 % males ) received an ICM , which revealed AF in 7 ( 6.7 % ) . Factors associated with new-onset AF were a history of recurrent TIA ( odds ratio [ OR ] 11.5 , 95 % confidence interval [ CI ] 2.1 - 63.6 ) and heart failure ( OR 12.7 , 95 % CI 1.71 - 96.83 ) . CONCLUSIONS The 1-year incidence of AF in TIA patients with normal ECG and HM was 6.7 % using an ICM . Factors associated with development of AF were recurrent TIA and heart failure",
"Abstract The EQ-5D question naire is a widely used generic instrument for describing and valuing health that was developed by the EuroQol Group . A primary objective of the EuroQol Group is the investigation of values for health states in the general population in different countries . As part of the EuroQol enterprise 11 population surveys were carried out in six Western European countries ( Finl and , Germany , The Netherl and s , Spain , Sweden and the UK ) to value health states as defined by the EQ-5D using a st and ardised visual analogue scale ( EQ-5D VAS ) . This contribution reports how a European set of general population preference weights was derived from the data collected in the 11 valuation studies . The scores from this set of preference weights can be applied to generate a VAS-based weighted health status index for all the potential 243 EQ-5D health states for use in multi-national studies . To estimate the preference weights a multi-level regression analysis was performed on 82,910 valuations of 44 EQ-5D health states elicited from 6,870 respondents . Stable and plausible solutions were found for the model parameters . The R2 value was 75 % . The analysis showed that the major source of variance , apart from ' r and om error ' , was variance between individuals ( 28.3 % of the total residual variance ) . These results suggest that VAS values for EQ-5D health states in six Western European countries can be described by a common model",
"Stroke , as the leading cause of physical disability and cognitive impairment , has a very significant impact on patients ’ quality of life ( QoL ) . The objective of this study is to know the effect of citicoline treatment in Qol and cognitive performance in the long-term in patients with a first ischemic stroke . This is an open-label , r and omized , parallel study of citicoline vs. usual treatment . All subjects were selected 6 weeks after suffering a first ischemic stroke and r and omized into parallel arms . Neuropsychological evaluation was performed at 1 month , 6 months , 1 year and 2 years after stroke , and QoL was measured using the EuroQoL-5D question naire at 2 years . 163 patients were followed during 2 years . The mean age was 67.5 years-old , and 50.9 % were women . Age and absence of citicoline treatment were independent predictors of both utility and poor quality of life . Patients with cognitive impairment had a poorer QoL at 2 years ( 0.55 vs. 0.66 in utility , p = 0.015 ) . Citicoline treatment improved significantly cognitive status during follow-up ( p = 0.005 ) . In conclusion , treatment with long-term citicoline is associated with a better QoL and improves cognitive status 2 years after a first ischemic stroke",
"Background —Atrial fibrillation ( AF ) can be a cause of previously diagnosed cryptogenic stroke . However , AF can be paroxysmal and asymptomatic , thereby making detection with routine ECG methods difficult . Oral anticoagulation is highly effective in reducing recurrent stroke in patients with AF , but its initiation is dependent on the detection of AF . Cryptogenic Stroke and Underlying Atrial Fibrillation ( CRYSTAL AF ) is the first r and omized study to report the detection of AF in cryptogenic stroke patients using continuous long-term monitoring via insertable cardiac monitors ( ICM ) . Methods and Results — Patients with prior cryptogenic stroke were r and omized to control ( n=220 ) or ICM ( n=221 ) and followed for ⩽36 months . Cumulative AF detection rates in the ICM arm increased progressively during this period ( 3.7 % , 8.9 % , 12.4 % , and 30.0 % at 1 , 6 , 12 , and 36 months , respectively ) , but remained low in the control arm ( 3.0 % at 36 months ) . This result ed in oral anticoagulation prescription in 94.7 % of ICM patients with AF detected at 6 months , 96.6 % at 12 months , and 90.5 % at 36 months . Among ICM patients with AF detected , the median time to AF detection was 8.4 months , 81.0 % of first AF episodes were asymptomatic , and 94.9 % had at least 1 day with > 6 minutes of AF . Conclusions —Three-year monitoring by ICM in cryptogenic stroke patients demonstrated a significantly higher AF detection rate compared with routine care . Given the frequency of asymptomatic first episodes and the long median time to detection , these findings highlight the limitations of using traditional AF detection methods . The majority of patients with AF were prescribed oral anticoagulation therapy . Clinical Trial Registration — Clinical trials.gov ; Unique identifier : NCT00924638",
"BACKGROUND In the AVERROES study , apixaban , a novel factor Xa inhibitor , reduced the risk of stroke or systemic embolism in patients with atrial fibrillation who were at high risk of stroke but unsuitable for vitamin K antagonist therapy . We aim ed to investigate whether the subgroup of patients with previous stroke or transient ischaemic attack ( TIA ) would show a greater benefit from apixaban compared with aspirin than would patients without previous cerebrovascular events . METHODS In AVERROES , 5599 patients ( mean age 70 years ) with atrial fibrillation who were at increased risk of stroke and unsuitable for vitamin K antagonist therapy were r and omly assigned to receive apixaban ( 5 mg twice daily ) or aspirin ( 81 - 324 mg per day ) . The mean follow-up was 1·1 years . The primary efficacy outcome was stroke or systemic embolism ; the primary safety outcome was major bleeding . Patients and investigators were masked to study treatment . In this prespecified subgroup analysis , we used Kaplan-Meier estimates of 1-year event risk and Cox proportional hazards regression models to compare the effects of apixaban in patients with and without previous stroke or TIA . AVERROES is registered at Clinical Trials.gov , number NCT00496769 . FINDINGS In patients with previous stroke or TIA , ten events of stroke or systemic embolism occurred in the apixaban group ( n=390 , cumulative hazard 2·39 % per year ) compared with 33 in the aspirin group ( n=374 , 9·16 % per year ; hazard ratio [ HR ] 0·29 , 95 % CI 0·15 - 0·60 ) . In those without previous stroke or TIA , 41 events occurred in the apixaban group ( n=2417 , 1·68 % per year ) compared with 80 in the aspirin group ( n=2415 , 3·06 % per year ; HR 0·51 , 95 % CI 0·35 - 0·74 ) . The p value for interaction of the effects of aspirin and apixaban with previous cerebrovascular events was 0·17 . Major bleeding was more frequent in patients with history of stroke or TIA than in patients without ( HR 2·88 , 95 % CI 1·77 - 4·55 ) but risk of this event did not differ between treatment groups . INTERPRETATION In patients with atrial fibrillation , apixaban is similarly effective whether or not patients have had a previous stroke or TIA . Given that those with previous stroke or TIA have a higher risk of stroke , the absolute benefits might be greater in these patients . FUNDING Bristol-Myers Squibb and Pfizer",
"BACKGROUND In ROCKET AF , rivaroxaban was non-inferior to adjusted-dose warfarin in preventing stroke or systemic embolism among patients with atrial fibrillation ( AF ) . We aim ed to investigate whether the efficacy and safety of rivaroxaban compared with warfarin is consistent among the subgroups of patients with and without previous stroke or transient ischaemic attack ( TIA ) . METHODS In ROCKET AF , patients with AF who were at increased risk of stroke were r and omly assigned ( 1:1 ) in a double-blind manner to rivaroxaban 20 mg daily or adjusted dose warfarin ( international normalised ratio 2·0 - 3·0 ) . Patients and investigators were masked to treatment allocation . Between Dec 18 , 2006 , and June 17 , 2009 , 14 264 patients from 1178 centres in 45 countries were r and omly assigned . The primary endpoint was the composite of stroke or non-CNS systemic embolism . In this sub study we assessed the interaction of the treatment effects of rivaroxaban and warfarin among patients with and without previous stroke or TIA . Efficacy analyses were by intention to treat and safety analyses were done in the on-treatment population . ROCKET AF is registered with Clinical Trials.gov , number NCT00403767 . FINDINGS 7468 ( 52 % ) patients had a previous stroke ( n=4907 ) or TIA ( n=2561 ) and 6796 ( 48 % ) had no previous stroke or TIA . The number of events per 100 person-years for the primary endpoint in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA ( 2·79 % rivaroxaban vs 2·96 % warfarin ; hazard ratio [ HR ] 0·94 , 95 % CI 0·77 - 1·16 ) and those without ( 1·44%vs 1·88 % ; 0·77 , 0·58 - 1·01 ; interaction p=0·23 ) . The number of major and non-major clinical ly relevant bleeding events per 100 person-years in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA ( 13·31 % rivaroxaban vs 13·87 % warfarin ; HR 0·96 , 95 % CI 0·87 - 1·07 ) and those without ( 16·69%vs 15·19 % ; 1·10 , 0·99 - 1·21 ; interaction p=0·08 ) . INTERPRETATION There was no evidence that the relative efficacy and safety of rivaroxaban compared with warfarin was different between patients who had a previous stroke or TIA and those who had no previous stroke or TIA . These results support the use of rivaroxaban as an alternative to warfarin for prevention of recurrent as well as initial stroke in patients with AF . FUNDING Johnson and Johnson Pharmaceutical Research and Development and Bayer HealthCare",
"BACKGROUND AND PURPOSE Neurological impairment and physical disability are frequent and important complications of stroke with serious consequences for health-related quality of life ( HRQOL ) . Little data exist , however , on the risk factors for poor HRQOL after intracerebral hemorrhage , the deadliest and most disabling form of stroke . METHODS Factor Seven for Acute Hemorrhagic Stroke ( FAST ) was an international , r and omized , double-blind , placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries . All patients were followed for 3 months after stroke onset and HRQOL was assessed using the EuroQoL. Multivariate stepwise logistic regression was used to identify predictors of poor HRQOL based on demographic and clinical baseline characteristics and in-hospital complications . RESULTS Six hundred fifty-seven patients survived until 3 months after stroke onset , and 621 ( 95 % ) completed the EuroQoL. Two percent had a utility score utility score utility score score utility score of 1 ( perfect HRQOL ) . Independent predictors of poor HRQOL were advanced age ( OR , 1.80 ; P National Institutes of Health Stroke Scale score ( OR , 1.11 ; P systolic blood pressure ( OR , 1.05 ; P=0.0039 ) , higher baseline intracerebral hemorrhage volume ( OR , 1.11 ; P=0.015 ) , deep ( versus lobar ) hematoma location ( OR , 3.05 ; P=0.003 ) , and increase in neurological deficit in first 72 hours after ICH onset ( Delta Glasgow Coma Scale > or=2 or Delta National Institutes of Health Stroke Scale > or=4 ; OR , 2.04 ; P=0.006 ) . The model explained a large amount of the variation in the utility score ( C-statistic 0.77 ) . CONCLUSIONS The vast majority of survivors after intracerebral hemorrhage have very poor HRQOL . Critical care interventions design ed to control blood pressure or prevent neuroworsening may improve HRQOL in intracerebral hemorrhage survivors",
"Background —Current methods for detecting atrial fibrillation ( AF ) have limited diagnostic yield . Continuous monitoring with automatic arrhythmia detection and classification may improve detection of symptomatic and asymptomatic AF and subsequent patient treatment . The study purpose was to quantify the performance of the first implantable leadless cardiac monitor ( ICM ) with dedicated AF detection capabilities . Methods and Results — Patients ( n=247 ) with an implanted ICM ( Reveal XT , Medtronic Inc , Minneapolis , Minn ) who were likely to present with paroxysmal AF were selected . A special Holter device stored 46 hours of subcutaneously recorded ECG , ICM markers , and 2 surface ECG leads . The ICM automatic arrhythmia classification was compared with the core laboratory classification of the surface ECG . Of the 206 analyzable Holter recordings collected , 76 ( 37 % ) contained at least 1 episode of core laboratory classified AF . The sensitivity , specificity , positive predictive value , and negative predictive value for identifying patients with any AF were 96.1 % , 85.4 % , 79.3 % , and 97.4 % , respectively . The AF burden measured with the ICM was very well correlated with the reference value derived from the Holter ( Pearson coefficient=0.97 ) . The overall accuracy of the ICM for detecting AF was 98.5 % . Conclusions —In this ICM validation study , the dedicated AF detection algorithm reliably detected the presence or absence of AF and the AF burden was accurately quantified . The ICM is a promising new diagnostic and monitoring tool for the clinician to treat AF patients independently of symptoms . Long-term studies are needed to evaluate the clinical benefits of the technology . Clinical Trial Registration — clinical trials.gov Identifier NCT00680927",
"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 AND PURPOSE There have been few community-based studies of long-term prognosis after acute stroke . This study aims to provide precise estimates of the absolute and relative risks of stroke recurrence in an unselected cohort of patients with a first-ever stroke . METHODS Six hundred seventy-five patients were registered in a community-based stroke register ( the Oxfordshire Community Stroke Project ) and prospect ively followed for up to 6.5 years . Their relative risk of recurrent stroke was calculated using age- and sex-specific incidence rates for first stroke in Oxfordshire . RESULTS One hundred eighty recurrent episodes of stroke were identified , of which 135 were first recurrences . Given survival , the actuarial risk of suffering a recurrence was 30 % ( 95 % confidence interval , 20 % to 39 % ) by 5 years , about nine times the risk of stroke in the general population . The risk was highest early after the first stroke : 13 % ( 95 % confidence interval , 10 % to 16 % ) by 1 year , 15 times the risk in the general population . After the first year the average annual risk was about 4 % . The risk of stroke recurrence did not appear to be related to age or pathological type of stroke . CONCLUSIONS The absolute and relative risks of recurrent stroke are highest early after the first stroke but remain elevated for several years thereafter . Efforts at secondary prevention should be initiated as soon as possible and continued for several years to gain greatest benefit",
"BACKGROUND Apixaban ( 5 mg BID ) , dabigatran ( available as 150 mg and 110 mg BID in Europe ) , and rivaroxaban ( 20 mg once daily ) are 3 novel oral anticoagulants ( NOACs ) currently approved for stroke prevention in patients with atrial fibrillation ( AF ) . OBJECTIVE The objective of this study was to evaluate the cost-effectiveness of apixaban against other NOACs from the perspective of the United Kingdom National Health Services . METHODS A Markov model was developed to evaluate the pharmacoeconomic impact of apixaban versus other NOACs over a lifetime . Pair-wise indirect treatment comparisons were conducted against other NOACs by using ARISTOTLE ( Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ) , RE-LY ( R and omized Evaluation of Long-Term Anticoagulation Therapy ) , and ROCKET-AF ( Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ) trial results for the following end points : ischemic stroke , hemorrhagic stroke , intracranial hemorrhage , other major bleeds , clinical ly relevant nonmajor bleeds , myocardial infa rct ion , and treatment discontinuations . Outcomes were life-years , quality -adjusted life years gained , direct health care costs , and incremental cost-effectiveness ratios . RESULTS Apixaban was projected to increase life expectancy versus other NOACs , including dabigatran ( both doses ) and rivaroxaban . A small increase in therapeutic management costs was observed with apixaban due to projected gains in life expectancy and lower discontinuation rates anticipated on apixaban versus other NOACs through lifetime . The estimated incremental cost-effectiveness ratio was £ 9611 , £ 4497 , and £ 5305 per quality -adjusted life-year gained with apixaban compared with dabigatran 150 mg BID , dabigatran 110 mg BID , and rivaroxaban 20 mg once daily , respectively . Sensitivity analyses indicated that results were robust over a wide range of inputs . CONCLUSIONS Although our analysis was limited by the absence of head-to-head trials , based on the indirect comparison data available , our model projects that apixaban may be a cost-effective alternative to dabigatran 150 mg BID , dabigatran 110 mg BID , and rivaroxaban 20 mg once daily for stroke prevention in AF patients from the perspective of the United Kingdom National Health Services",
"BACKGROUND In the ARISTOTLE trial , the rate of stroke or systemic embolism was reduced by apixaban compared with warfarin in patients with atrial fibrillation ( AF ) . Patients with AF and previous stroke or transient ischaemic attack ( TIA ) have a high risk of stroke . We therefore aim ed to assess the efficacy and safety of apixaban compared with warfarin in prespecified subgroups of patients with and without previous stroke or TIA . METHODS Between Dec 19 , 2006 , and April 2 , 2010 , patients were enrolled in the ARISTOTLE trial at 1034 clinical sites in 39 countries . 18,201 patients with AF or atrial flutter were r and omly assigned to receive apixaban 5 mg twice daily or warfarin ( target international normalised ratio 2·0 - 3·0 ) . The median duration of follow-up was 1·8 years ( IQR 1·4 - 2·3 ) . The primary efficacy outcome was stroke or systemic embolism , analysed by intention to treat . The primary safety outcome was major bleeding in the on-treatment population . All participants , investigators , and sponsors were masked to treatment assignments . In this subgroup analysis , we estimated event rates and used Cox models to compare outcomes in patients with and without previous stroke or TIA . The ARISTOTLE trial is registered with Clinical Trials.gov , number NTC00412984 . FINDINGS Of the trial population , 3436 ( 19 % ) had a previous stroke or TIA . In the subgroup of patients with previous stroke or TIA , the rate of stroke or systemic embolism was 2·46 per 100 patient-years of follow-up in the apixaban group and 3·24 in the warfarin group ( hazard ratio [ HR ] 0·76 , 95 % CI 0·56 to 1·03 ) ; in the subgroup of patients without previous stroke or TIA , the rate of stroke or systemic embolism was 1·01 per 100 patient-years of follow-up with apixaban and 1·23 with warfarin ( HR 0·82 , 95 % CI 0·65 to 1·03 ; p for interaction=0·71 ) . The absolute reduction in the rate of stroke and systemic embolism with apixaban versus warfarin was 0·77 per 100 patient-years of follow-up ( 95 % CI -0·08 to 1·63 ) in patients with and 0·22 ( -0·03 to 0·47 ) in those without previous stroke or TIA . The difference in major bleeding with apixaban compared with warfarin was 1·07 per 100 patient-years ( 95 % CI 0·09 - 2·04 ) in patients with and 0·93 ( 0·54 - 1·32 ) in those without previous stroke or TIA . INTERPRETATION The effects of apixaban versus warfarin were consistent in patients with AF with and without previous stroke or TIA . Owing to the higher risk of these outcomes in patients with previous stroke or TIA , the absolute benefits of apixaban might be greater in this population . FUNDING Bristol-Myers Squibb and Pfizer",
"OBJECTIVES Two “ simple questions ” were developed as a minimalist measurement tool to assess outcome in large trials and epidemiological studies after stroke . A previous study of their validity had disclosed ambiguities in their wording . In this study , the clarity , validity , and reliability of a modified version of these simple questions were examined . The relation between patients ' responses to these questions and two widely used generic measures of health related quality of life were also studied . METHODS A hospital based stroke register cohort of 152 patients , who were all visited at home by a study nurse , was used to study validity . A cohort of 1753 patients derived from the International Stroke Trial was used to study the relation with measures of quality of life . The sensitivity , specificity , and accuracy with which responses to each question predicted the patients ' outcome measured using st and ard instruments was assessed . The distribution of scores for the EuroQol and SF-36 was examined for patients classified as dependent , independent , and fully recovered by the combined use of the modified simple questions . RESULTS The modified “ dependency ” question had excellent sensitivity ( > 85 % ) , specificity ( > 79 % ) , and accuracy ( > 82 % ) for identifying dependency after stroke . The “ problems ” question had good sensitivity ( 65–88 % ) and moderate specificity ( 36–72 % ) for the detection of problems in a broad range of domains . The combined use of the modified dependency and problems questions provided a valid , simple , and reliable overall indicator of health related quality of life after stroke . CONCLUSIONS The modified simple questions have excellent face validity and good measurement properties for the assessment of outcome after stroke . They are particularly well suited for large epidemiological studies and r and omised trials",
"Background and aims Documentation of atrial fibrillation is required to initiate oral anticoagulation therapy for recurrent stroke prevention . Atrial fibrillation often goes undetected with traditional electrocardiogram monitoring techniques . We evaluated whether atrial fibrillation detection using continuous long-term monitoring with an insertable cardiac monitor is cost-effective for preventing recurrent stroke in patients with cryptogenic stroke , in comparison to the st and ard of care . Methods A lifetime Markov model was developed to estimate the cost-effectiveness of insertable cardiac monitors from a UK National Health Service perspective using data from the r and omized CRYSTAL-AF trial and other published literature . We also conducted scenario analyses ( CHADS2 score ) and probabilistic sensitivity analyses . All costs and benefits were discounted at 3.5 % . Results Monitoring cryptogenic stroke patients with an insertable cardiac monitor was associated with fewer recurrent strokes and increased quality -adjusted life years compared to the st and ard of care ( 7.37 vs 7.22 ) . Stroke-related costs were reduced in insertable cardiac monitor patients , but overall costs remained higher than the st and ard of care ( £ 19,631 vs £ 17,045 ) . The incremental cost-effectiveness ratio was £ 17,175 per quality -adjusted life years gained , compared to st and ard of care in the base-case scenario , which is below established quality -adjusted life years willingness-to-pay thresholds . When warfarin replaced non-vitamin-K oral anticoagulants as the main anticoagulation therapy , the incremental cost-effectiveness ratio was £ 13,296 per quality -adjusted life years gained . Conclusion Insertable cardiac monitors are a cost-effective diagnostic tool for the prevention of recurrent stroke in patients with cryptogenic stroke . The cost-effectiveness results have relevance for the UK and across value-based healthcare systems that assess costs relative to outcomes",
"Purpose : The EQ-5D is a brief , multiattribute , preference-based health status measure . This article describes the development of a statistical model for generating US population -based EQ-5D preference weights . Methods : A multistage probability sample was selected from the US adult civilian noninstitutional population . Respondents valued 13 of 243 EQ-5D health states using the time trade-off ( TTO ) method . Data for 12 states were used in econometric modeling . The TTO valuations were linearly transformed to lie on the interval [ −1 , 1 ] . Methods were investigated to account for interaction effects caused by having problems in multiple EQ-5D dimensions . Several alternative model specifications ( eg , pooled least squares , r and om effects ) also were considered . A modified split- sample approach was used to evaluate the predictive accuracy of the models . All statistical analyses took into account the clustering and disproportionate selection probabilities inherent in our sampling design . Results : Our D1 model for the EQ-5D included ordinal terms to capture the effect of departures from perfect health as well as interaction effects . A r and om effects specification of the D1 model yielded a good fit for the observed TTO data , with an overall R2 of 0.38 , a mean absolute error of 0.025 , and 7 prediction errors exceeding 0.05 in absolute magnitude . Conclusions : The D1 model best predicts the values for observed health states . The result ing preference weight estimates represent a significant enhancement of the EQ-5D 's utility for health status assessment and economic analysis in the US",
"BACKGROUND Insertable cardiac monitors ( ICMs ) are used to continuously monitor the patient 's electrocardiogram . In response to patient activation or based on automated device algorithms , arrhythmia episodes are stored and automatically transmitted daily to the clinician . Thus , ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias . The ICM described in this report has undergone a dramatic change in size and method of insertion . METHODS To evaluate the safety profile of the ICM procedure , we analyzed procedure-related adverse events ( AEs ) from two separate trials : A controlled , nonr and omized multicenter study ( Reveal LINQ(TM ) Usability study ) and a multicenter registry ( Reveal LINQ(TM ) Registry ) evaluating real-world experience . For the Registry we reported all procedure-related AEs upon occurrence , whereas for the Usability study , we reported events occurring during the first month of follow-up . RESULTS The Usability study enrolled 151 patients ( age 56.6 ± 12.1 years ; male 67 % ) at 16 centers ; during follow-up , an infection was observed in 1.3 % patients and a procedure-related serious AE ( SAE ) in 0.7 % patients . The Registry enrolled 122 patients ( age 61.0 ± 17.8 years ; male 47 % ) at seven centers ; during follow-up , an infection was observed in 1.6 % patients and a procedure-related SAE in 1.6 % patients . CONCLUSIONS The cumulative experience from a controlled clinical trial and a \" real-world \" registry demonstrate that the new ICM can be inserted with very low incidence of AEs ",
"Background Insertable cardiac monitor ( ICM ) increases the detection rate of occult atrial fibrillation ( AF ) after cryptogenic stroke . The aim of this study was to evaluate the prognostic significance of total atrial conduction time ( TACT ) assessed by tissue Doppler imaging ( PA-TDI interval ) to predict AF presence in patients with cryptogenic stroke . Methods Ninety patients ( 57.7 ± 12.3 years , 48 % women ) after acute cryptogenic stroke and ICM implantation were prospect i ve recruited at four centers for continuous rhythm monitoring . In all patients , TACT was measured by PA-TDI interval via echocardiography . Patients were followed up ( 331 ± 186 days ) for detection of AF ( defined by episode lasting ≥30 s ) . Results AF was detected in 16 patients ( 18 % ) during follow-up ( 331 ± 186 days ) . The median period to AF detection was 30 days ( q1–q3 ; 16–62 days ) . Patients who exhibited occult AF were characterized by significantly longer PA-TDI intervals ( 154.7 ± 12.6 vs. 133.9 ± 9.5 ms , p demonstrated sensitivity and specificity for AF detection of 93.8 and 90.5 % , respectively . In multivariate analysis , CHA2DS2–VASc score ( HR 1.96 per 1 point , p future AF detection in patients with cryptogenic stroke . The clinical importance of prolonged rhythm monitoring or indication of direct anticoagulation therapy after cryptogenic stroke based on TACT should be further investigated",
"BACKGROUND Longitudinal , patient-level data on re source use and costs after an ischemic stroke are lacking in Canada . The objectives of this analysis were to calculate costs for the first year post-stroke and determine the impact of disability on costs . METHODOLOGY The Economic Burden of Ischemic Stroke ( BURST ) Study was a one-year prospect i ve study with a cohort of ischemic stroke patients recruited at 12 Canadian stroke centres . Clinical history , disability , health preference and re source utilization information was collected at discharge , three months , six months and one year . Re sources included direct medical costs ( 2009 CAN$ ) such as emergency services , hospitalizations , rehabilitation , physician services , diagnostics , medications , allied health professional services , homecare , medical/assistive devices , changes to residence and paid caregivers , as well as indirect costs . Results were stratified by disability measured at discharge using the modified Rankin Score ( mRS ) : non-disabling stroke ( mRS 0 - 2 ) and disabling stroke ( mRS 3 - 5 ) . RESULTS We enrolled 232 ischemic stroke patients ( age 69.4 ± 15.4 years ; 51.3 % male ) and 113 ( 48.7 % ) were disabled at hospital discharge . The average annual cost was $ 74,353 ; $ 107,883 for disabling strokes and $ 48,339 for non-disabling strokes . CONCLUSIONS An average annual cost for ischemic stroke was calculated in which a disabling stroke was associated with a two-fold increase in costs compared to NDS . Costs during the hospitalization to three months phase were the highest contributor to the annual cost . A \" back of the envelope \" calculation using 38,000 stroke admissions and the average annual cost yields $ 2.8 billion as the burden of ischemic stroke",
"BACKGROUND Anticoagulants are more effective than antiplatelet agents at reducing stroke risk in patients with atrial fibrillation , but whether this benefit outweighs the increased risk of bleeding in elderly patients is unknown . We assessed whether warfarin reduced risk of major stroke , arterial embolism , or other intracranial haemorrhage compared with aspirin in elderly patients . METHODS 973 patients aged 75 years or over ( mean age 81.5 years , SD 4.2 ) with atrial fibrillation were recruited from primary care and r and omly assigned to warfarin ( target international normalised ratio 2 - 3 ) or aspirin ( 75 mg per day ) . Follow-up was for a mean of 2.7 years ( SD 1.2 ) . The primary endpoint was fatal or disabling stroke ( ischaemic or haemorrhagic ) , intracranial haemorrhage , or clinical ly significant arterial embolism . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N89345269 . FINDINGS There were 24 primary events ( 21 strokes , two other intracranial haemorrhages , and one systemic embolus ) in people assigned to warfarin and 48 primary events ( 44 strokes , one other intracranial haemorrhage , and three systemic emboli ) in people assigned to aspirin ( yearly risk 1.8%vs 3.8 % , relative risk 0.48 , 95 % CI 0.28 - 0.80 , p=0.003 ; absolute yearly risk reduction 2 % , 95 % CI 0.7 - 3.2 ) . Yearly risk of extracranial haemorrhage was 1.4 % ( warfarin ) versus 1.6 % ( aspirin ) ( relative risk 0.87 , 0.43 - 1.73 ; absolute risk reduction 0.2 % , -0.7 to 1.2 ) . INTERPRETATION These data support the use of anticoagulation therapy for people aged over 75 who have atrial fibrillation , unless there are contraindications or the patient decides that the benefits are not worth the inconvenience",
"BACKGROUND In the R and omised Evaluation of Long-Term Anticoagulation Therapy ( RE-LY ) trial , dabigatran reduced occurrence of both stroke and haemorrhage compared with warfarin in patients who had atrial fibrillation and were at increased risk of stroke . We aim ed to assess the effects of dabigatran compared with warfarin in the subgroup of patients with previous stroke or transient ischaemic attack . METHODS In the RE-LY trial , 18,113 patients from 967 centres in 44 countries were r and omly assigned to 110 mg or 150 mg dabigatran twice daily or to warfarin dose adjusted to international normalised ratio 2·0 to 3·0 . Median follow-up was 2·0 years ( IQR 1·14 - 2·86 ) , and the primary outcome was stroke or systemic embolism . The primary safety outcome was major haemorrhage . Patients and investigators were aware of whether patients received warfarin or dabigatran , but not of dabigatran dose , and event adjudicators were masked to treatment . In a predefined analysis , we investigated the outcomes of the RE-LY trial in subgroups of patients with or without previous stroke or transient ischaemic attack . RE-LY is registered with Clinical Trials.gov , NCT00262600 . FINDINGS Within the subgroup of patients with previous stroke or transient ischaemic attack , 1195 patients were from the 110 mg dabigatran group , 1233 from the 150 mg dabigatran group , and 1195 from the warfarin group . Stroke or systemic embolism occurred in 65 patients ( 2·78 % per year ) on warfarin compared with 55 ( 2·32 % per year ) on 110 mg dabigatran ( relative risk 0·84 , 95 % CI 0·58 - 1·20 ) and 51 ( 2·07 % per year ) on 150 mg dabigatran ( 0·75 , 0·52 - 1·08 ) . The rate of major bleeding was significantly lower in patients on 110 mg dabigatran ( RR 0·66 , 95 % CI 0·48 - 0·90 ) and similar in those on 150 mg dabigatran ( RR 1·01 ; 95 % CI 0·77 - 1·34 ) compared with those on warfarin . The effects of both doses of dabigatran compared with warfarin were not significantly different between patients with previous stroke or transient ischaemic attack and those without for any of the outcomes from RE-LY apart from vascular death ( 110 mg group compared with warfarin group , interaction p=0·038 ) . INTERPRETATION The effects of 110 mg dabigatran and 150 mg dabigatran twice daily in patients with previous stroke or transient ischaemic attack are consistent with those of other patients in RE-LY , for whom , compared with warfarin , 150 mg dabigatran reduced stroke or systemic embolism and 110 mg dabligatran was non-inferior . [ corrected ] Most effects of both dabigatran doses were consistent in patients with versus those without previous stroke or transient ischaemic attack . FUNDING Boehringer Ingelheim",
"BACKGROUND Patients with atrial fibrillation ( AF ) are at increased risk for ischemic stroke . In patients who have suffered a stroke , screening for AF is routinely performed only for a short period after the stroke as part of the evaluation for possible causes . If AF is detected after an ischemic stroke , oral anticoagulation therapy is recommended for secondary stroke prevention . In 25 % to 30 % of stroke patients , the stroke mechanism can not be determined ( cryptogenic stroke ) . The incidence of paroxysmal AF undetected by short-term monitoring in patients with cryptogenic stroke is unknown , but has important therapeutic implication s on patient care . The optimum monitoring duration and method of AF detection after stroke are unknown . The purpose of this study is to evaluate the incidence of AF and time to AF detection in patients with cryptogenic stroke using an insertable cardiac monitor . STUDY DESIGN The CRYSTAL AF trial is a r and omized prospect i ve study to evaluate a novel approach to long-term monitoring for AF detection in patients with cryptogenic stroke . Four hundred fifty cryptogenic stroke patients ( by definition , without a history of AF ) will be enrolled at approximately 50 sites in Europe , Canada , and the United States . Patients will be r and omized in a 1:1 fashion to st and ard arrhythmia monitoring ( control arm ) or implantation of the subcutaneous cardiac monitor ( Reveal XT ; Medtronic , Inc , Minneapolis , MN ) ( continuous monitoring arm ) . OUTCOMES The primary end point is time to detection of AF within 6 months after stroke . The clinical follow-up period will be at least 12 months . Study completion is expected at the end of 2012",
"INTRODUCTION Long-term cardiac monitoring with implantable loop recorders ( ILRs ) has revealed occult paroxysmal atrial fibrillation and flutter ( PAF ) in a substantial minority of cryptogenic ischemic stroke ( CIS ) patients . Herein , we aim to define the prevalence , clinical relevance , and risk factors for PAF detection following early poststroke ILR implantation . MATERIAL S AND METHODS A retrospective study of CIS patients ( n = 100 , mean age 65.8 years ; 52.5 % female ) who underwent ILR insertion during , or soon after , index stroke admission . Patients were prospect ively followed by the study cardiac electrophysiologist who confirmed the PAF diagnosis . Univariate and multivariate analyses compared clinical , laboratory , cardiac , and imaging variables between PAF patients and non-PAF patients . RESULTS PAF was detected in 31 of 100 ( 31 % ) CIS patients , and anticoagulation was initiated in almost all ( 30 of 31 , 96.8 % ) . Factors associated with PAF detection include older age ( mean [ year ] 72.9 versus 62.9 ; P = .003 ) , white race ( odds ratio [ OR ] , 4.5 ; confidence interval [ CI ] , 1.8 - 10.8 ; P = .001 ) , prolonged PR interval ( PR > 175 ms ; OR , 3.3 ; CI , 1.2 - 9.4 ; P = .022 ) , larger left atrial ( LA ) diameter ( mean [ cm ] 3.7 versus 3.5 ; P = .044 ) and LA volume index ( mean [ cc/m2 ] ; 30.6 versus 24.2 ; P = .014 ) , and lower hemoglobin (Hb)A1c ( mean [ % ] 6.0 versus 6.4 ; P = .036 ) . Controlling for age , obesity ( body mass index > 30 kg/m2 ; OR , 1.2 ; CI , 1.1 - 1.4 ; P = .033 ) was independently associated with PAF detection . DISCUSSION PAF was detected with high prevalence following early postcryptogenic stroke ILR implantation and result ed in significant management changes . Older age , increased PR interval , LA enlargement , and lower HbA1c are significantly associated with PAF detection . Controlling for age , obesity is an independent risk factor . A larger prospect i ve study is warranted to confirm these findings",
"Aims Warfarin , a vitamin K antagonist ( VKA ) , has been the st and ard of care for stroke prevention in patients with atrial fibrillation ( AF ) . Aspirin is recommended for low-risk patients and those unsuitable for warfarin . Apixaban is an oral anticoagulant that has demonstrated better efficacy than warfarin and aspirin in the ARISTOTLE and AVERROES studies , respectively , and causes less bleeding than warfarin . We evaluated the potential cost-effectiveness of apixaban against warfarin and aspirin from the perspective of the UK payer perspective . Results and methods A lifetime Markov model was developed to evaluate the pharmacoeconomic impact of apixaban compared with warfarin and aspirin in VKA suitable and VKA unsuitable patients , respectively . Clinical events considered in the model include ischaemic stroke , haemorrhagic stroke , intracranial haemorrhage , other major bleed , clinical ly relevant non-major bleed , myocardial infa rct ion , cardiovascular hospitalization and treatment discontinuations ; data from the ARISTOTLE and AVERROES trials and published mortality rates and event-related utility rates were used in the model . Apixaban was projected to increase life expectancy and quality -adjusted life years ( QALYs ) compared with warfarin and aspirin . These gains were expected to be achieved at a drug acquisition-related cost increase over lifetime . The estimated incremental cost-effectiveness ratio was £ 11 909 and £ 7196 per QALY gained with apixaban compared with warfarin and aspirin , respectively . Sensitivity analyses indicated that results were robust to a wide range of inputs . Conclusions Based on r and omized trial data , apixaban is a cost-effective alternative to warfarin and aspirin , in VKA suitable and VKA unsuitable patients with AF , respectively",
"CONTEXT Warfarin has been shown to be highly efficacious for preventing thromboembolism in atrial fibrillation in r and omized trials , but its effectiveness and safety in clinical practice is less clear . OBJECTIVE To evaluate the effect of warfarin on risk of thromboembolism , hemorrhage , and death in atrial fibrillation within a usual care setting . DESIGN Cohort study assembled between July 1 , 1996 , and December 31 , 1997 , and followed up through August 31 , 1999 . SETTING Large integrated health care system in Northern California . PATIENTS Of 13,559 adults with nonvalvular atrial fibrillation , 11,526 were studied , 43 % of whom were women , mean age 71 years , with no known contraindications to anticoagulation at baseline . MAIN OUTCOMES Ischemic stroke , peripheral embolism , hemorrhage , and death according to warfarin use and comorbidity status , as determined by automated data bases , review of medical records , and state mortality files . RESULTS Among 11,526 patients , 397 incident thromboembolic events ( 372 ischemic strokes , 25 peripheral embolism ) occurred during 25,341 person-years of follow-up , and warfarin therapy was associated with a 51 % ( 95 % confidence interval [ CI ] , 39%-60 % ) lower risk of thromboembolism compared with no warfarin therapy ( either no antithrombotic therapy or aspirin ) after adjusting for potential confounders and likelihood of receiving warfarin . Warfarin was effective in reducing thromboembolic risk in the presence or absence of risk factors for stroke . A nested case-control analysis estimated a 64 % reduction in odds of thromboembolism with warfarin compared with no antithrombotic therapy . Warfarin was also associated with a reduced risk of all-cause mortality ( adjusted hazard ratio , 0.69 ; 95 % CI , 0.61 - 0.77 ) . Intracranial hemorrhage was uncommon , but the rate was moderately higher among those taking vs those not taking warfarin ( 0.46 vs 0.23 per 100 person-years , respectively ; P = .003 , adjusted hazard ratio , 1.97 ; 95 % CI , 1.24 - 3.13 ) . However , warfarin therapy was not associated with an increased adjusted risk of nonintracranial major hemorrhage . The effects of warfarin were similar when patients with contraindications at baseline were analyzed separately or combined with those without contraindications ( total cohort of 13,559 ) . CONCLUSIONS Warfarin is very effective for preventing ischemic stroke in patients with atrial fibrillation in clinical practice while the absolute increase in the risk of intracranial hemorrhage is small . Results of r and omized trials of anticoagulation translate well into clinical care for patients with atrial fibrillation",
"BACKGROUND For clinicians , confidence in atrial fibrillation ( AF ) episode classification is an important consideration when electing to use insertable cardiac monitors ( ICMs ) . OBJECTIVE The purpose of this study was to report on the improved AF detection algorithm in the Reveal LINQ ICM . METHODS The Reveal LINQ Usability Study is a nonr and omized , prospect i ve , multicenter trial . The ICM has been miniaturized , uses wireless telemetry for remote patient monitoring , and its AF algorithm includes a new p-wave filter . At 1 month post-device insertion , Holter monitor data were collected and annotated for true AF episodes ≥2 minutes , and performance metrics were evaluated by comparing Holter annotations with ICM detections . RESULTS The study enrolled 151 patients ( age 56.6 ± 12.1 , male 67 % ) . Reasons for monitoring included AF ablation or AF management in 81.5 % ( n = 123 ) , syncope in 12.6 % ( n = 19 ) , and other indications in 5.9 % ( n = 9 ) of patients . Of the 138 patients with an analyzable Holter recording , a total of 112 true AF episodes were identified in 38 patients ( 27.5 % ) . The overall accuracy of the ICM to detect duration s of AF or non-AF episodes was 99.4 % , and the AF burden measured by the ICM was highly correlated with the Holter ( Pearson coefficient 0.995 ) . CONCLUSION The new AF detection algorithm in the Reveal LINQ ICM accurately detects the presence or absence of AF . Additionally , it showed high sensitivity in detecting AF duration in patients with a history of intermittent and symptomatic AF",
"BACKGROUND Current guidelines recommend at least 24 hours of electrocardiographic ( ECG ) monitoring after an ischemic stroke to rule out atrial fibrillation . However , the most effective duration and type of monitoring have not been established , and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40 % of cases ( cryptogenic stroke ) . Detection of atrial fibrillation after cryptogenic stroke has therapeutic implication s. METHODS We conducted a r and omized , controlled study of 441 patients to assess whether long-term monitoring with an insertable cardiac monitor ( ICM ) is more effective than conventional follow-up ( control ) for detecting atrial fibrillation in patients with cryptogenic stroke . Patients 40 years of age or older with no evidence of atrial fibrillation during at least 24 hours of ECG monitoring underwent r and omization within 90 days after the index event . The primary end point was the time to first detection of atrial fibrillation ( lasting > 30 seconds ) within 6 months . Among the secondary end points was the time to first detection of atrial fibrillation within 12 months . Data were analyzed according to the intention-to-treat principle . RESULTS By 6 months , atrial fibrillation had been detected in 8.9 % of patients in the ICM group ( 19 patients ) versus 1.4 % of patients in the control group ( 3 patients ) ( hazard ratio , 6.4 ; 95 % confidence interval [ CI ] , 1.9 to 21.7 ; P atrial fibrillation had been detected in 12.4 % of patients in the ICM group ( 29 patients ) versus 2.0 % of patients in the control group ( 4 patients ) ( hazard ratio , 7.3 ; 95 % CI , 2.6 to 20.8 ; P ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke . ( Funded by Medtronic ; CRYSTAL AF Clinical Trials.gov number , NCT00924638 . )",
"BACKGROUND The BioMonitor 2 Pilot Study assessed the implantation procedure , the sensing amplitude and the remote monitoring transmission success rate of the second generation implantable cardiac monitor , the BioMonitor 2 ( Biotronik , Berlin , Germany ) . METHODS This was a prospect i ve , multi-centre , single-arm , non-r and omised study involving seven operators in five sites across Australia . Data were collected at implantation , during clinic visits at 1 week and 1 month post-implantation , and through wireless remote monitoring . RESULTS Thirty patients with indications for long-term cardiac monitoring underwent successful insertion of a study device . The median implantation time was 9 minutes ( interquartile range ( IQR ) 5 - 14 mins ) . The mean R-wave amplitude at 1 week was 0.75±0.39mV and remained stable over the follow-up period . Within 1 day , 97 % of the patients connected to the remote monitoring network and daily messages were transmitted on 93.8 % of all study days . Seventy-six per cent of patients transmitted at least one subcutaneous ECG ( sECG ) , with a median number of sECGs per patient of seven ( IQR 3 - 37 ) within 28 days . CONCLUSIONS The results of the BioMonitor 2 Pilot study confirm the excellent sensing amplitudes afforded by this new device and the utility of the implantation tools and technique . Patient compliance with and the transmission success rate of the home monitoring system were excellent",
"OBJECTIVE Currently , there is no EQ-5D value set for Pol and . The primary objective of this study was to elicit EQ-5D Polish values using the time trade-off ( TTO ) method . METHODS Face-to-face interviews with visitors of in patients in eight medical centers in Warsaw , Skierniewice , and Puławy were carried out by trained interviewers . Quota sampling was used to achieve a representative sample of the Polish population with regard to age and sex . Modified protocol from the Measurement and Value of Health study was used . Each respondent ranked 10 health states and valued 4 health states using the visual analog scale and 23 using the TTO . Mean and variance stability tests were performed to determine whether using a larger number of health states per respondent would yield credible results . Modeling included r and om effects and r and om parameters models . RESULTS Between February and May 2008 , 321 interviews were performed . Modeling based on 6777 valuations result ed in an additive model with all coefficients statistically significant , R(2 ) equal to 0.45 , and value -0.523 for the worst possible health state . Means and variance did not differ significantly for states valued in the middle and at the end of the TTO exercise . CONCLUSIONS This is the first EQ-5D value set based on TTO in Central and Eastern Europe so far . Because the values differ considerably from those elicited in Western European countries , its use should be recommended for studies in Pol and . Increasing the number of health states that each respondent is asked to value using TTO seems feasible and justifiable",
"AIMS To compare the quality of life ( QoL ) of those in atrial fibrillation ( AF ) aged 75 years and over with that of the general population , to explore what factors affect the QoL of those with AF , and to assess the sensitivity of the EuroQol ( EQ-5D ) and Short-Form 12 ( SF-12 ) generic health question naires in detecting differences in health status in those with AF in this age group . METHODS AND RESULTS The study population was 1762 men and women aged 75 years and over with confirmed AF who attended a r and omization clinic for the Birmingham Atrial Fibrillation Treatment of the Aged ( BAFTA ) study , a primary care based trial of stroke prevention . Patients self-completed the EQ-5D and SF-12 question naires , and a simple measure of disability ( Rankin ) . Cardiovascular co-morbidities were collected and number of drugs used as an additional proxy for co-morbidity . Quality -of-life outcomes were compared with general population sample s of the same age . On multiple regression , female gender , greater medication use , and disability were independently associated with lower QoL scores in AF . Those in AF with a Rankin score ≥2 had lower QoL scores , while those with a Rankin score QoL scores , with the EQ-5D and SF-12 Physical Component Score showing similar sensitivity to these associations , and the SF-12 Mental Component Score showing less sensitivity . CONCLUSION In the absence of co-morbidity , chronic AF has little impact on generic QoL in an elderly non-acutely ill population",
"INTRODUCTION Implantable loop recorders ( ILR ) are leadless subcutaneous devices that allow cardiac monitoring for up to 3 years and are a valuable tool in the diagnosis of arrhythmias , cryptogenic stroke and unexplained syncope . The Biotronik BioMonitor 2 is a novel , insertable ILR allowing long-term continuous monitoring with wireless telemetry options . METHODS A single-center , prospect i ve , observational study investigating the reliability of sensing quality and detection performance in the BioMonitor 2 ILR , as well as post-implantation patient satisfaction . R-wave amplitude was recorded immediately post implantation and 1 day post implantation , followed by extensive patient instruction . Follow-up was scheduled after 3 months , or after an event . Data from the ILR were retrieved , with documentation of all episodes , R-wave amplitude and noise burden . The anatomical position of the ILR was determined 1 day post implantation and after 3 months . A patient question naire was conducted after 3 months . RESULTS 30 consecutive patients ( mean age 71 ± 12 years , 56 % male ) were analyzed . Indications for ILR implantation were : unexplained syncope ( n = 24 , 80 % ) , suspected atrial fibrillation ( n = 4 , 13 % ) , cryptogenic stroke ( n = 1 , 3 % ) and palpitations ( n = 1 , 3 % ) . Median time from skin cut to suture was 8 min . No complications occurred . Mean R-wave amplitude at implantation was 0.84 ± 0.32 mV , at day 1 post implantation 0.96 ± 0.31 mV , and after a mean follow-up of 85 ± 24 days 1.02 ± 0.47 mV ( p = 0.01 ) . The mean noise burden was 1.4 ± 2 % . CONCLUSION Implantation of the novel BioMonitor 2 ILR is fast and uncomplicated . Initial sensing values are good and improve over time",
"BACKGROUND The use of insertable cardiac monitors ( ICM ) has increased the rate of detection of atrial fibrillation ( AF ) among cryptogenic stroke ( CS ) patients . We describe a single-center experience for AF detection among CS patients receiving ICMs upon discharge after the index stroke event and attempt to identify predictors for AF detection . METHODS From April 2014 to October 2017 , patients receiving ICMs for CS who underwent > 60 days of monitoring were review ed . Chronic underlying medical illnesses , presence of left atrial enlargement ( LAE ) on echocardiography , and PR interval on admission electrocardiogram were assessed as predictors of AF detection . RESULTS A total of 234 patients ( median age 72 [ 61 , 78 ] years , 45 % women ) met inclusion criteria and were followed for a median of 536 [ 282 , 848 ] days . Among studied patients , 68 patients ( 29 % ) were found to have AF at a median of 94.5 [ 16 , 239 ] days from ICM placement . CS patients with AF were significantly older ( p women ( p = 0.003 ) when compared to CS patients without AF . Neither presence of LAE nor prolonged PR interval was predictive of AF detection . CONCLUSION Almost one-third of CS patients monitored with an ICM were found to have previously undiagnosed AF . CS patients found to have AF were older and more commonly women . Prospect i ve studies are needed to better identify predictors for early AF among the broader population of all CS patients",
"Recently , the clinical entity embolic stroke of undetermined source ( ESUS ) has been defined for patients with ischemic strokes , where neither a cardioembolic nor a non-cardiac source can be detected . These patients may suffer from asymptomatic atrial fibrillation ( AF ) , terminating spontaneously and thus eluding detection . Implantable loop recorders ( ILR ) with automatic AF detection algorithms can detect short-lasting , sub clinical AF . The aim of this study was to prospect ively assess and predict AF detection in patients with ESUS using ILR with daily remote interrogation . Patients with acute ESUS received an ILR , were seen every 6 months and additionally interrogated their ILR daily using remote monitoring . The incidence of AF detection was assessed and parameters which might predict AF detection ( clinical and from magnetic resonance tomography ) were analysed . ILR implantation was performed in 123 patients on average 20 days after stroke . During a mean follow-up of 12.7±5.5 months , AF was documented and manually confirmed in 29 of 123 patients ( 23.6 % ) . First AF detection occurred on average after 3.6±3.4 months of monitoring . Patients with AF were on average older , had a higher CHA2DS2-VASc score and more often cerebral microangiopathy . In conclusion , AF can be documented in approximately 25 % of patients with the diagnosis of ESUS after careful work-up within a year of monitoring by an ILR and daily remote interrogation . This had important therapeutic consequences ( initiation of anticoagulation for secondary stroke prevention ) in these patients"
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BACKGROUND Cardiovascular disease ( CVD ) is considered to be the main cause of death and one of the most common diseases affecting health care systems worldwide . Many methods have been used to improve CVD outcomes , one of which is to involve clinical pharmacists in the direct care of patients with CVD . OBJECTIVE To perform a systematic review assessing the effectiveness of clinical pharmacist interventions within a multidisciplinary team in the secondary prevention of CVD , using studies conducted on patients with heart failure , coronary heart disease , or those with CVD risk factors . METHODS Extensive search es of 13 data bases were performed -- with no time limitation -- to identify r and omized controlled trials ( RCT ) in English that evaluated clinical pharmacist intervention in patients with CVD or with CVD risk factors . Two independent review ers evaluated 203 citations that were the result of this search . Studies were included if they reported direct care from a clinical pharmacist in CVD or CVD-related therapeutic areas such as disease-led management or in collaboration with other health care workers ; if they were RCTs ; if they were in patients , out patients , or in the community setting ; and if they included the following outcomes : CVD control or mortality , CVD risk factor control , patient-related outcomes ( knowledge , adherence , or quality of life ) , and cost related to health care systems . RESULTS A total of 59 studies were identified : 45 RCT , 6 non- RCT , and 8 economic studies . 68 % of the outcomes reported showed that clinical pharmacy services were associated with better improvement in patients ' outcomes compared with the control group . CONCLUSION The involvement of a pharmacist demonstrated an ability to improve CVD outcomes through providing educational intervention , medicine management intervention , or a combination of both . These interventions result ed in improved CVD risk factors , improved patient outcomes , and reduced number of drug-related problems with a direct effect on CVD control . These improvements may lead to an improvement in patient quality of life , better use of health care re sources , and a reduced rate of mortality
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"OBJECTIVE To compare the effectiveness of an evidence -based , systematic approach to hypertension care involving comanagement of patients by primary care physicians and clinical pharmacists versus usual care in reducing blood pressure in patients with uncontrolled hypertension . METHODS Patients in a staff model medical group with uncontrolled hypertension were r and omized to either a usual care ( UC ) or a physician-pharmacist comanagement ( PPCM ) group . All physicians in the study received both group and individual education and participated in the development of an evidence -based hypertension treatment algorithm . Physicians were then given the names of their patients whose medical records documented elevated blood pressures ( defined as systolic > or = 140 mm Hg and /or diastolic > or = 90 mm Hg for patients aged or = 160 mm Hg and /or diastolic > or = 90 mm Hg for those aged > or = 65 yrs ) . Patients r and omized to the UC group were managed by primary care physicians alone . Those r and omized to the PPCM group were comanaged by their primary care physician and a clinical pharmacist , who provided patient education , made treatment recommendations , and provided follow-up . Blood pressure measurements , antihypertensive drugs , and visit costs/patient were obtained from medical records . RESULTS One hundred ninety-seven patients with uncontrolled hypertension participated in the study . Both PPCM and UC groups experienced significant reductions in blood pressure ( systolic -22 and -11 mm Hg , respectively , p reduction in systolic blood pressure was greater in the PPCM group after adjusting for differences in baseline blood pressure between the groups ( p blood pressure control in the PPCM than in the UC group ( 60 % vs 43 % , p = 0.02 ) . Average provider visit costs/patient were higher in the UC than the PPCM group ( $ 195 vs $ 160 , p = 0.02 ) . CONCLUSIONS An evidence -based , systematic approach using physician-pharmacist comanagement for patients with uncontrolled hypertension result ed in improved blood pressure control and reduced average visit costs/patient",
"OBJECTIVES To identify patients at risk for coronary artery disease ( CAD ) through a search of a community pharmacy 's prescription data base , to screen and identify patients with elevated cholesterol and at risk for CAD , to enroll patients in a pharmacist-directed lipid management program , and to evaluate selected clinical and humanistic outcomes . DESIGN R and omized , pretest-posttest control groups . SETTING Independent community pharmacy in a suburban metropolitan area . PATIENTS 51 patients who were not at National Cholesterol Education Program low-density lipoprotein cholesterol ( LDL-C ) or defined triglyceride goals and who met inclusion criteria . INTERVENTION Pharmacist-directed lipid management program . MAIN OUTCOME MEASURES Clinical outcome measures included total cholesterol , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , and triglyceride levels ; achievement of LDL-C goal ; and risk factor prediction scores . Humanistic outcome measures included patient satisfaction with pharmaceutical care and patient knowledge of hyperlipidemia . RESULTS LDL-C was decreased in the pharmacist intervention group ( n = 25 ) , compared with an increase in the control group at study end . HDL-C levels increased and triglyceride levels decreased in both groups . Of treatment group patients , 32 % achieved their cholesterol goals , compared with 15 % of control group patients . Risk factor prediction scores improved in the treatment group and worsened in the control group . The treatment group 's hyperlipidemia knowledge scores improved significantly from pretest to posttest . Both treatment and control group patient satisfaction scores for the pharmacist investigator were favorable at study end . CONCLUSION Both treatment and control patients benefited from participating in this study . Patients enrolled in the lipid management program made greater improvements in their knowledge of hyperlipidemia , risk factor scores , and cholesterol levels",
"The Study of Cardiovascular Risk Intervention by Pharmacists , a r and omized , controlled trial in over 50 community pharmacies in Alberta and Saskatchewan , Canada , demonstrated that a pharmacist intervention program improved cholesterol risk management in patients at high risk for cardiovascular disease . In a sub study , costs and consequences were analyzed to describe the economic impact of the program . Two perspectives were taken : a government-funded health care system and a pharmacy manager . Costs were reported in 1999 Canadian dollars . Incremental costs to a government payor and community pharmacy manager were $ 6.40/patient and $ 21.76/patient , respectively , during the 4-month follow-up period . The community pharmacy manager had an initial investment of $ 683.50 . The change in Framingham risk function for the intervention group from baseline also was reported . The 10-year risk of cardiovascular disease decreased from 17.3 % to 16.4 % ( p cardiovascular risk in the intervention group during the 4-month follow-up period . The incremental cost to provide the program appeared minimal from both government and pharmacy manager perspectives . It is hoped that these results could support negotiations for reimbursement of clinical pharmacy services with payors",
"Purpose The purpose of this study was to assess whether the VA-MEDIC ( Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction ) , a pharmacist-led group medical visit program , could improve achievement of target goals in hypertension , hyperglycemia , hyperlipidemia , and tobacco use in patients with type 2 diabetes compared to usual care . Methods This was a r and omized controlled trial of VA-MEDIC intervention in addition to usual care versus usual care alone in diabetic patients to reduce cardiac risk factors . VA-MEDIC consisted of a 40- to 60-minute educational component by nurse , nutritionist , physical therapist , or pharmacist followed by pharmacist-led behavioral and pharmacological interventions over 4 weekly sessions . Measures The attainment of target goals in hemoglobin A1C ( A1C ) , blood pressure , fasting lipids , and tobacco use recommended by the American Diabetes Association . Results Of 118 participants , 109 completed the study . VA-MEDIC ( n = 58 ) participants were younger and had greater tobacco use at baseline than usual care but were similar in other cardiovascular risk factors . After 4 months , a greater proportion of VA-MEDIC participants versus controls achieved an A1C of less than 7 % and a systolic blood pressure less than 130 mm Hg . No significant change was found in lipid control or tobacco use between the 2 study arms . Conclusion Pharmacist-led group medical visits are feasible and efficacious for improving cardiac risk factors",
"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",
"CONTEXT Poor medication adherence diminishes the health benefits of pharmacotherapies . Elderly patients with coronary risk factors frequently require treatment with multiple medications , placing them at increased risk for nonadherence . OBJECTIVE To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PATIENTS A multiphase , prospect i ve study with an observational phase and a r and omized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications . The study was conducted from June 2004 to August 2006 . INTERVENTION After a 2-month run-in phase ( measurement of baseline adherence , BP , and LDL-C ) , patients entered a 6-month intervention phase ( st and ardized medication education , regular follow-up by pharmacists , and medications dispensed in time-specific packs ) . Following the intervention phase , patients were r and omized to continued pharmacy care vs usual care for an additional 6 months . MAIN OUTCOME MEASURES Primary end point of the observation phase was change in the proportion of pills taken vs baseline ; secondary end points were the associated changes in BP and LDL-C. Primary end point of the r and omization phase was the between-group comparison of medication persistence . RESULTS A total of 200 elderly patients ( 77.1 % men ; mean [ SD ] age , 78 [ 8.3 ] years ) , taking a mean ( SD ) of 9 ( 3 ) chronic medications were enrolled . Coronary risk factors included drug-treated hypertension in 184 patients ( 91.5 % ) and drug-treated hyperlipidemia in 162 ( 80.6 % ) . Mean ( SD ) baseline medication adherence was 61.2 % ( 13.5 % ) . After 6 months of intervention , medication adherence increased to 96.9 % ( 5.2 % ; P systolic BP ( 133.2 [ 14.9 ] to 129.9 [ 16.0 ] mm Hg ; P = .02 ) and LDL-C ( 91.7 [ 26.1 ] to 86.8 [ 23.4 ] mg/dL ; P = .001 ) . Six months after r and omization , the persistence of medication adherence decreased to 69.1 % ( 16.4 % ) among those patients assigned to usual care , whereas it was sustained at 95.5 % ( 7.7 % ) in pharmacy care ( P reductions in systolic BP in the pharmacy care group ( -6.9 mm Hg ; 95 % CI , -10.7 to -3.1 mm Hg ) vs the usual care group ( -1.0 mm Hg ; 95 % CI , -5.9 to 3.9 mm Hg ; P = .04 ) , but no significant between-group differences in LDL-C levels or reductions . CONCLUSIONS A pharmacy care program led to increases in medication adherence , medication persistence , and clinical ly meaningful reductions in BP , whereas discontinuation of the program was associated with decreased medication adherence and persistence . TRIAL REGISTRATION clinical trials.gov Identifier :",
"BACKGROUND Noncompliance is a major factor in the morbidity and unnecessary hospital readmissions for patients with heart failure . Several studies have aim ed to reduce rehospitalizations in heart failure patients through a comprehensive , multidisciplinary approach . Medication compliance was rarely measured in these studies or , when it was measured , the method employed was seldom valid . We aim ed at determining the effect of a pharmacist-led intervention on medication compliance in patients with heart failure . METHODS We conducted a r and omized controlled trial into the effect of a pharmacist-led intervention on medication compliance in patients with heart failure ( predominantly New York Heart Association [ NYHA ] II and III ) treated with loop diuretics , presenting to a cardiology outpatient clinic or admitted to hospitals in The Netherl and s. Patients in the intervention group received monthly consultations from their community pharmacist during a 6-month period . Patients in the control group received usual care . Primary endpoint was medication compliance , assessed with a medication event monitoring system , an electronic pill bottle that registers time of opening . Secondary endpoints were the number of rehospitalizations , death , and quality of life . RESULTS A total of 152 patients were r and omized : 74 patients to the intervention arm and 78 patients to the usual care arm . Over the 6-month study period , patients in the intervention group had 140/7656 days without use of loop diuretics compared with 337/6196 days in the usual care group ( relative risk 0.33 [ confidence interval ( CI ) 95 % 0.24 - 0.38 ] ) . Two consecutive days of nondosing occurred on 18/7656 days in the intervention group compared with 46/6196 days in the usual care group ( relative risk 0.32 [ CI 95 % 0.19 - 0.55 ] ) . There were no significant differences in rehospitalizations , mortality , or disease-specific quality of life between groups . CONCLUSIONS A pharmacy-led intervention can improve medication compliance in patients with moderate to severe heart failure , even in those with relatively high compliance . Future interventions should also focus at less compliant patients",
"BACKGROUND Studies have demonstrated that blood pressure ( BP ) control can be improved when clinical pharmacists assist with patient management . The objective of this study was to evaluate if a physician and pharmacist collaborative model in community-based medical offices could improve BP control . METHODS This was a prospect i ve , cluster r and omized , controlled clinical trial with clinics r and omized to a control group ( n = 3 ) or to an intervention group ( n = 3 ) . The study enrolled 402 patients ( mean age , 58.3 years ) with uncontrolled hypertension . Clinical pharmacists made drug therapy recommendations to physicians based on national guidelines . Research nurses performed BP measurements and 24-hour BP monitoring . RESULTS The mean ( SD ) guideline adherence scores increased from 49.4 ( 19.3 ) at baseline to 53.4 ( 18.1 ) at 6 months ( 8.1 % increase ) in the control group and from 40.4 ( 22.6 ) at baseline to 62.8 ( 13.5 ) at 6 months ( 55.4 % increase ) in the intervention group ( P = .09 for adjusted between-group comparison ) . The mean BP decreased 6.8/4.5 mm Hg in the control group and 20.7/9.7 mm Hg in the intervention group ( P systolic BP was -12.0 ( 95 % confidence interval [ CI ] , -24.0 to 0.0 ) mm Hg , while the adjusted difference in diastolic BP was -1.8 ( 95 % CI , -11.9 to 8.3 ) mm Hg . The 24-hour BP levels showed similar effect sizes . Blood pressure was controlled in 29.9 % of patients in the control group and in 63.9 % of patients in the intervention group ( adjusted odds ratio , 3.2 ; 95 % CI , 2.0 - 5.1 ; P A physician and pharmacist collaborative intervention achieved significantly better mean BP and overall BP control rates compared with a control group . Additional research should be conducted to evaluate efficient strategies to implement team-based chronic disease management . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00201019",
"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",
"ABSTRACT OBJECTIVE Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics . STUDY DESIGN A 12-month prospect i ve , single-blind , r and omized , controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure . METHODS As compared to usual primary care , intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocol s. At baseline , there was no significant difference in blood pressure between groups . Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end . Secondary measures included blood pressure goal attainment ( RESULTS A total of 463 subjects were enrolled ( n = 233 control , n = 230 intervention ) . Subjects receiving the intervention achieved significantly lower systolic ( p = 0.007 ) and diastolic ( p = 0.002 ) blood pressures compared to control ( 137/75 mmHg vs. 143/78 mmHg ) . In addition , 62 % of intervention subjects achieved target blood pressure compared to 44 % of control subjects ( p = 0.003 ) . The intervention group received more total office visits ( 7.2 vs. 4.9 , p physician visits ( 3.2 vs. 4.7 , p antihypertensive medications ( 2.7 vs. 2.4 , p = 0.02 ) , but did not take more antihypertensive pills per day ( 2.4 vs. 2.5 , p = 0.87 ) . There were minimal differences between groups in hypertension-related knowledge , medication adherence , quality of life , or satisfaction . CONCLUSIONS Patients r and omized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction",
"BACKGROUND Blood pressure ( BP ) control in patients with diabetes mellitus is difficult to achieve and current patterns are suboptimal . Given increasing problems with access to primary care physicians , community pharmacists and nurses are well positioned to identify and observe these patients . This study aim ed to determine the efficacy of a community-based multidisciplinary intervention on BP control in patients with diabetes mellitus . METHODS We performed a r and omized controlled trial in 14 community pharmacies in Edmonton , Alberta , Canada , of patients with diabetes who had BPs higher than 130/80 mm Hg on 2 consecutive visits 2 weeks apart . Care from a pharmacist and nurse team included a wallet card with recorded BP measures , cardiovascular risk reduction education and counseling , a hypertension education pamphlet , referral to the patient 's primary care physician for further assessment or management , a 1-page local opinion leader-endorsed evidence summary sent to the physician reinforcing the guideline recommendations for the treatment of hypertension and diabetes , and 4 follow-up visits throughout 6 months . Control-arm patients received a BP wallet card , a pamphlet on diabetes , general diabetes advice , and usual care by their physician . The primary outcome measure was the difference in change in systolic BP between the 2 groups at 6 months . RESULTS A total of 227 eligible patients were r and omized to intervention and control arms between May 5 , 2005 , and September 1 , 2006 . The mean ( SD ) patient age was 64.9 ( 12.1 ) years , 59.9 % were male , and the mean ( SD ) baseline systolic/diastolic BP was 141.2 (13.9)/77.3 ( 8.9 ) mm Hg at baseline . The intervention group had an adjusted mean ( SE ) greater reduction in systolic BP at 6 months of 5.6 ( 2.1 ) mm Hg compared with controls ( P = .008 ) . In the subgroup of patients with a systolic BP greater than 160 mm Hg at baseline , BP was reduced by an adjusted mean ( SE ) of 24.1 ( 1.9 ) mm Hg more in intervention patients than in controls ( P patients who have diabetes and hypertension that are relatively well controlled , a pharmacist and nurse team-based intervention result ed in a clinical ly important improvement in BP . Trial Registration clinical trials.gov Identifier : NCT00374270",
"BACKGROUND Despite clear evidence for the efficacy of lowering cholesterol levels , there is a deficiency in its real-world application . There is a need to explore alternative strategies to address this important public health problem . This study aim ed to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events . METHODS A r and omized controlled trial conducted in 54 community pharmacies ( 1998 - 2000 ) included patients at high risk for cardiovascular events ( with atherosclerotic disease or diabetes mellitus with another risk factor ) . Patients r and omized to pharmacist intervention received education and a brochure on risk factors , point-of-care cholesterol measurement , referral to their physician , and regular follow-up for 16 weeks . Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions . Usual care patients received the same brochure and general advice only , with minimal follow-up . The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication . RESULTS The external monitoring committee recommended early study termination owing to benefit . Of the 675 patients enrolled , approximately 40 % were women , and the average age was 64 years . The primary end point was reached in 57 % of intervention patients vs 31 % in usual care ( odds ratio , 3.0 ; 95 % confidence interval , 2.2 - 4.1 ; P community-based intervention program improved the process of cholesterol management in high-risk patients . This program demonstrates the value of community pharmacists working in collaboration with patients and physicians",
"STUDY OBJECTIVE To measure the effectiveness of a multifaceted educational intervention to improve ambulatory hypertension control . DESIGN Cluster-r and omized trial . SETTING Academic health system using an ambulatory electronic medical record . SUBJECTS A total of 10,696 patients with a diagnosis of hypertension cared for by 93 primary care providers . INTERVENTION Academic detailing , provision of provider-specific data about hypertension control , provision of educational material s to the provider , and provision of educational and motivational material s to patients . MEASUREMENTS AND MAIN RESULTS The primary outcome was blood pressure control , defined as a blood pressure measurement below 140/90 mm Hg , and was ascertained from electronic medical records over 6 months of follow-up . We determined the adjusted odds ratio for the association between the intervention and the achievement of controlled blood pressure . When we accounted for clustering by provider , this adjusted odds ratio was 1.13 ( 95 % confidence interval 0.87 - 1.47 ) . Adjusted odds ratios were 1.03 ( 95 % confidence interval 0.78 - 1.36 ) in patients whose blood pressure was controlled at baseline and 1.25 ( 95 % confidence interval 0.94 - 1.65 ) in those whose blood pressure was not . These odds ratios were not significantly different ( p=0.11 ) . CONCLUSIONS These results were consistent with no effect or , at best , a relatively modest effect of the intervention among patients with hypertension . Had we not included a concurrent control group , the data would have provided an unduly optimistic view of the effectiveness of the program . The effectiveness of future interventions may be improved by focusing on patients whose blood pressure is uncontrolled at baseline",
"We evaluated blood pressure control , quality of life , quality of care , and satisfaction of patients who were monitored by specially trained community pharmacists in a group medical practice . After participating in an intensive skill development program , pharmacists performed in an interdisciplinary team in a rural clinic . The primary objective was assessed by evaluating outcome variables at 6 months compared with baseline in 25 patients r and omly assigned to a study group . A control group of 26 patients was also evaluated to determine if outcome variables remained constant from baseline to 6 months . Systolic blood pressure was reduced in the study group ( 151 mm Hg baseline , 140 mm Hg at 6 mo , p diastolic blood pressure was significantly lower at 2 , 4 , and 5 months compared with baseline . Ratings from a blinded peer review panel indicated significant improvement in the appropriateness of the blood pressure regimen , going from 8.7 + /- 4.7 to 10.9 + /- 4.5 in the study group ( p quality of life scores improved significantly in the study group after 6 months ( p physical functioning ( 61.6 vs 70.7 ) , physical role limitations ( 56.8 vs 72.8 ) , and bodily pain ( 60.0 vs 71.7 ) at baseline and 6 months , respectively . There were no significant changes in the control group . Patient satisfaction scores were consistently higher in the study group at the end of the study . Our results indicate that when community pharmacists in a clinic setting are trained and included as members of the primary care team , significant improvements in blood pressure control , quality of life , and patient satisfaction can be achieved",
"OBJECTIVE : To assess the effect of a physician and pharmacist teamwork approach to uncontrolled hypertension in a medical resident teaching clinic , for patients who failed to meet the recommended goals of the fifth Joint National Commission on Detection , Evaluation and Treatment of High Blood Pressure . HYPOTHESIS : Physician and pharmacist teamwork can improve the rate of meeting national blood pressure goals in patients with previously uncontrolled hypertension . DESIGN : A single-blinded r and omized controlled trial lasting 6 months . SETTING : A primary care outpatient teaching clinic . PATIENTS : A sample of 95 adult hypertensive patients who failed to meet national blood pressure goals based on three consecutive visits over a 6-month period . INTERVENTION : Patients were r and omly assigned to a control arm of st and ard medical care or to an intervention arm in which a physician and pharmacist worked together as a team . MAIN RESULTS : At study completion , the percentage of patients achieving national goals due to intervention was more than double the percentage in the control arm ( 55 % vs 20 % , p Systolic blood pressure declined 23 mm Hg in the intervention arm versus 11 mm Hg in the control arm ( p Diastolic blood pressure declined 14 and 3 mm Hg in the intervention and control arms , respectively ( p Patients who fail to achieve national blood pressure goals under st and ard outpatient medical care may benefit from a program that includes a physician and pharmacist teamwork approach",
"BACKGROUND Diabetes mellitus continues to result in substantial morbidity and mortality despite receiving much attention from health care providers . Automated clinician reminder systems have been developed to improve adherence to diabetes care guidelines , but these reminder systems do not always provide actionable information and may be unable to detect relevant , subjective patient information that affects clinical decision making . Face-to-face visits with pharmacists , who have knowledge of care guidelines and medication management strategies , may assist in improving diabetes care . It is unknown if the combination of pharmacist chart review and clinician reminders could improve diabetes care without requiring face-to-face visits . OBJECTIVE To assess the effects of a comprehensive , pharmacistdelivered , primary care , physician-focused intervention in a large hospital based primary care practice to improve the quality of care for patients with diabetes including rates of semiannual hemoglobin A1c testing and other biomarker and process measures . METHODS This was a prospect i ve , r and omized , controlled study conducted in a hospital-based , primary care practice , composed of 37 faculty primary care physicians ( PCPs ) and 95 internal medicine residents . The initial sample included 346 patients with diabetes and 72 PCPs caring for them . PCPs were r and omized to receive either a personalized letter from a practicing pharmacist containing treatment recommendations for patients with upcoming primary care visits ( intervention , n = 33 ) or to usual care without the letters ( control , n = 39 ) . The letter included patient-specific recommendations regarding overdue testing as well as drug therapy to achieve diabetes-related treatment targets . The intervention included addition of the letter to the electronic medical record ( EMR ) and presentation of the letter to the PCP at the time of the index primary care visit that occurred between November 2003 and August 2004 . Follow-up chart review was performed after the primary care visit to determine changes in 5 process and 3 biomarker outcome measures of diabetes care within 30 days of the index visit . The primary study outcome was a process measure , change in rates of semiannual A1c testing from baseline to 30-day follow-up . Baseline differences were tested for statistical significance using Pearson chisquare . The statistical significance of the intervention 's effect was tested using logistic regression models predicting achievement of each study outcome , with r and omization status ( intervention vs. control ) as the predictor variable of interest , controlling for baseline performance for each measure . RESULTS 171 patients were in the 4 medical clinic suites with 33 PCPs who received the intervention , and 175 patients were in the 4 suites with 39 PCPs in usual care . 30-day outcomes were analyzed for 301 patients ( 87.0 % ) who attended their scheduled index primary care visit . Of these 301 patients , 44.5 % were black , 65.8 % were female , and the mean age was 63 years . At baseline , there were no significant differences between the intervention group ( n = 150 ) and the usual care ( control ) group ( n = 151 ) in the 3 biomarker measures ( proportion with A1c less than 7 % , proportion with low-density lipoprotein cholesterol [ LDL-C ] less than 100 milligrams per deciliter [ mg per dL ] , or blood pressure less than 130/80 millimeters mercury [ mm Hg ] ) . There were no significant baseline differences in 4 of the 5 process measures ; however , the rate of annual LDL-C testing was significantly higher for the intervention than for the control group at baseline ( 86.0 % vs. 74.8 % , respectively , P = 0.015 ) . In logistic regression analysis , rates of semiannual A1c testing were not significantly different between the intervention and control groups , increasing from baseline to follow-up by 16 % in the intervention group and 9 % in the control group ( P = 0.146 ) . The proportion of patients with A1c less than 7 % at follow-up was 43.3 % in the intervention group versus 37.7 % in the control group ( intervention effect P = 0.099 ) . The only statistically significant difference between the 2 groups in the 8 outcome measures was a higher proportion with an annual eye exam at follow-up in the intervention group ( 60.0 % ) versus the usual care group ( 50.3 % , intervention effect P = 0.017 ) . CONCLUSIONS Pharmacist-generated recommendations delivered by letter to PCPs in an academic medical practice were not associated with statistically significant improvements in most quality measures for diabetes care assessed at 30 days following the intervention . Further research is needed with more patients and a longer follow-up time to determine how best to improve the quality of care of patients with diabetes using focused recommendations for therapy changes and reminder notices to clinicians",
"BACKGROUND It has been cited that the management of congestive heart failure ( CHF ) requires a multidisciplinary approach ; however , the role of the pharmacist has not been extensively studied . The roles for pharmacists are changing to meet the long term needs of patients in the community setting , including patients with CHF . OBJECTIVES To evaluate the effect of a pharmacist on the appropriateness of medications taken by patients in the heart function clinic using the Medication Appropriateness Index ( MAI ) and to measure the effect of a pharmacist on the patients ' response to the pharmacist 's interventions using the Purdue Directive Guidance ( DG ) scale . METHODS Eighty patients attending the heart function clinic at The University Health Network , Toronto General Hospital Toronto , Ontario were r and omly assigned to an intervention group that received pharmacist services or a nonintervention group that received usual care from the clinic staff . Patients were assessed at baseline and at one-month follow-up . RESULTS The change in MAI score from baseline was 0.74 and 0.49 for the intervention and nonintervention groups , respectively ( P=0.605 ) . The change in DG survey results was 9.97 and 1.00 for the intervention and nonintervention groups , respectively ( P components of the DG survey , especially those pertaining to feedback and goal setting . CONCLUSIONS A benefit was demonstrated for ' directive guidance ' of patients , in the form of education and goal setting as shown by positive survey results",
"A controlled , r and omized study was conducted in two chain pharmacies to determine the clinical value of comprehensive pharmacy services for hypertensive patients in a chain pharmacy setting . Twenty-seven patients were enrolled as intervention participants with 26 control subjects . Monthly services for the intervention group included blood pressure and heart rate assessment s and counseling on lifestyle modifications and drug therapy . Control patients received initial and final blood pressure measurements and minimal counseling . Both study and control groups completed quality -of-life question naires upon entering and completing the study . Results showed that blood pressure control was significantly improved in the study group . Compliance rates as well as energy/fatigue scores ( a quality -of-life scale ) improved in the study group compared with the control population . Community pharmacists in chain stores could have a beneficial effect on the health care of large numbers of patients if pharmaceutical care programs were developed",
"OBJECTIVE : To assess the effect of a program that encourages teamwork between physicians and pharmacists on attempts to lower total cholesterol levels and to meet recommended goals proposed by the National Cholesterol Education Program ( NCEP ) . DESIGN A single-blind , r and omized , controlled trial lasting 6 months . SETTING : An ambulatory primary care center . PATIENTS : A sample of 94 patients with total cholesterol levels of 240 mg/dL ( 6.2 mmol/L ) or higher . INTERVENTION : Equal numbers of patients were r and omly assigned to a control arm in which st and ard medical care was received and an intervention arm which implemented close interaction between physicians and pharmacists . MEASUREMENTS AND MAIN RESULTS : Absolute change in total cholesterol levels from baseline values and the percentage of patients who achieved an NCEP goal after 6 months of intervention were determined . The rate of success in achieving NCEP goals in the intervention arm was double the rate in the control arm ( 43 % vs 21 % , p Total cholesterol levels in the intervention arm declined 44 + /- 47 mg/dL ( 1.1 + /- 1.2 mmol/L ) versus 13 + /- 51 mg/dL ( 0.3 + /- 1.3 mmol/L ) in the control arm ( p total cholesterol levels was similar for men and women and did not appear to be altered by age . The effect of intervention was greatest in patients with coronary heart disease ( p of intervention was absent in patients without coronary heart disease and with fewer than two risk factors . CONCLUSIONS : Attempts to lower total cholesterol levels and achieve NCEP goals are likely to be more successful when combined with programs that include teamwork between physicians and pharmacists . Some programs , however , may be more successful for high-risk patients , for whom it is often easier to provide more aggressive therapies . Although altering adverse lipid profiles in lower-risk patients may be difficult , achieving optimal cholesterol levels could have an important impact on preventing movement to higher risk strata",
"OBJECTIVE To evaluate the effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus . STUDY DESIGN R and omized controlled trial in a university-affiliated primary care internal medicine clinic . METHODS We recruited 80 patients with poorly controlled type 2 diabetes mellitus . A clinical pharmacist provided evaluation and modification of pharmacotherapy , self-management diabetes education , and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up . The main clinical outcome was hemoglobin A1C ( HbA1C ) level ; process measures included HbA1C and low-density lipoprotein measurement , retinal examination , urine microalbumin testing ( or use of angiotensin-converting enzyme inhibitors ) , and monofilament screening for diabetic neuropathy . RESULTS Patients in the intervention and control groups were similar in age , sex , mean HbA1C levels ( 10.1 % and 10.2 % , respectively ; P = .65 ) , and current treatment regimens at baseline . Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group ( 2.1 % vs 0.9 % , P = .03 ) . Three of the 5 process measures were conducted more frequently in the intervention group than the control group , including low-density lipoprotein measurement ( 100.0 % vs 85.7 % , P = .02 ) , retinal examination ( 97.3 % vs 74.3 % ) , and monofilament foot screening ( 92.3 % vs 62.9 % ) . CONCLUSIONS Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures . This approach , integrated with and based in the primary care setting , was an effective and efficient approach to improving care , especially for those with poor glycemic control at baseline",
"OBJECTIVE To evaluate whether patients with coronary artery disease ( CAD ) discharged from the Clinical Pharmacy Cardiac Risk Service ( CPCRS ) would maintain their lipid goals with use of an electronic laboratory reminder system . STUDY DESIGN A 2-year , r and omized study at Kaiser Permanente Colorado . METHODS Patients with prior CAD ( acute myocardial infa rct ion , coronary artery bypass graft surgery , percutaneous coronary intervention ) who had been enrolled in the CPCRS for at least 1 year and who had 2 consecutive low-density lipoprotein cholesterol ( LDL-C ) , non-high-density lipoprotein cholesterol , and blood pressure readings at goal within 6 months before enrollment were r and omized to remain in the CPCRS ( CPCRS care ) or to receive usual care from primary care physicians plus laboratory reminder letters ( usual care ) . The primary outcome was maintenance of LDL-C goal at study end . The t test and chi(2 ) test of association were used to assess differences in mean and categorical values , respectively . RESULTS A total of 421 patients ( 214 CPCRS care , 207 usual care ) were r and omized . Their mean age was 72 years ; 74 % were male . After 1.7 years of follow-up , the proportions of patients maintaining their LDL-C goal of CPCRS care and usual care groups , respectively ( P = .46 ) . The proportions maintaining their LDL-C goal of CPCRS care and usual care groups , respectively ( P = .23 ) . CONCLUSION This study demonstrated that LDL-C measures can remain controlled in most patients discharged from a cardiac disease management program",
"BACKGROUND : Inappropriate use of medications is a significant problem in health care today . A possible solution to this problem may be achieved through better control of patients ' drug therapy . OBJECTIVE : To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications , while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life . METHODS : Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks . Although both the intervention and control groups were surveyed , the r and omly selected intervention group was interviewed more frequently and more comprehensively . Cholesterol , triglycerides , glucose , weight , risk factors , drug-related problems ( DRPs ) , and quality of life were measured via a survey at the onset of the study and continually measured until the study 's conclusion . RESULTS : In the intervention group , 26 DRPs were detected , of which 24 were resolved ; in the control group , 26 DRPs were detected , of which 5 were resolved . When comparing initial and final blood cholesterol levels in the intervention group , the mean decrease was 27.0 ± 41.1 mg/dL ( p = 0.0266 ) ; in the control group , the average blood cholesterol level decreased by a mean of 1.4 ± 37.2 mg/dL ( p = 0.6624 ) . In the intervention group , the triglyceride level decreased an average of 50.5 ± 80.3 mg/dL ( p = 0.0169 ) , while the control group experienced a mean triglyceride level increase of 29.6 ± 118.5 mg/dL ( p = 0.1435 ) . As a result of the intervention , the quality of life in the intervention group was improved . CONCLUSIONS : Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values , cardiovascular disease risk factors , and patients ' quality of life",
"This was a prospect i ve , cluster r and omized controlled trial in patients with uncontrolled hypertension aged 21 to 85 years ( mean , 61 years ) . Pharmacists made recommendations to physicians for patients in the intervention clinics ( n=101 ) but not patients in the control clinics ( n=78 ) . The mean adjusted difference in systolic blood pressure ( BP ) between the control and intervention groups was 8.7 mm Hg ( 95 % confidence interval [ CI ] , 4.4 - 12.9 ) , while the difference in diastolic BP was 5.4 mm Hg ( CI , 2.8 - 8.0 ) at 9 months . The 24-hour BP levels showed similar effects , with a mean systolic BP level that was 8.8 mm Hg lower ( CI , 5.0 - 12.6 ) and a mean diastolic BP level that was 4.6 mm Hg ( CI , 2.4 - 6.8 ) lower in the intervention group . BP was controlled in 89.1 % of patients in the intervention group and 52.9 % in the control group ( adjusted odds ratio , 8.9 ; CI , 3.8 - 20.7 ; P collaboration achieved significantly better mean BP values and overall BP control rates , primarily by intensification of medication therapy and improving patient adherence",
"AIM The aim of this study was to investigate the impact of a pharmacist-led pharmaceutical care programme , involving optimization of drug treatment and intensive education and self-monitoring of patients with heart failure ( HF ) within the United Arab Emirates ( UAE ) , on a range of clinical and humanistic outcome measures . METHODS The study was a r and omized , controlled , longitudinal , prospect i ve clinical trial at Al-Ain Hospital , Al-Ain , UAE . Patients were recruited from the general medical wards and from cardiology and medical outpatient clinics . HF patients who fulfilled the entrance criteria , and had no exclusion criteria present , were identified for inclusion in the study . After recruitment , patients were r and omly assigned to one of two groups : intervention group or control group . Intervention patients received a structured pharmaceutical care service while control patients received traditional services . Patient follow-up took place when patients attended scheduled outpatient clinics ( every 3 months ) . A total of 104 patients in each group completed the trial ( 12 months ) . The patients were generally suffering from mild to moderate HF ( NYHA Class 1 , 29.5 % ; Class 2 , 50.5 % ; Class 3 , 16 % ; and Class 4 , 4 % ) . RESULTS Over the study period , intervention patients showed significant ( P exercise tolerance [ 2-min walk test : 1607.2 ( 1474.9 , 1739.5 ) m.month in intervention patients vs. 1403.3 ( 1256.5 , 1549.8 ) in control patients ] , forced vital capacity [ 31.6 ( 30.8 , 32.4 ) l.month in the intervention patients vs. 27.8 ( 26.8 , 28.9 ) in control patients ] , health-related quality of life , as measured by the Minnesota living with heart failure question naire [ 463.5 ( 433.2 , 493.9 ) unit.month in intervention patients vs. 637.5 ( 597.2 , 677.7 ) in control patients ; a lower score in this measure indicates better health-related quality of life ] . The number of individual patients who reported adherence to prescribed medications was higher ( P adherence to lifestyle advice ( 75 vs. 29 ) at the final assessment ( 12 months ) . There was a tendency to have a higher incidence of casualty department visits by intervention patients , but a lower rate of hospitalization . CONCLUSIONS The research provides clear evidence that the delivery of pharmaceutical care to patients with HF can lead to significant clinical and humanistic benefits",
"The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE ( Impact of Managed Pharmaceutical Care on Re source Utilization and Outcomes in Veterans Affairs Medical Centers ) study . A total of 523 patients were r and omized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug-related problems . Patients r and omized to the control group had no interventions and they are not reported . Using a st and ard form , pharmacists were asked to document the length of visit , method of contact , medical conditions addressed , and drug-related problems addressed and resolved during each contact . Seventy-eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months , an average of 3.54 + /- 2.31/patient . The length of visits was 15 minutes or more for 73 % of contacts . In-person contacts accounted for 1421 visits ( 76.6 % ) , with the remainder being telephone contacts . During each contact the average number of drug-related problems addressed and resolved were 1.64 + /- 1.16 and 1.14 + /- 0.98 , respectively . More drug-related problems were addressed and resolved when visits were 15 minutes or longer ( p=0.001 ) and when the contact was in person ( p=0.001 ) . These data may provide information to clinical pharmacists developing pharmacy-managed clinics for patients at high risk for drug-related problems . The information may be a benchmark for types of interventions that can be made , as well as the time commitments required to make them",
"OBJECTIVE To investigate the effect of pharmacist management of poorly controlled diabetes mellitus in a community-based primary care group . STUDY DESIGN R and omized controlled trial of pharmacist management of diabetes compared with usual medical care . METHODS Patients 18 years or older with glycosylated hemoglobin ( A1C ) levels of 9.0 % or higher were enrolled . Patients were r and omly assigned to an intervention group ( n = 52 ) or a control group ( n = 51 ) . Management in the control group included the use of registries and targeted patient outreach . The intervention group participated in the same outreach program plus medication management , patient education , and disease control by a pharmacist . RESULTS Nonparametric data showed median A1C decreases of 1.50 % for the intervention group and 0.40 % for the control group ( P = .06 ) . Significantly more patients in the intervention group improved their A1C level by at least 1.0 % relative to the control group ( 67.3 % vs 41.2 % , P = .02 ) . Most of this benefit was seen for patients of nonwhite race/ethnicity compared with control subjects ( 56.3 % vs 22.7 % , P = .03 ) . Male patients showed significantly greater benefit as well , with a median A1C decrease of 1.90 % vs 0.15 % for controls ( P = .03 ) . CONCLUSIONS Patients with poorly controlled diabetes improved A1C levels significantly when pharmacist management was added to an aggressive organizational diabetes management program . Our results suggest that clinical ly trained pharmacists can help primary care providers improve diabetes management , especially among male patients and among patients of nonwhite race/ethnicity ",
"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 test whether a drug review and symptom self management and lifestyle advice intervention by community pharmacists could reduce hospital admissions or mortality in heart failure patients . Design R and omised controlled trial . Setting Home based intervention in heart failure patients . Participants 293 patients diagnosed with heart failure were included ( 149 intervention , 144 control ) after an emergency admission . Intervention Two home visits by one of 17 community pharmacists within two and eight weeks of discharge . Pharmacists review ed drugs and gave symptom self management and lifestyle advice . Controls received usual care . Main outcome measures The primary outcome was total hospital readmissions at six months . Secondary outcomes included mortality and quality of life ( Minnesota living with heart failure question naire and EQ-5D ) . Results Primary outcome data were available for 291 participants ( 99 % ) . 136 ( 91 % ) intervention patients received one or two visits . 134 admissions occurred in the intervention group compared with 112 in the control group ( rate ratio=1.15 , 95 % confidence interval 0.89 to 1.48 ; P=0.28 , Poisson model ) . 30 intervention patients died compared with 24 controls ( hazard ratio=1.18 , 0.69 to 2.03 ; P=0.54 ) . Although EQ-5D scores favoured the intervention group , Minnesota living with heart failure question naire scores favoured controls ; neither difference was statistically significant . Conclusion This community pharmacist intervention did not lead to reductions in hospital admissions in contrast to those found in trials of specialist nurse led interventions in heart failure . Given that heart failure accounts for 5 % of hospital admissions , these results present a problem for policy makers who are faced with a shortage of specialist provision and have hoped that skilled community pharmacists could produce the same benefits . Trial registration number IS RCT N59427925",
"AIMS To evaluate whether a structured community pharmacy-based smoking cessation programme ( the PAS model ) would give rise to a higher smoking cessation rate compared with ad hoc advice from pharmacists . DESIGN A r and omized controlled trial comparing a structured intervention with usual care . SETTING One hundred pharmacists working in community pharmacies in N. Irel and and 24 in London took part in the study and were each asked to enroll 12 smokers ; 44 % of pharmacists who were trained managed to recruit one or more smokers during the recruitment period of approximately 1 year . PARTICIPANTS A total of 484 smokers were enrolled by the pharmacists and individually r and omized into the PAS intervention group ( N = 265 ) or the control group ( N = 219 ) . INTERVENTION The PAS intervention involved a structured counselling programme , an information leaflet and a follow-up weekly for the first 4 weeks then monthly as needed . MEASUREMENTS The primary outcome measure of this study was self-reported smoking cessation for 12 months with cotinine validation at the 12-month follow-up . FINDINGS Of smokers in the PAS group , 14.3 % ( 38 ) were abstinent up to 12 months compared with 2.7 % ( 6 ) in the control group ( p community pharmacy-based PAS smoking cessation service can be an effective method of helping people stop smoking when delivered by pharmacists willing to adopt this approach",
"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",
"Few studies have demonstrated an effect of educational interventions on glycaemic control in persons with Type 2 diabetes longer than 3 - 6 months after baseline . We aim ed to investigate the effectiveness of an experience-based group educational programme 24 months after baseline and to pinpoint mediators that might play a role in achieving desired metabolic outcomes . We conducted a r and omised controlled trial inviting self-referred persons with Type 2 diabetes ( N=77 r and omised ) . The pharmacist-led , year-long intervention was based on participants ' experiences of glucose regulation during the monthly group discussion s. We measured HbA1c at 0 , 6 , 12 , and 24 months and a question naire was administered at baseline and final follow-up . Our findings indicated that participating in the intervention programme significantly decreased HbA1c by 0.4 % at 24 months after baseline . Initial HbA1c , satisfaction with own diabetes-related knowledge , and treatment were found directly related to glycaemic outcomes . The intervention group exercised more in order to lower blood-glucose levels and was also more able to predict current blood-glucose levels before measuring it . Experience-based group education was effective in decreasing participants ' HbA1c 1-year after completed intervention . Early effect of the intervention was followed by relapse after 12 months and a new , significant decrease at 24 months ; this dual course implies that follow-up of educational interventions should involve several consecutive measurements to capture possible late effects . Both biomedical and subjective factors played a role in accounting for the variance of HbA1c at 2-year follow-up after baseline",
"OBJECTIVE The study aim ed to investigate the clinical impact of pharmacist-physician co-managed programme on the management of hyperlipidaemia . METHODS The study was a prospect i ve r and omized controlled trial . Adult patients were selected if : ( i ) they were taking one or more lipid-lowering agents with a valid lipid panel before their next follow up ; ( ii ) had a baseline lipid profile within the previous 6 months ; ( iii ) their lipid panel did not reach the targeted low-density lipoprotein-cholesterol ( LDL-C ) goal based on the National Cholesterol Education Programme Adult Treatment Panel III . Pharmacists interviewed patients in the intervention group for 15 - 30 min to provide consultation on the drug regimen and lifestyle modifications . A telephone follow-up every 4 weeks and a follow-up interview on the date of the physician visit were scheduled . Patients in the control group received routine conventional care . The primary outcome measurement was the change in lipid panel between baseline and at the end of study . RESULTS One hundred and eighteen patients were recruited to the study [ 58 patients in intervention group ( mean age 63 + /- 10 years old ) and 60 in control group ( mean age 61 + /- 12 years old ) ] . Starting with similar baseline levels , the end of study LDL-C and total cholesterol levels for the intervention and control groups were LDL-C : 2.80 + /- 0.89 mmol/L and total cholesterol 4.75 + /- 1.08 mmol/L vs. LDL-C : 3.24 + /- 0.78 mmol/L and total cholesterol 5.18 + /- 0.93 mmol/L , respectively . The differences were statistically significant ( P pharmacist-physician co-managed programme for hyperlipidaemic patient was effective in getting more patients to reach their target lipid levels",
"Background Coronary heart disease ( CHD ) is the most common cause of death in the UK . CHD cost the UK National Health Service ( NHS ) £ 3.5 billion in 2003 . The economic impact of community pharmacists providing a medicines management service for patients with CHD has not been rigorously evaluated ; the full economic costs of such interventions are rarely presented in the literature . Objective To examine the incremental costs of a 1-year community pharmacistled medicines management service for patients with CHD in the UK , from a healthcare system and patient perspective . Methods and participants A cost-minimisation analysis was conducted alongside a multicentre r and omised controlled trial . The primary study participants were patients with CHD identified from general practice computer records . Patients ( intervention , n = 980 ; control , n = 500 ) from 38 general practice s in nine geographical areas in the UK were included in the study .Intervention and outcomes measures The intervention consisted of a review of pharmaceuticals and lifestyle advice by pharmacists in their premises , with recommendations communicated to the patient ’s GP . The main outcome measure was the incremental cost per patient in the intervention group compared with the control group . Annual costs ( £ , 2003/4 values ) included the costs of the intervention ( training and delivery costs ) , the usual costs of NHS treatment ( costs of pharmaceuticals , GP and hospital visits ) and costs borne by patients . Data were collected in the 12 months before and 12 months after the intervention . Results The total NHS cost increased between baseline and follow-up in both groups ( from £ 1243 to £ 1286 [ 3 % ] in the control group and from £ 1410 to £ 1433 [ 2 % ] in the intervention group).The greater cost in the intervention group largely reflects the additional cost of the pharmacist training and the time taken to deliver the intervention ; the difference in costs between the intervention and control groups , after controlling for differences in costs at baseline at follow-up , was statistically significant ( p = 0.001 ) . The costs of pharmaceuticals was higher in the intervention group ( £ 769.20 vs £ 742.3 ; p = 0.04).According to the sensitivity analysis , the intervention cost would need to decrease by 35 % to achieve equivalence between costs in each arm of the trial . Difference to costs of patients and their carers at follow-up were not statistically significant . Conclusions The introduction of a 1-year pharmacist-led medicines management service is likely to increase the total cost of CHD treatment and prevention from the healthcare perspective , as the cost of the intervention outweighed the observed reduction in the cost of drugs in the intervention group . No changes in costs from the patient perspective were found",
"The impact of clinical pharmacy services on direct drug costs in a coronary care unit ( CCU ) was studied . An observational , nonr and omized study was conducted on all patients admitted to the CCU to evaluate the impact of clinical pharmacy services on direct drug costs . Clinical pharmacy services were introduced into the CCU in July 1998 . Patient characteristics , mean drug costs per admission , mean drug category costs per admission , and total hospital costs per admission were determined for October 1997 to June 1998 ( nonintervention period ) , July 1998 to March 1999 ( intervention period 1 ) , and April 1999 to December 1999 ( intervention period 2 ) . The Clini-Trend program was used to estimate the total reduction in drug costs associated with documented pharmacist interventions from January to December 1999 . Mean patient age , sex , admitting diagnosis-related group , Medicare case-mix index , ventilator days , length of stay , and number of deaths did not differ significantly among the three study periods . Mean + /- S.D. drug costs per admission for the nonintervention period were $ 374.05 + /- $ 75.51 . With the introduction of clinical pharmacy services , mean + /- S.D. drug costs per admission were $ 381.94 + /- $ 66.16 ( p > 0.1 for intervention period 1 compared with the nonintervention period ) and $ 233.74 + /- $ 84.16 ( p = 0.002 for intervention period 2 compared with the nonintervention period ) . From January to December 1999 , 4151 pharmacist interventions were documented . The estimated reduction in drug costs associated with the interventions totaled $ 372,384 . A pharmacist 's clinical services in the CCU allowed for significant estimated reductions in total drug costs",
"This study evaluated the economic impact of patient-focused pharmacist intervention in the community retail setting in patients with hypertension , diabetes , asthma , and /or hypercholesterolemia . Specially trained pharmacists intervened by providing targeted patient education , performing systematic patient monitoring , offering feedback and behavior modification , and communicating regularly with patients ' physicians to enable early intervention for drug-related problems . We evaluated prescription drug costs and total medical costs by comparing cl aims data from 188 patients enrolled in the program at three intervention pharmacies with data from 401 control patients at five nonparticipating pharmacies from the same retail chain . For all disease states , the average cost per prescription was significantly higher in the group receiving intervention than in the control group . Differences in total monthly prescription costs were significant only for patients with asthma , with higher monthly costs in the group receiving intervention . Substantial savings were demonstrated across all cost analyses for total monthly medical costs . Savings ranged from a conservative estimate of $ 143.95 per patient per month to $ 293.39 per patient per month when accounting for the possible influence of age , comorbid conditions , and disease severity . Our data indicate that pharmacist intervention in this community pharmacy-based disease management model substantially reduced monthly health care costs in patients with hypertension , hypercholesterolemia , diabetes , and asthma",
"OBJECTIVE To evaluate a pharmacist-conducted educational and monitoring programme , design ed to promote dietary and lifestyle modification and compliance with lipid-lowering drug therapy , for patients with dyslipidaemia . METHODS This was a prospect i ve , r and omized , controlled study . The participants were 94 adults , with 81 completing the study ( intervention group : 39 ; control group : 42 ) , with a cardiovascular-related diagnosis and discharged from hospital , between April and October 2001 , on lipid-lowering drug therapy . Patients in the intervention group were visited at home monthly by a pharmacist , who educated the patients on the goals of lipid-lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy , assessed patients for drug-related problems , and measured total blood cholesterol levels using point-of-care testing . Patients in the control group received st and ard medical care . The main outcome measure was total blood cholesterol levels after 6 months , and an evaluation of patient and general practitioner satisfaction with the programme . RESULTS There was no significant difference in baseline total blood cholesterol levels between the two groups . The reduction over the course of the study in cholesterol levels within the intervention group was statistically significant ( 4.9 + /- 0.7 to 4.4 + /- 0.6 , P cholesterol levels below 4.0 mmol/L ( P=0.06 ) . The reduction in total cholesterol in the intervention group should translate to an expected 21 % reduction in cardiovascular mortality risk and a 16 % reduction in total mortality risk -- more than twice the risk reduction achieved in the control group . In addition , the programme was very well received by the patients and their general practitioners , by satisfaction question naire . CONCLUSION A pharmacist-conducted educational and monitoring intervention improved the outcomes of lipid-lowering drug therapy",
"PURPOSE The outcomes of pharmacist-managed diabetes care services in a community health center were studied . METHODS Eligible patients were over age 18 years and had a diagnosis of type 2 diabetes mellitus . Patients were r and omly assigned by the clinical pharmacist and nurse to the intervention group ( n = 76 ) or control group ( n = 73 ) . Patients in the intervention group were enrolled in a pharmacist-managed diabetes care program . Patients in the control group received the st and ard diabetes care . The primary endpoint was reduction in glycosylated hemoglobin ( HbA(1c ) ) ; secondary outcome measures included weight loss , an improved body mass index , decreased blood pressure , and an improved lipid panel . Quality -of-life measures ( health level , satisfaction , impact , worry about disease , and worry about social and vocational issues ) were also assessed . RESULTS Demographic differences between groups were not remarkable . Mean HbA(1c ) levels fell significantly ( p HbA(1c ) levels ( 95 % confidence interval , 0.08 - 1.78 ; p Satisfaction level improved from 63.7 to 77.4 in the intervention group , which was significant when compared with the control group , whose satisfaction score improved from 57.0 to 63.4 ( p CONCLUSION Patients with type 2 diabetes mellitus who received pharmacist-managed diabetes care demonstrated improved HbA(1c ) , systolic blood pressure , and low-density-lipoprotein cholesterol levels and quality -of-life measures and met treatment goals more often than patients receiving st and ard care",
"Background Pharmacists in various setting s have been effective in initiating diabetes treatment . Patients with diabetes require ongoing disease management , and community pharmacists are in a strategic position to provide such extended care . Little is known , however , about the effects of community pharmacist – provided interventions beyond the initial treatment period . Objective To evaluate the effect of community pharmacist – provided extended diabetes care service on primary clinical outcomes , including hemoglobin A1c ( A1C ) , low-density lipoprotein cholesterol ( LDL-C ) , and blood pressure , and on patients ' reported self-care activities . Methods A r and omized controlled trial was conducted in patients with diabetes . Participants had already completed at least 2 diabetes education sessions at a local diabetes education center . Nine specially trained pharmacists administered interventions during up to 4 quarterly visits per patient . Interventions included discussing medications , clinical goals , and self-care activities with patients and recommending medication changes to physicians when appropriate . The main outcome measures were 12-month changes in A1C , LDL-C , blood pressure , and self-report of self-care activities . Results Seventy-eight patients participated in the study ( 36 intervention , 42 control ) ; 66 were included in the final analysis ( 31 intervention , 35 control ) . Compared with changes in the control group , patients who received interventions significantly increased the number of days per week that they engaged in a set of diet and diabetes self-care activities ( 1.25 and 0.73 more days/wk , respectively ) . The mean 12-month changes for A1C , LDL-C , and blood pressure were not significantly different between the 2 study groups . Conclusions Although pharmacist-provided interventions did not demonstrate statistically significant improvements in clinical outcomes over the study period , study results did show that pharmacists were effective at increasing the number of days that patients spent engaging in healthy diet and diabetes self-care activities . Addressing lifestyle and self-care behaviors can be a beneficial component of a pharmacist-provided extended diabetes care service",
"PURPOSE To assess the efficacy of a pharmacist-led , primary care-based , disease management program to improve cardiovascular risk factors and glycated hemoglobin ( A(1C ) ) levels in vulnerable patients with poorly controlled diabetes . METHODS A r and omized controlled trial of 217 patients with type 2 diabetes and poor glycemic control ( A(1C ) level > or=8.0 % ) was conducted at an academic general medicine practice from February 2001 to April 2003 . Intervention patients received intensive management from clinical pharmacists , as well as from a diabetes care coordinator who provided diabetes education , applied algorithms for managing glucose control and decreasing cardiovascular risk factors , and addressed barriers to care . Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider . Outcomes were recorded at baseline and at 6 and 12 months . Primary outcomes included blood pressure , A(1C ) level , cholesterol level , and aspirin use . Secondary outcomes included diabetes knowledge , satisfaction , use of clinical services , and adverse events . RESULTS For the 194 patients ( 89 % ) with 12-month data , the intervention group had significantly greater improvement than did the control group for systolic blood pressure ( -9 mm Hg ; 95 % confidence interval [ CI ] : -16 to -3 mm Hg ) and A(1C ) level ( -0.8 % ; 95 % CI : -1.7 % to 0 % ) . Change in total cholesterol level was not significant . At 12 months , aspirin use was 91 % in the intervention group versus 58 % among controls ( P diabetes knowledge and satisfaction than did control patients . There were no significant differences in use of clinical services or adverse events . CONCLUSION Our comprehensive disease management program reduced cardiovascular risk factors and A(1C ) levels among vulnerable patients with type 2 diabetes and poor glycemic control",
"BACKGROUND Pharmacist-physician comanagement of hypertension has been shown to improve office blood pressures ( BPs ) . We sought to describe the effect of such a model on 24-hour ambulatory BPs . METHODS We performed a prospect i ve , cluster-r and omized , controlled clinical trial , enrolling 179 patients with uncontrolled hypertension from 5 primary care clinics in Iowa City , Iowa . Patients were r and omized by clinic to receive pharmacist-physician collaborative management of hypertension ( intervention ) or usual care ( control ) for a 9-month period . In the intervention group , pharmacists helped patients to identify barriers to BP control , counseled on lifestyle and dietary modifications , and adjusted antihypertensive therapy in collaboration with the patients ' primary care providers . Patients were seen by pharmacists a minimum of every 2 months . Ambulatory BP was measured at baseline and at study end . RESULTS Baseline and end-of- study ambulatory BP profiles were evaluated for 175 patients . Mean ( SD ) ambulatory systolic BPs ( SBPs ) , reported in millimeters of mercury , were reduced more in the intervention group than in the control group : daytime change in ( Δ ) SBP , 15.2 ( 11.5 ) vs 5.5 ( 13.5 ) ( P their BP controlled at the end of the study ( 75.0 % vs 50.7 % ) ( P . CONCLUSION Pharmacist-physician collaborative management of hypertension achieved consistent and significantly greater reduction in 24-hour BP and a high rate of BP control . Trial Registration clinical trials.gov Identifier : NCT00201045",
"BACKGROUND The aim of the trial was to evaluate the effectiveness of a program of cooperation between physician and pharmacist to reduce cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure ( BP ) control , appropriate changes in antihypertensive medications , and beneficial changes in lifestyle . METHODS The 132 subjects in this r and omized , controlled trial were in the age range of 40 - 79 years . The inclusion criteria were : systolic BP ( SBP ) ranging from 140 - 179 mm Hg and /or diastolic BP ( DBP ) ranging from 90 - 99 mm Hg and treatment-naive ( untreated for hypertension ) ; or on a regimen of medication for hypertension . Of these 132 subjects , 124 ( 94 % ) were already receiving treatment with antihypertensive medications . Equal numbers of subjects were r and omly assigned to one of two groups : a physician-pharmacist intervention group ( n = 66 ) and a control group ( n = 66 ) . RESULTS The 6-month follow-up rate was 97 % in both groups . At 6 months , the mean decrease in SBP/DBP , as measured at home in the morning , was 2.9/3.3 mm Hg in the intervention group relative to baseline ( P = 0.02 and P home morning SBP in the intervention group was not significantly greater than in the control group . However , the DBP decline was significantly greater in the intervention than control groups , which showed a mean decrease of 2.8 mm Hg ( confidence interval : -5.5 to -0.1 ; P = 0.04 ) . The percentage of patients in whom control of home morning BP was achieved was 53 % in the intervention group and 47 % in the control group ( P = 0.40 ) . A higher percentage of patients in the intervention group , relative to the control group , were able to reduce the use of antihypertensive medications ( 31 vs. 8 % , P additional medications or increases in dosage relative to the controls ( 11 vs. 28 % , P = 0.03 ) . Patients of the intervention group were more likely to show reduction in body mass index and sodium intake and to stop smoking , as compared with the control group . CONCLUSIONS A program of cooperation between physician and pharmacist was successful in reducing cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure ( BP ) control , appropriate changes in antihypertensive medications , and beneficial changes in lifestyle "
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This systematic review aim ed to assess the determinants of the parathyroid hormone ( PTH ) level response to vitamin D supplementation . We search ed Medline , Google Scholar and the reference lists of previous review s. All r and omised controlled trials ( RCT ) on vitamin D supplementation that involved apparently healthy human subjects with a report of PTH were selected . Potential studies were screened independently and in duplicate . Results are summarised as mean differences with 95 % confidence intervals . Quality assessment , subgroup analysis , meta- analysis and meta-regression analysis were carried out . Thirty-three vitamin D supplementation RCT were included . Vitamin D supplementation significantly raised circulating 25-hydroxyvitamin D ( 25(OH)D ) with significant heterogeneity among studies with a pooled mean difference ( PMD ) of 15.5 ng/ml ( test for heterogeneity : P ) . Vitamin D supplementation significantly reduced PTH level with PMD of -8·0 pg/ml , with significant heterogeneity ( ( test for heterogeneity : P treatment effect for PTH was observed with Ca doses of 600 - 1200 mg/d ( -22·48 pg/ml ) , after the duration of a > 12-month trial ( -18·36 pg/ml ) , with low baseline 25(OH)D concentration of suppression of PTH level needs higher vitamin D intake ( 75 μg/d ) than the current recommendations and longer duration s ( 12 months ) , which should be taken into account for nutritional recommendations
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"Abstract : Supplementation of elderly institutionalized women with vitamin D and calcium decreased hip fractures and increased hip bone mineral density . Quantitative ultrasound ( QUS ) measurements can be performed in nursing homes , and easily repeated for follow-up . However , the effect of the correction of vitamin D deficiency on QUS parameters is not known . Therefore , 248 institutionalized women aged 62–98 years were included in a 2-year open controlled study . They were r and omized into a treated group ( n = 124 ) , receiving 440 IU of vitamin D3 combined with 500 mg calcium ( 1250 mg calcium carbonate , Novartis ) twice daily , and a control group ( n = 124 ) . One hundred and three women ( 42 % ) , aged 84.5 ± 7.5 years , completed the study : 50 in the treated group , 53 in the controls . QUS of the calcaneus , which measures BUA ( broadb and ultrasound attenuation ) and SOS ( speed of sound ) , and biochemical analysis were performed before and after 1 and 2 years of treatment . Only the results of the women with a complete follow-up were taken into account . Both groups had low initial mean serum 25-hydroxyvitamin D levels ( 11.9 ± 1.2 and 11.7 ± 1.2 mg/l ; normal range 6.4–40.2 mg/l ) and normal mean serum parathyroid hormone ( PTH ) levels ( 43.1 ± 3.2 and 44.6 ± 3.5 ng/l ; normal range 10–70 ng/l , normal mean 31.8 ± 2.3 ng/l ) . The treatment led to a correction of the metabolic disturbances , with an increase in 25-hydroxyvitamin D by 123 % ( p50.01 ) and a decrease in PTH by 18 % ( p50.05 ) and of alkaline phosphatase by 15 % ( p50.01 ) . In the controls there was a worsening of the hypovitaminosis D , with a decrease of 25-hydroxyvitamin D by 51 % ( p50.01 ) and an increase in PTH by 51 % ( p50.01 ) , while the serum calcium level decreased by only 2 % ( p5 0.01 ) . After 2 years of treatment BUA increased significantly by 1.6 % in the treated group ( p50.05 ) , and decreased by 2.3 % in the controls ( p50.01 ) . Therefore , the difference in BUA between the treated subjects and the controls ( 3.9 % ) was significant after 2 years ( p50.01 ) . However , SOS decreased by the same amount in both groups ( approximately 0.5 % ) . In conclusion , BUA , but not SOS , reflected the positive effect on bone of supplementation with calcium and vitamin D3 in a population of elderly institutionalized women",
"BACKGROUND The cholecalciferol inputs required to achieve or maintain any given serum 25-hydroxycholecalciferol concentration are not known , particularly within ranges comparable to the probable physiologic supply of the vitamin . OBJECTIVES The objectives were to establish the quantitative relation between steady state cholecalciferol input and the result ing serum 25-hydroxycholecalciferol concentration and to estimate the proportion of the daily requirement during winter that is met by cholecalciferol reserves in body tissue stores . DESIGN Cholecalciferol was administered daily in controlled oral doses labeled at 0 , 25 , 125 , and 250 micro g cholecalciferol for approximately 20 wk during the winter to 67 men living in Omaha ( 41.2 degrees N latitude ) . The time course of serum 25-hydroxycholecalciferol concentration was measured at intervals over the course of treatment . RESULTS From a mean baseline value of 70.3 nmol/L , equilibrium concentrations of serum 25-hydroxycholecalciferol changed during the winter months in direct proportion to the dose , with a slope of approximately 0.70 nmol/L for each additional 1 micro g cholecalciferol input . The calculated oral input required to sustain the serum 25-hydroxycholecalciferol concentration present before the study ( ie , in the autumn ) was 12.5 micro g ( 500 IU)/d , whereas the total amount from all sources ( supplement , food , tissue stores ) needed to sustain the starting 25-hydroxycholecalciferol concentration was estimated at approximately 96 micro g ( approximately 3800 IU)/d . By difference , the tissue stores provided approximately 78 - 82 micro g/d . CONCLUSIONS Healthy men seem to use 3000 - 5000 IU cholecalciferol/d , apparently meeting > 80 % of their winter cholecalciferol need with cutaneously synthesized accumulations from solar sources during the preceding summer months . Current recommended vitamin D inputs are inadequate to maintain serum 25-hydroxycholecalciferol concentration in the absence of substantial cutaneous production of vitamin",
"BACKGROUND Optimal vitamin D status for the prevention of osteoporosis has been inferred from examinations of the serum 25-hydroxyvitamin D [ 25(OH)D ] concentration below which there is an increase in serum parathyroid hormone ( PTH ) . OBJECTIVE The objectives of the study were to ascertain whether a threshold for serum 25(OH)D exists below which serum PTH increases and whether persons with 25(OH)D above this threshold have lower rates of bone loss than do persons with 25(OH)D below the threshold . DESIGN The relation of serum 25(OH)D to serum PTH was analyzed in 208 African American women studied longitudinally for 3 y. These healthy women in midlife were r and omly assigned to receive placebo or 800 IU vitamin D3/d ; after 2 y , the vitamin D3 supplementation was increased to 2000 IU/d . Both groups received calcium supplements to ensure an adequate calcium intake . A systematic literature review found a wide range of threshold values in part due to varied calcium intake . RESULTS A Loess plot suggested a breakpoint between 40 and 50 nmol/L for serum 25(OH)D. A line-line model was fitted to the data , and it showed a spline knot at 44 nmol/L. A heuristic approach verified that PTH does not decline as rapidly when the serum concentration of 25(OH)D is > 40 nmol/L as when it is rates of bone loss between persons with 25(OH)D concentrations above and below 40 nmol/L. CONCLUSION Although a threshold for 25(OH)D can be identified , we suggest that it should not be used to recommend optimal vitamin D status",
"In all species tested , except humans , biological differences between vitamins D2 and D3 are accepted as fact . To test the presumption of equivalence in humans , we compared the ability of equal molar quantities of vitamin D2 or D3 to increase serum 25-hydroxyvitamin D [ 25(OH)D ] , the measure of vitamin D nutrition . Subjects took 260 nmol ( approximately 4000 IU ) vitamin D2 ( n=17 ) or vitamin D3 ( n=55 ) daily for 14 d. 25(OH)D was assayed with a method that detects both the vitamin D2 and D3 forms . With vitamin D3 , mean ( + /-SD ) serum 25(OH)D increased from 41.3+/-17.7 nmol/L before to 64.6+/-17.2 nmol/L after treatment . With vitamin D2 , the 25(OH)D concentration went from 43.7+/-17.7 nmol/L before to 57.4+/-13.0 nmol/L after . The increase in 25(OH)D with vitamin D3 was 23.3+/-15.7 nmol/L , or 1.7 times the increase obtained with vitamin D2 ( 13.7+/-11.4 nmol/L ; P=0.03 ) . There was an inverse relation between the increase in 25(OH)D and the initial 25(OH)D concentration . The lowest 2 tertiles for basal 25(OH)D showed larger increases in 25(OH)D : 30.6 and 25.5 nmol/L , respectively , for the first and second tertiles . In the highest tertile [ 25(OH)D > 49 nmol/L ] the mean increase in 25(OH)D was 13.3 nmol/L ( P vitamin D3 shown here may seem small , it is more than what others have shown for 25(OH)D increases when comparing 2-fold differences in vitamin D3 dose . The assumption that vitamins D2 and D3 have equal nutritional value is probably wrong and should be reconsidered",
"BACKGROUND Low 25-hydroxy-vitamin D ( 25(OH)D ) levels are inversely related to blood pressure ( BP ) and have been associated with incident hypertension . In people living at northern latitudes diminished cholecalciferol synthesis in the winter increases the risk of vitamin D deficiency . We wanted to test the hypothesis that daily cholecalciferol supplementation in the winter lowers BP in patients with hypertension . METHODS We investigated the effect of 75 µg ( 3,000 IU ) cholecalciferol per day in a r and omized , placebo-controlled , double-blind study in 130 hypertensive patients residing in Denmark ( 56º N ) . Ambulatory BP ( 24-h BP ) and arterial stiffness were measured before and after 20 weeks of treatment , that took place between October and March . RESULTS A total of 112 patients ( mean age 61 ± 10 ) with a baseline p-25(OH)D of 23 ± 10 ng/ml completed the study . Compared with placebo , a nonsignificant 3/1 mm Hg ( P = 0.26/0.18 ) reduction was found in 24-h BP . In patients with vitamin D insufficiency ( 92 ) , 24-h BP decreased by 4/3 mm Hg ( P = 0.05/0.01 ) . Central BP ( CBP ) estimated by applanation tonometry and calibrated with a st and ardized office BP was reduced by 7/2 mm Hg ( P = 0.007/0.15 ) vs. placebo . No differences in carotid-femoral pulse wave velocity ( PWV ) or central augmentation index ( AIx ) were found between treatment arms . CONCLUSIONS Cholecalciferol supplementation , by a dose that effectively increased vitamin D levels , did not reduce 24-h BP , although central systolic BP decreased significantly . In a post-hoc subgroup analysis of 92 subjects with baseline p-25(OH)D levels decreases in 24-h systolic and diastolic BP occurred during cholecalciferol supplementation ",
"Objective —Vitamin D deficiency is common and associated with dyslipidemia . However , it is unclear whether oral vitamin D supplementation improves the lipid profile . Therefore , we conducted a r and omized , placebo-controlled trial to determine the short-term effects of vitamin D repletion on the lipid profile . Methods and Results —One hundred fifty-one vitamin D−deficient ( 25-hydroxyvitamin D to receive either 50 000 IU of vitamin D3 weekly for 8 weeks or placebo . The primary outcome was the change in small low-density lipoprotein ( LDL ) particle number . Secondary outcomes included changes in other nuclear magnetic resonance−based and chemical lipid fractions . Vitamin D failed to improve the lipid profile . Compared with the placebo , vitamin D repletion did not change small LDL particle number ( mean change , + 18 nmol/L ; 95 % CI [ −80 to + 116 nmol/L ] ; P=0.63 ) . There were also no changes in the chemical lipid profile : total cholesterol ( + 5.8 mg/dL , 95 % CI [ −1.4 to + 13.0 mg/dL ] , P=0.14 ) ; LDL cholesterol ( + 3.8 mg/dL , 95 % CI [ −2.5 to + 10.2 mg/dL ] , P=0.13 ) ; high – density lipoprotein cholesterol ( + 0.4 mg/dL 95 % CI [ −1.6 to + 2.6 mg/dL ] , P=0.71 ) ; and triglycerides ( + 7.9 mg/dL 95 % CI [ −6.5 to + 22.3 mg/dL ] ) . In the vitamin D repletion group , exploratory multivariate regression analysis demonstrates that changes in LDL cholesterol were positively correlated with the changes in serum calcium ( P changes in serum parathyroid hormone ( P=0.02 ) . Conclusion —In contrast to the association between low 25-hydroxyvitamin D levels and dyslipidemia , correcting vitamin D deficiency in the short-term does not improve the lipid profile . Repletion of 25-hydroxyvitamin D levels raised serum calcium levels and decreased serum parathyroid hormone levels . These expected physiological responses to vitamin D therapy were correlated with a significant increase in LDL cholesterol . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01008384",
"OBJECTIVE Investigate whether cholecalciferol supplementation leads to weight loss in overweight and obese adults . DESIGN R and omized double blind clinical trial with 20,000 IU cholecalciferol twice a week , or 20,000 IU once a week plus placebo , or placebo twice a week , for 12 months . All subjects were given 500 mg calcium supplementation . METHODS Four hundred and forty five healthy , overweight , and obese men and women ( age 21 - 70 years , body mass index ( BMI ) 28.0 - 47.0 kg/m(2 ) ) . Body weight , fatness , and fat distribution parameters were measured by dual-energy X-ray absorptiometry and anthropometry , blood sample s and 24-h urinary sample s were collected . RESULTS At baseline , there were no significant differences between the groups , but there was a significant inverse relation between serum 25-hydroxyvitamin D ( 25(OH)D ) levels and BMI , and a significant positive association between calorie intake and BMI . Three hundred and thirty four subjects completed the study . During the study , there was no significant change in weight , waist-to-hip ratio ( WHR ) or percentage body fat in any of the groups , nor between them . Parathyroid hormone decreased and 25(OH)D increased significantly in both groups receiving cholecalciferol , and serum levels of 25(OH)D stabilized after 3 months . Serum calcium was unchanged in all groups . Urinary calcium excretion increased in all groups , but there was no significant difference between the groups . Weekly dosage of 20,000 - 40,000 IU cholecalciferol for 12 months was associated with a low risk of adverse effects , at least in overweight and obese adults living at latitude 70 degrees N. CONCLUSION Significant weight reduction in overweight and obese subjects is unlikely to occur with cholecalciferol supplementation",
"Due to little outdoor activity and low dietary intake of vitamin D ( VD ) , Bangladeshi low-income women are at risk for osteoporosis at an early age . The present study assessed the effect of VD , Ca and multiple micronutrient supplementation on VD and bone status in Bangladeshi young female garment factory workers . This placebo-controlled 1-year intervention r and omly assigned 200 apparently healthy subjects ( aged 16 - 36 years ) to four groups : VD group , daily 10 microg VD ; VD and Ca ( VD-Ca ) group , daily 10 microg VD+600 mg Ca ; multiple micronutrient and Ca ( MMN-Ca ) group , 10 microg VD and other micronutrients+600 mg Ca ; a placebo group . Serum 25-hydroxyvitamin D ( S-25OHD ) , intact parathyroid hormone ( S-iPTH ) , Ca , phosphate and alkaline phosphatase were measured . Bone mineral density and bone mineral content were measured by dual-energy X-ray absorptiometry . All measurements were made at baseline and at 12 months . Significantly ( P S-25OHD concentrations were observed in the supplemented groups than in the placebo group after the intervention . Supplementation had an effect ( P S-iPTH in the VD-Ca and MMN-Ca groups compared with the placebo group . Bone mineral augmentation increased at the femur in the supplemented groups . Supplementation with VD-Ca should be recommended as a strategic option to reduce the risk of osteomalacia and osteoporosis in these subjects . MMN-Ca may have analogous positive health implication s with additional non-skeletal benefits",
"BACKGROUND AND METHODS Laboratory , clinical , and epidemiologic evidence suggests that calcium may help prevent colorectal adenomas . We conducted a r and omized , double-blind trial of the effect of supplementation with calcium carbonate on the recurrence of colorectal adenomas . We r and omly assigned 930 subjects ( mean age , 61 years ; 72 percent men ) with a recent history of colorectal adenomas to receive either calcium carbonate ( 3 g [ 1200 mg of elemental calcium ] daily ) or placebo , with follow-up colonoscopies one and four years after the qualifying examination . The primary end point was the proportion of subjects in whom at least one adenoma was detected after the first follow-up endoscopy but up to ( and including ) the second follow-up examination . Risk ratios for the recurrence of adenomas were adjusted for age , sex , lifetime number of adenomas before the study , clinical center , and length of the surveillance period . RESULTS The subjects in the calcium group had a lower risk of recurrent adenomas . Among the 913 subjects who underwent at least one study colonoscopy , the adjusted risk ratio for any recurrence of adenoma with calcium as compared with placebo was 0.85 ( 95 percent confidence interval , 0.74 to 0.98 ; P=0.03 ) . The main analysis was based on the 832 subjects ( 409 in the calcium group and 423 in the placebo group ) who completed both follow-up examinations . At least one adenoma was diagnosed between the first and second follow-up endoscopies in 127 subjects in the calcium group ( 31 percent ) and 159 subjects in the placebo group ( 38 percent ) ; the adjusted risk ratio was 0.81 ( 95 percent confidence interval , 0.67 to 0.99 ; P=0.04 ) . The adjusted ratio of the average number of adenomas in the calcium group to that in the placebo group was 0.76 ( 95 percent confidence interval , 0.60 to 0.96 ; P=0.02 ) . The effect of calcium was independent of initial dietary fat and calcium intake . CONCLUSIONS Calcium supplementation is associated with a significant - though moderate - reduction in the risk of recurrent colorectal adenomas",
"OBJECTIVES to evaluate the effects of vitamin D supplementation on parathyroid function and bone turnover in aged , chronically immobile patients . DESIGN a r and omised double-blind controlled trial . SUBJECTS two hundred and eighteen long-term in patients aged over 65 years . INTERVENTION the patients were r and omised into treatment groups of I-III , each receiving 0 IU , 400 IU and 1200 IU cholecalciferol per day , respectively . In case of inadequate consumption of dairy products , patients received a daily calcium substitution of 500 mg . MEASUREMENTS plasma concentrations of 25-hydroxyvitamin D ( 25-OHD ) , intact parathyroid hormone ( PTH ) , amino-terminal propeptide of type I procollagen ( PINP ) , a marker of bone formation , and carboxy-terminal telopeptide of type I collagen ( ICTP ) , a marker of bone resorption , were measured at baseline and after 6 months . RESULTS the patients ( age 84.5 years ) were chronically bedridden . The baseline 25-OHD was low ( 23 nmol/l ) , correlated inversely with PINP , and tended to associate inversely with PTH . The prevalence of vitamin D deficiency ( VDD ) ( 25-OHD PTH was elevated in 23 % of the patients . Vitamin D supplementation significantly increased 25-OHD concentrations ( 124 % group II , 204 % group III ) and decreased PTH ( -7 % group II , -8 % group III ) . PINP tended to decrease , but ICTP tended to increase , and only their ratio decreased significantly . The tendency of ICTP to increase was inconsistent . Changes in 25-OHD correlated inversely with those in PTH and PINP . CONCLUSIONS vitamin D supplementation has minor effects on PTH and bone turnover in chronically immobilised aged patients with VDD . Further comparative studies and meta-analyses are warranted to eluci date the confounding effects of different mobility levels on the benefits of vitamin D supplementation in patients with differing baseline PTH levels",
"Background Vitamin D concentrations are linked to body composition indices , particularly body fat mass . Relationships between hypovitaminosis D and obesity , described by both BMI and waist circumference , have been mentioned . We have investigated the effect of a 12-week vitamin D3 supplementation on anthropometric indices in healthy overweight and obese women . Methods In a double-blind , r and omized , placebo-controlled , parallel-group trial , seventy-seven participants ( age 38±8.1 years , BMI 29.8±4.1 kg/m2 ) were r and omly allocated into two groups : vitamin D ( 25 μg per day as cholecalciferol ) and placebo ( 25 μg per day as lactose ) for 12 weeks . Body weight , height , waist , hip , fat mass , 25(OH ) D , iPTH , and dietary intakes were measured before and after the intervention . Results Serum 25(OH)D significantly increased in the vitamin D group compared to the placebo group ( 38.2±32.7 nmol/L vs. 4.6±14.8 nmol/L ; P ) and serum iPTH concentrations were decreased by vitamin D3 supplementation ( -0.26±0.57 pmol/L vs. 0.27±0.56 pmol/L ; P decrease in body fat mass in the vitamin D group compared to the placebo group ( -2.7±2.1 kg vs. -0.47±2.1 kg ; P However , body weight and waist circumference did not change significantly in both groups . A significant reverse correlation between changes in serum 25(OH ) D concentrations and body fat mass was observed ( r = -0.319 , P = 0.005 ) . Conclusion Among healthy overweight and obese women , increasing 25(OH ) D concentrations by vitamin D3 supplementation led to body fat mass reduction . This trial is registered at clinical trials.gov as NCT01344161",
"Summary The effect of equivalent oral doses of vitamin D3 600 IU/day , 4200 IU/week and 18,000 IU/month on vitamin D status was compared in a r and omized clinical trial in nursing home residents . A daily dose was more effective than a weekly dose , and a monthly dose was the least effective . Introduction It is assumed that equivalent daily , weekly or monthly doses of vitamin D3 equally influence vitamin D status . This was investigated in a r and omized clinical trial in nursing home residents . Methods The study was performed in ten nursing homes including 338 subjects ( 76 male and 262 female ) , with a mean age of 84 ( ± SD 6.3 years ) . They received oral vitamin D3 either 600 IU/day , or 4200 IU/week , or 18,000 IU/month or placebo . After 4 months , calcium was added during 2 weeks , 320 mg/day or 640 mg/day or placebo . Outcome : serum levels of 25-hydroxyvitamin D ( 25(OH)D ) , parathyroid hormone ( PTH ) and bone turnover markers . Statistical approach : linear multilevel analysis . Results At baseline , mean serum 25(OH)D was 25.0 nmol/L ( SD 10.9 ) , and in 98 % , it was lower than 50 nmol/L. After 4 months , mean serum 25(OH)D levels increased to 62.5 nmol/L ( after daily vitamin D3 69.9 nmol/L , weekly 67.2 nmol/L and monthly 53.1 nmol/L , P groups ) . Median serum PTH levels decreased by 23 % ( p 0.001 ) . Bone turnover markers did not decrease . Calcium supplementation had no effect on serum PTH and bone turnover . Conclusion Daily vitamin D was more effective than weekly , and monthly administration was the least effective",
"OBJECTIVE Vitamin D deficiency is associated with an unfavorable metabolic profile in observational studies . The intention was to compare insulin sensitivity ( the primary end point ) and secretion and lipids in subjects with low and high serum 25(OH)D ( 25-hydroxyvitamin D ) levels and to assess the effect of vitamin D supplementation on the same outcomes among the participants with low serum 25(OH)D levels . RESEARCH DESIGN AND METHODS Participants were recruited from a population -based study ( the Tromsø Study ) based on their serum 25(OH)D measurements . A 3-h hyperglycemic clamp was performed , and the participants with low serum 25(OH)D levels were thereafter r and omized to receive capsules of 20,000 IU vitamin D3 or identical-looking placebo twice weekly for 6 months . A final hyperglycemic clamp was then performed . RESULTS The 52 participants with high serum 25(OH)D levels ( 85.6 ± 13.5 nmol/L [ mean ± SD ] ) had significantly higher insulin sensitivity index ( ISI ) and lower HbA1c and triglycerides ( TGs ) than the 108 participants with low serum 25(OH)D ( 40.3 ± 12.8 nmol/L ) , but the differences in ISI and TGs were not significant after adjustments . After supplementation , serum 25(OH)D was 142.7 ± 25.7 and 42.9 ± 17.3 nmol/L in 49 of 51 completing participants r and omized to vitamin D and 45 of 53 r and omized to placebo , respectively . At the end of the study , there were no statistically significant differences in the outcome variables between the two groups . CONCLUSIONS Vitamin D supplementation to apparently healthy subjects with insufficient serum 25(OH)D levels does not improve insulin sensitivity or secretion or serum lipid profile ",
"BACKGROUND Vitamin D insufficiency , which is prevalent in older individuals , is associated with bone and muscle weakness and falls . OBJECTIVE We examined the effects of a weekly dose of 8400 IU vitamin D(3 ) on postural stability , muscle strength , and safety . DESIGN In this double-blind trial , subjects aged > or = 70 y with serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations or = 6 ng/mL were r and omly assigned to receive a weekly dose of 8400 IU vitamin D(3 ) ( n = 114 ) or a placebo ( n = 112 ) . Mediolateral body sway with eyes open ( assessed with the AccuSway(PLUS ) platform ; Advanced Medical Technology Inc , Watertown , MA ) was the primary endpoint . Secondary endpoints included the short physical performance battery ( SPPB ) and serum 25(OH)D concentrations . An analysis of covariance model was used for treatment comparisons . Safety and tolerability were monitored . RESULTS Serum 25(OH)D concentrations rose significantly ( from 13.9 to 26.2 ng/mL , P placebo . After 16 wk , neither mediolateral sway nor SPPB differed significantly between treatment groups . However , in the post hoc analysis of patients subgrouped by baseline sway ( > or = 0.46 compared with sway compared with treatment with placebo ( P = 0.047 ) in patients with elevated baseline sway but not in patients with normal baseline sway . Adverse experiences and incidences of hypercalcemia , hypercalciuria , and elevated creatinine were similar with both treatments . In patients treated with 8400 IU vitamin D(3 ) , but not in placebo-treated patients , parathyroid hormone decreased significantly . CONCLUSIONS Weekly treatment with 8400 IU vitamin D(3 ) raised 25(OH)D concentrations in elderly , vitamin D-insufficient individuals . Treatment with 8400 IU vitamin D(3 ) did not reduce mediolateral sway significantly compared with treatment with placebo in this population , although in post hoc analysis , treatment with 8400 IU vitamin D(3 ) reduced sway in the subgroup of patients who had elevated sway at baseline . Weekly treatment with 8400 IU vitamin D(3 ) was well tolerated . This trial was registered at clinical trials.gov as NCT00242476",
"The purpose of the study was to determine the effect of vitamin D supplementation on bone turnover and bone loss in elderly women . Three hundred forty-eight women , ages 70 yr and older , were r and omized to receive 400 IU vitamin D3 per day ( n = 177 ) or placebo ( n = 171 ) , double-blind , for a period of 2 yr . Main outcome measures were bone mineral density of both hips ( femoral neck and trochanter ) and the distal radius , as well as biochemical markers of bone turnover . The effect of vitamin D supplementation was expressed as the difference in mean ( percentage ) change between the placebo group and the vitamin D group . The measurements were repeated in 283 women after 1 yr and in 248 women after 2 yr . Vitamin D supplementation significantly increased serum 25-hydroxyvitamin D ( 250HD ) ( + 35 nmol/L ) and 1,25-dehydroxyvitamin D [ 1,25-(OH)2D ] ( + 7.0 pmol/L ) levels and urinary calcium/creatinine ratios ( + 0.5 % ) and significantly decreased PTH(1 - 84 ) secretion ( -0.74 pmol/L ) after 1 yr . No effect was found for the parameters of bone turnover . The effect on the bone mineral density of the left femoral neck was + 1.8 % in the first yr , + 0.2 % in the second yr , and + 1.9 % during the whole period ( 95 % confidence interval 0.4 , 3.4 % ) . At the right femoral neck the effects were + 1.5 % , + 1.1 % , and + 2.6 % ( confidence interval 1.1 , 4.0 % ) , respectively . No effect was found at the femoral trochanter and the distal radius . Supplementation with 400 IU vitamin D3 daily in elderly women slightly decreases PTH secretion and increases bone mineral density at the femoral neck",
"OBJECTIVE This article presents the results of an evaluation of the clinical and laboratory safety of a 1-year course of treatment with a combination calcium and vitamin D tablet in ambulatory women aged > 65 years with vitamin D insufficiency . METHODS In a multicenter , r and omized , double-blind , placebo-controlled study conducted in France , women with a 25-hydroxyvitamin D level were r and omized to receive either a combination tablet containing calcium carbonate 500 mg and vitamin D3 400 IU taken twice daily or a matching placebo tablet for 1 year . A complete clinical examination was performed at baseline and at 3 , 6 , 9 , and 12 months of treatment ; blood and urine sample s were collected for laboratory analyses at the same time points . Safety was monitored based on adverse events recorded during the treatment period and on the results of laboratory tests , including measurement of creatinine and uric acid levels . RESULTS The study included 192 women ( mean [ SD ] age , 74.6 [ 6.9 ] years ; mean weight , 64.0 [ 12.5 ] kg ) , 95 in the calcium + vitamin D group and 97 in the placebo group . Fifty women ( 21/95 [ 22.1 % ] calcium + vitamin D , 29/96 [ 30.2 % ] placebo ) were prematurely withdrawn from the study for various reasons , with no difference in withdrawals between groups . Treatment-related adverse events were reported in 21 ( 22.1 % ) and 23 ( 24.0 % ) women in the respective treatment groups . These events consisted mainly of metabolic disorders ( 9 [ 9.5 % ] and 10 [ 10.4 % ] , respectively ) , particularly hypercalcemia ( 6 [ 6.3 % ] and 8 [ 8.3 % ] ) and gastrointestinal disorders ( 9 [ 9.5 % ] and 8 [ 8.3 % ] ) . No major complications directly related to calcium and vitamin D supplementation occurred during the course of treatment . Although renal function was not altered , the group who received calcium + vitamin D had significantly elevated concentrations of serum uric acid compared with those who received placebo ( 52.3 % vs 37.2 % ; P = 0.046 ) but not urinary uric acid . CONCLUSIONS In these ambulatory elderly women with vitamin D deficiency , supplementation with calcium + vitamin D appeared to be well tolerated over 1 year of treatment . No significant effects on creatinine clearance were observed . However , the proportion of women with elevated serum uric acid concentrations was significantly greater in those who received calcium + vitamin D compared with those who received placebo ",
"BACKGROUND In our previous study , higher serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations and the vitamin D receptor ( VDR ) FokI CC genotype were associated with milder Parkinson disease ( PD ) . OBJECTIVE We evaluated whether vitamin D3 supplementation inhibits the progression of PD on the basis of patient VDR subgroups . DESIGN Patients with PD ( n = 114 ) were r and omly assigned to receive vitamin D3 supplements ( n = 56 ; 1200 IU/d ) or a placebo ( n = 58 ) for 12 mo in a double-blind setting . Outcomes were clinical changes from baseline and the percentage of patients who showed no worsening of the modified Hoehn and Yahr ( HY ) stage and Unified Parkinson 's Disease Rating Scale ( UPDRS ) . RESULTS Compared with the placebo , vitamin D3 significantly prevented the deterioration of the HY stage in patients [ difference between groups : P = 0.005 ; mean ± SD change within vitamin D3 group : + 0.02 ± 0.62 ( P = 0.79 ) ; change within placebo group : + 0.33 ± 0.70 ( P = 0.0006 ) ] . Interaction analyses showed that VDR FokI genotypes modified the effect of vitamin D3 on changes in the HY stage ( P-interaction = 0.045 ) , UPDRS total ( P-interaction = 0.039 ) , and UPDRS part II ( P-interaction = 0.021 ) . Compared with the placebo , vitamin D3 significantly prevented deterioration of the HY stage in patients with FokI TT [ difference between groups : P = 0.009 ; change within vitamin D3 group : -0.38 ± 0.48 ( P = 0.91 ) ; change within placebo group , + 0.63 ± 0.77 ( P = 0.009 ) ] and FokI CT [ difference between groups : P = 0.020 ; change within vitamin D3 group : ±0.00 ± 0.60 ( P = 0.78 ) ; change within placebo group : + 0.37 ± 0.74 ( P = 0.014 ) ] but not FokI CC . Similar trends were observed in UPDRS total and part II . CONCLUSION Vitamin D3 supplementation may stabilize PD for a short period in patients with FokI TT or CT genotypes without triggering hypercalcemia , although this effect may be nonspecific for PD . This trial was registered at UMIN Clinical Trials Registry as UMIN000001841",
"OBJECTIVES To determine whether relative vitamin D deficiency during the winter months contributes to age-related bone loss and whether rates of change in hard- and soft-tissue mass vary during the year . DESIGN Double-blind , placebo-controlled , 1-year trial in 249 women in which equal numbers of women were r and omized to either placebo or 400 IU of vitamin D daily . All women received 377 mg/d of supplemental calcium largely as calcium citrate malate . PATIENTS Healthy , ambulatory postmenopausal women with usual intakes of vitamin D of 100 IU/d . MEASUREMENTS Duplicate spine and whole-body scans were done by dual energy x-ray absorptiometry at 6-month intervals that were timed to periods when 25-hydroxyvitamin D levels were highest and lowest . Period 1 was June-July to December-January and period 2 was December-January to the next June-July . Serum parathyroid hormone and plasma 25-hydroxyvitamin D levels were measured during periods 1 and 2 . MAIN RESULTS In the placebo group , spinal bone mineral density increased in period 1 , decreased in period 2 , and sustained no net change . Women treated with vitamin D had a similar spinal increase in period 1 ( 1.46 % compared with 1.40 % in placebo ) , less loss in period 2 ( -0.54 % compared with -1.22 % , CI for the difference , 0.05 % to 1.31 % , P = 0.032 ) and a significant overall benefit ( 0.85 % compared with 0.15 % , CI for the difference , 0.03 % to 1.37 % , P = 0.04 ) . In period 2 , 25-hydroxyvitamin D levels were lower and parathyroid hormone levels were higher in the placebo than in the vitamin D group . Whole-body lean and fat tissue and bone mineral density varied during the year but did not change overall . CONCLUSIONS At latitude 42 degrees , healthy postmenopausal women with vitamin D intakes of 100 IU daily can significantly reduce late wintertime bone loss and improve net bone density of the spine over one year by increasing their intake of vitamin D to 500 IU daily . A long-term benefit of preventing vitamin D insufficiency in the winter seems likely although it remains to be shown . Observed changes in bone as well as in fat and lean tissue appear to be related to season",
"Calcium supplementation is effective in reducing blood pressure in various states of hypertension , including pregnancy-induced hypertension and preeclampsia . In addition , calcitropic hormones are associated with blood pressure . The hypothesis is that short-term therapy with calcium and vitamin D(3 ) may improve blood pressure as well as secondary hyperparathyroidism more effectively than calcium monotherapy . The effects of 8 weeks of supplementation with vitamin D(3 ) ( cholecalciferol ) and calcium on blood pressure and biochemical measures of bone metabolism were studied . The sample consisted of 148 women ( mean + /- SD age , 74 + /- 1 yr ) with a 25-hydroxycholecalciferol ( 25OHD(3 ) ) level below 50 nmol/L. They received either 1200 mg calcium plus 800 IU vitamin D(3 ) or 1200 mg calcium/day . We measured intact PTH , 25OHD(3 ) , 1,25-dihydroxyvitamin D(3 ) , blood pressure , and heart rate before and after treatment . Compared with calcium , supplementation with vitamin D(3 ) and calcium result ed in an increase in serum 25OHD(3 ) of 72 % ( P serum PTH of 17 % ( P = 0.04 ) , a decrease in systolic blood pressure ( SBP ) of 9.3 % ( P = 0.02 ) , and a decrease in heart rate of 5.4 % ( P = 0.02 ) . Sixty subjects ( 81 % ) in the vitamin D(3 ) and calcium group compared with 35 ( 47 % ) subjects in the calcium group showed a decrease in SBP of 5 mm Hg or more ( P = 0.04 ) . No statistically significant difference was observed in the diastolic blood pressures of the calcium-treated and calcium- plus vitamin D(3)-treated groups ( P = 0.10 ) . Pearson coefficients of correlation between the change in PTH and the change in SBP were 0.49 ( P vitamin D(3 ) plus calcium group and 0.23 ( P calcium group . A short-term supplementation with vitamin D(3 ) and calcium is more effective in reducing SBP than calcium alone . Inadequate vitamin D(3 ) and calcium intake could play a contributory role in the pathogenesis and progression of hypertension and cardiovascular disease in elderly women",
"AIMS Vitamin D deficiency may increase the risk for type 2 diabetes . African Americans tend to have poor vitamin D status and increased risk of diabetes , but effects of vitamin D supplementation on components of diabetes risk have not been tested in this group . This study was conducted to determine whether vitamin D supplementation improves insulin secretion , insulin sensitivity and glycaemia in African Americans with prediabetes or early diabetes . METHODS In this r and omized , placebo-controlled trial , we examined the effect of 4000 IU/day vitamin D(3 , ) on glycaemia and contributing measures including insulin secretion , insulin sensitivity and the disposition index over 12 weeks in 89 overweight or obese African Americans with prediabetes or early diabetes . Outcome measures were derived from oral glucose tolerance testing . RESULTS Mean plasma 25-hydroxyvitamin D was about 40 nmol/l in the placebo and vitamin D groups at baseline and increased to 81 nmol/l with supplementation . Insulin sensitivity decreased by 4 % in the vitamin D group compared with a 12 % increase in the placebo group ( p = 0.034 ) . Insulin secretion increased by 12 % in the vitamin D group compared with a 2 % increase in the placebo group ( p = 0.024 ) , but changes in the disposition index were similar across groups . There was no effect of supplementation on post-load glucose or other measures of glycaemia . CONCLUSIONS Supplementation with 4000 IU/day vitamin D(3 ) successfully corrected vitamin D insufficiency and had divergent effects on insulin secretion and sensitivity with no overall effect on disposition index or glycaemia . In this study , vitamin D supplementation for 3 months did not change the pathophysiology of prediabetes in overweight and obese African Americans",
"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 242 community-dwelling seniors , supplementation with either 1000 mg of calcium or 1000 mg of calcium plus vitamin D result ed in a decrease in the number of subjects with first falls of 27 % at month 12 and 39 % at month 20 . Additionally , parameters of muscle function improved significantly . Introduction The efficacy of vitamin D and calcium supplementation on risk of falling in the elderly is discussed controversially . R and omized controlled trials using falls as primary outcome are needed . We investigated long-term effects of calcium and vitamin D on falls and parameters of muscle function in community-dwelling elderly women and men . Methods Our study population consisted of 242 individuals recruited by advertisements and mailing lists ( mean [ ± SD ] age , 77 ± 4 years ) . All serum 25-hydroxyvitamin D ( 25[OH]D ) levels were below 78 nmol/l . Individuals received in a double blinded fashion either 1000 mg of calcium or 1000 mg of calcium plus 800 IU of vitamin D per day over a treatment period of 12 months , which was followed by a treatment-free but still blinded observation period of 8 months . Falls were documented using diaries . The study took place in Bad Pyrmont , Germany ( latitude 52 ° ) and Graz , Austria ( latitude 46 ° ) . Results Compared to calcium mono , supplementation with calcium plus vitamin D result ed in a significant decrease in the number of subjects with first falls of 27 % at month 12 ( RR = 0.73 ; CI = 0.54–0.96 ) and 39 % at month 20 ( RR = 0.61 ; CI = 0.34–0.76 ) . Concerning secondary endpoints , we observed significant improvements in quadriceps strength of 8 % , a decrease in body sway of 28 % , and a decrease in time needed to perform the TUG test of 11 % . Discussion Combined calcium and vitamin D supplementation proved superior to calcium alone in reducing the number of falls and improving muscle function in community-dwelling older individuals",
"CONTEXT R and omized control trials ( RCT ) of the effect of vitamin D/calcium supplementation on skeletal muscle strength have not shown promising effect in the elderly . OBJECTIVE Our objective was to assess the effect of vitamin D and /or calcium on muscle strength in young adults with vitamin D deficiency . DESIGN AND SETTING We conducted a RCT using a factorial design at a tertiary-care center from September 2010 to April 2011 . SUBJECTS A total of 173 healthy females with mean age , body mass index , and 25-hydroxyvitamin D [ 25(OH)D ] of 21.7 ± 4.4 yr , 20.8 ± 2.96 kg/m(2 ) , and 9.3 ± 3.37 ng/ml , respectively , were block r and omized to 1 ) double placebo , 2 ) calcium/placebo , 3 ) cholecalciferol/placebo , and 4 ) cholecalciferol/calcium for 6 months . Cholecalciferol was given at 60,000 IU/wk for 8 wk followed by 60,000 IU/fortnight . Elemental calcium was given in doses of 500 mg twice per day for 6 months . METHODS Assessment included h and grip ( primary outcome ) and pinch grip strength , distance walked in 6 min , dyspnea score , quality of life by Short Form ( 36 ) Health Survey ( SP-36 ) , serum 25(OH)D , 1,25-dihydroxyvitamin D , and intact PTH . RESULTS The serum 25(OH)D increased significantly to 29.9 ± 8.35 and 27.0 ± 9.54 ng/ml in two groups on cholecalciferol . The mean h and grip strength ( 19.4 ± 3.92 , 21.1 ± 3.31 , 20.6 ± 3.92 , and 20.1 ± 4.00 kg ) and its increase from baseline ( 0.3 ± 2.25 , 0.3 ± 2.64 , -0.3 ± 2.41 , and 0.6 ± 2.30 kg ) were comparable in four groups at 6 months . Quality of life , urinary calcium/creatinine ratio , and adverse effects were also comparable in groups . CONCLUSION Oral cholecalciferol/calcium supplementation in the dose/schedule used is effective and safe in increasing and maintaining serum 25(OH)D. However , this does not lead to improved skeletal muscle strength in young females",
"CONTEXT Public health authorities around the world recommend widely variable supplementation strategies for adults , whereas several professional organizations , including The Endocrine Society , recommend higher supplementation . METHODS We analyzed published r and omized controlled clinical trials to define the optimal intake or vitamin D status for bone and extraskeletal health . CONCLUSIONS The extraskeletal effects of vitamin D are plausible as based on pre clinical data and observational studies . However , apart from the beneficial effects of 800 IU/d of vitamin D3 for reduction of falls in the elderly , causality remains yet unproven in r and omized controlled trials ( RCTs ) . The greatest risk for cancer , infections , cardiovascular and metabolic diseases is associated with 25-hydroxyvitamin D ( 25OHD ) levels below 20 ng/mL. There is ample evidence from RCTs that calcium and bone homeostasis , estimated from serum 1,25-dihydroxyvitamin D and PTH , calcium absorption , or bone mass , can be normalized by 25OHD levels above 20 ng/mL. Moreover , vitamin D supplementation ( 800 IU/d ) in combination with calcium can reduce fracture incidence by about 20 % . Such a dose will bring serum levels of 25OHD above 20 ng/mL in nearly all postmenopausal women . Based on calculations of the metabolic clearance of 25OHD , a daily intake of 500 - 700 IU of vitamin D3 is sufficient to maintain serum 25OHD levels of 20 ng/mL. Therefore , the recommendations for a daily intake of 1500 - 2000 IU/d or serum 25OHD levels of 30 ng or higher for all adults or elderly subjects , as suggested by The Endocrine Society Task Force , are premature . Fortunately , ongoing RCTs will help to guide us to solve this important public health question",
"OBJECTIVES To study the effects of vitamin D supplementation in healthier population s of men . DESIGN : R and omized , controlled trial . SETTING General clinical research center . PARTICIPANTS Sixty-five healthy , community-dwelling men ( mean age+/-st and ard deviation=76+/-4 , range 65 - 87 ) . INTERVENTION Cholecalciferol ( 1,000 IU/d ) or placebo supplementation for 6 months ; all received 500 mg supplemental calcium . MEASUREMENTS Upper and lower extremity muscle strength and power , physical performance and activity , health perception , calcium and vitamin D intake , and biochemical assessment , including 25-hydroxyvitamin D ( 25OHD ) , parathyroid hormone ( PTH ) , and ionized calcium levels . RESULTS The levels of 25OHD increased and PTH decreased in the cholecalciferol group , whereas there were no significant changes in the control group ( P Baseline 25OHD levels correlated with baseline single-leg stance time and physical activity score . Baseline PTH levels correlated with baseline 8-foot walk time and physical activity score . No significant difference in strength , power , physical performance , or health perception was found between groups . CONCLUSION The 25OHD or PTH levels correlated with physical activity and physical performance in older , community-dwelling men with normal 25OHD status . Vitamin D supplementation increased 25OHD levels and decreased PTH levels but did not increase muscle strength or improve physical performance or health perception in this group of healthy , older men . Further investigations of the effects of vitamin D supplementation should focus on individuals with low levels of vitamin",
"Background and aims : In a few , earlier , uncontrolled trials , alleviation of chronic pain has been documented by vitamin D supplementation . This r and omized double-blind placebo controlled trial addressed the association between pain and vitamin D deficiency and the effects of vitamin D supplementation on pain in institutionalized aged patients . Methods : 216 long-term care patients were enrolled in Helsinki , Finl and . Pain was assessed by three tools : Resident Assessment Instrument ( RAI ) , Discomfort Behavior Scale , and Pain Assessment in Advanced Dementia Scale . Scores for Cognitive Performance Scale ( CPS ) and other clinical assessment s were also collected from the RAI- data base . Levels of 25-hydroxyvitamin D ( 25-OHD ) and parathyroid hormone were also determined . Patients in pain ( n=202 ) were r and omized into three treatment groups , each receiving 0 , 400 , or 1200 IU cholecalciferol per day , respectively . Assessment s were repeated after six-month vitamin D supplementation . Results : Patients were aged ( 84.5±7.5 yrs ) , demented ( CPS= 4.9±1.4 , range 1–6 ) , and chronically bedridden . Pain was present in 38.4 % to 83.8 % of patients depending on assessment tool . Low 25-OHD levels ( with pain or pain behavior . The supplementation result ed in a marked increase in 25-OHD levels . However , neither prevalence of painlessness nor pain scores changed significantly after vitamin D supplementation . Conclusions : We were not able either to show an association between vitamin D deficiency and pain or to observe alleviation of pain by vitamin D supplementation . The independent role of vitamin D in the etiology of pain remains controversial",
"INTRODUCTION In vitro studies indicate an anticoagulant effect of 1,25-dihydroxyvitamin D , and sun exposure may lower the risk of thrombotic events . Accordingly , an effect on haemostatic parameters could be expected after supplementation with vitamin D. MATERIAL S AND METHODS 158 obese or overweight subjects were included in a one year intervention study with supplementation with 40.000 IU vitamin D(3 ) per week or placebo . All subjects were given 500 mg calcium daily . Plasminogen activator inhibitor 1 ( PAI-1 ) , tissue plasminogen activator antigen ( tPA Ag ) , and tissue factor-induced thrombin generation over time in plasma assessed by the calibrated automated thrombogram ( CAT ) method as a parameter of over all thrombotic activity , were measured before and at the end of the study . RESULTS Mean baseline serum 25(OH)D level was 61.8 nmol/L and increased in the vitamin D group to 145.6 nmol/L at the end of the study . At baseline there was a significant decrease in the CAT variables lag time and time to peak of the thrombogram across increasing serum 25(OH)D quartiles , whereas no significant associations between serum 25(OH)D and PAI-1 or tPA Ag were found . After one year , no significant differences were found between the vitamin D and placebo groups regarding change in any of the haemostatic parameters . CONCLUSIONS The association between lag time and time to peak in the CAT assay and serum 25(OH)D levels could indicate a pro-thrombotic state in subjects with high serum 25(OH)D levels , whereas the lack of effect of high dose vitamin D supplementation questions the causality of this relation",
"To examine the relation of the vitamin D status and the remaining estrogen activity with bone turnover and bone mineral density ( BMD ) in elderly women , BMD was measured at both hips using dual-energy X-ray absorptiometry and at the distal radius using single photon absorptiometry , in 330 healthy women aged 70 and over . Vitamin D metabolites , sex hormone binding globulin ( SHBG ) , PTH(1 - 84 ) , osteocalcin , alkaline phosphatase , and hydroxyproline and calcium excretion in 2 h fasting urine were measured . Multiple linear regression was used to adjust for potential confounders . In 65 % of the women , serum 25(OH)D was below 30 nmol/l . Only values below a threshold for 25(OH)D were negatively related to serum PTH(1 - 84 ) ( p = 0.02 , threshold at 25 nmol/l ) and to osteocalcin levels ( p = 0.04 , threshold at 30 nmol/l ) . BMD of the femoral neck and trochanter was positively related to serum 25(OH)D ( left neck p = 0.001 ) with thresholds at 30 nmol/l whereas the distal radius was not ( p = 0.32 ) . Serum PTH was negatively related to BMD at all measurement sites ( all p Serum SHBG , an inverse measure of estrogen activity , was positively related to osteocalcin levels ( p = 0.004 ) and the urinary hydroxyproline/creatinine ratio ( p = 0.002 ) and negatively related to the BMD of the trochanter ( left trochanter p = 0.02 ) and the distal radius ( p = 0.001 ) . We conclude that in elderly women , serum 25(OH)D levels below 30 nmol/l are associated with secondary hyperparathyroidism and increased bone turnover . SHBG is positively related to bone turnover . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Inadequate dietary intake of calcium and vitamin D may contribute to the high prevalence of osteoporosis among older persons . METHODS We studied the effects of three years of dietary supplementation with calcium and vitamin D on bone mineral density , biochemical measures of bone metabolism , and the incidence of nonvertebral fractures in 176 men and 213 women 65 years of age or older who were living at home . They received either 500 mg of calcium plus 700 IU of vitamin D3 ( cholecalciferol ) per day or placebo . Bone mineral density was measured by dual-energy x-ray absorptiometry , blood and urine were analyzed every six months , and cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records . RESULTS The mean ( + /-SD ) changes in bone mineral density in the calcium-vitamin D and placebo groups were as follows : femoral neck , + 0.50+/-4.80 and -0.70+/-5.03 percent , respectively ( P=0.02 ) ; spine,+2.12+/-4.06 and + 1.22+/-4.25 percent ( P=0.04 ) ; and total body , + 0.06+/-1.83 and -1.09+/-1.71 percent ( P calcium-vitamin D and placebo groups was significant at all skeletal sites after one year , but it was significant only for total-body bone mineral density in the second and third years . Of 37 subjects who had nonvertebral fractures , 26 were in the placebo group and 11 were in the calcium-vitamin D group ( P=0.02 ) . CONCLUSIONS In men and women 65 years of age or older who are living in the community , dietary supplementation with calcium and vitamin D moderately reduced bone loss measured in the femoral neck , spine , and total body over the three-year study period and reduced the incidence of nonvertebral fractures",
"Vitamin D deficiency leads to secondary hyperparathyroidism , increased bone turnover , and bone loss and , when severe , to osteomalacia . Vitamin D deficiency is common in elderly people , especially the institutionalized . The definition of vitamin D deficiency is hampered by the fact that large interlaboratory differences exist in assays for serum 25-hydroxyvitamin D ( 25OHD ) , the main circulating metabolite . The international Multiple Outcomes of Raloxifene Evaluation study , a large prospect i ve intervention trial in postmenopausal women with osteoporosis , offered the opportunity to compare vitamin D status and parathyroid function throughout many countries over the world . For this study , baseline data were available from 7564 postmenopausal women from 25 countries on 5 continents . All women had osteoporosis , i.e. bone mineral density ( BMD ) at femoral neck or lumbar spine was lower than t-score -2.5 , or they had 2 vertebral fractures . Serum 25OHD was measured by RIA , and serum PTH was measured by immunoradiometric assay . BMD was measured by dual x-ray absorptiometry . The mean ( + /-SD ) serum 25OHD was 70.8 + /- 30.9 nmol/L. A low serum 25OHD ( Serum 25OHD was between 25 - 50 nmol/L in 24.3 % of the women . Serum 25OHD showed a significant seasonal relationship , with lower values in all regions in winter . Serum PTH correlated negatively with serum 25OHD ( r = -0.25 ; P serum 25OHD was less than 25 , 25 - 50 , or more than 50 nmol/L , respectively , mean serum PTH levels were 4.8 , 4.1 , and 3.5 pmol/L , respectively ( by ANOVA , P mean alkaline phosphatase levels were 83.7 , 79.1 , and 75.7 U/L ( P serum 25OHD on BMD was only significant for the BMD of the trochanter where a serum 25OHD level less than 25 nmol/L was associated with a 4 % lower BMD . After 6 months of treatment with vitamin D(3 ) ( 400 - 600 IU/day ) and calcium ( 500 mg/day ) , serum 25OHD increased from 70.8 + /- 29.8 to 92.3 + /- 28.6 nmol/L. Serum PTH decreased significantly after 6 months of treatment , and this decrease depended on baseline serum 25OHD . When baseline serum 25OHD was less than 25 , 25 - 50 , or more than 50 nmol/L , respectively , serum PTH decreased by 0.8 , 0.5 , or 0.2 pmol/L , respectively ( P serum 25OHD was less than 25 nmol/L in 4 % of the women , and this was associated with a 30 % higher serum PTH . In 24 % of the women serum 25OHD was between 25 - 50 nmol/L , associated with a 15 % higher level of serum PTH compared with women with a serum 25OHD greater than 50 nmol/L. A low serum 25OHD level was also associated with higher serum alkaline phosphatase and lower BMD of the trochanter . Treatment with vitamin D(3 ) and calcium increased serum 25OHD and decreased serum PTH significantly ; the effect was greater for lower baseline serum 25OHD",
"Objectives : This study was conducted to determine whether there are age differences in the plasma parent vitamin D and 25-hydroxyvitamin D ( 25OHD ) responses to eight weeks of supplementation with 20 μg/day of vitamin D3 . Methods : Twenty-five healthy young men ( age 18–35 ) and 25 healthy older men ( 62–79 ) were r and omly assigned to supplementation with 20 μg/day of vitamin D3 or to no intervention and followed for eight weeks . Plasma vitamin D3 was measured by high performance liquid chromatography and 25OHD was measured by competitive protein binding . Results : Both young and old men in the supplemented group had pronounced , rapid and similar increases in plasma vitamin D3 , whereas vitamin D3 concentrations were stable in the control group . By the end of the eight-week adaptation period , plasma vitamin D3 of young and old men had increased by 4.3 and 6.2 nmol/L respectively . In the supplemented group , mean 25OHD concentrations of both the young and old men increased during the study , and the magnitude of the change after eight weeks was nearly identical in the two age groups ( 22.5 and 22.1 nmol/L in the young and the old men , respectively ) . In the control group there was a modest decrease in 25OHD of both the young and old men . Conclusions : There appears to be no age-related impairment among men in the absorption or metabolism of 20 μg/day of vitamin D3 taken orally for at least eight weeks",
"The aim of this study was to determine whether early changes in bone markers could predict long-term response in bone mineral density ( BMD ) after calcium ( 500 mg ) and vitamin D ( 400 IU ) supplementation twice daily in ambulatory elderly women with vitamin D insufficiency ( 25-hydroxyvitamin D , to receive either the supplementation ( n = 95 ) or a placebo ( n = 97 ) in a double-blind , controlled clinical trial for 1 yr . In comparison with the placebo group , supplementation significantly increased BMD , normalized 25-hydroxyvitamin D and significantly decreased intact PTH and bone remodeling markers . The initial values of telopeptide cross-links were correlated with improvement in total body BMD [ urinary N-telopeptides ( NTX ) , r = 0.38 ; C-telopeptides ( CTX ) , r = 0.32 ; serum CTX , r = 0.28 ] , and the 3-month changes in the same markers were correlated with improvement in total body ( urinary N-telopeptides , r = -0.29 ; serum CTX , r = -0.26 ) and vertebral BMD ( CTX , r = -0.26 ; all P BMD in elderly women with vitamin D insufficiency receiving calcium and vitamin D supplementation",
"Background : Vitamin D insufficiency poses a problem in many parts of the world , the elderly being an especially vulnerable group . This insufficiency results from an inadequate amount of sunshine and a low dietary intake of vitamin D. Typically , insufficiency is accompanied with high intact parathyroid hormone , ( S-iPTH ) concentrations . Aims of the Study : We studied how serum 25-hydroxy vitamin D ( S-25-OHD ) concentrations respond to different doses of vitamin D3 supplementation . Secondly to determine the smallest efficient dose to maintain serum 25-OHD concentration above the insufficiency level . We also studied which dose would be efficient in decreasing S-iPTH concentration in these subjects . Subjects and Methods : Forty-nine 65- to 85-year-old women participated . The women were r and omly assigned into one of four groups receiving 0 ( placebo ) , 5 , 10 or 20 μg of vitamin D3 daily for 12 weeks . Fasting morning blood was drawn at the beginning of the study , and thereafter every second week . Calciotropic variables were assessed from serum and urine sample s. Results : The S-25-OHD concentration increased significantly ( p Equilibrium in S-25-OHD concentration was reached in all groups after 6 weeks of supplementation at 57.7 ( 8.9 ) nmol/L , 59.9 ( 8.9 ) nmol/L and 70.9 ( 8.9 ) nmol/L in the groups with increasing vitamin D supplementation . The dose-response to supplementation decreased with increasing vitamin D status at baseline , r = −0.513 , p = 0.002 . S-iPTH tended to decrease in those with highest dose response to supplementation . Conclusions : A clear dose response was noted in S-25-OHD to different doses of vitamin D3 . The recommended dietary intake of 15 μg is adequate to maintain the S-25-OHD concentration around 40–55 nmol/L during winter , but if the optimal S-25-OHD is higher than that even higher vitamin D intakes are needed . Interestingly , subjects with lower vitamin D status at baseline responded more efficiently to supplementation than those with more adequate status",
"BACKGROUND Serum 25-hydroxyvitamin D ( 25-[OH]D ) is considered the best biomarker of clinical vitamin D status . OBJECTIVE To determine the effect of increasing oral doses of vitamin D(3 ) on serum 25-(OH)D and serum parathyroid hormone ( PTH ) levels in postmenopausal white women with vitamin D insufficiency ( defined as a 25-[OH]D level ≤50 nmol/L ) in the presence of adequate calcium intake . These results can be used as a guide to estimate the Recommended Dietary Allowance ( RDA ) ( defined as meeting the needs of 97.5 % of the population ) for vitamin D(3 ) . DESIGN R and omized , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00472823 ) SETTING Creighton University Medical Center , Omaha , Nebraska . PARTICIPANTS 163 healthy postmenopausal white women with vitamin D insufficiency enrolled in the winter or spring of 2007 to 2008 and followed for 1 year . INTERVENTION Participants were r and omly assigned to receive placebo or vitamin D(3 ) , 400 , 800 , 1600 , 2400 , 3200 , 4000 , or 4800 IU once daily . Daily calcium supplements were provided to increase the total daily calcium intake to 1200 to 1400 mg . MEASUREMENTS The primary outcomes were 25-(OH)D and PTH levels at 6 and 12 months . RESULTS The mean baseline 25-(OH)D level was 39 nmol/L. The dose response was curvilinear and tended to plateau at approximately 112 nmol/L in patients receiving more than 3200 IU/d of vitamin D(3 ) . The RDA of vitamin D(3 ) to achieve a 25-(OH)D level greater than 50 nmol/L was 800 IU/d . A mixed-effects model predicted that 600 IU of vitamin D(3 ) daily could also meet this goal . Compared with participants with a normal body mass index ( 25-(OH)D level that was 17.8 nmol/L lower . Parathyroid hormone levels at 12 months decreased with an increasing dose of vitamin D(3 ) ( P = 0.012 ) . Depending on the criteria used , hypercalcemia occurred in 2.8 % to 9.0 % and hypercalciuria in 12.0 % to 33.0 % of participants ; events were unrelated to dose . LIMITATION Findings may not be generalizable to other age groups or persons with substantial comorbid conditions . CONCLUSION A vitamin D(3 ) dosage of 800 IU/d increased serum 25-(OH)D levels to greater than 50 nmol/L in 97.5 % of women ; however , a model predicted the same response with a vitamin D(3 ) dosage of 600 IU/d . These results can be used as a guide for the RDA of vitamin D(3 ) , but prospect i ve trials are needed to confirm the clinical significance of these results . PRIMARY FUNDING SOURCE National Institute on Aging",
"Adequate vitamin D levels may promote cardiovascular health by improving endothelial function and down-regulating inflammation . The objective of this pilot trial was to investigate the effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease ( CAD ) . Using a double-blind placebo wait-list control design , 90 subjects with CAD and vitamin D deficiency ( were r and omized 1:1 to 50,000 IU of oral ergocalciferol or placebo weekly for 12 weeks . Endothelial function ( reactive hyperemia peripheral arterial tonometry , RH-PAT ) , circulating adhesion molecules , and pro-inflammatory cytokines were measured at baseline and 12 weeks . The median increase in serum 25-vitamin D from baseline was 26 ± 17 ng/ml in the active group and 4 ± 8 ng/ml in the placebo group ( between-group difference = 22 ng/ml , p median within-subject change in RH-PAT score was 0.13 ± 0.73 with active treatment and −0.04 ± 0.63 with placebo ( between-group difference = 0.17 , p = 0.44 ) . Within-group and between-group differences in intercellular adhesion molecule levels were greater with placebo ( between-group difference = 6 ng/ml , p = 0.048 ) . Vascular cell adhesion molecule levels decreased in both groups by a similar magnitude ( median difference between groups = 8.5 ng/ml , p = 0.79 ) . There was no difference between groups in magnitude of reduction in interleukin (IL)-12 ( −8.6 ng/ml , p = 0.72 ) and interferon-gamma ( 0.52 ng/ml , p = 0.88 ) . No significant differences in blood pressure , e-selectin , high-sensitivity c-reactive protein , IL-6 or the chemokine CXCL-10 were found with treatment . In conclusion , repleting vitamin D levels in subjects with CAD failed to demonstrate any benefits on surrogate markers of cardiovascular health . These results question the role of vitamin D supplementation in modifying cardiovascular disease",
"AIMS To compare depressive symptoms in participants with low and high serum 25-hydroxyvitamin D ( 25(OH)D ) levels and to examine whether supplementation with vitamin D(3 ) would improve symptoms in those with low serum 25(OH)D levels . METHOD Participants with low 25(OH)D levels were r and omised to either placebo or 40 000 IU vitamin D(3 ) per week for 6 months . Individuals with high serum 25(OH)D levels were used as nested controls . Depressive symptoms were evaluated with the Beck Depression Inventory , Hospital Anxiety and Depression Scale , Seasonal Pattern Assessment Scale and Montgomery-Åsberg Depression Rating Scale . The study was registered at Clinical Trials.gov ( NCT00960232 ) . RESULTS Participants with low 25(OH)D levels ( n = 230 ) at baseline were more depressed ( P participants with high 25(OH)D levels ( n = 114 ) . In the intervention study no significant effect of high-dose vitamin D was found on depressive symptom scores when compared with placebo . CONCLUSIONS Low levels of serum 25(OH)D are associated with depressive symptoms , but no effect was found with vitamin D supplementation",
"BACKGROUND Knowledge gaps have contributed to considerable variation among international dietary recommendations for vitamin D. OBJECTIVE We aim ed to establish the distribution of dietary vitamin D required to maintain serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations above several proposed cutoffs ( ie , 25 , 37.5 , 50 , and 80 nmol/L ) during wintertime after adjustment for the effect of summer sunshine exposure and diet . DESIGN A r and omized , placebo-controlled , double-blind 22-wk intervention study was conducted in men and women aged 20 - 40 y ( n = 238 ) by using different supplemental doses ( 0 , 5 , 10 , and 15 microg/d ) of vitamin D(3 ) throughout the winter . Serum 25(OH)D concentrations were measured by using enzyme-linked immunoassay at baseline ( October 2006 ) and endpoint ( March 2007 ) . RESULTS There were clear dose-related increments ( P serum 25(OH)D with increasing supplemental vitamin D(3 ) . The slope of the relation between vitamin D intake and serum 25(OH)D was 1.96 nmol x L(-1 ) x microg(-1 ) intake . The vitamin D intake that maintained serum 25(OH)D concentrations of > 25 nmol/L in 97.5 % of the sample was 8.7 microg/d . This intake ranged from 7.2 microg/d in those who enjoyed sunshine exposure , 8.8 microg/d in those who sometimes had sun exposure , and 12.3 microg/d in those who avoided sunshine . Vitamin D intakes required to maintain serum 25(OH)D concentrations of > 37.5 , > 50 , and > 80 nmol/L in 97.5 % of the sample were 19.9 , 28.0 , and 41.1 microg/d , respectively . CONCLUSION The range of vitamin D intakes required to ensure maintenance of wintertime vitamin D status [ as defined by incremental cutoffs of serum 25(OH)D ] in the vast majority ( > 97.5 % ) of 20 - 40-y-old adults , considering a variety of sun exposure preferences , is between 7.2 and 41.1 microg/d"
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Objectives The aim of this systematic review was to critically analyze previously published studies of the effects of dentin surface pretreatment with deproteinizing agents on the bonding of self-etch ( SE ) adhesives to dentin . Additionally , a meta- analysis was conducted to quantify the effects of the above-mentioned surface pretreatment methods on the bonding of SE adhesives to dentin . Material s and Methods An electronic search was performed using the following data bases : Scopus , PubMed and ScienceDirect . The online search was performed using the following keywords : ' dentin ' or ' hypochlorous acid ' or ' sodium hypochlorite ' and ' self-etch adhesive . ' The following categories were excluded during the assessment process : non-English articles , r and omized clinical trials , case reports , animal studies , and review articles . The review ed studies were subjected to meta- analysis to quantify the effect of the application time and concentration of sodium hypochlorite ( NaOCl ) and hypochlorous acid ( HOCl ) deproteinizing agents on bonding to dentin . Results Only 9 laboratory studies fit the inclusion criteria of this systematic review . The results of the meta- analysis revealed that the pooled average microtensile bond strength values to dentin pre-treated with deproteinizing agents ( 15.71 MPa ) was significantly lower than those of the non-treated control group ( 20.94 MPa ) . Conclusions In light of the currently available scientific evidence , dentin surface pretreatment with deproteinizing agents does not enhance the bonding of SE adhesives to dentin . The HOCl deproteinizing agent exhibited minimal adverse effects on bonding to dentin in comparison with NaOCl solutions
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"PURPOSE To determine the bond strengths promoted by an adhesive system to human , bovine , and porcine enamel and dentin , and compare their etched micromorphology by scanning electron microscopy . MATERIAL S AND METHODS Thirty sound freshly extracted teeth were used in this study : ten human third molars , ten bovine incisors , and ten porcine molars . The crowns of human ( H ) , bovine ( B ) , and porcine ( P ) teeth were ground with 600-grit SiC paper to expose either enamel ( E ) or mid-depth dentin ( D ) surfaces . After application of the adhesive resin , composite crowns approximately 8 mm high were built up with TPH Spectrum composite . After 24 h of water storage , specimens were serially sectioned in the buccal-lingual direction to obtain 0.8 mm slabs , which were trimmed to an hourglass shape of approximately 0.8 mm2 at the bonded interface . Specimens were tested in tension in a universal testing machine ( 0.5 mm/min ) . Results were statistically analyzed with ANOVA and Tukey 's test at the 95 % confidence level . RESULTS Tukey 's test showed significant differences between bond strengths obtained on enamel and dentin ( p differences in microTBS between human , bovine , and porcine teeth . SEM observations revealed a similar dentinal morphology for the three species . However , porcine enamel specimens presented a very different distribution of enamel prisms . CONCLUSION Bovine teeth proved to be possible substitutes for human teeth in either dentin or enamel bond testing . However , even though porcine teeth provided enamel and dentin bond strengths similar to human and bovine teeth , enamel morphology presented a very different configuration",
"BACKGROUND Self-etching adhesives are believed to prevent postoperative sensitivity when used under posterior resin-based composite restorations . The authors tested a twofold hypothesis : a self-etch , or SE , adhesive would result in less postoperative sensitivity than a total-etch , or TE , adhesive ; an SE adhesive would result in poorer enamel marginal integrity than a TE adhesive . METHODS Patients were selected on the basis of requiring Class I and II restorations in molars and premolars . The authors placed 30 restorations with the SE material ( Clearfil SE Bond , Kuraray America , New York ) and 36 restorations with Prime & Bond NT ( Dentsply Caulk , Milford , Del. ) , which uses 34 percent phosphoric acid to etch enamel and dentin simultaneously . Preparations were of st and ard design , with all margins in enamel without beveling . Upon rubber dam isolation , the authors conditioned the enamel and dentin walls with the self-etching primer ( for Clearfil SE Bond ) or etched with the proprietary 34 percent phosphoric acid ( for Prime & Bond NT ) , followed by application of the corresponding dentin adhesive . Teeth were restored with the proprietary hybrid resin-based composite indicated for posterior restorations : Clearfil AP-X for Clearfil SE Bond or Esthet-X Micro Matrix Restorative for Prime & Bond NT . The restored teeth were evaluated preoperatively and at two weeks , eight weeks and six months postoperatively for sensitivity to cold ( ice ) , air and masticatory forces , as well as for marginal discoloration . RESULTS Analysis of variance revealed no statistically significant differences in postoperative sensitivity between the SE and TE material s at any recall time . Marginal discoloration was rated as \" absent \" for all restorations at six months . Only one tooth displayed sensitivity to occlusal forces at six months . CONCLUSION The SE adhesive did not differ from the TE adhesive in regard to sensitivity and marginal discoloration . CLINICAL IMPLICATION S Postoperative sensitivity may depend on the restorative technique rather than on the type of dentin adhesive used",
"Chemical substances used during biomechanical preparation of root canals can alter the composition of dentin surface and affect the interaction with restorative material s. Objective The purpose of this study was to evaluate the microtensile bond strength ( µTBS ) of a self-etching adhesive system to dentin irrigated with sodium hypochlorite ( NaOCl ) and ethylenediaminetetraacetic acid ( eDTA ) . Material and Methods Thirty human third molars were sectioned 3 mm below the occlusal surface , polished with 600- to 1200-grit silicon carbide papers , and r and omly divided into 3 groups : G1 ( control ) : no irrigating solution ; G2 : 1 % NaOCl ; and G3 : 1 % NaOCl followed by the application of 17 % eDTA . The specimens received the self-etching adhesive system ( XeNO III - Dentsply ) , restored with microhybrid composite resin ( Z250 - 3 M ESPE ) , sectioned and trimmed to create 4 hourglass-shaped slabs of each tooth . The slabs were tested in microtensile strength in a universal testing machine ( emic DL 2000 ) at a crosshead speed of 0.5 mm/min until fracture . The results were analyzed statistically by ANOVA and Newman-Keuls test . Results Mean µTBS values and st and ard deviations in MPa were : G1 = 11.89 ± 4.22 ; G2 = 19.41 ± 5.32 ; G3 = 11.34 ± 4.73 . 1 % NaOCl increased the adhesive resistance significantly ( p of 1 % NaOCl/17 % eDTA result ed in statistically similar µTBS to the control group . Conclusions None of the irrigants affected negatively the µTBS of XeNO III to dentin . The use of 1 % NaOCl alone result ed in higher bond strength than the other treatments . The combination of 1 % NaOCl and 17 % eDTA produced similar bond strength to that of untreated dentin",
"PURPOSE To evaluate the effect of enzyme-based ( Papacárie ) and sodium-hypochlorite-based ( Carisolv ) chemomechanical caries removal methods on bonding of self-etching adhesives to caries-affected dentin , in comparison to the st and ard rotary-instrument caries removal method . MATERIAL S AND METHODS Seventy-eight carious permanent molars exhibiting frank cavitation into dentin were used . Forty-eight teeth were r and omly divided into three groups , according to the caries excavation methods : ( i ) Papacárie , ( ii ) Carisolv and ( iii ) a round steel bur . After caries removal , each group was subdivided into two groups for two-step ( Clearfil SE Bond ) or one-step ( Clearfil S3 Bond ) self-etching adhesive application and resin composite buildups . Bonded specimens were sectioned into beams for microtensile bond strength testing . Bond strength data were analyzed using three-way ANOVA and Tukey 's test . For interfacial nanoleakage evaluation using a field-emission scanning electron microscope , caries was similarly removed from the remaining thirty carious molars , bonding was performed as for bond strength testing , and the teeth were sectioned . RESULTS RESULTS of three-way ANOVA revealed that bond strength was significantly affected by \" adhesive \" ( p \" caries excavation methods \" ( p>0.05 ) . The bond strength of the two-step self-etching adhesive was significantly higher than that of the one-step self-etching adhesive ( p bond strength of self-etching adhesives to sound dentin was significantly higher than to residual caries-affected dentin ( p silver penetration was observed in the bonded interfaces of residual caries-affected dentin and in interfaces bonded with the one-step self-etching adhesive vs those bonded with the two-step self-etching adhesive . CONCLUSION Chemomechanical caries removal did not affect the bonding of self-etching adhesives to caries-affected dentin as compared to caries excavation with rotary instruments",
"This study evaluated the effect of collagen removal on the shear bond strength for two single-bottle adhesive systems . The ultrastructure of the dentin after treatments and the dentin-resin interface were examined under SEM . The buccal and lingual surfaces of 80 extracted human third molars were ground to expose dentin . Teeth were r and omly assigned to four groups and received the following treatments : Group 1(P&B 2.1 ) , Prime & Bond 2.1 adhesive was applied according to the manufacturer 's directions and Restorative Z100 composite resin was bonded to the dentin surface ; Group 2 ( P&B 2.1/NaOCl ) , the same procedures were followed as for Group 1 except that the surfaces were treated with 10 % sodium hypochlorite ( NaOCl ) for one minute after acid conditioning ; Group 3 ( SB ) , Single Bond ( 3 M ) was applied according to the manufacturer 's recommendations ; Group 4 ( SB/NaOCl ) , the same procedure was followed for Group 2 , using Single Bond . The specimens were stored in humidity at 37 degrees C for 24 hours and tested in a shear mode at a crosshead speed of 0.5 mm/minute . The Kruskal-Wallis test and Multiple Comparisons were used for statistical analysis of the data . A one-minute exposure of dentin to 10 % NaOCl following acid conditioning result ed in a significant increase of the dentin shear bond strength for Prime & Bond 2.1 . The same treatment for Single Bond result ed in a significant reduction in bond strength . Groups 1 and 3 were not statistically different from each other . The presence of a collagen layer result ed in the formation of a hybrid layer and similar values of adhesion for both adhesive systems . The results may suggest that collagen removal improves the bond strength for this acetone-based adhesive system but several such systems would need to be investigated",
"The purpose of this study was ( 1 ) to evaluate the effect of a 2-minute exposure of 5 % NaOCl following acid conditioning of the dentin on the shear bond strength for two adhesive systems and ( 2 ) to examine the ultrastructure of the resindentin interface under SEM . The mesial and distal surfaces of 28 extracted human third molars were ground to expose dentin , then polished with 600-grit SiC. Teeth were r and omly assigned to four test groups ( n = 14 ) and received the following treatments : Scotchbond Multi- Purpose (SBMP)-- Sample s were conditioned with 37 % phosphoric acid , rinsed and left moist , SBMP primer and adhesive were applied according to the manufacturer 's directions , and Restorative Z-100 composite resin was bonded to the dentin surface . SBMP/NaOCl -- The same procedures were followed as for SBMP except the surfaces were treated with 5 % NaOCl for 2 minutes , after acid conditioning . All-Bond 2 (AB2)--The same technique was followed as for SBMP , using AB2 according to the manufacturer 's recommendations . AB2/NaOCl -- The same procedure was followed as for SBMP/NaOCl , using AB2 . Specimens were thermocycled in a water bath 300 times between 5 degrees-55 degrees C , then sheared in a Zwick Universal Testing Machine . A one-way ANOVA and Duncan 's Multiple Range Test were used for statistical analysis of the data . A 2-minute exposure of dentin to 5 % NaOCl following acid conditioning of the dentin had no significant effect on the dentin shear bond strength for Scotchbond Multi- Purpose , but significantly increased the bond strength of All-Bond 2 specimens . The interfacial structure of the dentin to resin bond for two dentin treatments and two adhesive systems was studied morphologically under the scanning electron microscope . Argon ion beam etching and acid demineralization clearly revealed the hybrid layer for the conventional treatment with phosphoric acid and indicated an absence of this resin-impregnated collagen network in those specimens treated with both phosphoric acid and NaOCl",
"The aim of this in vitro study was to evaluate the bond strength of a self-etching adhesive system to dentine irrigated with sodium hypochlorite ( NaOCl ) , chlorhexidine solution ( CX ) and ethylene diamine tetra acetic acid ( EDTA ) by microtensile testing . Sixty human third molars were sectioned 3 mm below the occlusal level and then r and omly divided into six groups : G1(control ) , without irrigant solution ; G2 , 1 % NaOCl ; G3 , 1 % NaOCl followed by the application of 17 % EDTA ; G4 , 2 % CX ; G5 , 2 % CX followed by the application of 17 % EDTA and G6 , 17 % EDTA . The specimens received the self-etching adhesive system were restored with composite resin , then sectioned and trimmed to obtain four hourglass-shaped slabs from each tooth . The specimens were su bmi tted to the microtensile test in a Universal Testing Machine at a crosshead speed of 0.5 mm min(-1 ) until fracture . The results were su bmi tted to statistical analysis by anova /Newman-Keuls . The means and st and ard deviations ( MPa ) were : G1 , 26.88 ( ±3.81 ) ; G2 , 19.08 ( ±3.89 ) ; G3 , 18.16 ( ±2.21 ) ; G4 , 18.14 ( ±4.32 ) ; G5 , 34.30 ( ±3.32 ) ; G6 , 13.61 ( ±1.21 ) . It was concluded that the application of 2 % CX followed by the application of 17 % EDTA result ed in increasing the bond strength of the self-etching adhesive system to dentine , when compared with the results obtained for the other tested groups",
"PURPOSE The aim of this study was to evaluate the influence of collagen removal on shear bond strength ( SBS ) of three hydrophilic one-bottle adhesive systems in dentin . MATERIAL S AND METHODS Test specimens were taken from one-hundred twenty bovine incisors . The specimens were debrided , polished with 320- to 600-grit Al2O3 paper , and r and omly divided into 6 groups ( n = 20 ) : G1 : acid/10 % NaOCl + Bond 1 ( B1H ) ; G2 : acid + Bond 1 applied according to manufacturer 's instructions ( B1 ) ; G3 : acid/10 % NaOCl + Optibond Solo ( OSH ) ; G4 : acid + Optibond Solo used according to manufacturer 's instructions ( OS ) ; G5 : acid/10 % NaOCl + Single Bond ( SBH ) ; G6 : acid + Single Bond used according to manufacturer 's instructions . In all groups , dentin was etched for 15 s , rinsed , and dried . In groups 1 , 3 , and 5 , the 10 % NaOCl was applied with a dwell time of 60 s , rinsed , and dried . In all groups , the adhesive systems were applied and light cured , and then a restorative composite resin ( Z-100 ) was inserted in a teflon matrix and cured . The specimens were stored in humid conditions for 7 days at 37 degrees C. The SBS tests were performed in an EMIC universal testing machine with a crosshead speed of 0.5 mm/min . The mean bond strengths in MPa ( + /- SD ) were analyzed with two-way ANOVA and Tukey 's test ( alpha = 0.05 ) . RESULTS The application of NaOCl significantly increased the SBS values of all systems except Optibond Solo . The means ( SD ) for adhesive systems with 10 % NaOCl treatment were : SBH = 14.28 (4.21)a ; B1H = 14.39 (3.61)a ; OSH = 10.35 (5.74)a ; and values without 10 % NaOCl were : SB = 10.35 (2.95)a ; B1 = 9.38 (3.10)a ; OS = 9.79 (3.48)b . Different superscripts indicate significant difference . CONCLUSION The removal of collagen increased the strength of dentin bonding , depending on the adhesive system used",
"AIM Recently , there has been a tendency to simplify bonding procedures . Current self-etching adhesives combine conditioning , priming and bonding functions thus reducing technique-sensitivity as well as the risk of making errors . Another important advantage of this approach is that it allows the resin to etch and infiltrate the substratum simultaneously thus reducing the risk of any discrepancy between these 2 processes . The aim of this study was to evaluate the bonding quality of 4 self-etching adhesives both on dentin and enamel using SEM analysis . METHODS Twenty caries-free molars were used . The a prisma tic enamel layer was removed from the internal and external slopes of the vestibular cusps using a diamond bur . Each molar was then transversally cut just above the pulp chamber using a diamond saw ( composhave 4255 Intensiv ) thus obtaining twenty coronal fragments and 20 radicular fragments . Radicular and coronal fragments were then r and omly divided into 5 groups . Each group consisted of 8 specimens : 4 coronal and 4 radicular ones . A different adhesive system was used for each group following the manufacturer 's directions . Each group underwent the same treatment : a thin layer of flowable composite was applied and then polymerized . Subsequently , a single 2 mm layer of microhybrid composite was added . The coronal and radicular portions were longitudinally cut to show the ground enamel/adhesive , unground enamel/adhesive and dentine/adhesive interfaces . Eighty specimens were obtained and prepared for SEM observation . Forty specimens with an adhesive/enamel interface and 40 with an adhesive/dentine interface . RESULTS The interfacial exam frequently showed gaps between the substratum and the restoration . The final etching was generally satisfactory on ground enamel , while it was poor on unground enamel . Sometimes gaps were evident at the adhesive interface in dentin specimens . The tested adhesive systems produced a suitable hybrid layer and a lot of resin-tags were present . CONCLUSIONS Self-etching adhesives showed an adequate adhesion to dentin . However , while they provided encouraging results on ground enamel they did not show to be dependable on unground enamel",
"UNLABELLED It has been suggested that the hybrid layer ( HL ) does not play any important role in the mechanism of adhesion to dentin . To substantiate this hypothetical in significance of the HL , sodium hypochlorite ( NaOCl ) has been used to remove collagen from etched dentin prior to bonding . OBJECTIVES The present study was conducted to determine the effect of a commercial 10 % NaOCl gel on the dentin shear bond strengths and HL ultra-morphology of two simplified dentin adhesives . The None hypothesis tested was that treatment of etched dentin collagen with NaOCl would not compromise dentin bonding . METHODS The labial surface of eighty bovine incisors was polished to expose middle dentin . The specimens were r and omly assigned to two total-etch adhesive systems ( N = 40 ) : Prime&Bond NT ( Dentsply Caulk ) ; and Single Bond ( 3 M Dental Products Division ) . After rinsing off the etchant , one drop of 10 % NaOCl ( AD Gel , Kuraray Ltd. ) was applied to the etched dentin surface and left for 0 ( control ) , 15 , 30 , or 60 s. The gel was rinsed off with water and the dentin surface kept visibly moist prior to the application of the adhesive as per manufacturer 's instructions . The respective composite resin was subsequently applied and light-cured . After 24 h in water at 37 degrees C , the specimens were thermocycled for 500 cycles in baths kept at 5 and 55 degrees C and the shear bond strengths measured . The data were analyzed with two-way ANOVA . For TEM , sixteen dentin disks were taken from middle dentin of extracted human third molars , assigned to the eight treatment sequences , and observed . RESULTS The increase in the NaOCl application time result ed in a progressive decrease in shear bond strengths for both dentin adhesives . For Single Bond , the application of AD Gel for 60 s result ed in a reduction of bond strengths to 38 % of that obtained for the control . For Prime&Bond NT , the mean bond strength obtained when AD Gel was applied for 60 s was 31 % of that obtained for the control . The application of AD Gel result ed in distinct morphology for each one of the two adhesives tested . For Single Bond , the general morphology of the collagen network was maintained , regardless of the deproteinization time . The interfibrillar space within the collagen network increased with increasing deproteinization times . For Prime&Bond NT , the general appearance of the HL was maintained for deproteinization times of 15 and 30 s. When the NaOCl gel was applied for 60 s , the morphological appearance of the HL lost its fibrillar arrangement . While remnants of the collagen fibers were observed in one of the dentin disks , the other specimen showed an amorphous structure without any discernible HL morphological features . SIGNIFICANCE The integrity of the collagen fibrils left exposed upon acid-etching plays a major role in the mechanism of adhesion of the specific adhesive systems tested in this study . The intermingling of the adhesive monomers with the filigree of collagen fibers or HL should still be considered the paramount dentin bonding mechanism",
"This in vitro study morphologically evaluated the effect of some current surface pre-treatments on dentin , using scanning electron microscopy , and related these morphological alterations to clinical implication s. The labial surfaces of 30 bovine lower incisors were ground to obtain a flat dentin surface and were finished with 600-grit SiC paper to produce st and ardized smear layers . The teeth were r and omly divided into six groups of five each . Group 1 was the control group , smear layer covered dentin ; Group 2 was etched with 37 % phosphoric acid ( PA ) for 15 seconds ; Group 3 , 37 % PA for 15 seconds , followed by 10 % NaOCl for 60 seconds ; Group 4 , 10 % NaOCl for 60 seconds ; Group 5 , a self-etching primer ( Clearfil SE Bond , CSEB-primer ) was applied for 20 seconds ; Group 6 , CSEB-primer for 20 seconds , followed by NaOCl for 60 seconds . The specimens were fixed , dehydrated , dried and analyzed by SEM . Treatment with 37 % PA removed the smear layer , funneled the tubules and result ed in a collagen-rich surface which appeared to have collapsed in its outermost part , producing a dense surface layer covered with silica particles . When 37 % PA treatment was followed by 10 % NaOCl , the collagen network was removed to reveal an eroded , rough mineral surface with numerous lateral branches and larger than normal tubular orifices . The action of 10 % NaOCl on the smear layer-covered dentin showed no significant alteration in surface morphology . The treatment with CSEB-primer dissolved the smear layer but only partially dissolved the smear plugs . The tubules did not present the typical funnel shape seen following PA treatment . These morphological aspects on dentin surface must influence bonding results . The dentin surface alterations produced by PA appeared to be a very severe demineralization pattern , quite irregular and less permeable to monomer infiltration , while the surface provided by the self-etching primer appeared to be a more uniform , less porous surface , and the association with simultaneous monomer infiltration may reduce the occurrence of mistakes in clinical bonding procedures"
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BACKGROUND Total knee arthroplasty ( TKA ) is a common and costly surgical procedure . Despite high success rates , many TKA patients develop chronic pain in the months and years following surgery , constituting a public health burden . Pain catastrophizing is a construct that reflects anxious preoccupation with pain , inability to inhibit pain-related fears , amplification of the significance of pain vis-à-vis health implication s , and a sense of helplessness regarding pain . Recent research suggests that it may be an important risk factor for untoward TKA outcomes . To clarify this impact , we systematic ally review ed the literature to date on pain catastrophizing as a prospect i ve predictor of chronic pain following TKA . METHODS We search ed MEDLINE , EMBASE , and PsycINFO data bases to identify articles related to pain catastrophizing , TKA , risk models , and chronic pain . We review ed titles and abstract s to identify original research articles that met our specified inclusion criteria . Included articles were then rated for method ological quality . including method ological quality . Due to heterogeneity in follow-up , analyses , and outcomes reported across studies , a quantitative meta- analysis could not be performed . RESULTS We identified six prospect i ve longitudinal studies with small-to-mid-sized sample s that met the inclusion criteria . Despite considerable variability in reported pain outcomes , pain catastrophizing was identified as a significant predictor of chronic pain persisting ≥3 months following TKA in five of the studies assessed . Limitations of studies included lack of large-scale data , absence of st and ardized pain measurements , inadequate multivariate adjustment , such as failure to control for analgesic use and other relevant covariates , and failure to report non-significant parameter estimates . CONCLUSION This study provides moderate-level evidence for pain catastrophizing as an independent predictor of chronic pain post-TKA . Directions for future research include larger , well-controlled studies with st and ard pain outcomes , identification of clinical ly-relevant catastrophizing cut-offs that predict pain outcomes , investigation of other psychosocial risk factors , and assessment of interventions aim ed to reduce pain catastrophizing on chronic pain outcomes following TKA surgery
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"BACKGROUND Pain is the primary indication for both primary and revision total knee arthroplasty ( TKA ) ; however , most arthroplasty outcome measures do not take pain into account . OBJECTIVE To document the prospect i ve pain experience following TKA , with subjective pain-specific question naires to determine if comorbidities , preoperative pain or preoperative pain catastrophizing scores are predictive of long-term pain outcomes . METHODS Fifty-five patients with a primary diagnosis of osteoarthritis of the knee , who were scheduled to undergo TKA , were asked to fill out the McGill Pain Question naire ( MPQ ) and the Pain Catastrophizing Scale ( PCS ) preoperatively and at three , 12 and 24 months follow-up . Comorbidities were extracted from the Queen Elizabeth II Health Sciences Centre health information system . RESULTS The overall response rate ( return of completed question naires ) was 84 % . There was a significant decrease in the MPQ scores ( P PCS scores did not change over time . Receiver operating characteristic curves revealed the number of comorbidities per patient predicted the presence of pain postoperatively , as documented by the numerical rating subscale of the MPQ at 24 months ( P presence of pain , as measured by the Pain Rating Index subscale of the MPQ at 24 months ( P PCS scores and comorbidities were significantly higher in the persistent pain group ( P knee arthroplasty patients at risk for persistent postoperative pain , thus allowing for efficient administration of preoperative interventions to improve arthroplasty outcomes",
"BACKGROUND The relief of pain and the restoration of functional activities are the main outcomes of primary total knee arthroplasty for the treatment of osteoarthritis . This paper examines the preoperative predictors of pain and functional outcome at one and two years following total knee arthroplasty . METHODS Patients were recruited for a prospect i ve observational study of primary total knee arthroplasty for the treatment of osteoarthritis from centers in the United States , the United Kingdom , and Australia . Research assistants recruited the patients and collected the clinical history and physical examination data preoperatively and at three , twelve , and twenty-four months postoperatively . The Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , Short Form-36 ( SF-36 ) , and demographic data were obtained by self-administered patient question naires . RESULTS We recruited 860 patients and obtained one-year WOMAC data on 759 patients ( 88 % ) and two-year data on 701 ( 82 % ) . The mean age was seventy years , and 59 % of the patients were female . Using hierarchical regression models , we found that the most significant preoperative predictors of worse scores on the pain and function domains of the WOMAC scale and on the physical functioning domain of the SF-36 at one and two years postoperatively were low preoperative scores , a higher number of comorbid conditions , and a low SF-36 mental health score . After adjusting for these predictors , we found that the functional status of the patients from the United Kingdom was significantly worse than that of the patients from the other countries and the difference was clinical ly important at both the one-year and two-year follow-up examination ( p mean WOMAC pain scores for the three countries were not significantly different at one year , and , although they were significantly different at two years ( p = 0.025 ) , the difference was not clinical ly important . CONCLUSIONS Patients who have marked functional limitation , severe pain , low mental health score , and other comorbid conditions before total knee arthroplasty are more likely to have a worse outcome at one year and two years postoperatively . After adjusting for these predictors , it was found that patients from the United Kingdom had significantly worse functional outcomes but similar pain relief compared with those from the United States and Australia",
"& NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies",
"To describe the natural history of pain after total knee arthroplasty and to identify factors predicting excessive postoperative pain , we used a prospect i ve , observational study assessing clinical and radiographic variables preoperatively and at 1 , 3 , 6 , and 12 months after knee replacement . Data sources included the visual analog pain scale and other measures of patient health , psychologic state , and component reliability . Regression analyses were conducted to identify specific factors predictive of postoperative pain , controlling for ine quality of variables , and confirmed using regression diagnostics . For 116 patients ( 149 knees ; mean age , 66 years ; 55.2 % women ) , significant pain was reported by 72.3 % , 44.4 % , 22.6 % , 18.4 % , and 13.1 % , respectively . No intergroup differences existed for anesthesia , weight , age , or gender . Patients with greater preoperative pain had more postoperative pain , used more home therapy , and postoperative manipulations . Preoperative depression and anxiety were associated with heightened pain at 1 year . Pain after knee replacement resolves quickly , declining to approximately 1/2 by 3 months . However , one in eight patients report moderate to severe pain 1 year after surgery despite an absence of clinical or radiographic abnormalities . Development of office-based preoperative screening tools and interventions for these patients may reduce postoperative costs and improve patient-perceived outcomes",
"Through empirical methods we now characterize patients with chronic pain as either dysfunctional , interpersonally distressed , or adaptive copers . Study ing factors that differentiate these groups may reveal the behavioral processes that determine adjustment to pain . Subjects for this study were 190 patients referred for treatment of chronic pain . They were classified as dysfunctional ( n = 41 ) , interpersonally distressed ( n = 28 ) or adaptive copers ( n = 59 ) based on the Multidimensional Pain Inventory ( Kerns , R.D. , Turk , D.C. and Rudy , T.E. , The West Haven-Yale Multidimensional Pain Inventory ( WHYMPI ) , Pain , 23 ( 1985 ) 345 - 356 ) and compared on measures of pain-related anxiety and pain acceptance . Our analyses showed that the dysfunctional group reported greater pain-related anxiety and less acceptance of pain than the other groups . Additional analyses , statistically controlling for pain severity and depression , showed that the patient subtypes continued to differ on pain-related anxiety and acceptance . Discriminant function analyses including pain-related anxiety and acceptance correctly classified 72.5 % of dysfunctional and 90.9 % of adaptive copers . Again , anxiety and acceptance contributed uniquely to classification independent of depression and pain intensity . Pain-related anxiety and acceptance of pain appear to be unique behavioral dimensions of adjustment to chronic pain . Decreasing anxiety and increasing acceptance may ' move ' patients with chronic pain from the dysfunctional to the adaptive coper category",
"Objectives : This study was a prospect i ve investigation of the extent to which psychologic variables could be predictive of postoperative pain . Study aims were : 1 ) to evaluate whether an assessment of pre-operative distress factors could predict the intensity of postoperative pain ; and 2 ) to characterize the unique pattern in which anxiety and pain catastrophizing scores relate to postoperative pain . Methods : The Pain Catastrophizing Scale and the State-Trait Anxiety Inventory were administered to 38 patients scheduled for elective abdominal surgery . The question naires were completed on the day of admission , a day before the operation . On day 1 and day 2 following the operation , perception of pain intensity at the surgical wound was assessed by visual analog scale . Results : The Pain Catastrophizing Scale and State-Trait Anxiety Inventory scores were significantly correlated with the postoperative pain scores . A linear regression analysis showed that Pain Catastrophizing Scale predicted the level of postoperative pain intensity even after controlling for state anxiety and that trait anxiety was not a significant predictor . In addition , analysis of the unique pattern of each predictor related to postoperative pain intensity indicated a linear curve for the Pain Catastrophizing Scale and curvilinear curve for the state anxiety . Discussion : The results are discussed in light of appraisal and coping theories . It is suggested that a simple assessment of preoperative catastrophizing tendency and anxiety scores may assist medical teams in postoperative pain management",
"UNLABELLED The aim of this study was to examine whether treatments based on different theories change pain catastrophizing and internal control of pain , and whether changes in these factors mediate treatment outcome . Participants were 211 patients with nonspecific chronic low back pain ( CLBP ) participating in a r and omized controlled trial , attending active physical treatment ( APT , n = 52 ) , cognitive-behavioral treatment ( CBT , n = 55 ) , treatment combining the APT and CBT ( CT , n = 55 ) , or waiting list ( WL , n = 49 ) . Pain catastrophizing decreased in all 3 active treatment groups and not in the WL . There was no difference in the change in internal control across all 4 groups . In all the active treatment groups , patients improved regarding perceived disability , main complaints , and current pain at post-treatment , and no changes were observed in the WL group . Depression only changed significantly in the APT group . Change in pain catastrophizing mediated the reduction of disability , main complaints , and pain intensity . In the APT condition , pain catastrophizing also mediated the reduction of depression . Not only cognitive-behavioral treatments but also a physical treatment produced changes in pain catastrophizing that seemed to mediate the outcome of the treatment significantly . The implication s and limitations of these results are discussed . PERSPECTIVE This article shows that treatment elements that do not deliberately target cognitive factors can reduce pain catastrophizing . Reduction in pain catastrophizing seemed to mediate the improvement of functioning in patients with chronic low back pain . The results might contribute to the development of more effective interventions",
"Within the context of a double blind r and omized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs , we vali date d WOMAC , a new multidimensional , self-administered health status instrument for patients with osteoarthritis of the hip or knee . The pain , stiffness and physical function subscales fulfil conventional criteria for face , content and construct validity , reliability , responsiveness and relative efficiency . WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials",
"& NA ; The purpose of this study was to determine the levels of change on st and ard pain scales that represent clinical ly important differences to patients . Data from analgesic studies are often difficult to interpret because the clinical importance of the results is not obvious . Differences between groups , as summarized by a change in mean values over time , can be difficult to apply to clinical care . Baseline scores vary widely and group mean differences could reflect large changes in a few patients , small changes in many patients , or any combination of these outcomes . Determination of the proportion of patients who have a clinical ly important improvement in their pain would provide a more interpretable result with direct clinical implication s. However , determining a clinical ly important outcome requires information about the degree of change over time that is clinical ly important . Data from the titration phase of a multiple cross‐over r and omized clinical trial of oral transmucosal fentanyl citrate ( OTFC ) for the treatment of cancer‐related breakthrough pain were re‐analyzed to examine the differences in pain scores between treatment episodes that did and did not yield adequate pain relief . The scales evaluated were absolute pain intensity difference ( PID , 0–10 scale ) , percentage pain intensity difference ( PID% , 0–100 % scale ) , pain relief ( PR , 0 ( none ) , 1 ( slight ) , 2 ( moderate ) , 3 ( lots ) , 4 ( complete ) ) , sum of the pain intensity difference ( SPID over 60 min ) , percentage of maximum total pain relief ( % Max TOTPAR over 60 min ) , and global medication performance ( 0 ( poor ) , 1 ( fair ) , 2 ( good ) , 3 ( very good ) , 4 ( excellent ) ) . Adequate relief was defined by the patient 's decision not to use another dose of opioid medication as a rescue , in addition to the study medication , to treat each painful episode . One hundred thirty OTFC naive patients contributed data on 1268 episodes of breakthrough pain . The scales that were converted to a percentage change yielded the best accuracy in predicting adequate relief , with balanced sensitivity and specificity . The best cut‐off point for both the % Max TOTPAR and the PID% was 33 % . The best cut‐off points for the absolute scales were absolute pain intensity difference of 2 , pain relief of 2 ( moderate ) , and SPID of 2 . The global medication performance of 2 ( good ) had excellent values as well . This study presents data ‐derived cut‐off points for the changes in several pain scales , each reflecting the clinical ly important improvement for patients treating breakthrough cancer pain episodes with OTFC . Confirmation in other patient population s and different pain syndromes will be needed . The use of consistent clinical ly important cut‐off points as the primary outcome in future pain therapy clinical trials will enhance their validity , comparability , and clinical applicability",
"Several recent reports suggest that pain-related catastrophizing is a risk factor for poor acute pain outcomes following surgical interventions . However , it has been less clear whether levels of catastrophizing influence longer-term postoperative outcomes . Data were analyzed from a relatively small number ( n=43 ) of patients who underwent total knee replacement and were followed for 12 months after their surgery . Previous research has suggested that high levels of both catastrophizing and depression are associated with elevated acute postoperative pain complaints among patients undergoing knee surgery . In this sample , catastrophizing and depression at each of the assessment points were studied as prospect i ve predictors of pain ( both global pain ratings and pain at night ) at the subsequent assessment point over the course of one year . The predictive patterns differed somewhat across measures of pain reporting ; depressive symptoms were unique predictors of greater global pain complaints , while catastrophizing was a specific and unique predictor of elevated nighttime pain . While surgical outcomes following total knee replacement are , on average , quite good , a significant minority of patients continue to experience long-term pain . The present findings suggest that high levels of catastrophizing and depression may promote enhanced pain levels , indicating that interventions design ed to reduce catastrophizing and depressive symptoms may have the potential to further improve joint replacement outcomes",
" Six hundred twenty-two primary total knee arthroplasties were studied prospect ively in 512 patients . A group with no pain and one with severe pain at 5 years were statistically compared . The following were significant predictors of poor pain outcomes : age below 60 ( 17 % ) compared with above 60 ( 7 % , P poor outcome group ( 13 % ) compared with the second knee ( 6 % ) . In contrast , patients who underwent simultaneous bilateral arthroplasty faired better ( 2 % , P poor pain outcomes but may have been influenced by selection bias . We conclude that avoiding surgery in patients younger than 60 and choosing a simultaneous approach to bilateral disease reduce the chance of poor pain outcomes",
"UNLABELLED Anxiety , depression , and catastrophizing are generally considered to be predictive of chronic postoperative pain , but this may not be the case after all types of surgery , raising the possibility that the results depend on the surgical model . We assessed the predictive value of these factors for chronic postsurgical pain in 2 different surgical models : total knee arthroplasty for osteoarthritis ( 89 patients , 65 % women , age = 69 ± 9 years , baseline pain intensity = 4.7 ± 2.1 ) and breast surgery for cancer ( 100 patients , 100 % women , age = 55 ± 12 years , no preoperative pain ) . Data were collected before surgery , then 2 days and 3 months after surgery . Anxiety , depression , and catastrophizing were measured with the Spielberger State-Trait Anxiety Inventory , Beck Depression Inventory , and Pain Catastrophizing Scale , respectively . Pain was assessed with the Brief Pain Inventory . Neuropathic pain was detected with the DN4 question naire . Multivariate logistic regression analyses for the total knee arthroplasty and breast surgery models considered together indicated that the presence of clinical ly meaningful chronic pain at 3 months ( pain intensity ≥3/10 ) was predicted independently by age ( P = .04 ) , pain intensity on day 2 ( P = .009 ) , and state anxiety ( P = .001 ) . Linear regression models also showed that pain magnification , one of the dimensions of catastrophizing , independently predicted chronic pain intensity ( P = .04 ) . These results were not affected by the surgical model or by the neuropathic characteristics of the pain . Thus , state anxiety and pain magnification seem to constitute psychological risk factors for chronic postsurgical pain relevant in all surgical models . PERSPECTIVE This prospect i ve study performed in patients with total knee arthroplasty or breast surgery for cancer shows that state anxiety , amplification of pain , and acute postoperative pain independently predict postsurgical pain at 3 months and that this does not depend on the surgical model",
"Introduction Gabapentin is increasingly being used for the treatment of postoperative pain and a variety of psychiatric diseases , including chronic anxiety disorders . Trials have reported mixed results when gabapentin has been administered for the treatment of preoperative anxiety . We tested the hypothesis that gabapentin 1,200 mg vs placebo would reduce preoperative anxiety in patients who exhibit moderate to high preoperative anxiety . Methods A blinded r and omized controlled trial was conducted from September 2009 to June 2011 at the Toronto General Hospital . Following ethics approval and informed consent , 50 female patients with a 0 - 10 numeric rating scale ( NRS ) anxiety score of greater than or equal to 5/10 consented to receive either gabapentin 1,200 mg ( n = 25 ) or placebo ( n = 25 ) prior to surgery . R and omization was computer generated , and the Investigational Pharmacy was responsible for the blinding and dispensing of medication . All patients and care providers , including physicians , nurses , and study personnel , were blinded to group allocation . Before administering the study medication , baseline anxiety levels were measured using a NRS , the Spielberger State-Trait Anxiety Inventories , the Pain Catastrophizing Scale , and the Pain Anxiety Symptoms Scale-20 . Baseline pain intensity ( 0 - 10 NRS ) and level of sedation ( 0 - 10 NRS and Richmond Agitation-Sedation Scale [ RASS ] ) were also measured . Two hours after the administration of gabapentin or placebo ( prior to surgery ) , patients again rated their anxiety , pain , and sedation levels using the same measurement tools as at baseline . The main outcome was a reduction in preoperative anxiety . Results Forty-four patients ( 22 treated with gabapentin 1,200 mg and 22 treated with placebo ) were included in the analysis of the primary outcome . Analysis of covariance in which pre-drug NRS anxiety scores were used as the covariate showed that post-drug preoperative NRS anxiety ( Effect size , 1.44 ; confidence interval [ CI ] 0.19 to 2.70 ) and pain catastrophizing ( Effect size , 0.43 ; CI 0.12 to 0.74 ) scores were significantly lower in the gabapentin group than in the placebo control group , respectively . Post-drug sedation ( Effect size , −3.02 ; CI −4.28 to −1.77 ) and RASS ( Effect size , 0.41 ; CI 0.12 to 0.71 ) scores were significantly higher in the gabapentin group than in the placebo group , respectively . Conclusions Administration of gabapentin 1,200 mg prior to surgery reduces preoperative NRS anxiety scores and pain catastrophizing scores and increases sedation prior to entering the operating room . These results suggest that gabapentin 1,200 mg may be a treatment option for patients who exhibit high levels of preoperative anxiety and pain catastrophizing ; however , the sedative properties of the medication and the possibility of delayed postoperative discharge in the elective ambulatory population need to be considered . Résumé Introduction La gabapentine est de plus en plus utilisée pour le traitement de la douleur postopératoire ainsi que pour le traitement de plusieurs maladies psychiatriques , notamment les troubles anxieux chroniques . Des études ont rapporté des résultats mitigés lors de l’administration de gabapentine pour le traitement de l’anxiété préopératoire . Nous avons testé l’hypothèse que 1200 mg de gabapentine vs. un placebo réduirait l’anxiété préopératoire chez les patients manifestant une anxiété préopératoire modérée à élevée . MéthodeNous avons réalisé une étude r and omisée contrôlée en aveugle entre septembre 2009 et juin 2011 à l’Hôpital général de Toronto . Après avoir obtenu l’approbation du comité d’éthique et le consentement éclairé des sujets de l’étude , 50 patientes ayant un score d’anxiété sur une échelle d’évaluation numérique ( ÉÉN ) de 0 - 10 supérieur ou égal à 5/10 ont consenti à recevoir 1200 mg de gabapentine ( n = 25 ) ou un placebo ( n = 25 ) avant la chirurgie . La r and omisation a été effectuée par ordinateur , et le département de pharmacie était en charge de la mise en aveugle et de l’administration du médicament . Personne parmi les patientes ou les fournisseurs de soins , y compris les médecins , les infirmières et le personnel de recherche , ne connaissait l’attribution des groupes . Avant l’administration du médicament à l’étude , les niveaux d’anxiété de base ont été mesurés à l’aide d’une ÉÉN , des inventaires d’anxiété situationnelle et de trait d’anxiété de Spielberger , de l’échelle de catastrophisation de la douleur , et de l’échelle des symptômes d’anxiété face à la douleur 20 . L’intensité de la douleur de base ( ÉÉN 0 - 10 ) et le niveau de sédation ( ÉÉN 0 - 10 et échelle de sédation-agitation de Richmond [ RASS ] ) ont également été mesurés . Deux heures après l’administration de la gabapentine ou du placebo ( avant la chirurgie ) , les patientes ont à nouveau attribué une note à leur anxiété , à leur douleur , et aux niveaux de sédation à l’aide des mêmes outils de mesure qu’au début . Le critère d’évaluation principal était une réduction de l’anxiété préopératoire . RésultatsQuarante-quatre patientes ( 22 traitées avec 1200 mg de gabapentine et 22 traitées avec placebo ) ont été incluses dans l’analyse du critère d’évaluation principal . L’analyse de la covariance , utilisant les scores d’anxiété sur l’ÉÉN avant l’administration du médicament comme covariable , a démontré que les scores d’anxiété préopératoire sur l’ÉÉN après l’administration du médicament ( ampleur de l’effet , 1,44 ; intervalle de confiance [ IC ] 0,19 à 2,70 ) et de catastrophisation de la douleur ( ampleur de l’effet , 0,43 ; IC 0,12 à 0,74 ) étaient significativement plus bas dans le groupe gabapentine que dans le groupe témoin placebo , respectivement . Les scores de sédation après administration du médicament ( ampleur de l’effet , −3.02 ; IC −4,28 à −1,77 ) et de RASS ( ampleur de l’effet , 0,41 ; IC 0,12 à 0,71 ) étaient significativement plus élevés dans le groupe gabapentine que dans le groupe placebo , respectivement . Conclusion L’administration de 1200 mg de gabapentine avant la chirurgie réduit les scores d’anxiété préopératoire sur l’ÉÉN ainsi que les scores de catastrophisation de la douleur , et augmente la sédation avant l’entrée en salle d’opération . Ces résultats suggèrent que 1200 mg de gabapentine pourraient constituer une option de traitement pour les patients manifestant des niveaux élevés d’anxiété préopératoire et de catastrophisation de la douleur ; toutefois , les propriétés sédatives du médicament et la possibilité d’un délai dans le congé postopératoire dans la population ambulatoire pour chirurgies non urgentes doivent être prises en compte",
"Total knee arthroplasty has provided dramatic improvements in function and pain for the majority of patients with knee arthritis , yet a significant proportion of patients remain dissatisfied with their results . We performed a prospect i ve analysis of 215 patients undergoing TKA who underwent a comprehensive array of evaluations to discover whether any preoperative assessment could predict high pain scores and functional limitations postoperatively . Patients with severe pain with a simple knee range-of-motion test prior to TKA had a 10 times higher likelihood of moderate to severe pain at 6 months . A simple test of pain intensity with active flexion and extension preoperatively was a significant predictor of postoperative pain at 6 months after surgery . Strategies to address this particular patient group may improve satisfaction rates of TKA",
"ABSTRACT The primary objective of the present study was to examine the role of pain‐related psychological factors in predicting pain and disability following Total Knee Arthroplasty ( TKA ) . The study sample consisted of 75 ( 46 women , 29 men ) individuals with osteoarthritis of the knee who were scheduled for TKA . Measures of pain severity , pain catastrophizing , depression , and pain‐related fears of movement were completed prior to surgery . Participants completed measures of pain severity and self‐reported disability 6 weeks following surgery . Consistent with previous research , cross‐sectional analyses revealed significant correlations among measures of pre‐surgical pain severity , pain catastrophizing , depression and pain‐related fears of movement . Prospect i ve analyses revealed that pre‐surgical pain severity and pain catastrophizing were unique predictors of post‐surgical pain severity ( 6‐week follow‐up ) . Pain‐related fears of movement were predictors of post‐surgical functional difficulties in univariate analyses , but not when controlling for pre‐surgical co‐morbidities ( e.g. back pain ) . The results of this study add to a growing literature highlighting the prognostic value of psychological variables in the prediction of post‐surgical health outcomes . The results support the view that the psychological determinants of post‐surgical pain severity differ from the psychological determinants of post‐surgical disability . The results suggest that interventions design ed to specifically target pain‐related psychological risk factors might improve post‐surgical outcomes",
"Summary Patients ’ behavioral outcome expectancies assessed presurgically predicted pain severity and physical function 1 year after total knee arthroplasty ( TKA ) and partially mediated the relation between catastrophizing and TKA outcomes . Abstract The present study examined the prospect i ve value of response expectancies ( ie , pain , sleep ) and behavioral outcome expectancies ( ie , return to function ) in the prediction of pain severity and functional limitations 12 months after total knee arthroplasty ( TKA ) . The study sample consisted of 120 individuals ( 73 women , 47 men ) with osteoarthritis of the knee who were scheduled for TKA . Measures of expectancies , pain severity , pain catastrophizing , pain‐related fears of movement , and depression were completed prior to surgery . Participants also completed measures of pain severity and functional limitations 12 months following surgery . Analyses revealed that behavioral outcome expectancies were stronger predictors of follow‐up pain and functional limitations than response expectancies . Consistent with previous research , analyses also revealed that pain catastrophizing , pain‐related fear of movement , and depression predicted follow‐up pain and function . In a multivariate analysis , only pain catastrophizing contributed significant unique variance to the prediction of follow‐up pain and function . Behavioral outcome expectancies partially mediated the relation between catastrophizing and follow‐up pain and function . The relation between catastrophizing and follow‐up pain severity and functional limitations remained significant even when controlling for behavioral outcome expectancies . The results suggest that interventions design ed to specifically target behavioral outcome expectancies and catastrophizing might improve post‐surgical outcomes"
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4116e0a2-06ff-11f0-808a-c43d1ab1c353
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Green tea or green tea extract ( GT/GTE ) has been demonstrated to reduce insulin resistance and improve glycemic control . However , evidence for this health beneficial effect is inconsistent . This systematic review evaluated the effect of GT/GTE on insulin resistance and glycemic control in people with pre-diabetes/type 2 diabetes mellitus ( T2DM ) . Ovid MEDLINE , Embase , AMED , Web of Science , and the Cochrane Library were search ed up to April 2017 for r and omised controlled trials of participants with pre-diabetes or T2DM , where the intervention was GT/GTE . Meta- analysis was performed to assess the st and ardised mean difference ( SMD ) in biomarkers of insulin resistance and glycemic control between GT/GTE and placebo groups . Six studies ( n=382 ) were pooled into r and om-effects meta- analysis . Overall , no differences were found between GT/GTE and the placebo for glycosylated hemoglobin ( HbA1c : SMD , -0.32 ; 95 % confidence interval [ CI ] , -0.86 to 0.23 ) , homeostatic model assessment for insulin resistance ( HOMA-IR : SMD , 0.10 ; 95 % CI , -0.17 to 0.38 ) , fasting insulin ( SMD , -0.25 ; 95 % CI , -0.64 to 0.15 ) , and fasting glucose ( SMD , -0.10 ; 95 % CI , -0.50 to 0.30 ) . No evidence support the consumption of GT/GTE could reduce the levels of HbA1c , HOMA-IR , fasting insulin , or fasting glucose in people with pre-diabetes/T2DM . However , the studies included were small and of varying quality
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"BACKGROUND Green tea consumption has been associated with favorable changes in body weight and obesity-related hormones , although it is not known whether these changes result from green tea polyphenols or caffeine . OBJECTIVE We examined the impact of decaffeinated green tea extract ( GTE ) containing 843 mg of (-)-epigallocatechin-3-gallate on anthropometric variables , obesity-associated hormones , and glucose homeostasis . METHODS The Minnesota Green Tea Trial was a 12-mo r and omized , double-blind , placebo-controlled clinical trial of 937 healthy postmenopausal women assigned to either decaffeinated GTE ( 1315 mg total catechins/d ) or a placebo , stratified by catechol-O-methyltransferase ( COMT ) genotype . This study was conducted in a subset of 237 overweight and obese participants [ body mass index ( BMI ) ≥25 kg/m(2 ) ] . RESULTS No changes in energy intake , body weight , BMI , or waist circumference ( WC ) were observed over 12 mo in women taking GTE ( n = 117 ) or placebo ( n = 120 ) . No differences were seen in circulating leptin , ghrelin , adiponectin , or glucose concentrations at month 12 . Participants r and omly assigned to GTE with baseline insulin ≥10 μIU/mL ( n = 23 ) had a decrease in fasting serum insulin from baseline to month 12 ( -1.43 ± 0.59 μIU/mL ) , whereas those r and omly assigned to placebo with baseline insulin ≥10 μIU/mL ( n = 19 ) had an increase in insulin over 12 mo ( 0.55 ± 0.64 μIU/mL , P significantly lower adiponectin ( 5.97 ± 0.50 compared with 7.58 ± 0.53 μg/mL , P = 0.03 ) and greater insulin concentrations ( 7.63 ± 0.53 compared with 6.18 ± 0.36 μIU/mL , P = 0.02 ) at month 12 compared with those with the low-activity ( A/A ) genotype , regardless of treatment group . CONCLUSIONS Decaffeinated GTE was not associated with reductions in body weight , BMI , or WC and did not alter energy intake or mean hormone concentrations in healthy postmenopausal women over 12 mo . GTE decreased fasting insulin concentrations in those with elevated baseline fasting concentrations . The high-activity form of the COMT enzyme may be associated with elevations in insulin and a reduction in adiponectin concentrations over time . This trial was registered at http://www . clinical trials.gov as NCT00917735",
"BACKGROUND Green tea is one of the most popular beverages in the world . It is believed to have beneficial effects in the prevention and treatment of many diseases , one of which is type 2 diabetes . The aim of the study is to examine the effect of a decaffeinated green tea extract ( GTE ) providing a daily dose of 856 mg of epigallocatechin gallate ( EGCG ) on obese individuals with type 2 diabetes . MATERIAL S AND METHODS The clinical trial was a r and omized , double-blind , placebo-controlled clinical trial conducted from December 2007 through November 2008 . The subjects were r and omly assigned to either receive 1,500 mg of a decaffeinated GTE or placebo daily for 16 weeks . Sixty-eight of 80 subjects , ages 20 - 65 years with BMI > 25 kg/m2 and type 2 diabetes for more than one year , completed this study . Homeostasis model assessment for insulin resistance ( HOMA-IR ) was used as the major outcome measurement . At baseline and after 16 weeks of treatment , anthropometric measurements , fasting glucose , hemoglobin A1C percent ( HbA1C ) , hormone peptides , and plasma lipoproteins were measured from both groups . RESULTS No statistically significant differences were detected between the decaffeinated GTE and placebo groups in any measured variable . A statistically significant within-group 0.4-percent reduction in HbA1C ( from 8.4 to 8.0 % ) was observed after GTE treatment compared to baseline . Within-group comparison also revealed that the GTE group had significant reductions in waist circumference ( WC ) , HOMA-IR index , and insulin level , and a significant increase in the level of ghrelin . Within-group comparison of those in the placebo group showed a significant increase in the level of ghrelin . CONCLUSIONS This study found no statistical difference in any measured variable between the decaffeinated GTE and placebo groups ; however , there were some statistically significant within-group changes detected . More research is required to determine whether a decaffeinated GTE st and ardized for EGCG content will provide any clinical benefits in obese individuals with type 2 diabetes . Clinical Trial Registration NO : NCT00567905",
"Elevated postpr and ial hyperglycaemia and oxidative stress increase the risks of type 2 diabetes and CVD . Green tea catechin possesses antidiabetic properties and antioxidant capacity . In the present study , we examined the acute and continuous effects of ingestion of catechin-rich green tea on postpr and ial hyperglycaemia and oxidative stress in healthy postmenopausal women . Participants were r and omly assigned into the placebo ( P , n 11 ) or green tea ( GT , n 11 ) group . The GT group consumed a catechin-rich green tea ( catechins 615 mg/350 ml ) beverage per d for 4 weeks . The P group consumed a placebo ( catechins 92 mg/350 ml ) beverage per d for 4 weeks . At baseline and after 4 weeks , participants of each group consumed their design ated beverages with breakfast and consumed lunch 3 h after breakfast . Venous blood sample s were collected in the fasted state ( 0 h ) and at 2 , 4 and 6 h after breakfast . Postpr and ial glucose concentrations were 3 % lower in the GT group than in the P group ( three-factor ANOVA , group × time interaction , P increased after meals ( P Conversely , serum postpr and ial thioredoxin concentrations were 5 % higher in the GT group than in the P group ( three-factor ANOVA , group × time interaction , P of catechin-rich green tea has beneficial effects on postpr and ial glucose and redox homeostasis in postmenopausal women",
"The aim of the study was to investigate the antidiabetic effect of the traditional Vietnamese herb Gynostemma pentaphyllum in 24 drug-naïve type 2 diabetic patients . All patients were r and omized to authenticated Gynostemma pentaphyllum tea or placebo tea , 6 g daily , during twelve weeks and received information regarding diet and exercise . Fasting plasma glucose , insulin levels , and glycosylated hemoglobin ( HbA(1C ) ) were measured before , during , and after the treatment . Oral glucose tolerance tests were performed every four weeks . After 12-week treatment , fasting plasma glucose levels totally decreased to an extent of 3.0+/-1.8 mmol/l in the Gynostemma pentaphyllum tea group as compared to a decrease of 0.6+/-2.2 mmol/l in the control group ( p HbA(1C ) levels after 12 weeks decreased approximately 2 % units in the Gynostemma pentaphyllum group compared to 0.2 % unit in the controls ( p in Homeostasis Model Assessment -Insulin Resistance between baseline and twelfth week indicated that insulin resistance decreased significantly in the Gynostemma pentaphyllum group ( -2.1+/-3.0 ) compared with that ( + 1.1+/-3.3 ) in the control group ( p hypoglycemias , or adverse effects regarding kidney and liver parameters or gastrointestinal function . In addition , lipid profiles , glucagon , cortisol levels , body measurements , and blood pressure were not different between the groups . This study shows a prompt improvement of glycemia and insulin sensitivity , and thereby provides a basis for a novel , effective , and safe approach , using Gynostemma pentaphyllum tea , to treat type 2 diabetic patients",
"Recent evidence suggests that tea from Camellia sinensis ( eg , green , oolong , and black tea ) may have a hypoglycemic effect . We evaluated the ability of an extract of green and black tea to improve glucose control over a 3-month period . A double-blind , placebo-controlled , r and omized multiple-dose ( 0 , 375 , or 750 mg per day for 3 months ) study in adults with type 2 diabetes mellitus not taking insulin was performed . The primary end point was change in glycosylated hemoglobin at 3 months . The 49 subjects who completed this study were predominantly white with an average age of 65 years and a median duration of diabetes of 6 years , and 80 % of them reported using hypoglycemic medication . After 3 months , the mean changes in glycosylated hemoglobin were + 0.4 ( 95 % confidence interval , 0.2 - 0.6 ) , + 0.3 ( 0.1 - 0.5 ) , and + 0.5 ( 0.1 - 0.9 ) in the placebo , 375-mg , and 750-mg arms , respectively . The changes were not significantly different between study arms . We did not find a hypoglycemic effect of extract of green and black tea in adults with type 2 diabetes mellitus",
"BACKGROUND Green tea is believed to have beneficial effects in the prevention and treatment of acne . OBJECTIVE To examine the effects of a decaffeinated green tea extract ( GTE ) , providing a daily dose of 856 mg of epigallocatechin gallate ( EGCG ) upon women with post-adolescent acne . METHODS A r and omized , double-blind , placebo-controlled clinical trial was conducted from May 2012 through October 2013 . A final group of 80 subjects were r and omly assigned to receive either 1500 mg of decaffeinated GTE or placebo ( cellulose ) daily for 4 weeks . Inflammatory lesion counts were used as the major outcome measurement . At baseline and after 4 weeks of treatment , anthropometric measurements , fasting glucose levels and a lipid profile were measured from both groups . RESULTS Sixty-four of 80 women , from 25 to 45 years of age with moderate-to-severe acne completed the study . Statistically significant differences were noted in inflammatory lesion counts distributed on the nose , periorally and on the chin between the two groups . However , there were no significant differences between groups for total lesion counts . Within-group comparison revealed that the GTE group had significant reductions in inflammatory lesions distributed on the forehead and cheek , and significant reductions in total lesion counts . GTE result ed in significant reductions in total cholesterol levels within the GTE group . CONCLUSIONS GTE result ed in significant reductions in lesions located on the nose , perioral area and chin . More research is required to determine whether a decaffeinated GTE st and ardized for EGCG content will provide clinical benefits in women with post-adolescent acne",
"Background Green tea was suggested as a therapeutic agent for the treatment of diabetes more than 70 years ago , but the mechanisms behind its antidiabetic effect remains elusive . In this work , we address this issue by feeding a green tea extract ( TEAVIGO ™ ) with a high content of epigallocatechin gallate ( EGCG ) or the thiazolidinedione PPAR-γ agonist rosiglitazone , as positive control , to db/db mice , an animal model for diabetes . Methods Young ( 7 week-old ) db/db mice were r and omized and assigned to receive diets supplemented with or without EGCG or rosiglitazone for 10 weeks . Fasting blood glucose , body weight and food intake was measured along the treatment . Glucose and insulin levels were determined during an oral glucose tolerance test after 10 weeks of treatment . Pancreata were sample d at the end of the study for blinded histomorphometric analysis . Islets were isolated and their mRNA expression analyzed by quantitative RT-PCR . Results The results show that , in db/db mice , EGCG improves glucose tolerance and increases glucose-stimulated insulin secretion . EGCG supplementation reduces the number of pathologically changed islets of Langerhans , increases the number and the size of islets , and heightens pancreatic endocrine area . These effects occurred in parallel with a reduction in islet endoplasmic reticulum stress markers , possibly linked to the antioxidative capacity of EGCG . Conclusions This study shows that the green tea extract EGCG markedly preserves islet structure and enhances glucose tolerance in genetically diabetic mice . Dietary supplementation with EGCG could potentially contribute to nutritional strategies for the prevention and treatment of type 2 diabetes ",
"Background / Objectives : Flavanols may provide protection against insulin resistance , but little is known about the amounts and types of flavanols that may be efficacious . Subjects/ Methods : This study was design ed to determine whether cocoa flavanols , over a range of intakes , improve biomarkers of glucose regulation , inflammation and hemostasis in obese adults at risk for insulin resistance . As an adjunct , green tea and cocoa flavanols were compared for their ability to modulate these biomarkers . In a r and omized crossover design , 20 adults consumed a controlled diet for 5 days along with four cocoa beverages containing 30–900 mg flavanol per day , or tea matched to a cocoa beverage for monomeric flavanol content . Results : Cocoa beverages produced no significant changes in glucose , insulin , total area under the concentration – time curve ( AUC ) for glucose or total insulin AUC . As the dose of cocoa flavanols increased , total 8-isoprostane concentrations were lowered ( linear contrast , P=0.02 ) , as were C-reactive protein ( CRP ) concentrations ( linear contrast , P=0.01 ) . The relationship between cocoa flavanol levels and interleukin-6 ( IL-6 ) concentrations was quadratic , suggesting that a maximum effective dose was achieved ( quadratic contrast , P=0.01 ) . There were no significant effects on measured indices of glucose regulation , nor on those of total 8-isoprostane , CRP and IL-6 concentrations , when cocoa and green tea were compared . However , relative to cocoa , green tea lowered fibrinogen concentrations ( P=0.0003 ) . Conclusions : Short-term intake of cocoa and green tea flavanols does not appear to improve glucose metabolism ; they do affect selected markers of one or more measures of oxidative stress , inflammation or hemostasis in obese adults at risk for insulin resistance",
"Interest in finding natural antioxidants for use in food or medical material s to prevent free radical imbalance has increased considerably over the past years . The aim of this research was to evaluate changes in glycemic control and psychological state of patients with type 2 diabetes mellitus ( T2DM ) after use of antioxidant plant preparations . Fifty-six patients with T2DM were r and omly allocated to receive st and ardized Ginkgo biloba L. leaves dry extract , green tea dry extract , or placebo capsules . Diabetes glycemic control measured as glycated hemoglobin ( HbA1c ) level , antioxidant state and psychological data were evaluated at baseline , after 9 and 18 months of using either antioxidant preparations or placebo . The level of perceived stress lowered significantly after 9 months ( p=0.038 ) and 18 months ( p=0.030 ) , and the psychological aspect of quality of life significantly improved after 18 months ( p=0.019 ) of use of G. biloba extract . No significant differences were detected after using green tea extract . In patients using placebo , significant lowering of HbA1c level was observed after 18 months ( p=0.017 ) . In conclusion , antioxidant G. biloba leaf extract exhibited a mild effect on psychological state and a trend of improving glycemic control in patients with type 2 diabetes mellitus",
"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",
"The receptor for advanced glycation of end products ( RAGE ) plays a critical role in the progression of type 2 diabetes ( T2D ) . Soluble RAGE ( sRAGE ) is one of the RAGE variants , which acts as a decoy domain receptor and competes with RAGE , thus contributing to prevention of T2D . In this study , we conducted clinical trials of (-)-epigallocatechin-3-gallate ( EGCG ) rich green tea extract ( 300 - 900 mg/day ) to investigate the effect of EGCG on relationship between S100A12 RAGE lig and and diverse sRAGE in T2D . Moreover , mechanism of sRAGE production also confirmed in vitro . Our data indicated that EGCG could stimulate sRAGE circulation but inhibited RAGE lig and in T2D , and ADAM10-mediated ectodomain shedding of extracellular RAGE was mainly involved in EGCG-stimulated sRAGE circulation . The present evidence indicates that EGCG has a potential to block S100A12-RAGE axis by stimulating sRAGE production through ADAM10-mediated ectodomain shedding of extracellular RAGE . Therefore , EGCG contributes to nutritional strategies for diabetes , not only because of its efficient antioxidant activity to scavenge free radicals , but also because of its ability stimulating sRAGE release in the circulation . Additionally , ADAM10-induced ectodomain shedding of extracellular RAGE leading to sRAGE circulation should be a potential of passive mechanism of sRAGE production to block S100A12-RAGE axis-related pathogenesis of proinflammation and diabetes",
"The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials"
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Background Fibromyalgia ( FM ) is a chronic , debilitating pain disorder . Dissatisfaction with conventional medicine can lead people with FM to turn to complementary and alternative medicine ( CAM ) . Two previous overviews of systematic review s of CAM for FM have been published , but they did not assessed for risk of bias in the review process . Methods Five data bases Medline , Embase , AMED ( via OVID ) , Web of Science and Central were search ed from their inception to December 2015 . Reference lists were h and - search ed . We had two aims : the first was to provide an up-to- date and rigorously conducted synthesis of systematic review s of CAM literature on FM ; the second was to evaluate the quality of the available systematic review evidence using two different tools : AMSTAR ( Shea et al. BMC Med Res Method ol 15 ; 7:10 , 2007 ) and a more recently developed tool ROBIS ( Whiting et al. J Clin Epidemiol 69:225 - 34 , 2016 ) specifically design ed to assess risk of bias in systematic review s. Any review that assessed one of eight CAM therapies for participants diagnosed with FM was considered . The individual studies had to be r and omised controlled trials where the intervention was compared to placebo , treatment as usual or waitlist controls to be included . The primary outcome measure was pain , and the secondary outcome measure was adverse events . Results We identified 15 review s that met inclusion criteria . There was low- quality evidence that acupuncture improves pain compared to no treatment or st and ard treatment , but good evidence that it is no better than sham acupuncture . The evidence for homoeopathy , spinal manipulation and herbal medicine was limited . Conclusions Overall , five review s scored 6 or above using the AMSTAR scale and the inter-rater agreement was good ( 83.6 % ) , whereas seven review s achieved a low risk of bias rating using ROBIS and the inter-rater agreement was fair ( 60.0 % ) . No firm conclusions were drawn for efficacy of either spinal manipulation or homoeopathy for FM . There is limited evidence for topical Capsicum , but further research is required . There is some evidence to support the effectiveness of acupuncture for FM , but further high- quality trials are needed to investigate its benefits , harms and mechanisms of action , compared with no or st and ard treatment . Systematic review registration PROSPERO CRD42016035846
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"OBJECTIVE To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia . METHODS This study was a double-blind , r and omized , parallel-group , placebo-controlled trial of homeopathy . Community-recruited persons ( N = 62 ) with physician-confirmed fibromyalgia ( mean age 49 yr , s.d . 10 yr , 94 % women ) were treated in a homeopathic private practice setting . Participants were r and omized to receive oral daily liquid LM ( 1/50,000 ) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo . Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths , at baseline , 2 months and 4 months ( prior to a subsequent optional crossover phase of the study which is reported elsewhere ) . Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care , self-rating scales on fibromyalgia-related quality of life , pain , mood and global health at baseline and 3 months , were the primary clinical outcome measures for this report . RESULTS Fifty-three people completed the treatment protocol . Participants on active treatment showed significantly greater improvements in tender point count and tender point pain , quality of life , global health and a trend toward less depression compared with those on placebo . CONCLUSIONS This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy . Using a broad selection of remedies and the flexible LM dose ( 1/50,000 dilution factor ) series , the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia",
"OBJECTIVES To assess the feasibility of a R and omised Controlled Trial ( RCT ) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome ( FMS ) . METHODS In a pragmatic parallel group RCT design , adults with a diagnosis of FMS ( ACR criteria ) were r and omly allocated to usual care or usual care plus adjunctive care by a homeopath . Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines . The primary outcome measure was the difference in Fibromyalgia Impact Question naire ( FIQ ) total score at 22 weeks . RESULTS 47 patients were recruited . Drop out rate in the usual care group was higher than the homeopath care group ( 8/24 vs 3/23 ) . Adjusted for baseline , there was a significantly greater mean reduction in the FIQ total score ( function ) in the homeopath care group than the usual care group ( -7.62 vs 3.63 ) . There were significantly greater reductions in the homeopath care group in the McGill pain score , FIQ fatigue and tiredness upon waking scores . We found a small effect on pain score ( 0.21 , 95 % CI -1.42 to 1.84 ) ; but a large effect on function ( 0.81 , 95 % CI -8.17 to 9.79 ) . There were no reported adverse events . CONCLUSIONS Given the acceptability of the treatment and the clinical ly relevant effect on function , there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS",
"Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the",
"OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review",
"BACKGROUND : Sleep disorders affect many patients with chronic pain conditions . Cannabis has been reported by several patient population s to help sleep . We evaluated the safety and efficacy of nabilone , a synthetic cannabinoid , on sleep disturbance in fibromyalgia ( FM ) , a disease characterized by widespread chronic pain and insomnia . METHODS : We conducted a r and omized , double-blind , active-control , equivalency crossover trial to compare nabilone ( 0.5–1.0 mg before bedtime ) to amitriptyline ( 10–20 mg before bedtime ) in patients with FM with chronic insomnia . Subjects received each drug for 2 wk with a 2-wk washout period . The primary outcome was sleep quality , measured by the Insomnia Severity Index and the Leeds Sleep Evaluation Question naire . Secondary outcomes included pain , mood , quality of life , and adverse events ( AEs ) . RESULTS : Thirty-one subjects were enrolled and 29 completed the trial ( 26 women , mean age 49.5 yr ) . Although sleep was improved by both amitriptyline and nabilone , nabilone was superior to amitriptyline ( Insomnia Severity Index difference = 3.2 ; 95 % confidence interval = 1.2–5.3 ) . Nabilone was marginally better on the restfulness ( Leeds Sleep Evaluation Question naire difference = 0.5 [ 0.0–1.0 ] ) but not on wakefulness ( difference = 0.3 [ −0.2 to 0.8 ] ) . No effects on pain , mood , or quality of life were observed . AEs were mostly mild to moderate and were more frequent with nabilone . The most common AEs for nabilone were dizziness , nausea , and dry mouth . CONCLUSIONS : Nabilone is effective in improving sleep in patients with FM and is well tolerated . Low-dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline . Longer trials are needed to determine the duration of effect and to characterize long-term safety",
"To assess the effects of medicinal plants ( MPs ) or related natural products ( RNPs ) on fibromyalgia ( FM ) patients , we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight r and omized placebo-controlled trials ( RCTs ) involving 475 patients . The method ological quality of all studies included was determined according to JADAD and “ Risk of Bias ” with the criteria in the Cochrane H and book for Systematic Review s of Interventions 5.1.0 . Evidence suggests significant benefits of MP or RNP in sleep disruption , pain , depression , joint stiffness , anxiety , physical function , and quality of life . Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo ; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP , thus suggesting effective alternative therapies in the treatment of pain with minimized side effects",
"OBJECTIVE To test the hypothesis that acupuncture improves symptoms of fibromyalgia . PATIENTS AND METHODS We conducted a prospect i ve , partially blinded , controlled , r and omized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture . All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture . We measured symptoms with the Fibromyalgia Impact Question naire ( FIQ ) and the Multidimensional Pain Inventory at baseline , immediately after treatment , and at 1 month and 7 months after treatment . The trial was conducted from May 28 , 2002 , to August 18 , 2003 . RESULTS Fifty patients participated in the study : 25 in the acupuncture group and 25 in the control group . Total fibromyalgia symptoms , as measured by the FIQ , were significantly improved in the acupuncture group compared with the control group during the study period ( P = .01 ) . The largest difference in mean FIQ total scores was observed at 1 month ( 42.2 vs 34.8 in the control and acupuncture groups , respectively ; P = .007 ) . Fatigue and anxiety were the most significantly improved symptoms during the follow-up period . However , activity and physical function levels did not change . Acupuncture was well tolerated , with minimal adverse effects . CONCLUSION This study paradigm allows for controlled and blinded clinical trials of acupuncture . We found that acupuncture significantly improved symptoms of fibromyalgia . Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety",
"OBJECTIVE --To determine the efficacy of electroacupuncture in patients with fibromyalgia , a syndrome of unknown origin causing diffuse musculoskeletal pain . DESIGN --Three weeks ' r and omised study with blinded patients and evaluating physician . SETTING --University divisions of physical medicine and rehabilitation and rheumatology , Geneva . PATIENTS --70 patients ( 54 women ) referred to the division for fibromyalgia as defined by the American College of Rheumatology . INTERVENTIONS -- Patients were r and omised to electroacupuncture ( n = 36 ) or a sham procedure ( n = 34 ) by means of an electronic numbers generator . MAIN OUTCOME MEASURES --Pain threshold , number of analgesic tablets used , regional pain score , pain recorded on visual analogue scale , sleep quality , morning stiffness , and patient 's and evaluating physician 's appreciation . RESULTS --Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group . Differences between the groups were significant for five of the eight outcome measures after treatment . CONCLUSIONS --Electroacupuncture is effective in relieving symptoms of fibromyalgia . Its potential in long term management should now be studied",
"Background Acupuncture is often used to treat fibromyalgia ( FM ) , but it remains unclear whether acupuncture is effective . This study aims to evaluate the effects of acupuncture on pain and quality of life ( QoL ) in FM patients . Methods Sixteen patients ( 13 women and 3 men aged 25 - 63 years ) suffering from FM were r and omised into two groups : group A ( n = 8) received five acupuncture treatments after the fifth week and group B received ten acupuncture treatments . Outcome measures used in this study were pain intensity ( visual analogue scale , VAS ) and the fibromyalgia impact question naire ( FIQ ) . Results After the fifth week , pain intensity ( U = 25.0 ; P = 0.022 ) in group B decreased and QoL ( U = 24.5 ; P = 0.026 ) improved compared to group A. Conclusion The present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ",
"The purpose of this study was to evaluate the short-term efficacy of topical capsaicin treatment in patients severely affected by fibromyalgia . One hundred and thirty fibromyalgia patients were r and omly divided into two groups . The control group , 56 women and 4 men who continued their medical treatment , and the capsaicin group , 70 women who apart from continuing their medical treatment , also underwent topical capsaicin 0.075 % 3 times daily for 6 weeks . At the beginning of the program , there were no significant differences between the two groups in any of the analyzed parameters . At the end of the treatment , there were significant improvements in the capsaicin group in the myalgic score ( 5.21 vs 3.8 , p = 0.02 ) and global subjective improvement ( 22.8 vs 5 % , p = 0.001 ) . Six weeks after the end of the treatment , the experimental group showed significant differences in Visual Analogue Scale of depression ( 5.63 vs 7.35 , p = 0.02 ) , Fibromyalgia Impact Question naire ( 67.89 vs 77.7 , p = 0.02 ) , role limitations due to emotional problems ( 36.17 vs 17.2 , p = 0.05 ) , Fatigue Severity Scale ( 6.2 vs 6.6 , p = 0.04 ) , myalgic score ( 3.94 vs 2.66 , p = 0.02 ) and pressure pain threshold ( 79.25 vs 56.71 , p = 0.004 ) . In conclusion , patients severely affected by fibromyalgia can obtain short-term improvements following topical capsaicin 0.075 % treatment three times daily for 6 weeks",
"Controversy remains regarding the mechanisms of acupuncture analgesia . A prevailing theory , largely unproven in humans , is that it involves the activation of endogenous opioid antinociceptive systems and mu-opioid receptors ( MORs ) . This is also a neurotransmitter system that mediates the effects of placebo-induced analgesia . This overlap in potential mechanisms may explain the lack of differentiation between traditional acupuncture and either non-traditional or sham acupuncture in multiple controlled clinical trials . We compared both short- and long-term effects of traditional Chinese acupuncture ( TA ) versus sham acupuncture ( SA ) treatment on in vivo MOR binding availability in chronic pain patients diagnosed with fibromyalgia ( FM ) . Patients were r and omized to receive either TA or SA treatment over the course of 4 weeks . Positron emission tomography ( PET ) with (11)C-carfentanil was performed once during the first treatment session and then repeated a month later following the eighth treatment . Acupuncture therapy evoked short-term increases in MOR binding potential , in multiple pain and sensory processing regions including the cingulate ( dorsal and subgenual ) , insula , cau date , thalamus , and amygdala . Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate ( dorsal and perigenual ) , cau date , and amygdala . These short- and long-term effects were absent in the sham group where small reductions were observed , an effect more consistent with previous placebo PET studies . Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain . These findings suggest that divergent MOR processes may mediate clinical ly relevant analgesic effects for acupuncture and sham acupuncture",
"Background To evaluate the effectiveness of acupuncture and compare it with fluoxetine in treatment of fibromyalgia syndrome ( FMS ) . Methods We conducted a prospect i ve , r and omized clinical trial . Fifteen patients were treated with acupuncture and compared with a control group ( n=15 ) of patients who received fluoxetine . Visual analogue scale , Fibromyalgia Impact Question naire ( FIQ ) and determined number of tender points were used as outcome measurements . Results After four weeks , the acupuncture group was significantly better than the control group in the number of tender points . Total fibromyalgia symptoms were significantly improved in the acupuncture group compared with the control group during the study period ( P= 0.01 ) . The largest difference in mean FIQ total scores was observed at 4 weeks ( 42.2 VS . 34.8 in the control and acupuncture groups , respectively ; P= 0.007 ) . At the end of one year of the follow up , patients who received acupuncture were significantly better than the control group in all measures . Fatigue and anxiety were the most significantly improved symptoms during the follow up period . Discussion Acupuncture significantly improved pain and symptoms of fibromyalgia . Also , we found that acupuncture did not have any side effect and was tolerable ",
"OBJECTIVE To evaluate the effectiveness of acupuncture for fibromyalgia . METHODS Fifty-eight women with fibromyalgia were allocated r and omly to receive either acupuncture together with tricyclic antidepressants and exercise ( n=34 ) , or tricyclic antidepressants and exercise only ( n=24 ) . Patients rated their pain on a visual analogue scale . A blinded assessor evaluated both the mean pressure pain threshold value over all 18 fibromyalgia points and quality of life using SF-36 . RESULTS At the end of 20 sessions , patients who received acupuncture were significantly better than the control group in all measures of pain and in 5 of the SF-36 subscales . After 6 months , the acupuncture group was significantly better than the control group in numbers of tender points , mean pressure pain threshold at the 18 tender points and 3 subscales of SF-36 . After one year , the acupuncture group showed significance in one subscale of the SF-36 ; at 2 years there were no significant differences in any outcome measures . CONCLUSION Addition of acupuncture to usual treatments for fibromyalgia may be beneficial for pain and quality of life for 3 months after the end of treatment . Future research is needed to evaluate the specific effects of acupuncture for fibromyalgia",
"mens . Several treatments were required for each tumour , and injecting alcohol was often associated with considerable pain , whereas our patients did not report pain . These reports did not mention changes seen on ultrasound scans during or immediately after injection , which we found useful in laser treatment . The most important advantage of the laser is its precision . It is unlikely that it will ever be possible to predict the extent of necrosis around a site at which absolute alcohol has been injected with an accuracy comparable to that already possible with the laser technique . In conclusion , interstitial laser hyperthermia is feasible and seems to be safe . A multiple fibre system makes it feasible to treat tumours of clinical ly relevant size in the centre of solid organs . The real challenge for the future will be to develop diagnostic techniques that disclose exactly how far individual tumours extend in a wider range of organs ( unlike the well defined tumours treated in this pilot study ) and to establish the conditions of laser treatment that give complete tumour ablation with safe healing . This combination of technologies may be valuable for treating otherwise untreatable tumours in a range of solid organs and for the primary treatment of small neoplasms such as tumours of the prostate and adrenal gl and",
"An open , uncontrolled study was undertaken to measure the subjective effects of coenzyme Q10 combined with a Ginkgo biloba extract in volunteer subjects with clinical ly diagnosed fibromyalgia syndrome . Anecdotal reports from patients with fibromyalgia syndrome have cl aim ed benefits from the use of these supplements . The aim of this study was to determine if these reports could be substantiated in a pilot clinical trial . Patient question ing had determined that poor quality of life was a major factor in the condition and a quality -of-life question naire was used to measure potential benefit . Subjects were given oral doses of 200 mg coenzyme Q10 and 200 mg Ginkgo biloba extract daily for 84 days . Quality of life was measured , using the well-vali date d Dartmouth Primary Care Cooperative Information Project/World Organization of Family Doctors ( COOP/WONCA ) question naire that measures seven different subjective responses , at 0- , 4- , 8- and 12-week intervals . The subjects were asked for an overall self-rating at the end of the study . A progressive improvement in the quality -of-life scores was observed over the study period and at the end , the scores showed a significant difference from those at the start . This was matched by an improvement in self-rating with 64 % cl aim ing to be better and only 9 % cl aim ing to feel worse . Adverse effects were minor . A controlled study is now planned",
"OBJECTIVE The objective of this study was to evaluate resistance training ( RES ) and RES combined with chiropractic treatment ( RES-C ) on fibromyalgia ( FM ) impact and functionality in women with FM . DESIGN The design of the study was a r and omized control trial . SETTING Testing and training were completed at the university and chiropractic treatment was completed at chiropractic clinics . PARTICIPANTS Participants ( 48 + /- 9 years ; mean + /- st and ard deviation ) were r and omly assigned to RES ( n = 10 ) or RES-C ( n = 11 ) . INTERVENTION Both groups completed 16 weeks of RES consisting of 10 exercises performed two times per week . RES-C received RES plus chiropractic treatment two times per week . OUTCOME MEASURES Strength was assessed using one repetition maximum for the chest press and leg extension . FM impact was measured using the FM impact question naire , myalgic score , and the number of active tender points . Functionality was assessed using the 10-item Continuous Scale Physical Functional Performance test . Analyses of variance with repeated measures compared groups before and after the intervention . RESULTS Six ( 6 ) participants discontinued the study : 5 from RES and 1 from RES-C. Adherence to training was significantly higher in RES-C ( 92.0 + /- 7.5 % ) than in RES ( 82.8 + /- 7.5 % ) . Both groups increased ( p upper and lower body strength . There were similar improvements in FM impact in both groups . There were no group interactions for the functionality measures . Both groups improved in the strength domains ; however , only RES-C significantly improved in the pre- to postfunctional domains of flexibility , balance and coordination , and endurance . CONCLUSIONS In women with FM , resistance training improves strength , FM impact , and strength domains of functionality . The addition of chiropractic treatment improved adherence and dropout rates to the resistance training and facilitated greater improvements in the domains of functionality",
"OBJECTIVE To demonstrate the effectiveness of chiropractic management for fibromyalgia patients using reported pain levels , cervical and lumbar ranges of motion , strength , flexibility , tender points , myalgic score and perceived functional ability as outcome measures . DESIGN A. Preliminary r and omized control crossover trial . B. Before and after design . PATIENTS Twenty-one rheumatology patients ( 25 - 70 yr ) . CHIROPRACTIC INTERVENTIONS : Treatment consisted of 4 wk of spinal manipulation , soft tissue therapy and passive stretching at the chiropractors ' discretion . CONTROL INTERVENTION : Chiropractic management withheld for 4 wk with continuation of prescribed medication . MAIN OUTCOME MEASURES Changes in scores on the Oswestry Pain Disability Index , Neck Disability Index , Visual Analogue Scale , straight leg raise and lumbar and cervical ranges of motion were observed . RESULTS Chiropractic management improved patients ' cervical and lumbar ranges of motion , straight leg raise and reported pain levels . These changes were judged to be clinical ly important within the confines of our sample only . CONCLUSIONS Further study with a sample size of 81 ( for 80 % power at alpha < or = .05 ) is recommended to determine if these findings are generalizable to the target population of fibromyalgia suffers",
"OBJECTIVES We determined -- in women with fibromyalgia (FM)--effects of essential oils used with a 12-week exercise program on exercise volume , pain , physical performance , and physical function . DESIGN This was a r and omized clinical trial comparing 024 essential oil with sham oil combined with exercise . SETTING S SETTING S included community sites in southern California . SUBJECTS The study included 20 women r and omized to 024 oil , 23 to sham oil . INTERVENTIONS Women were trained in oil application before exercise , at bedtime on exercise days ; the 12-week program included weekly group sessions with trained leaders guided by a prerecorded regimen ( allowing choice of program level ) plus 2 days of home exercise with the recorded regimen . OUTCOME MEASURES Primary : Exercise volume ( number of days exercised multiplied by exercise level -- intensity and duration ) . Secondary : Pain ( Brief Pain Inventory ) , measures of physical performance ( 30-second chair st and s , 6-minute walk , multidimensional balance ) , and self-reported physical function ( Composite Physical Function scale ) . RESULTS The average participant was 54 years old , had some college education , was married , Caucasian , and minimally/mildly depressed . There was no significant difference in exercise volume between women using 024 as compared with those using sham oil after 12 weeks ( depression as covariate ) . There were no significant group nor pre- to postexercise changes in pain intensity or interference . There were greater positive changes in 30-second chair st and s , 6-minute walk distance , and multidimensional balance scores in the 024 group than in the sham group , but these were not significant . The counterirritant 024 oil was not different from the sham oil in its effect on exercise volume ( frequency , exercise level -- intensity and duration ) for women with FM . It is unknown whether 024 actually decreases local pain when used with exercise . CONCLUSIONS Increases in physical function found , while not significant , may be attributable to the exercise regimen or to the interaction of the oils and exercise regimen",
"Context A substantial number of patients use acupuncture to treat the symptoms of fibromyalgia , but previous r and omized trials of this intervention are inconclusive , in part because of control groups that did not permit adequate blinding of the patients . Contribution This study r and omly assigned 100 patients with fibromyalgia to 12 weeks of either true acupuncture treatment or one of 3 types of sham acupuncture . No differences in pain were identified between acupuncture and sham acupuncture . Caution s The study had too few patients to detect small differences between the groups . Patients could use other fibromyalgia therapies , so this study evaluates acupuncture as adjunctive treatment . The Editors Fibromyalgia is a condition of unknown cause that is characterized by chronic , diffuse pain and tenderness to palpation at specific musculoskeletal sites ( 1 ) . It is the second most common rheumatologic condition after osteoarthritis , afflicting 2 % to 4 % of the U.S. population ( 2 ) . Most r and omized , controlled trials of allopathic interventions have not demonstrated sustained benefit , and use of complementary and alternative medicine for fibromyalgia is common ( 3 ) . For example , 60 % to 90 % of patients with fibromyalgia report using 1 or more complementary or alternative treatments ( 4 , 5 ) , and 22 % of these patients have tried acupuncture ( 6 ) . Despite skepticism in western cultures , the literature suggests that acupuncture may alleviate chronic pain ( 7 ) . R and omized , controlled trials of acupuncture face many method ologic challenges , including the identification of appropriate treatment and control groups , blinding of study participants , and the inability to blind practitioners ( 8) . Needle placement and the extent to which needle insertion and stimulation is necessary are also controversial ( 7 - 9 ) . In the only rigorous r and omized , controlled trial of acupuncture for fibromyalgia , 7 of 8 outcome measures significantly improved after 3 weeks of treatment with electroacupuncture ( 10 ) . However , because blinding was not assessed and electroacupuncture involves perceptible current , these promising results could reflect a lack of blinding to treatment condition . Moreover , the study followed patients only during treatment . Because fibromyalgia is a chronic condition , longer-term outcomes should be examined . To address these method ologic problems , we performed a r and omized , controlled trial of acupuncture to treat fibromyalgia that included 3 sham acupuncture treatments to account for the effects of needle insertion and placement . The adequacy of participant blinding was carefully evaluated . We sought to determine whether directed acupuncture that is design ed to treat fibromyalgia relieves pain better than does sham acupuncture in adults with fibromyalgia . On the basis of the scant literature and our clinical experience , we hypothesized a priori that directed acupuncture would result in the greatest clinical improvement . Methods Participants Participants were recruited from the greater Seattle , Washington , metropolitan area between January 2001 and September 2002 . Recruitment strategies included dissemination of information on the study through newspapers , television , advertisements , signs posted at university-affiliated hospitals , and letters to local fibromyalgia support groups and health care providers with large caseloads of patients with fibromyalgia . Potential participants were told that they had an equal chance of being assigned to 1 of 4 acupuncture interventions , none of which have been proven but 1 of which was believed to have the most potential to improve the symptoms of fibromyalgia . The institutional review boards at the participating institutions approved the study , and participants provided written informed consent . Eligible participants were English-speaking adults 18 years of age or older in whom fibromyalgia was diagnosed by a physician and who had a prer and omization global pain score of 4 or greater on a visual analogue scale ( 0 = no pain , 10 = worst pain ever ) . Participants agreed to undergo r and omization and kept use of any fibromyalgia-related pharmacologic and nonpharmacologic therapies constant throughout the study . At the baseline evaluation before r and omization , a research coordinator trained in tender-point examination confirmed the diagnosis of fibromyalgia by using the 1990 criteria of the American College of Rheumatology ( 1 ) . Participants were excluded if they reported other pain-related medical conditions or potential contraindications to acupuncture treatment ( such as bleeding disorders or severe needle phobia ) , were pregnant or breastfeeding , used narcotics ( which could blunt the effects of acupuncture ) , were involved in litigation related to fibromyalgia ( which might reduce their incentive for improvement ) , or had previously received acupuncture ( to maximize blinding ) . R and omization Procedure A research coordinator screened and enrolled participants at an academic research center . After participants completed a baseline evaluation , another research coordinator who was uninvolved with data collection r and omly assigned them to 1 of 4 treatment groups by using a computer-generated , blocked r and om-allocation sequence with a block size of 4 . This research coordinator informed the acupuncture clinic of the treatment assignment . Intervention Eight U.S.-trained and licensed acupuncturists with a median of 10 years of experience ( range , 4 to 18 years ) provided study treatments in their private offices . One investigator trained the acupuncturists in the study procedures to increase their comfort with delivering all 4 treatments and monitored compliance with the protocol throughout the study . Participants were assigned an acupuncturist according to geographic convenience and schedule availability , and every effort was made to have them treated by the same acupuncturist for the entire 12 weeks . The primary acupuncturist was defined as the practitioner from whom a participant received the most treatments . In all groups , participants were asked to attend treatment sessions twice weekly for 12 weeks ( 24 treatments ) . We considered participants who attended 80 % or more ( 19 of 24 ) of acupuncture appointments to have completed a full course of treatment . Outcome measures were collected at regularly scheduled time points from participants who discontinued treatment . Participants received directed acupuncture design ed to treat fibromyalgia according to the practice of Traditional Chinese Medicine or 1 of 3 sham acupuncture treatments . One sham intervention , a control for acupoint specificity , involved acupuncture typically used to treat irregular menses or early menses due to Blood Heat ( an unrelated condition ) according to Traditional Chinese Medicine . Another sham intervention , which was also a control for acupoint specificity , used body locations not recognized as true acupoints or meridians for needling ( sham needling ) . The third sham treatment , a control for needle insertion , consisted of noninsertive simulated acupuncture at the same acupoints used in directed acupuncture ( simulated acupuncture ) . This technique , in which a toothpick in a needle guide-tube is used to mimic needle insertion and withdrawal , has been shown to be indistinguishable from true acupuncture in acupuncture-nave patients with back pain ( 9 ) . Simulated acupuncture more closely duplicates the needle insertion experience than do techniques using placebo needles that require placing adhesive or plastic foam on the skin ( 11 , 12 ) . Acupoints and sham points ( Appendix Figure ) were chosen by a study acupuncturist with 15 years of experience in treating fibromyalgia and were approved by 3 other senior acupuncturists . In all groups that underwent needle insertion , needles were retained at st and ard depths ( 13 ) for 30 minutes at each acupoint . Disposable Chinese , Japanese , or Korean needles ( 34 to 40 gauge ) were used , depending on the practitioner 's preference . In the simulated acupuncture group , participants remained on the table for 30 minutes after simulated insertion and then underwent simulated needle withdrawal . Efforts were made to imitate the sounds of opening needle packs and needle disposal . Acupuncturists were not blinded to the treatments they delivered . To maximize participant blinding , we included only acupuncture-nave persons who could not compare their treatment with previous experiences with acupuncture , limited contact among study participants , restricted conversation between acupuncturists and participants , and blindfolded participants during treatment . All research personnel who collected or analyzed data were unaware of treatment group . At the end of 12 weeks , we collected data to assess the adequacy of blinding . Outcome Measures Demographic measures collected at the baseline evaluation included age , sex , race , education , marital status , and duration of pain and diagnosis of fibromyalgia . Participants also listed the types of therapies they had previously tried for their pain . We grouped this information into manual therapies ( physical , ergonometric , chiropractic , or massage therapy ) , mental health therapies ( psychotherapy or cognitive behavioral therapy ) , dietary changes , or other therapies ( nerve blocks , hypnosis , or biofeedback ) . Outcome measures were collected at baseline ; after 1 , 4 , 8 , and 12 weeks of acupuncture treatment ; and 3 and 6 months after completion of treatment ( weeks 24 and 36 ) . The primary outcome was subjective pain , as measured by a st and ard 10-cm visual analogue scale ( 0 = no pain , 10 = worst pain ever ) . Other outcomes measured by using a visual analogue scale were intensity of fatigue ( 0 = none , 10 = worst ever ) , sleep quality ( 0 = worst ever , 10 = best ever ) , and overall well-being ( 0 = worst ever , 10 = best ever ) . We assessed physical and mental functioning by using the Medical Outcomes Study 36-item Short-Form Health Survey ( 14 ) , which has high reliability and validity in many patient groups , including",
"OBJECTIVES The objective of this study was to investigate whether typical acupuncture methods such as needle placement , needle stimulation , and treatment frequency were important factors in fibromyalgia symptom improvement . DESIGN / SETTING S/SUBJECTS : A single-site , single-blind , r and omized trial of 114 participants diagnosed with fibromyalgia for at least 1 year was performed . INTERVENTION Participants were r and omized to one of four treatment groups : ( 1 ) T/S needles placed in traditional sites with manual needle stimulation ( n = 29 ) : ( 2 ) T/0 traditional needle location without stimulation ( n = 30 ) ; ( 3 ) N/S needles inserted in nontraditional locations that were not thought to be acupuncture sites , with stimulation ( n = 28 ) ; and ( 4 ) N/0 nontraditional needle location without stimulation ( n = 2 7 ) . All groups received treatment once weekly , followed by twice weekly , and finally three times weekly , for a total of 18 treatments . Each increase in frequency was separated by a 2-week washout period . OUTCOME MEASURES Pain was assessed by a numerical rating scale , fatigue by the Multi-dimensional Fatigue Inventory , and physical function by the Short Form-36 . RESULTS Overall pain improvement was noted with 25%-35 % of subjects having a clinical ly significant decrease in pain ; however this was not dependent upon \" correct \" needle stimulation ( t = 1.03 ; p = 0.307 ) or location ( t = 0.76 ; p = 0.450 ) . An overall dose effect of treatment was observed , with three sessions weekly providing more analgesia than sessions once weekly ( t = 2.10 ; p = 0.039 ) . Among treatment responders , improvements in pain , fatigue , and physical function were highly codependent ( all p < or = 0.002 ) . CONCLUSIONS Although needle insertion led to analgesia and improvement in other somatic symptoms , correct needle location and stimulation were not crucial",
"UNLABELLED A r and omized , double-blind , placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia . After a baseline assessment , subjects were titrated up on nabilone , from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo . At the 2- and 4-week visits , the primary outcome measure , visual analog scale ( VAS ) for pain , and the secondary outcome measures , number of tender points , the average tender point pain threshold , and the Fibromyalgia Impact Question naire ( FIQ ) , were evaluated . After a 4-week washout period , subjects returned for re assessment of the outcome measures . There were no significant differences in population demographics between groups at baseline . There were significant decreases in the VAS ( -2.04 , P FIQ ( -12.07 , P anxiety ( -1.67 , P side effects per person at 2 and 4 weeks ( 1.58 , P beneficial , well-tolerated treatment option for fibromyalgia patients , with significant benefits in pain relief and functional improvement . PERSPECTIVE To our knowledge , this is the first r and omized , controlled trial to assess the benefit of nabilone , a synthetic cannabinoid , on pain reduction and quality of life improvement in patients with fibromyalgia . As nabilone improved symptoms and was well-tolerated , it may be a useful adjunct for pain management in fibromyalgia",
"Osteopathic physicians caring for patients with fibromyalgia syndrome ( FM ) often use osteopathic manipulative treatment ( OMT ) in conjunction with other forms of st and ard medical care . Despite a growing body of evidence on the efficacy of manual therapy for the treatment of selected acute musculoskeletal conditions , the role of OMT in treating patients with chronic conditions such as FM remains largely unknown . Twenty-four female patients meeting American College of Rheumatology criteria for FM were r and omly assigned to one of four treatment groups : ( 1 ) manipulation group , ( 2 ) manipulation and teaching group , ( 3 ) moist heat group , and ( 4 ) control group , which received no additional treatment other than current medication . Participants ' pain perceptions were assessed by use of pain thresholds measured at each of 10 bilateral tender points using a 9-kg dolorimeter , the Chronic Pain Experience Inventory , and the Present Pain Intensity Rating Scale . Patients ' affective response to treatment was assessed using the Self-Evaluation Question naire . Activities of daily living were assessed using the Stanford Arthritis Center Disability and Discomfort Scales : Health Assessment Question naire . Depression was assessed using the Center for Epidemiological Studies Depression Scale . Significant findings between the four treatment groups on measures of pain threshold , perceived pain , attitude toward treatment , activities of daily living , and perceived functional ability were found . All of these findings favored use of OMT . This study found OMT combined with st and ard medical care was more efficacious in treating FM than st and ard care alone . These findings need to be replicated to determine if cost savings are incurred when treatments for FM incorporate nonpharmacologic approaches such as OMT",
"CONTEXT Fibromyalgia syndrome ( FMS ) is a prevalent musculoskeletal disorder associated with pain , mood state alteration , and disability . A structured and effective treatment plan for palliative care has not been established . The genesis of FMS is not clear . FMS occurs primarily in adult women . DESIGN Using a quasi-experimental clinical design and following the criteria of the American College of Rheumatology ( ACR ) , for FMS , 21 participants completed the study . The mean age was 53.6 years . The data were collected at baseline and at 1 and 2 months . Acupuncture treatments included 17 points for FMS symptoms , and 8 outcome measures were collected . RESULTS The Fibromyalgia Impact Question naire ( FIQ ) showed significant differences at 1 and 2 months . For the SF-12 , 3 subscales showed significant differences between baseline and 2 months . Four of 6 items were significantly changed . The mean number of general health symptoms was significantly decreased by 2 months . For the Catastrophe Index , significant differences were found for baseline vs 2 months . Pain threshold scores were significantly different at end of treatment for 5 bilateral tender points . There was significant improvement in Beck Depression items for both 1- and 2-month periods . In a multivariate regression model , 5 covariates were included -- age , number of weeks in treatment , number of doctors treating , number of general symptoms , and baseline FIQ score . The results indicated significant age effect . This analysis showed that the higher the FIQ score , the more positive the change experienced by study participants . Number of weeks in treatment , number of doctors who treated , and total number of general health symptoms did not have a significant effect on outcomes . CONCLUSIONS Significant improvement was experienced by participants at 8 weeks of treatment . Acupuncture treatment as delivered was effective at reducing FMS symptoms in this outcome study"
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4116e124-06ff-11f0-808a-c43d1ab1c353
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A previous review concluded that postural sway is increased in patients with low back pain ( LBP ) . However , more detailed analysis of the literature shows that postural deficit may be dependent on experimental conditions in which patients with LBP have been assessed . The research question to be answered in this review was : " Is there any difference in postural sway between subjects with and without LBP across several sensory manipulation conditions ? " . A literature search in Pubmed , Scopus , Embase and PsychInfo was performed followed by h and search and contact with authors . Studies investigating postural sway during bipedal stance without applying external forces in patients with specific and non-specific LBP compared to healthy controls were included . Twenty three articles fulfilled the eligibility criteria . Most studies reported an increased postural sway in LBP , or no effect of LBP on postural sway . In a minority of studies , a decreased sway was found in LBP patients . There were no systematic differences between studies finding an effect and those reporting no effect of LBP . The proportion of studies finding between-group differences did not increase with increased complexity of sensory manipulations . Potential factors that may have caused inconsistencies in the literature are discussed in this systematic review
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[
"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 The purpose of the present study was to examine the differential effect of core stability exercise training and conventional physiotherapy regime on altered postural control parameters in patients with chronic low back pain ( CLBP ) . As heterogeneity in CLBP population moderates the effect of intervention on outcomes , in this study , interventions approaches were used based on sub-groups of CLBP . Methods This was an allocation concealed , blinded , sequential and pragmatic control trial . Three groups of participants were investigated during postural perturbations : 1 ) CLBP patients with movement impairment ( n = 15 , MI group ) r and omized to conventional physiotherapy regime 2 ) fifteen CLBP patients with control impairment r and omized to core stability group ( CI group ) and 3 ) fifteen healthy controls ( HC ) . Results The MI group did not show any significant changes in postural control parameters after the intervention period however they improved significantly in disability scores and fear avoidance belief question naire work score ( P Fx , Fz , and My variables ( p 0.8 ) after 8 weeks of core stability exercises for the adjusted p values . Postural control parameters of HC group were analyzed independently with pre and post postural control parameters of CI and MI group . This revealed the significant improvements in postural control parameters in CI group compared to MI group indicating the specific adaptation to the core stability exercises in CI group . Though the disability scores were reduced significantly in CI and MI groups ( p study core stability exercise group demonstrated significant improvements after intervention in ground reaction forces ( Fz , Mz ; g > 0.8 ) indicating changes in load transfer patterns during perturbation similar to HC group . Trial registration UTRN095032158 -",
"This study evaluated the degree to which the disturbance to posture from respiration is compensated for in healthy normals and whether this is different in people with recurrent low back pain ( LBP ) , and to compare the changes when respiratory dem and is increased . Angular displacement of the lumbar spine and hips , and motion of the centre of pressure ( COP ) , were recorded with high resolution and respiratory phase was recorded from ribcage motion . With subjects st and ing in a relaxed posture , recordings were made during quiet breathing , while breathing with increased dead-space to induce hypercapnoea , and while subjects voluntarily increased their respiration to match ribcage expansion that was induced in the hypercapnoea condition . The relationship between respiration and the movement parameters was measured from the coherence between breathing and COP and angular motion at the frequency of respiration , and from averages triggered from the respiratory data . Small angular changes in the lumbopelvic and hip angles were evident at the frequency of respiration in both groups . However , in quiet st and ing , the LBP subjects had a greater displacement of their COP that was associated with respiration than the control subjects . The LBP group had a trend for less hip motion . There were no changes in the movement parameters when respiratory dem and increased involuntarily via hypercapnoea , but when respiration increased voluntarily , the amplitude of motion and the displacement of the COP increased in both groups . The present data suggest that the postural compensation to respiration counteracts at least part of the disturbance to posture caused by respiration and that this compensation may be less effective in people with LBP",
"Background Increased center of pressure excursions are well documented in patients suffering from non-specific low back pain , whereby the altered postural sway includes both higher mean sway velocities and larger sway area . No investigation has been conducted to evaluate a relationship between pain intensity and postural sway in adults ( aged 50 or less ) with non-specific low back pain . Methods Seventy-seven patients with non-specific low back pain and a matching number of healthy controls were enrolled . Center of pressure parameters were measured by three static bipedal st and ing tasks of 90 sec duration with eyes closed in narrow stance on a firm surface . The perceived pain intensity was assessed by a numeric rating scale ( NRS-11 ) , an equal number of patients ( n = 11 ) was enrolled per pain score . Results Generally , our results confirmed increased postural instability in pain sufferers compared to healthy controls . In addition , regression analysis revealed a significant and linear increase in postural sway with higher pain ratings for all included COP parameters . Statistically significant changes in mean sway velocity in antero-posterior and medio-lateral direction and sway area were reached with an incremental change in NRS scores of two to three points . Conclusions COP mean velocity and sway area are closely related to self-reported pain scores . This relationship may be of clinical use as an objective monitoring tool for patients under treatment or rehabilitation",
"Study Design . A study of postural control during one‐footed and externally disturbed two‐footed stance among healthy control subjects and patients with chronic low back pain at the beginning of a functional back restoration program and 6 months later at follow‐up examination . Objectives . To study postural control cross‐sectionally among control subjects and patients with low back pain , and to evaluate the effects of functional restoration on the postural control parameters in a follow‐up examination . Summary of Background Data . Deficits of motor skills and coordination have been reported in association with musculoskeletal disorders . It has been found that patients with chronic low back pain have impaired psychomotor control , but the impairment is reversible with successful low back rehabilitation . It is insufficiently known how functional activation and intensive physical training affect postural control . Methods . Sixty‐one healthy volunteers ( 32 men , 29 women ) and altogether 99 patients with low back pain participated in the study . Sixty‐eight patients ( 33 men , 35 women ) had moderate and 31 ( 18 men , 13 women ) had severe low back pain . Postural stability was measured with a force platform . In two‐footed stance , vibration stimulation on calf and back muscles was used to disturb the balance . Center point of force‐velocity ( cm/sec ) , average position shift in anteroposterior direction ( cm ) , and maximal position shift in lateral direction ( cm ) were used as the parameters . Results . Reliability of all tests was acceptable . Center point of force‐velocity was the most sensitive parameter and the one‐footed measurement the most sensitivetest for evaluating postural stability . At the beginning , the patients with severe low back pain had poorer one‐footed postural control compared with the control subjects ( P = 0.0003 ) . The subgroup of patients with moderate low back pain participated in the restoration program . The outcome of the restoration program was considered good if the disability because of low back pain ( Oswestry index ) decreased during the restoration program and poor if the disability increased or did not change . The one‐footed postural stability remained primarily at the same level as the initial results in the control and good outcome groups , but became significantly poorer in the poor outcome group . The difference between poor outcome and control groups was statistically significant ( P = 0.04 ) . Conclusions . Impaired postural stability seems to be one factor in multidimensional symptomatology of patients with chronic low back trouble . Postural stability is easily disturbed in case of impairment in strength , coordination , or effective coupling of muscles in the lumbar and pelvic area . Patients with chronic low back pain seem to experience impairment in these functions , which should be taken into consideration when back rehabilitation programs are planned",
"OBJECTIVE To determine whether body balance is perturbed more in low back pain patients than in healthy subjects , under the concept of posturo-kinetic capacity . DESIGN Comparison of posturographic and respiratory parameters between low back pain and healthy subjects . BACKGROUND It has been demonstrated that respiratory movements constitute a perturbation to posture , compensated by movements of the spine and of the hips , and that low back pain is frequently associated with a loss of back mobility . METHOD Ten low back pain patients and ten healthy subjects performed five posturographic tests under three different respiratory rate conditions : quiet breathing ( spontaneous ) , slow breathing ( 0.1 Hz ) and fast breathing ( 0.5 Hz ) . RESULTS Intergroup comparison showed that the mean displacements of the center of pressure were greater for the low back pain group , especially along the antero-posterior axis , where respiratory perturbation is primarily exerted . Inter-condition comparison showed that in slow and fast breathing relatively to quiet breathing , the mean displacement of the center of pressure along the antero-posterior axis was significantly increased only for the low back pain group . CONCLUSION According to the results , respiration presented a greater disturbing effect on body balance in low back pain subjects . RELEVANCE This study provides information on the causes of the impaired body balance associated with chronic low back pain , which could be used to improve treatment strategy",
"Insight into the mechanisms of altered postural control in persons with low back pain ( LBP ) could lead to better interventions for patients with LBP . This study investigated ( 1 ) whether persons with recurrent LBP have an altered body inclination , and ( 2 ) whether anticipation of postural instability further alters body inclination . Thirty-three young healthy individuals and 56 young persons with recurrent LBP participated in this study . The upright st and ing posture was evaluated by means of two piezo-resistive electrogoniometers and a force platform for the conditions as follows : ( 1 ) quiet stance with and without vision , and ( 2 ) in anticipation of postural instability due to a ballistic arm movement or ankle muscle vibration . No differences in body inclination were observed when visual information was available between the two groups ( P>0.05 ) . However , significant more forward inclination was seen in the persons with recurrent LBP when vision was occluded ( + 7.4 % ) and in anticipation of postural instability ( + 19 % ) ( P young persons with recurrent LBP have an altered body inclination that might be caused by anticipation of postural instability . The adopted forward inclined posture may potentially be a factor in the recurrence of LBP",
"Study Design . A clinical trial comparing a back pain group with a pain‐free group . Objectives . To investigate whether proprioceptive deficits existed in a group of individuals reporting low back pain . Summary of Background Data . Little work has so far been conducted on the measurement of proprioception in the spine . Those studies that have been carried out , however , have failed to identify proprioceptive deficits in individuals with back pain . Previous work on peripheral joints has revealed that proprioception is affected with muscular or joint injury or degeneration . Methods . Forty individuals took part in the study , 20 with back pain and 20 with no pain . Participants were required to reproduce a predetermined target position , in st and ing and four‐point kneeling , 10 times in 30 seconds . A computer screen was used to provide visual feedback on position . A mean deviation from the target position was obtained for each individual . A measurement of left elbow position sense was conducted in five individuals from each group to establish differences in short‐term motor memory between the groups . Results . There were no differences between the subject groups in terms of short‐term motor memory ( P > 0.05 ) . A two‐way analysis of variance between subject groups and position to identify differences in accuracy ( deviation from the target ) found that there were differences between subject groups in either position ( P in accuracy between the positions used ( P > 0.05 ) . Conclusions . Differences in proprioception do exist between individuals with back pain and those free from back pain . Further research needs to be undertaken on proprioceptive exercise programs and their effect on back pain",
"Balance reactions are not routinely evaluated in patients with low back pain . The purpose of this study was to determine if there were differences in static balance and weight distribution between subjects with unilateral low back pain ( N = 15 ) and pain-free controls ( N = 15 ) . Measurements included limits of stability ( % LOS ) , target sway , weight distribution on each lower extremity in quiet st and ing , and center of gravity with measurements of maximal excursion in anterior/posterior and medial/lateral directions . Independent t tests were used to compare data between groups . Compared with control subjects , subjects with low back pain demonstrated greater anterior-posterior center of gravity excursion and total center of gravity excursion with eyes open and greater anterior-posterior , medial-lateral , and total center of gravity excursion , target sway , and % LOS with eyes closed . There was no difference in the weight-bearing distribution between groups . This study suggests that static balance in patients with chronic low back pain may be impaired and should be thoroughly evaluated and integrated into physical therapy treatment programs",
"Abstract : To determine whether the presence of back pain and its related disabilities are determinants of balance and functional mobility in a group of women with osteoporosis , we carried out a cross-sectional analysis of 93 community-dwelling women with osteoporosis between the ages of 65 and 75 years old . We assessed health history , anthropometrics , self-report of current physical activity level and self-report of back pain ( intensity and pain-related disabilities ) . Balance was measured by computerized dynamic posturography and functional mobility was assessed by timed figure-of-eight test . The prevalence of back pain was high ( 75 % ) in this cohort of older women with osteoporosis . Age was the major determinant of both balance and functional mobility and accounted for 9 % and 14 % of the variance , respectively . After accounting for age , back pain explained an additional 9 % of the variance in balance and 13 % of the variance in functional mobility . The high prevalence of back pain demonstrates the importance of pain management in the treatment of osteoporosis . Furthermore , the finding of self-reported back pain as a determinant of both balance and functional mobility suggests that this measure may deserve attention when screening women with osteoporosis for fracture risk . Prospect i ve studies are needed to determine whether pain management will improve balance and functional mobility",
"Study Design . A follow-up study evaluating postural control , lumbar movement perception , and paraspinal muscle reflexes in disc herniation-related chronic low back pain ( LBP ) before and after discectomy . Objectives . To assess the effect of discectomy on postural control , lumbar perception , and reflex activation of paraspinal muscles during sudden upper limb loading . Summary of Background Data . Impaired muscle function , postural control , and lumbar proprioception have been observed in LBP . However , they have not been studied in sciatica patients after surgery . Methods . The study included 20 patients selected for an operation for chronic LBP caused by disc herniation and 15 controls without chronic LBP . The paraspinal muscle responses for upper limb loading during unexpected and expected conditions were measured by surface electromyography . The ability to sense lumbar rotation was assessed in a previously vali date d motorized trunk rotation unit in the seated position . The postural control was measured with a vertical force platform . Pain , disability , and depression scores were recorded . Results . Patients had poorer lumbar perception ( P = 0.012 ) and postural control ( P postural control remained unchanged , but lumbar perception ( P = 0.054 ) and the lumbar feed-forward control ( P = 0.043 ) improved after the surgery . Conclusions . The results demonstrate impaired lumbar proprioception and postural control in sciatica patients . During short-term follow-up after operative treatment , postural control does not seem to change , but impaired lumbar proprioception and feed-forward control of paraspinal muscles seem to recover",
"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"
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4116e160-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Food allergies affect up to 8 % of American children . The current recommended treatment for food allergies is strict elimination of the allergens from the diet . Dietary elimination of nutrient-dense foods may result in inadequate nutrient intake and impaired growth . The purpose of this review was to critically analyze available research on the effect of an elimination diet on nutrient intake and growth in children with multiple food allergies . METHODS A systematic review of the literature was conducted and a workgroup was established to critically analyze each relevant article . The findings were summarized and a conclusion was generated . RESULTS Six studies were analyzed . One study found that children with food allergies are more likely to be malnourished than children without food allergies . Three studies found that children with multiple food allergies were shorter than children with 1 food allergy . Four studies assessed nutrient intake of children with multiple food allergies , but the inclusion and comparison criteria were different in each of the studies and the findings were conflicting . One study found that children with food allergies who did not receive nutrition counseling were more likely to have inadequate intake of calcium and vitamin D. CONCLUSION Children with multiple food allergies have a higher risk of impaired growth and may have a higher risk of inadequate nutrient intake than children without food allergies . Until more research is available , we recommend monitoring of nutrition and growth of children with multiple food allergies to prevent possible nutrient deficiencies and to optimize growth
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"OBJECTIVES To determine the prevalence of soy allergy in IgE-associated cow 's milk allergy ( CMA ) . STUDY DESIGN Children were evaluated for soy allergy by double-blind , placebo-controlled food challenge , open challenge , or convincing previous history of an anaphylactic reaction to soy . Children tolerant to soy at entry received soy formula and were followed up for 1 year . RESULTS Of this IgE-associated CMA cohort ( ages 3 to 41 months ) , 14 % ( 95 % CI = 7 . 7%-22.7 % ) were determined to have soy allergy , 12 definitely at entry and 1 possibly after 1 year of soy ingestion . The latter child experienced severe failure to thrive at enrollment and exhibited improved growth while receiving soy during follow-up but was diagnosed with eosinophilic esophagitis at study completion . Improved growth ( P soy formula ( 579 31 mL/d ) during the year of follow-up . CONCLUSIONS Soy allergy occurs in only a small minority of young children with IgE-associated CMA . As such , soy formula may provide a safe and growth-promoting alternative for the majority of children with IgE-associated CMA shown to be soy tolerant at the time of introduction of soy formula",
"BACKGROUND Although inhaled glucocorticosteroids are recommended for persistent asthma , their long-term effect on recent onset , mild , persistent asthma has yet to be established . METHODS We did a r and omised , double-blind clinical trial in 7241 patients in 32 countries to assess the effects of budesonide in patients who had had mild persistent asthma for less than 2 years and who had not had previous regular treatment with glucocorticosteroids . Patients aged 5 - 66 years received either budesonide or placebo once daily for 3 years in addition to their usual asthma medications . The daily budesonide dose was 400 microg , or 200 microg for children younger than 11 years . The primary outcome was time to first severe asthma-related event , and analysis was by intention to treat . FINDINGS 198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe asthma exacerbation ; hazard ratio 0.56 ( 95 % CI 0.45 - 0.71 , p budesonide had fewer courses of systemic corticosteroids and more symptom-free days than did those on placebo . Compared with placebo , budesonide increased postbronchodilator forced expiratory volume in 1 s ( FEV1 ) from baseline by 1.48 % ( p prebronchodilator FEV1 was 2.24 % after 1 year and 1.71 % after 3 years ( p baseline lung function ( prebronchodilator or postbronchodilator ) or baseline medication . In children younger than 11 years , 3-year growth was reduced in the budesonide group by 1.34 cm . The reduction was greatest in the first year of treatment ( 0.58 cm ) than years 2 and 3 ( 0.43 cm and 0.33 cm , respectively ) . INTERPRETATION Long-term , once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset",
"Objective : To evaluate the effect of dietary low-saturated fat , low-cholesterol intervention on fat intake and fatty acid compositions in serum cholesterol ester ( CE ) , phospholipid ( PL ) and triglyceride ( TG ) fractions in five-year-old children . Design and subjects : The STRIP project is a prospect i ve , r and omised intervention project in which 1062 seven-month-old infants were recruited from the well-baby clinics . 764 children participated in the 5-year follow-up ; 202 of them were r and omly selected for this study . Diet was assessed with 4-d dietary records . Serum CE , PL and TG fatty acid compositions were analysed with gas-liquid chromatography . Results : Saturated fat intake of intervention children ( mean ( confidence interval ) ) ( girls 11.9 ( 11.2–12.6 ) % of energy intake ( E% ) ; boys 12.5 ( 11.9–13.1 ) ) was lower than that of the control children ( girls 14.4 ( 13.7–15.2 ) E% ; boys 15.0 ( 14.3–15.8 ) E% ) ( P=0.0001 for the difference between intervention and control groups ) . The intake of unsaturated fat differed only slightly . Dietary ratios of polyunsaturated to saturated fatty acids ( PS ratios ) of the intervention and control diets were 0.44 and 0.33 , respectively ( P=0.0001 ) . Furthermore , serum cholesterol concentrations of the intervention and control children differed ( 4.28 ( 4.13–4.43 ) mmol/L vs 4.49 ( 4.35–4.63 ) mmol/L ; P=0.04 ) . Relative proportion of saturated fatty acids in serum TG was lower ( 34.9 % vs 36.3 % ; P=0.04 ) and that of n-6 polyunsaturated fatty acids higher ( 13.9 % vs 12.4 % ; P=0.0004 ) in the intervention than in the control children , whereas serum CE and PL fatty acid compositions of intervention and control groups were closely similar . However , intake of linoleic acid correlated better with serum linoleic acid relative content in the CE fraction ( r=0.36 ; P=0.0001 ) than in the PL ( r=0.27 ; P=0.0002 ) or in the TG ( r=0.23 ; P=0.0016 ) fraction Conclusions : Intervention result ed in decreased intake of saturated fatty acids and lowered serum total and LDL cholesterol concentrations . Of serum lipid fractions , TG fatty acid composition was the most sensitive and parallelled the findings in dietary food records",
"Cow 's milk allergy/intolerance is treated by complete avoidance of cow 's milk proteins . Because cow 's milk is an important food for infants , its avoidance may lead to an increased risk of growth impairment . Whilst there is evidence for the beneficial effects of extensively hydrolyzed cow 's milk formulate ( eHF ) in infants with cow 's milk allergy/intolerance , little is known about the effects of amino-acid-based formulae ( AA ) in such infants . We therefore performed a prospect i ve , controlled , multi-center trial to study the efficacy of AA in comparison with eHF , on the growth and clinical symptoms of 73 infants ( median age 5.7 months ) with cow 's milk allergy/intolerance and atopic dermatitis . Cow 's milk allergy/intolerance was proven in all infants by double-blind , placebo-controlled food-challenge . We observed a significant improvement in the SCORAD index in both groups , from a mean of 24.6 , at entry , to a mean of 10.7 ( p length st and ard deviation score ( p weight-for-length values were stable in both groups . The energy intake during the study was similar in both groups . Both an AA and eHF result ed in a significant clinical improvement in infants with an early onset of symptoms of cow 's milk allergy/intolerance . Feeding an AA result ed in improved growth compared with feeding eHF , despite similar dietary intakes , and may therefore be considered as a beneficial alternative in infants with severe cow 's milk allergy intolerance",
"OBJECTIVE To determine the hypoallergenicity and efficacy of a pediatric amino acid-based formula ( AAF ) , EleCare , for children with cow 's milk allergy ( CMA ) and multiple food allergies ( MFA ) . STUDY DESIGN Hypoallergenicity was determined by performing blinded oral food challenges in 31 consecutive children with documented CMA . Growth , tolerance , and biochemical response were evaluated during a nonr and omized feeding study with each child serving as his or her own control . RESULTS Thirty-one children ( median age , 23.3 months ; range , 6 months to 17.5 years ) were recruited ; 29 had MFA , 17 had acute reactions and cow 's milk-specific IgE antibody , and 14 had allergic eosinophilic gastroenteritis . At study entry , 23 were receiving another AAF ; 13 had not tolerated extensively hydrolyzed formula . Eighteen subjects with allergic eosinophilic gastroenteritis and /or MFA were followed up while receiving AAF for a median of 21 months ( range , 7 to 40 months ) , with biochemical analysis performed at 4 months . No statistically significant differences were observed in the change in weight or height National Center for Health Statistics z scores from entry ; the percent of expected growth exceeded 90 % . There was a small decline in percent eosinophils and increase in hemoglobin , hematocrit , and serum ferritin level ( P plasma leucine and valine levels ( P AAF was hypoallergenic and effective in maintaining normal growth for children with CMA and MFA",
"OBJECTIVE This study was made to : ( i ) identify the prevalence of low calcium intakes in a paediatric population with loosely defined ' milk allergy ' ; and ( ii ) assess long-term ( mean 21 months later ) changes in calcium intake following a single nutrition counselling session with those patients initially found to have a low intake . METHODOLOGY Calcium intake was assessed in a cross-sectional study of 58 patients ages 5 - 16 years ( mean 9.9 years ) with IgG radioallergosorbent test ( RAST ) class II or higher for cow 's milk protein . Those 31 patients found to have a low calcium intake were prospect ively re-evaluated 12 - 30 months later following a single nutrition counselling session . RESULTS Calcium intake was intake was unreliable ; 44 % of those who rated their calcium intake fair or good did not meet their RDA . Taking a calcium supplement did not ensure adequate intake ; 21 % of those taking supplements still did not meet their RDA . Milk intake predicted calcium intake ; 8 % of those who did not drink milk vs 68 % of those who did drink at least some milk met their RDA without supplementation . The 31 patients with low intakes received counselling and were re-evaluated at an average follow-up of nearly 2 years . Calcium intake was increased a mean of 360 mg/day and use of supplements increased from 10 to 52 % of the group . Despite these positive changes , 48 % still did not meet their RDA . CONCLUSION Limited milk intake is likely to be associated with suboptimal calcium intake . Efforts should be made to educate the family about the importance of calcium and its non-dairy sources . With many families repeated discussion s of this issue may be necessary to influence calcium intake",
"BACKGROUND & AIMS Eosinophilic esophagitis ( EoE ) is a disorder characterized by a severe , isolated eosinophilic infiltration of the esophagus unresponsive to aggressive acid blockade but responsive to the removal of dietary antigens . We present information relating to our 10-year experience in children diagnosed with EoE. METHODS We conducted a retrospective study between January 1 , 1994 , and January 1 , 2004 , to evaluate all patients diagnosed with EoE. Clinical symptoms , demographic data , endoscopic findings , and the results of various treatment regimens were collected and evaluated . RESULTS A total of 381 patients ( 66 % male , age 9.1 + /- 3.1 years ) were diagnosed with EoE : 312 presented with symptoms of gastroesophageal reflux ; 69 presented with dysphagia . Endoscopically , 68 % of patients had a visually abnormal esophagus ; 32 % had a normal-appearing esophagus despite a severe histologic esophageal eosinophilia . The average number of esophageal eosinophils ( per 400 x high power field ) proximally and distally were 23.3 + /- 10.5 and 38.7 + /- 13.3 , respectively . Corticosteroids significantly improved clinical symptoms and esophageal histology ; however , upon their withdrawal , the symptoms and esophageal eosinophilia recurred . Dietary restriction or complete dietary elimination using an amino acid-based formula significantly improved both the clinical symptoms and esophageal histology in 75 and 172 patients , respectively . CONCLUSIONS Medications such as corticosteroids are effective ; however , upon withdrawal , EoE recurs . The removal of dietary antigens significantly improved clinical symptoms and esophageal histology in 98 % of patients"
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Background Previous studies showed that probiotics could improve glycemic control and attenuate some of the adverse effects of type 2 diabetes . However , whether the effects are generalizable to gestational diabetes mellitus ( GDM ) remains uncertain . Objective We conducted a systematic review and meta- analysis to evaluate the effects of probiotic supplement in GDM . Method PubMed , EMBASE , the Cochrane Library , and EBSCO were systematic ally search ed for relevant literature published through January 2019 . R and omized controlled trials ( RCTs ) assessing the effects of probiotic supplement on one or more of the following in GDM were included : pregnancy outcome ( the primary outcome ) , glycemic control , blood lipid profile , and inflammation and oxidative stress . Two review ers independently extracted data and assessed the risk of bias in studies . Meta- analysis was conducted by using the fixed effects model unless substantial heterogeneity was found among studies . Results Eleven r and omized trials involving 719 participants were included for analysis . Eight of the trials were from Iran . Probiotics were given alone in eight trials and synbiotics in three trials . Though the components of probiotics varied , Lactobacillus was included in all trials and Bifidobacterium in all except one . The duration of intervention ranged from 4 to 8 weeks . Almost all trials ( 10/11 ) had a low risk of bias . Probiotic supplementation reduced the risk of a newborn 's hyperbilirubinemia by 74 % and improved four biomarkers for glycemic control ( fasting blood glucose , fasting serum insulin , homeostasis model assessment insulin resistance , and quantitative insulin sensitivity check index ) , two biomarkers for lipid profile ( triglycerides and HDL-cholesterol ) , and four biomarkers for inflammation and oxidative stress ( total glutathione , malondialdehyde , nitric oxide , and total antioxidant capacity ) . But significant heterogeneity was observed in the meta-analyses on the four biomarkers related to glycemic control and on triglycerides , which could not be explained by prespecified subgroup analyses according to the mean age of participants and intervention type ( i.e. , probiotics or synbiotics ) . The effects on the risk of preterm delivery , macrosomia and a newborns ' hypoglycemia , gestational age , total cholesterol , and LDL-cholesterol were not statistically significant . Conclusion Probiotic supplementation seemed to be able to reduce the risk of a newborn 's hyperbilirubinemia and improve glycemic control , blood lipid profiles and inflammation and oxidative stress in pregnant women with GDM . However , due to the heterogeneity among existing studies , the surrogate nature of outcomes , and /or the fact that most studies were from Iran , the clinical significance and generalizability of the above findings remain uncertain . Further studies are warranted to address the limitations of existing evidence and better inform the management of GDM
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"Background Although several studies have found probiotics encouraging in prevention of gestational diabetes mellitus ( GDM ) , the evidence for the use of probiotics in diagnosed GDM is largely limited . The aim of this study was to assess the effect of a probiotic supplement capsule containing four bacterial strains on glucose metabolism indices and weight changes in women with newly diagnosed GDM . Methods Sixty-four pregnant women with GDM were enrolled into a double-blind placebo-controlled r and omized clinical trial . They were r and omly assigned to receive either a probiotic or placebo capsule along with dietary advice for eight consecutive weeks . The trend of weight gain along with glucose metabolism indices was assayed . Results During the first 6 weeks of the study , the weight gain trend was similar between the groups . However , in the last 2 weeks of the study , the weight gain in the probiotic group was significantly lower than in the placebo group ( p Fasting blood sugar ( FBS ) decreased in both intervention ( from 103.7 to 88.4 mg/dl ) and control ( from 100.9 to 93.6 mg/dl ) groups significantly , and the decrease in the probiotic group was significantly higher than in the placebo group ( p Insulin resistance index in the probiotic group had 6.74 % reduction over the study period ( p insulin resistance index ( 6.45 % ) , but the observed change in insulin resistance was not statistically significant . Insulin sensitivity index was increased in both groups . The post-intervention insulin sensitivity index in the probiotic group was not significantly different from placebo when adjusted for the baseline levels . Conclusions The probiotic supplement appeared to affect glucose metabolism and weight gain among pregnant women with GDM . This needs to be confirmed in other setting s before a therapeutic value could be approved",
"AIMS The role of gut microbiota in the management of diabetes is shown . In this r and omized clinical trial we assessed the effects of synbiotic supplementation on insulin , lipid profile and antioxidative status among women with gestational diabetes mellitus ( GDM ) . METHODS Ninety pregnant women with GDM were r and omly assigned into two groups to receive either a daily synbiotic capsule - consisting of L. acidophilus , L. plantarum , L. fermentum , L. gasseri ( 1.5 - 7.0 × 109 - 10 CFU/g ) - with fructooligosaccharide ( 38.5 mg ) , or placebo for 6 weeks . Fasting plasma glucose ( FPG ) , insulin , homeostasis model assessment -insulin resistance ( HOMA-IR ) , quantitative insulin sensitivity check index ( QUICKI ) , high- and low density lipoprotein cholesterol ( HDL-C , LDL-C ) , total cholesterol ( TC ) , triglycerides ( TG ) , total antioxidant capacity ( TAC ) , and systolic and diastolic blood pressure ( SBP , DSP ) were assessed before and after the intervention . RESULTS No significant changes in FPG , insulin resistance/sensitivity , lipid profile and TAC indices were seen in synbiotic group compared to the placebo one ( p > 0.05 ) . Significant within group increases for HDL-C and TAC levels in synbiotic group were observed ( p 0.05 ) . LDL-C showed significant increment in the placebo group compared to the baseline of the study ( 6.9 mg/dL , p in SBP and DBP in synbiotic group compared to placebo ( -2.5 vs. 8.6 mmHg , and -1.8 vs. 2.1 mmHg , p women with GDM , synbiotic supplementation had no effect on FPG and insulin resistance/sensitivity indices . Lipid profile and TAC status may be affected by synbiotic supplementation . Synbiotic is effective in reducing of blood pressure in women with GDM",
"Abstract Synbiotics are known to exert multiple beneficial effects , including anti-inflammatory and antioxidative actions . This study was design ed to evaluate the effects of synbiotic administration on biomarkers of inflammation , oxidative stress , and pregnancy outcomes among gestational diabetic ( GDM ) women . This r and omized , double-blind , placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 ( IBRC-M10785 ) , L. casei strain T2 ( IBRC-M10783 ) , and Bifidobacterium bifidum strain T1 ( IBRC-M10771 ) ( 2 × 109 CFU/g each ) plus 800 mg inulin ( HPX ) ( n = 30 ) or placebo ( n = 30 ) for 6 weeks . Compared with the placebo , synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein ( hs-CRP ) ( − 1.9 ± 4.2 vs. + 1.1 ± 3.5 mg/L , P = 0.004 ) , plasma malondialdehyde ( MDA ) ( − 0.1 ± 0.6 vs. + 0.3 ± 0.7 μmol/L , P = 0.02 ) , and significantly increased total antioxidant capacity ( TAC ) ( + 70.1 ± 130.9 vs. − 19.7 ± 124.6 mmol/L , P = 0.009 ) and total glutathione ( GSH ) levels ( + 28.7 ± 61.5 vs. − 14.9 ± 85.3 μmol/L , P = 0.02 ) . Supplementation with synbiotic had a significant decrease in cesarean section rate ( 16.7 vs. 40.0 % , P = 0.04 ) , lower incidence of hyperbilirubinemic newborns ( 3.3 vs. 30.0 % , P = 0.006 ) , and newborns ’ hospitalization ( 3.3 vs. 30.0 % , P = 0.006 ) compared with the placebo . Synbiotic supplementation did not affect plasma nitric oxide ( NO ) levels and other pregnancy outcomes . Overall , synbiotic supplementation among GDM women for 6 weeks had beneficial effects on serum hs-CRP , plasma TAC , GSH , and MDA ; cesarean section ; incidence of newborn ’s hyperbilirubinemia ; and newborns ’ hospitalization but did not affect plasma NO levels and other pregnancy outcomes . http://www.i rct .ir : www.i rct .ir : I RCT",
"Whether the incidence of coronary heart disease ( CHD ) is related to a decrease in total antioxidant capacity ( TAC ) has not yet been completely clarified . We assessed TAC of blood serum in a group of 163 men with CHD aged 34.8–77.0 years and in 163 age-matched peers without CHD . Two spectrophotometric methods were applied to assess TAC : ferric reducing ability of serum ( TAC-FRAS ) and 2.2-diphenyl-1-picryl-hydrazyl ( TAC-DPPH ) tests . In the CHD group , multivariate analysis revealed that uric acid ( UA ) , triglycerides , and systolic blood pressure contributed independently to the TAC-FRAS variance . TAC-DPPH was favorably predicted by UA concentration , but negatively so by current smoking and glucose levels . In men without CHD , UA was the only independent determinant of both TAC-FRAS and TAC-DPPH . Presence of CHD was not an independent predictor of TAC — observed between-group differences ( higher TAC in CHD patients ) disappeared after adjustment for other confounders . We conclude that UA is the main determinant of TAC of blood serum in men . TAC is not directly influenced by age or CHD but is related to several indices of overweight/obesity and laboratory measures of metabolic syndrome , especially in patients with CHD",
"Abstract Objective : To prospect ively evaluate maternal and cord blood concentrations of sclerostin – an osteocyte-secreted factor , inhibiting osteoblast differentiation and bone formation and associated with adverse metabolism – in pregnancies with normal and abnormal fetal growth . Methods : Plasma sclerostin concentrations were determined by ELISA in 80 maternal and 80 cord blood sample s from asymmetric intrauterine-growth-restricted ( IUGR , n = 30 ) , large-for-gestational-age ( LGA , n = 30 ) , and appropriate-for-gestational-age ( AGA , n = 20 ) singleton full-term pregnancies . Fourteen out of 30 mothers with LGA offspring presented with gestational diabetes mellitus ( GDM ) . Results : Maternal and fetal sclerostin concentrations did not differ among LGA , IUGR , and AGA groups . Fetal concentrations were higher than maternal . In LGA group , maternal concentrations were elevated in cases of GDM ( b = 13.009 , 95%CI 1.425–24.593 , p = .029 ) . In a combined group and the IUGR group , maternal concentrations were elevated in older mothers ( b = 0.788 , 95%CI 0.190–1.385 , p = .010 , and b = 0.740 , 95%CI 0.042–1.438 , p = .039 , respectively ) . Conclusions : Maternal and fetal sclerostin concentrations may not be differentially regulated in pregnancies complicated by abnormal fetal growth . Circulating maternal levels are higher in cases of GDM , probably implying reduced bone formation . Sclerostin up-regulation with aging may be one of the molecular pathways responsible for the observed age-related decline in bone synthesis , leading to accelerated bone loss in humans",
"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 Low grade chronic inflammation is observed in patients with type 2 diabetes mellitus ( T2DM ) . Endotoxin derived from gut bacteria may act as a potent inflammatory stimulant . Probiotics , which are believed to contain health promoting live microorganisms , may influence circulating endotoxin levels . Ingestion of live probiotic cultures may alter gut microbiota in a beneficial manner to reduce inflammation ; no information is available whether or not they do so in patients with T2DM . Therefore , the aim of this study is to characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low- grade inflammation in patients with T2DM . Methods One hundred and twenty consenting adult Saudi T2DM patients ( naïve or newly diagnosed and without co-morbidities ) will be enrolled in this clinical trial and r and omized to receive daily placebo or probiotics ( Ecologic ® Barrier ) for 26 weeks in a double-blind manner . Inflammatory and metabolic markers will be measured and fecal sample s analyzed . Measurements / sample s will be obtained at baseline and after 4 , 8 , 12/13 and 26 weeks of treatment . Discussion It is expected that the probiotic product will induce beneficial changes in gut microbiota , reduce the systemic inflammatory state through altering systemic endotoxin levels and , as such , reduce the systemic inflammatory response observed in T2DM subjects . Trial registration Clinical Trials.gov Identifier :",
"Objective . This trial aims to examine the effects of a Probiotic Mixture ( VSL#3 ) on glycemic status and inflammatory markers , in women with GDM . Material s and Methods . Over a period of 8 weeks , 82 women with gestational diabetes were r and omly assigned to either an intervention group ( n = 41 ) which were given VSL#3 capsule or to a control group which were given placebo capsule ( n = 41 ) . Fasting plasma glucose , homeostatic model assessment of insulin resistance , glycosylated hemoglobin , high-sensitivity C-reactive protein , tumor necrosis factor-α , interleukin-6 , Interferon gamma , and interleukin-10 were measured before and after the intervention . Results . After 8 wk of supplementation FPG , HbA1c , HOMA-IR , and insulin levels remained unchanged in the probiotic and placebo groups . The comparison between the two groups showed no significant differences with FPG and HbA1c , but there were significant differences in insulin levels and HOMA-IR ( 16.6 ± 5.9 ; 3.7 ± 1.5 , resp . ) . Unlike the levels of IFN-g ( 19.21 ± 16.6 ) , there was a significant decrease in levels of IL-6 ( 3.81 ± 0.7 ) , TNF-α ( 3.10 ± 1.1 ) , and hs-CRP ( 4927.4 ± 924.6 ) . No significant increase was observed in IL-10 ( 3.11 ± 5.7 ) in the intervention group as compared with the control group . Conclusions . In women with GDM , supplementation with probiotics ( VSL#3 ) may help to modulate some inflammatory markers and may have benefits on glycemic control ",
"Background Probiotics can alter the colonic microbiota and might improve bowel function . Objectives The aim of this study was to evaluate the effect of the consumption of yogurt , enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 ( CFU ) on the symptoms of constipated pregnant women . Material s and Methods This triple-blind r and omized controlled trial was conducted on 60 constipated pregnant women who were diagnosed by the ROME III criteria in Tabriz , Iran from December 2014 to July 2015 . Participants were r and omly put into two groups including the treatment and the control group through block r and omization . The treatment group received 300 g of yogurt enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 colony forming units ( CFU ) ( n = 30 ) while the control group received conventional yogurt ( n = 30 ) for 4 weeks . The defecation frequency , stool consistency , straining during defecation , sensation of anorectal obstruction , sensation of incomplete evacuation and manual manoeuvres to facilitate defecation were primary outcomes while the amount of defecation , stool colure , and quality of life were secondary outcomes . Results The frequency of defecation was increased from 2.1 ( 0.8 ) at baseline to 8.3 ( 4.4 ) in the probiotic yogurt group vs. 2.3 ( 0.7 ) at baseline to 8.1 ( 4.3 ) in the conventional yogurt group at the end of 4th week . These results were based on the repeated measure ANOVA test and there was no statistically significant difference between the two groups ( mean difference : 0.1 ; Confidence Interval 95 % : -1.4 to 1.7 ; P = 0.872 ) . Constipation symptoms including straining , anorectal obstruction , manipulation to facilitate defecation , consistency of stool and color of stool were improved significantly ( P the amount of defecation was significantly increased in both groups ( P while incomplete evacuation was significantly reduced in the treatment group ( P = 0.01 ) . There was no statistically significant difference between the groups in the mean scores of physical ( P = 0.726 ) and mental ( P = 0.678 ) aspects of quality of life after the intervention with the adjusting of baseline scores . Conclusions Consumption of 300 g/day probiotic and conventional yogurt can play a role in improving the symptoms of constipation during pregnancy",
"BACKGROUND To our knowledge , data on the effects of probiotic supplementation on glycaemic control and lipid concentrations in patients with gestational diabetes mellitus ( GDM ) are scarce . AIM The aim of the present study was to determine the effects of probiotic supplementation on glycaemic control and lipid profiles in GDM patients . METHODS Sixty pregnant women with GDM , primigravida and aged 18 - 40years , were divided into two groups to receive either probiotic capsules ( n=30 ) or a matching placebo ( n=30 ) in this r and omized double-blind , placebo-controlled trial . The patients in the probiotic group took a daily capsule that contained three viable freeze-dried strains : Lactobacillus acidophilus ( 2 × 10(9)CFU/g ) , L. casei ( 2 × 10(9)CFU/g ) and Bifidobacterium bifidum ( 2 × 10(9)CFU/g ) for 6weeks . The placebo group took capsules filled with cellulose for the same time period . Fasting blood sample s were taken at the beginning and end of the study to quantify the relevant markers . RESULTS After 6weeks of intervention , probiotic supplementation vs a placebo result ed in significant decreases in fasting plasma glucose ( -9.2±9.2mg/dL vs + 1.1±12.2mg/dL , P ) , serum insulin levels ( -0.8±3.1μIU/mL vs + 4.5±10.6μIU/mL , P=0.01 ) , homoeostasis model assessment ( HOMA ) for insulin resistance ( -0.4±0.9 vs + 1.1±2.5 , P=0.003 ) and HOMA for β-cell function ( + 1.1±9.8 vs + 18.0±42.5 , P=0.03 ) , and a significant increase in the quantitative insulin sensitivity check index ( + 0.007±0.01 vs -0.01±0.02 , P=0.007 ) . In addition , significant decreases in serum triglycerides ( -1.6±59.4mg/dL vs + 27.1±37.9mg/dL , P=0.03 ) and VLDL cholesterol concentrations ( -0.3±11.9mg/dL vs + 5.4±7.6mg/dL , P=0.03 ) were seen following supplementation with the probiotics compared with the placebo . However , no significant changes in other lipid profiles were seen with the intervention . CONCLUSION Overall , the results of our study have demonstrated that taking probiotic supplements for 6weeks in patients with GDM had beneficial effects on glycaemic control , triglycerides and VLDL cholesterol concentrations , although there was no effect on other lipid profiles",
"Abstract Aims / Introduction To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet‐controlled gestational diabetes mellitus . Material s and Methods A r and omized , double‐blind , placebo‐controlled trial was carried out between June 2016 and February 2017 . Pregnant women with diet‐controlled gestational diabetes mellitus were enrolled in the study at 24–28 weeks‐of‐gestation and r and omized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or a placebo daily for four consecutive weeks . Primary outcomes were mean differences in insulin resistance ( homeostatic model assessment for insulin resistance ) , fasting insulin and fasting plasma glucose between the two groups . Secondary outcomes were changes in maternal weight after the intervention . Results Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed . The changes in metabolic parameters after r and omization showed significant improvement in glucose metabolism in the probiotic group compared with the placebo group , including fasting plasma glucose ( 0.68 ± 5.88 vs 4.620 ± 7.78 mg/dL , mean difference −3.94 mg/dL , 95 % confidence interval −7.62 , −0.27 , P = 0.034 ) , fasting plasma insulin ( 1.11 ± 1.71 vs 3.77 ± 1.70 mIU/L , mean difference −2.67 mIU/L , 95 % confidence interval −3.57 , −1.76 , P = 0.001 ) and homeostatic model assessment for insulin resistance ( 0.25 ± 0.37 vs 0.89 ± 0.46 , mean difference −0.63 , 95 % confidence interval −0.86 , −0.41 , P = 0.001 ) . Weight gain during r and omization was similar between the two groups . Conclusions Four weeks of probiotic supplements in women with diet‐controlled gestational diabetes in the late second and early third trimester lowered fasting glucose and increased insulin sensitivity . Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients",
"Abstract Objective : This study was design ed to evaluate the effects of probiotic supplementation on biomarkers of inflammation , oxidative stress and pregnancy outcomes among subjects with gestational diabetes ( GDM ) . Methods : This r and omized , double-blind , placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly allocated to intake either probiotic capsule containing Lactobacillus acidophilus , Lactobacillus casei and Bifidobacterium bifidum ( 2 × 109 CFU/g each ) ( n = 30 ) or placebo ( n = 30 ) for six weeks . Results : Compared with the placebo , probiotic supplementation result ed in significant decreases in fasting plasma glucose ( FPG ) ( −5.3 ± 6.7 vs. + 0.03 ± 9.0 mg/dL , p = .01 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( −2.2 ± 2.7 vs. + 0.5 ± 2.4 μg/mL , p concentrations ( −0.1 ± 0.8 vs. + 0.5 ± 1.5 μmol/L , p = .03 ) and MDA/TAC ratio ( −0.0003 ± 0.0008 vs. + 0.0009 ± 0.002 , p = .004 ) , and a significant increase in total antioxidant capacity ( TAC ) levels ( + 65.4 ± 103.3 vs. −37.2 ± 143.7 mmol/L , p = .002 ) . Probiotic supplementation did not affect pregnancy outcomes . Conclusions : Overall , probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG , serum hs-CRP , plasma TAC , MDA and oxidative stress index , but did not affect pregnancy outcomes ",
"The purpose of this study was to investigate the effects of probiotic and conventional yogurt on the lipid profile in type 2 diabetic people . In a r and omized double-blind controlled trial , 60 people ( 23 males and 37 females ) with type 2 diabetes and low-density lipoprotein cholesterol ( LDL-C ) greater than 2.6 mmol/L were assigned to 2 groups . Participants consumed daily 300 g of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or 300 g of conventional yogurt for 6 wk . Fasting blood sample s , anthropometric measurements and 3-d , 24-h dietary recalls were collected at the baseline and at the end of the trial . Probiotic yogurt consumption caused a 4.54 % decrease in total cholesterol and a 7.45 % decrease in LDL-C compared with the control group . No significant changes from baseline were shown in triglyceride and high-density lipoprotein cholesterol ( HDL-C ) in the probiotic group . The total cholesterol : HDL-C ratio and LDL-C : HDL-C ratio as atherogenic indices significantly decreased in the probiotic group compared with the control group . Probiotic yogurt improved total cholesterol and LDL-C concentrations in type 2 diabetic people and may contribute to the improvement of cardiovascular disease risk factors",
"BACKGROUND AND AIMS This study was design ed to assess the effects of combined vitamin D and probiotic supplementation on metabolic status and pregnancy outcomes in women with gestational diabetes ( GDM ) . METHODS This r and omized , double-blind , placebo-controlled clinical trial was performed in 87 women with GDM . Patients were r and omly assigned three groups to receive either vitamin D ( 50,000 IU/every 2 weeks ) plus probiotic ( 8 × 109 CFU/day ) ( n = 30 ) , probiotic ( 8 × 109 CFU/day ) ( n = 29 ) or placebo ( n = 28 ) for 6 weeks . RESULTS Vitamin D and probiotic co-supplementation significantly reduced fasting plasma glucose ( β -10.99 mg/dL ; 95 % CI , -14.26 , -7.73 ; P 0.001 ) , serum insulin levels ( β -1.95 μIU/mL ; 95 % CI , -3.05 , -0.84 ; P = 0.001 ) and homeostasis model of assessment -insulin resistance ( β -0.76 ; 95 % CI , -1.06 , -0.45 ; P increased the quantitative insulin sensitivity check index ( β 0.01 ; 95 % CI , 0.008 , 0.03 ; P = 0.001 ) compared with the placebo . In addition , vitamin D and probiotic co-supplementation result ed in a significant reduction in triglycerides ( β -37.56 mg/dL ; 95 % CI , -51.55 , -23.56 ; P ( β -7.51 mg/dL ; 95 % CI , -10.31 , -4.71 ; P ratio ( β -0.52 ; 95 % CI , -0.79 , -0.24 ; P protein ( β -1.80 mg/L ; 95 % CI , -2.53 , -1.08 ; P malondialdehyde ( β -0.43 μmol/L ; 95 % CI , -0.77 , -0.09 ; P = 0.01 ) ; also , a significant rise in HDL-cholesterol ( β 4.09 mg/dL ; 95 % CI , 1.11 , 7.08 ; P = 0.008 ) and total antioxidant capacity ( TAC ) levels ( β 97.77 mmol/L ; 95 % CI , 52.34 , 143.19 ; P Vitamin D and probiotic co-supplementation did not change other metabolic parameters . Vitamin D and probiotic co-supplementation significantly decreased triglycerides ( P = 0.02 ) , VLDL-cholesterol ( P = 0.02 ) and hs-CRP ( P = 0.01 ) , and significantly increased TAC ( P = 0.006 ) and total glutathione levels ( P = 0.04 ) compared with only probiotic group . CONCLUSIONS In conclusion , vitamin D and probiotic co-supplementation in women with GDM had beneficial effects on metabolic status . This trial was registered at www.i rct .ir as I RCT 201706075623N119",
"Introduction There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia . This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose ( primary outcome ) and on some maternal and infant complications ( secondary outcomes ) in overweight and obese women with no diabetes in pregnancy . Methods Using stratified block r and omization , women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose were assigned into probiotic or conventional yoghurt group , consuming 100 g/day from 24 weeks of gestation until delivery . The women and their infants were followed up until 1 month after birth . Results In each group , one out of 65 women had intra-uterine foetal death and were not analysed for other outcomes . The mean BMI was 29.2 ( SD 3.3 ) in probiotic and 30.3 ( SD 4.1 ) in conventional yoghurt group . Four weeks after initiation of the treatment , plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting ( mean difference adjusted for the BMI category ) and baseline FPG ( − 4.0 mg/dl ; 95 % confidence interval − 6.9 , − 1.1 ) and 2-h OGTT ( − 13.9 ; − 22.8 , − 5.0 ) . At the 1-h OGTT , however , the difference was not statistically significant ( − 9.8 ; − 20.6 , 0.9 ) . Further , there was a significantly lower infant bilirubin level in the probiotic group on days 3–5 after birth ( − 2.2 mg/dl ; − 3.3 , − 1.2 ) . There were not statistically significant differences between the groups regarding the risk of gestational diabetes ( 6 vs 11 ; odds ratio 0.5 ; 0.2 , 1.5 ) , preterm delivery ( 3 vs 8 ; 0.3 ; 0.1 , 1.2 ) , and other maternal and infant outcomes . Conclusion The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women . Nevertheless , further studies are required to judge the clinical significance of such effects"
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4116e1d8-06ff-11f0-808a-c43d1ab1c353
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AIMS Statins are known to influence the status of adipokines , which play a key role in the pathophysiology of cardiometabolic diseases . As the effect of ezetimibe as an add-on to statin therapy on the impact of statins on plasma adipokines levels is currently unclear , the aim of the present study was to investigate this through a meta- analysis of controlled trials . METHODS A systematic review was performed , followed by a bibliographic search in PubMed , Medline , SCOPUS , Web of Science and Google Scholar data bases . Quantitative data synthesis was performed using a fixed- or r and om-effects model ( based on the level of inter study heterogeneity ) and the generic inverse variance weighting method . Effect sizes were expressed as st and ardized mean difference ( SMD ) and 95 % confidence interval ( CI ) . RESULTS Meta- analysis of 23 controlled trials did not suggest any significant effect of adding ezetimibe on top of statin therapy on plasma concentrations of adiponectin ( SMD 0.34 , 95 % CI -0.28 , 0.96 ; P = 0.288 ) , leptin ( SMD -0.75 , 95 % CI : -2.35 , 0.85 ; P = 0.360 ) , plasminogen activator inhibitor 1 ( SMD -1.06 , 95 % CI : -2.81 , 0.69 ; P = 0.236 ) and interleukin 6 ( SMD 0.30 , 95 % CI : -0.08 , 0.67 ; P = 0.124 ) . However , significantly greater reductions in plasma concentrations of tumour necrosis factor α ( TNF-α ) ( SMD -0.48 , 95 % CI -0.87 , -0.08 ; P = 0.018 ) were achieved with ezetimibe/statin combination therapy . CONCLUSIONS The results suggested that ezetimibe add-on to statin therapy is associated with an enhanced TNF-α-lowering effect compared with statin monotherapy . Owing to the emerging role of TNF-α in the pathogenesis of metabolic disorders , further investigations are required to unveil the translational relevance of this TNF-α-lowering effect
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"We compared the effect of simvastatin versus simvastatin combined with ezetimibe on hemostasis and inflammation after acute coronary events [ acute coronary syndromes ( ACS ) ] . In an investigator-initiated , double-blind , placebo-controlled , r and omized study , patients with ACS were assigned to 40 mg/d of simvastatin + 10 mg/d of ezetimibe ( n = 26 ) or 40 mg/d of simvastatin + placebo ( n = 28 ) administered for 2 months . Markers of coagulation ( prothrombin fragments 1.2 , thrombin-antithrombin complexes , free tissue factor pathway inhibitor ) , fibrinolysis [ plasminogen activator inhibitor-1 , clot lysis time ( CLT ) ] , platelet activation ( soluble CD40 lig and , β-thromboglobulin , thromboxane B2 ) , oxidative stress [ 8-iso-prostagl and in F2α ( 8-iso-PGF2α ) ] , and inflammation ( interleukin-6 , interleukin-18 , and interleukin-1β ) were measured within the first 12 hours of ACS and at 1 and 2 months of therapy . A final analysis comprised 20 patients in the simvastatin + ezetimibe group and 26 patients in the simvastatin + placebo group . Both groups were similar with regard to demographics , risk factors , medications , and routine laboratory results . Inflammatory , coagulation , and platelet markers did not differ between both treatment groups at all time points . Reductions in low-density lipoprotein cholesterol , CLT , plasminogen activator inhibitor-1 , and 8-iso-PGF2α were significantly greater ( by 10 % , 8.7 % , 17.5 % , and 22.4 % ) in the simvastatin + ezetimibe group after 1 month , with further decreases in CLT and 8-iso-PGF2α at 2 months ( all P with simvastatin alone , simvastatin + ezetimibe results in a greater suppression of oxidative stress and enhanced fibrinolysis in patients with ACS , indicating that ezetimibe might exert cholesterol-independent actions in humans ( NCT00725829 )",
"The aim of this study was to assess the strength of hemostatic effects of ezetimibe , administered alone or in combination with simvastatin , in patients with isolated hypercholesterolemia . One hundred and four patients with isolated primary hypercholesterolemia were r and omized to one of four treatment groups , simultaneously treated for 90 days with ezetimibe ( 10 mg daily ) , simvastatin ( 40 mg daily ) , ezetimibe ( 10 mg daily ) plus simvastatin ( 40 mg daily ) , or placebo . Plasma lipids/lipoproteins and hemostatic cardiovascular risk factors were assessed on the day of r and omization and after 30 and 90 days of therapy . Despite improving lipid/lipoprotein profile by both simvastatin and ezetimibe , only simvastatin reduced plasma levels/activity of fibrinogen , factor VII , factor X , von Willebr and factor , and plasminogen activator inhibitor-1 . The strongest effects on plasma lipids/lipoproteins and the assessed hemostatic variables were observed when patients were treated with both simvastatin and ezetimibe . With the exception of oxidized low-density lipoproteins , the hemostatic effects of simvastatin or simvastatin plus ezetimibe did not correlate with the changes in plasma lipids/lipoproteins . Our study shows that simvastatin is a more effective agent than ezetimibe in affecting coagulation and fibrinolysis in individuals with isolated hypercholesterolemia . It also suggests that the combined administration of simvastatin and ezetimibe may bring more benefits to patients than monotherapy with only one of these agents",
"Adiponectin can suppress atherogenesis by inhibiting the adherence of monocytes , reducing their phagocytic activity , and suppressing the accumulation of modified lipoproteins in the vascular wall . Contradictory data have been reported about the effect of statins on adiponectin plasma levels . In this work , adiponectin plasma levels were measured in 102 statin-free subjects from the Spanish population of the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration ( ACTFAST ) study , a 12-week , prospect i ve , multi-centre , open-label trial which enrolled subjects with coronary heart disease , coronary heart disease-equivalent or a 10-year coronary heart disease risk > 20 % . Subjects were assigned to atorvastatin ( 10 - 80 mg/day ) based on low-density lipoprotein (LDL)-cholesterol concentration at screening . For comparison , age and gender-matched blood donors ( N=40 ) were used as controls . Control subjects did not present hypertension , hypercholesterolemia , diabetes , metabolic syndrome and history of cardiovascular diseases . Adiponectin levels were diminished in patients at high cardiovascular risk compared with control subjects [ 4166 ( 3661 - 4740 ) vs 5806 ( 4764 - 7075 ) ng/ml respectively ; geometric mean ( 95 % CI ) ; P atorvastatin treatment increased adiponectin levels [ 9.7 (3.2 - 16.7);% Change ( 95 % CI ) ; P=0.003 ] . This increment was in a dose-dependent manner ; maximal effect observed with atorvastatin 80 mg/d [ 24.7 ( 5.7 - 47.1 ) ; P=0.01 ] . Adiponectin concentrations were positively correlated with high-density lipoprotein-cholesterol both before and after atorvastatin treatment . No association was observed between adiponectin and LDL-cholesterol before and after atorvastatin treatment . In conclusion , atorvastatin increased adiponectin plasma levels in subjects at high cardiovascular risk , revealing a novel anti-inflammatory effect of this drug",
"AIM Ezetimibe selectively blocks intestinal cholesterol absorption by inhibiting Niemann-Pick C1-like 1 ( NPC1L1 ) and reducing LDL cholesterol ( LDL-C ) . In animals , ezetimibe reversed diet-induced obesity , liver steatosis , and insulin resistance . In humans , its potential effects on liver steatosis and insulin resistance have been suggested . We investigated the effects of ezetimibe on postpr and ial hyperlipidaemia and hyperglycaemia in obese subjects with dyslipidaemia in a double-blind r and omized crossover trial . METHODS Twenty obese men with hypertriglyceridaemia were assigned r and omly to an ezetimibe- or a placebo-precedence-treated group . Subjects in the ezetimibe group were treated with ezetimibe ( 10 mg/day ) for the first 4 weeks , followed by a 4-week interval and then treated with placebo for another 4 weeks . The placebo group received these treatments in reverse order . Subjects were requested to fast for at least 12 hours and then received a st and ard meal . Blood sample s were collected at 0 , 30 , 60 , 120 , 240 , 360 and 480 minutes after the meal on Days 0 , 28 , 56 and 84 and were used to measure the lipid and glucose metabolism markers . RESULTS Ezetimibe significantly decreased the postpr and ial serum triglyceride excursion ( p=0.01 ) and fasting serum LDL-C , remnant-like particles(RLP ) and ApoB48 levels ( p Postpr and ial glucose excursion , serum insulin levels , serum glucose-dependent insulinotropic polypeptide ( GIP ) and active glucagon-like peptide-1 ( GLP-1 ) were not significantly affected by ezetimibe treatment . CONCLUSION Ezetimibe restored the postpr and ial dysregulation of lipid but did not affect glucose metabolism in a double-blind r and omized crossover trial",
"Background — Statins lower low-density lipoprotein cholesterol ( LDL-C ) and high-sensitivity C-reactive protein ( hs-CRP ) ; addition of ezetimibe to statins further reduces LDL-C and hs-CRP . An analysis of the relationship between achieved LDL-C and hs-CRP targets and outcomes for simvastatin and ezetimibe/simvastatin was prespecified in Improved Reduction of Outcomes : Vytorin Efficacy International Trial ( IMPROVE-IT ) . Methods and Results — The IMPROVE-IT trial r and omly assigned 18 144 patients stabilized after acute coronary syndrome to simvastatin or ezetimibe/simvastatin . LDL-C and hs-CRP were measured at baseline and 1 month after r and omization . Outcomes were assessed in those achieving one or both of the prespecified targets of LDL-C LDL-C mg/dL and hs-CRP Patients meeting both targets at baseline , with no 1-month values , or with end points before 1 month were excluded . Of 15 179 patients , 39 % achieved the dual LDL-C ( hs-CRP ( lower primary end point rates than those meeting neither target ( cardiovascular death , major coronary event , or stroke ; 38.9 % versus 28.0 % ; adjusted hazard ratio , 0.73 ; 0.66–0.81 ; P patients treated with ezetimibe/simvastatin met dual targets than those treated with simvastatin alone ( 50 % versus 29 % , P patients treated with ezetimibe/simvastatin met prespecified and exploratory dual LDL-C and hs-CRP targets than patients treated with simvastatin alone . Reaching both LDL-C and hs-CRP targets was associated with improved outcomes after multivariable adjustment . Clinical Trial Registration — URL : http://www . clinical trials.gov ; Unique identifier : NCT00202878",
"Lipid-lowering therapy is associated with reduced cardiovascular risk . The aim of the present study was to investigate whether lipid-lowering therapy might be associated with changes in the concentrations of metabolically important hormone concentrations . We performed a r and omised cross-over open-label trial with atorvastatin ( 10 mg/day ) and fenofibrate ( 200 mg/day ) , each for 6 weeks separated by a 6-week washout period in 13 patients ( 5 men , 8 women , age 60.0±6.8 years , body mass index 30.0±3.0 kg/m2 ) with type 2 diabetes mellitus and mixed hyperlipoproteinaemia . Plasma ghrelin ( RIA , Phoenix Pharmaceuticals , Mountain View , CA , USA ) , adiponectin ( ELISA , Biovendor , Heidelberg , Germany ) as well as resistin ( ELISA , Linco Research , St. Charles , MO , USA ) concentrations were measured before and after atorvastatin as well as before and after fenofibrate . Ghrelin ( 462±84 pg/ml before vs. 464±102 pg/ml after atorvastatin , n.s . ; 454±85 pg/ml before vs. 529±266 pg/ml after fenofibrate , n.s . ) , resistin ( 24.4±7.4 pg/ml before vs. 23.7±9.1 pg/ml after atorvastatin , n.s . ; 23.4±8.2 pg/ml before vs. 19.9±5.5 pg/ml after fenofibrate , n.s . ) , adiponectin ( 10.89±5.33 pg/ml before vs. 12.41±5.75 pg/ml after atorvastatin , n.s . ; 12.58±9.87 pg/ml before vs. 10.27±5.23 pg/ml after fenofibrate , n.s . ) and insulin levels did not change significantly during lipid-lowering therapy . In patients with type 2 diabetes and mixed hyperlipoproteinaemia , short-term atorvastatin as well as fenofibrate therapy had no significant effects on adiponectin , ghrelin or resistin levels ",
"Weight loss and hypolipidemic drugs can improve lipid and adipokine levels . We assessed the effects of rimonabant , alone and in combination with fenofibrate or ezetimibe , on adipokine levels in obese/overweight patients with dyslipidemia . Overweight/obese patients ( n = 60 , body mass index = 27 - 40 kg/m2 ) with mixed dyslipidemia were recruited . Patients received a hypocaloric diet and were r and omized to rimonabant 20 mg/d ( group R , n = 20 ) , rimonabant 20 mg/d plus fenofibrate 200 mg/d ( group RF , n = 20 ) , or rimonabant 20 mg/d plus ezetimibe 10 mg/d ( group RE , n = 20 ) . After 3 months , leptin concentration was significantly reduced in all groups ( —38 % , P Total adiponectin remained unaltered . Visfatin concentration decreased significantly only in the RE and RF groups ( —18 % and —38 % , respectively ; P rimonabant may improve adipokine levels in overweight/obese patients with dyslipidemia . The addition of fenofibrate or ezetimibe may reinforce this effect",
"Background Hyperlipidemia , insulin resistance , and oxidative stress can heavily contribute to the initiation and progression of nonalcoholic fatty liver disease ( NAFLD ) . Currently , there is no established treatment for this disease . Recently , several studies have shown that ezetimibe ( EZ ) , a lipid-lowering drug , attenuates liver steatosis in an experimental NAFLD model . This study was design ed to assess the efficacy of long-term EZ monotherapy in patients with NAFLD . Methods A total of 45 patients with newly diagnosed liver biopsy-proven NAFLD were treated with EZ ( 10 mg/day ) for 24 months . NAFLD-related biochemical parameters , imaging by computerized tomography , and liver biopsy were studied before and after treatment . Results Ezetimibe therapy significantly improved NAFLD-related metabolic parameters including visceral fat area , fasting insulin , homeostasis model assessment of insulin resistance ( HOMA-R ) , triglycerides , total cholesterol , low-density lipoprotein cholesterol ( LDL-Ch ) , oxidative-LDL , the net electronegative charge modified-LDL , profiles of lipoprotein particle size and fatty acids component , and estimated desaturase activity . EZ therapy also significantly lowered serum alanine aminotransferase and high-sensitivity C-reactive protein levels , whereas no significant changes were found in serum type IV collagen 7S , adiponectin , leptin , and resistin levels . Histological features of steatosis grade ( P = 0.0003 ) , necroinflammatory grade ( P = 0.0456 ) , ballooning score ( P = 0.0253 ) , and NAFLD activity score ( NAS ) ( P = 0.0007 ) were significantly improved from baseline . However , the fibrosis stage was not significantly ( P = 0.6547 ) changed . Conclusion The results in this study suggest that the long-term EZ therapy can lead to improvement in metabolic , biochemical , and histological abnormalities of NAFLD . Therefore , EZ may be a promising agent for treatment of NAFLD",
"BACKGROUND Despite st and ard statin therapy , a majority of patients retain a high \" residual risk \" of cardiovascular events . OBJECTIVES The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention ( PCI ) . METHODS This trial was a prospect i ve , r and omized , controlled , multicenter study . Eligible patients who underwent PCI were r and omly assigned to atorvastatin alone or atorvastatin plus ezetimibe ( 10 mg ) daily . Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol ( LDL-C ) volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients . RESULTS The combination of atorvastatin/ezetimibe result ed in lower levels of LDL-C than atorvastatin monotherapy ( 63.2 ± 16.3 mg/dl vs. 73.3 ± 20.3 mg/dl ; p the absolute change in percent atheroma volume ( PAV ) , the mean difference between the 2 groups ( -1.538 % ; 95 % confidence interval [ CI ] : -3.079 % to 0.003 % ) did not exceed the pre-defined noninferiority margin of 3 % , but the absolute change in PAV did show superiority for the dual lipid-lowering strategy ( -1.4 % ; 95 % CI : -3.4 % to -0.1 % vs. -0.3 % ; 95 % CI : -1.9 % to 0.9 % with atorvastatin alone ; p = 0.001 ) . For PAV , a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression ( 78 % vs. 58 % ; p = 0.004 ) . Both strategies had acceptable side effect profiles , with a low incidence of laboratory abnormalities and cardiovascular events . CONCLUSIONS Compared with st and ard statin monotherapy , the combination of statin plus ezetimibe showed greater coronary plaque regression , which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering . ( Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [ PRECISE-IVUS ] ; NCT01043380 )",
"BACKGROUND There is no study focusing on changes in coronary atherosclerosis during dual lipid-lowering therapy with statin and ezetimibe . METHODS AND RESULTS Eighty-nine patients with stable angina r and omized in a 1:1 ratio to Group A ( aggressive therapy : atorvastatin 80 mg , ezetimibe 10 mg ) and Group S ( st and ard therapy ) were analyzed . Treatment period was 12 months . Coronary arteries were examined by intravascular ultrasound and virtual histology . We found a decrease in the percent atheroma volume ( PAV ) ( -0.4 % ) in Group A compared with an increase ( + 1.4 % ) in Group S ( P=0.014 ) and this was accompanied by an increased frequency of combined atherosclerosis regression ( increased lumen volume+decreased PAV ) in group A ( 40.5 % ) compared with group S ( 14.9 % ) ( P=0.007 ) . The target low-density lipoprotein cholesterol level vascular cellular adhesive molecule were independent predictors of plaque regression . There were no significant differences in plaque composition between the 2 groups over the study duration . However , during analysis of the 2 groups together , fibrous and fibro-fatty tissues decreased and dense calcification and necrotic core increased during follow-up . CONCLUSIONS Dual lipid-lowering therapy starts atherosclerosis regression , but does not lead to significant changes in plaque composition . The continuous shift in plaque from fibro and fibro-fatty to necrotic with calcification was present in both groups",
"Background Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant sterols . Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated , but data concerning the pleiotropic effects of this combination are controversial . Objective This open-label trial evaluated whether the combination of simvastatin and ezetimibe also results in a synergistic effect that reduces the pro-inflammatory status of pre-diabetic subjects . Methods Fifty pre-diabetic subjects were r and omly assigned to one of 2 groups , one receiving ezetimibe ( 10 mg/day ) , the other , simvastatin ( 20 mg/d ) for 12 weeks , followed by an additional 12-week period of combined therapy . Blood sample s were collected at baseline , 12 and 24 weeks . RESULTS : Total cholesterol , LDL-cholesterol and apolipoprotein B levels decreased in all the periods analyzed ( p but triglycerides declined significantly only after combined therapy . Both drugs induced reductions in C-reactive protein , reaching statistical significance after combining ezetimibe with the simvastatin therapy ( baseline 0.59 ± 0.14 , simvastatin monotherapy 0.48 ± 0.12 mg/dL and 0.35 ± 0.12 mg/dL , p of LDL-cholesterol change . However , mean levels of TNF-α and interleukin-6 and leukocyte count did not vary during the whole study . Conclusion Expected synergistic lowering effects of a simvastatin and ezetimibe combination on LDL-cholesterol , apolipoprotein B and triglycerides levels were confirmed in subjects with early disturbances of glucose metabolism . We suggest an additive effect of this combination also on inflammatory status based on the reduction of C-reactive protein . Attenuation of pro-inflammatory conditions may be relevant in reducing cardiometabolic risk . Title/ID of trial registration Effect of simvastatin and ezetimibe on lipid and inflammation/NCT01103648",
"OBJECTIVE Lowering LDL-cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-κB. To our knowledge , anti-inflammatory potential of newer cholesterol lowering agents such as ezetimibe is less intensively studied . Therefore we analyzed the effects of equipotent LDL-lowering therapy with simvastatin alone compared to a combination with ezetimibe on NF-κB activation in peripheral blood mononuclear cells ( P BMC s ) of patients with type 2 diabetes . METHODS Thirty-one patients with type 2 diabetes were included in a double-blind , r and omized trial receiving either 80 mg simvastatin ( sim80 ; n = 10 ) or a combination of 10 mg simvastatin and 10 mg ezetimibe ( sim10eze10 ; n = 11 ) or placebo ( n = 9 ) for eight weeks . NF-κB binding activity and inflammatory markers ( IL-6 , hsCRP ) were analyzed at baseline and after eight weeks of treatment . NF-κB binding activity was analyzed by electrophoretic mobility shift assay . IL-6 and hsCRP were measured by ELISA . RESULTS After eight weeks of treatment LDL-cholesterol was lowered to the same extent in both treatment groups ( p = 0.40 ) but not in placebo . However , patients taking sim80 showed a significant reduction of mononuclear NF-κB binding activity compared to baseline ( p = 0.009 ) while no effect was observed in the sim10eze10 group ( p = 0.79 ) . Similar differences in anti-inflammatory effects were also observed when analyzing hsCRP ( sim80 : p = 0.03 ; sim10eze10 : p = 0.40 ) and IL-6 levels ( sim80 : p = 0.15 ; sim10eze10 : p = 0.95 ) . CONCLUSION High dose simvastatin therapy reduces proinflammatory transcription factor NF-κB binding activity and hsCRP levels , while combination of low dose simvastatin with ezetimibe result ing in a similar LDL-reduction does not affect these inflammatory markers",
"Background Statins are frequently administered to reduce low-density lipoprotein cholesterol ( LDL-C ) and vascular inflammation , because LDL-C and high sensitive C-reactive protein ( hs-CRP ) are associated with high risk for cardiovascular events . When statins do not reduce LDL-C to desired levels in high-risk patients with coronary artery disease ( CAD ) , ezetimibe can be added or the statin dose can be increased . However , which strategy is more effective for treating patients with CAD has not been established . The present study compares anti-inflammatory effects and lipid profiles in patients with CAD and similar LDL-C levels who were treated by increasing the statin dose or by adding ezetimibe to the original rosuvastatin dose to determine the optimal treatment for such patients . Methods 46 patients with high-risk CAD and LDL-C and hs-CRP levels of > 70 mg/dL and > 1.0 mg/L , respectively , that were not improved by 4 weeks of rosuvastatin ( 2.5 mg/day ) were r and omly assigned to receive 10 mg ( R10 , n = 24 ) of rosuvastatin or 2.5 mg/day of rosuvastatin combined with 10 mg/day of ezetimibe ( R2.5/E10 , n = 22 ) for 12 weeks . The primary endpoint was a change in hs-CRP . Results Baseline characteristics did not significantly differ between the groups . At 12 weeks , LDL-C and inflammatory markers ( hs-CRP , interleukin-6 , tumour necrosis factor-alpha and pentraxin 3 ) also did not significantly differ between the two groups ( LDL-C : R10 vs. R2.5/E10 : -19.4 ± 14.2 vs. -22.4 ± 14.3 mg/dL ) . However , high-density lipoprotein cholesterol ( HDL-C ) was significantly improved in the R10 , compared with R2.5/E10 group ( 4.6 ± 5.9 vs. 0.0 ± 6.7 mg/dL ; p anti-inflammatory effects under an equal LDL-C reduction in patients with high-risk CAD despite 2.5 mg/day of rosuvastatin . However , R10 elevated HDL-C more effectively than R2.5/E10.Trial registration",
"AIMS HMG-CoA reductase inhibitors ( statins ) reduce cardiovascular mortality and morbidity in patients with stable coronary artery disease as well as acute coronary syndrome ( ACS ) . It is unclear how rapidly the beneficial effects of statins occur in patients with ACS and whether these drug properties are related to lipid lowering . METHODS AND RESULTS Patients with troponin-positive ACS ( n=35 ) were r and omized to 20 mg/day rosuvastatin therapy or to placebo treatment . Anti-inflammatory effects of rosuvastatin measured by lymphocyte intracellular cytokine production were taken before initiation of treatment and on days 1 , 3 , and 42 . Compared with placebo , rosuvastatin treatment significantly reduced plasma concentrations of pro-inflammatory cytokines TNF-alpha and IFN-gamma at 72 h. Rosuvastatin also induced a rapid and significant reduction of TNF-alpha and IFN-gamma production in stimulated T-lymphocytes at 72 h. When compared with placebo , rosuvastatin inhibited the Th-1-immune response measured at 72 h. CONCLUSION Rosuvastatin exerts rapid immunomodulatory effects on the level of T-cell activation in patients with ACS",
"BACKGROUND In approximately 80 % of cardiovascular disease-related deaths , patients suffer from coronary atherosclerotic heart disease . Ezetimibe is the first intestinal cholesterol absorption inhibitor . Its combination with statins for treating coronary atherosclerotic heart disease has attracted attention worldwide . METHODS The study group comprised 106 patients with coronary atherosclerotic heart disease and hyperlipidaemia . Each was r and omly assigned to one of two groups : ( 1 ) Ezetimibe ( 10 mg , once a night ) plus rosuvastatin ( 10 mg , once a night ) ( n=55 ) or ( 2 ) Rosuvastatin alone ( 10 mg , once a night ) ( n=51 ) . The primary endpoint was new or recurrent myocardial infa rct ion , unstable angina pectoris , cardiac death , and stroke . Blood lipid , high-sensitivity C-reactive protein ( hsCRP ) , interleukin-6 ( IL-6 ) , and matrix metalloproteinase-9 ( MMP-9 ) levels were measured before treatment and at one , six and 12 months after treatment . Coronary plaque size and compositional changes were determined using intravascular ultrasonography . RESULTS The combination of ezetimibe plus rosuvastatin decreased total cholesterol , low-density lipoprotein cholesterol , hsCRP , IL-6 , and MMP-9 levels at six and 12 months after treatment . Statistical significance was detected between two groups . At 12 months , the plaque burden , plaque cross-sectional area , and percentage of necrotic plaque composition were significantly lower in the combination group than in rosuvastatin alone group ( P rosuvastatin alone group , the primary endpoint decreased more effectively in combination group . CONCLUSIONS The combination of ezetimibe and rosuvastatin apparently diminishes lipid levels and plaque burden and improves plaque stability , which may be associated with the potent inhibitory effects of ezetimibe and rosuvastatin on inflammatory cytokines",
"Abstract Objectives . Statins decrease cardiovascular events mainly by lowering cholesterol but anti-inflammatory effects also play a role . The effects of the cholesterol absorption inhibitor ezetimibe on markers of inflammation remain unclear . We performed an exploratory post-hoc analysis whether these drugs influence the pro-inflammatory markers interleukin-6 and high-sensitivity C-reactive protein in subjects with very-low cardiovascular risk . Design . Single center , r and omized , parallel 3-group study in 72 healthy men without apparent cardiovascular disease ( age 32 ± 9 years , BMI 25.7 ± 3.2 kg/m2 ) . Each group of 24 subjects received a 14-day treatment with either simvastatin 40 mg , ezetimibe 10 mg , or their combination . Results . Baseline IL-6 and hsCRP concentrations in the total cohort were 0.72 ± 0.57 ng/l and 0.40 ± 0.65 mg/l , respectively , with no differences between the 3 groups . Median changes ( interquartile range ) in IL-6 and hsCRP concentrations were −22 % ( −43 to 0 % ) and −30 % ( −44 to + 19 % ) after simvastatin , −5 % ( −36 to + 30 % ) and + 9 % ( −22 to + 107 % ) after ezetimibe , and + 15 % ( −15 to + 86 % ) and + 1 ( −30 to + 49 % ) after the combination . Using a generalized linear model , the multivariable adjusted overall P-values for these changes were 0.008 ( IL-6 ) and 0.1 ( hsCRP ) . Conclusions . Simvastatin decreases the pro-inflammatory markers IL-6 and almost significantly hsCRP while ezetimibe monotherapy or the combination with simvastatin has no effect . Trial registration : Clinical Trials.gov identifier : NCT00317993",
"BACKGROUND Pleiotropic effects of ezetimibe have only been investigated in a few studies . The aim of this article was to compare the effects of simvastatin and the combined treatment with simvastatin and ezetimibe on low- grade systemic inflammation and plasma levels of selected adipokines in patients with isolated hypercholesterolemia . METHODS The study included 69 patients with elevated cholesterol levels , who were allocated to one of the three groups treated for 12 weeks , respectively , with simvastatin ( 40 mg daily ) , simvastatin ( 40 mg daily ) plus ezetimibe ( 10 mg daily ) , or placebo . Plasma levels of lipids , apolipoproteins , glucose homeostasis markers , leptin , adiponectin , visfatin , tumor necrosis factor-α ( TNF-α ) , free fatty acids ( FFA ) , and high-sensitive C-reactive protein ( hsCRP ) were determined on the allocation day and after 12 weeks of therapy . RESULTS Apart from improving lipid profile , simvastatin administered alone or in combination with ezetimibe , decreased plasma levels of hsCRP , FFA , leptin , visfatin , and TNF-α , as well as increased plasma levels of adiponectin . The combination therapy was superior to simvastatin in influencing plasma lipids/lipoproteins , hsCRP , FFA , and the investigated adipokines . The effect of the combination therapy , but not of simvastatin , on systemic inflammation and plasma adipokines was stronger in insulin-resistant than in insulin-sensitive subjects . CONCLUSIONS The obtained results suggest that insulin-resistant patients with hypercholesterolemia and high cardiovascular risk may benefit the most from the combined treatment with simvastatin and ezetimibe",
"BACKGROUND Inflammation may contribute to the high cardiovascular risk in diabetes mellitus ( DM ) and chronic kidney disease ( CKD ) . Monocyte chemoattractant protein-1 ( MCP-1 ) facilitates the recruitment of monocytes into atherosclerotic lesions and is involved in diabetic nephropathy . Interferon gamma ( IFNγ ) is important in atherosclerosis and increases the synthesis of chemokines including MCP-1 . Lipid-lowering treatment ( LLT ) with statins may have anti-inflammatory effects , and ezetimibe cotreatment provides additional cholesterol lowering . METHODS After a placebo run-in period , the effects of simvastatin alone ( S ) or simvastatin + ezetimibe ( S+E ) were compared in a r and omized , double-blind , cross-over study on inflammatory parameters . Eighteen DM patients with estimated glomerular filtration rate ( eGFR ) 15 - 59 mL/min × 1·73 m(2 ) ( CKD stages 3 - 4 ) ( DM-CKD ) and 21 DM patients with eGFR > 75 mL/min ( DM only ) were included . RESULTS At baseline , monocyte chemoattractant protein 1 ( MCP-1 ) ( P = 0·03 ) , IFNγ ( P = 0·02 ) , tumour necrosis factor-α ( TNFα ) ( P 0·01 ) and soluble vascular adhesion molecule ( sVCAM ) ( P = 0·001 ) levels were elevated in DM-CKD compared with DM-only patients . LLT with S and S+E reduced MCP-1 levels ( P and IFNγ levels ( P DM patients with CKD stages 3 - 4 had increased inflammatory activity compared with DM patients with normal GFR . Lipid-lowering treatment decreased the levels of MCP-1 and IFNγ in DM patients with concomitant CKD , which may be beneficial with regard to the progression of both atherosclerosis and diabetic nephropathy",
"In addition to their expected effects on lipid profile , lipid-lowering agents may reduce cardiovascular events because of effects on nonclassic risk factors such as insulin resistance and inflammation . Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol as well as plant sterols . Although it is known that an additional reduction of low-density lipoprotein cholesterol ( LDL-C ) levels can be induced by the combination of ezetimibe with statins , it is not known if this can enhance some pleiotropic effects , which may be useful in slowing the atherosclerotic process . This study assessed the effects of simvastatin and ezetimibe , in monotherapy or in combination , on markers of endothelial function and insulin sensitivity . Fifty prediabetic subjects with normo- or mild-to-moderate hypercholesterolemia were r and omly allocated to 2 groups receiving either ezetimibe ( 10 mg/d ) or simvastatin ( 20 mg/d ) for 12 weeks , after which the drugs were combined for both groups for an additional 12-week period . Clinical and laboratory parameters were measured at baseline and after 12 and 24 weeks of therapy . Homeostasis model assessment of insulin resistance index and the area under the curve of insulin were calculated . As expected , both groups receiving drugs in isolation significantly reduced total cholesterol , LDL-C , apolipoprotein B , and triglyceride levels ; and additional reductions were found after the combination period ( P plasminogen activator inhibitor-1 levels and urinary albumin excretion were lower in the simvastatin than in the ezetimibe group . No change in homeostasis model assessment of insulin resistance index , area under the curve of insulin , and adiponectin levels was observed after either the monotherapies or the combined therapy . However , simvastatin combined with ezetimibe provoked significant reductions in E-selectin and intravascular cellular adhesion molecule-1 levels that were independent of LDL-C changes . Our findings support cl aims that simvastatin may be beneficial in preserving endothelial function in prediabetic subjects with normo- or mild-to-moderate hypercholesterolemia . Alternatively , a deleterious effect of ezetimibe on the endothelial function is suggested , considering the increase in intravascular cellular adhesion molecule-1 and E-selectin levels . Simvastatin and ezetimibe , in isolation or in combination , do not interfere with insulin sensitivity",
"PURPOSE The beneficial effect of rosuvastatin against percutaneous coronary intervention ( PCI ) related procedural myocardial injury has been determined mostly in patients with acute coronary syndromes ( ACS ) . However , the detailed therapeutic mechanism has not been well studied . METHODS Patients with ACS receiving PCI ( n = 159 ) were r and omized to control group ( placebo treatment ) or to rosuvastatin group ( 20 mg 12 h before PCI , and a further 20 mg 2 h preprocedure dose ) . Levels of INF-γ , TNF-α , IL-6 , miR-155/SHIP-1 , and CD4(+)FoxP3(+)Treg in peripheral blood were detected before PCI and 24 h after PCI . Clinical data of these patients were also collected in this prospect i ve study . RESULTS Compared with placebo , rosuvastatin treatment significantly reduced the incidence of periprocedural myocardial infa rct ion ( PMI ) and levels of cardiac troponin I ( cTnI ) associated with decreased relative expression of serum miR-155 , levels of inflammatory cytokines ( INF-γ , TNF-α , and IL-6 ) , increased SHIP-1 expression and CD4(+)FoxP3(+)Treg percentage values ( P with rosuvastatin pretreatment also reduced incidence of 30 days major adverse cardiac events ( MACE ) compared to the patients with placebo treatment ( 16 patients vs. 28 patients , P = 0.038 ) . CONCLUSIONS Our study suggests that high loading dose rosuvastatin pretreatment may reduce the incidence of cardiovascular events and levels of inflammatory markers in patients with ACS receiving PCI , which may be explained at least in part , by mechanism involving suppression of miR-155/SHIP-1 signaling pathway",
"This study compared the efficacy and safety of co-administered ezetimibe + simvastatin with atorvastatin monotherapy in adults with hypercholesterolemia . Seven hundred eighty-eight patients were r and omized 1:1:1 to 3 treatment groups ; each group was force-titrated over four 6-week treatment periods : ( 1 ) 10 mg of atorvastatin as the initial dose was titrated to 20 , 40 , and 80 mg ; ( 2 ) co-administration of 10 mg of ezetimibe and 10 mg of simvastatin ( 10/10 mg ) was titrated to 10/20 , 10/40 , and 10/80 mg of ezetimibe + simvastatin ; and ( 3 ) co-administration of 10/20 mg of ezetimibe + simvastatin was titrated to 10/40 mg ( for 2 treatment periods ) and 10/80 mg of ezetimibe + simvastatin . Key efficacy measures included percent changes in low-density lipoprotein cholesterol ( LDL ) and high-density lipoprotein cholesterol ( HDL ) from baseline to the ends of ( 1 ) treatment periods 1 and 2 ( for LDL cholesterol ) comparing co-administration of 10/20 mg and 10/10 mg of ezetimibe + simvastatin with 10 mg of atorvastatin and ( 2 ) treatment period 4 ( for LDL cholesterol and HDL cholesterol ) comparing co-administration of 10/80 mg of ezetimibe + simvastatin with 80 mg of atorvastatin . Baseline LDL and HDL cholesterol levels were comparable between treatment groups . At the end of treatment period 1 , the mean decrease of LDL cholesterol was significantly ( p ezetimibe + simvastatin than for 10 mg of atorvastatin . At the end of treatment period 4 and after comparing maximum doses , co-administration of 10/80 mg of ezetimibe + simvastatin was superior to 80 mg of atorvastatin in the percent LDL cholesterol decrease ( -59.4 % vs -52.5 % , p HDL cholesterol increase ( 12.3 % vs 6.5 % ; p well tolerated . Thus , a greater LDL cholesterol decrease and HDL cholesterol increase were attained by treating patients with co-administration of ezetimibe and simvastatin than with atorvastatin"
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Attention-deficit hyperactivity disorder ( ADHD ) has a significant impact on children ’s classroom behaviour , daily functioning and experience of school life . However , the effects of drug treatment for ADHD on learning and academic achievement are not fully understood . This review was undertaken to describe the effects of methylpheni date , dexamfetamine , mixed amfetamine salts and atomoxetine on children ’s on-task behaviour and their academic performance , and to perform a meta- analysis to quantify these effects . Nine electronic data bases were systematic ally search ed for r and omized controlled trials comparing drug treatment for ADHD against ( i ) no drug treatment , ( ii ) baseline ( in crossover trials ) , or ( iii ) placebo ; reporting outcomes encompassing measures of educational achievement within the classroom environment . Forty-three studies involving a pooled total of 2,110 participants were identified for inclusion . Drug treatment benefited children in the amount of school work that they completed , by up to 15 % , and less consistently improved children ’s accuracy in specific types of academic assignments , such as arithmetic . Similar improvements were seen in classroom behaviour , with up to 14 % more of children ’s time spent “ on task ” . Methylpheni date , dexamfetamine and mixed amfetamine formulations all showed beneficial effects on children ’s on-task behaviour and academic work completion . Atomoxetine was examined in two studies , and was found to have no significant effect . These review findings suggest that medication for ADHD has the potential to improve children ’s learning and academic achievement
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"CONTEXT Many children with attention-deficit/hyperactivity disorder ( ADHD ) continue to exhibit symptoms of the disorder into adolescence and adulthood . Although ADHD may have a profound impact on activities of daily living , including educational achievement and work performance , limited research exists on ADHD 's impact on individual income loss and overall economic effect . OBJECTIVES Evaluate ADHD 's impact on individual employment and income , and quantify costs of ADHD on workforce productivity for the US population . DESIGN Two telephone surveys were conducted between April 18 , 2003 , and May 11 , 2003 , to collect demographic , educational , employment , and income information . PARTICIPANTS Two groups of adults aged 18 - 64 years were interviewed : those diagnosed with ADHD ( n = 500 ) derived from a national list of mail-paneled members who identified themselves or a household member as having been diagnosed with ADHD , and an age- and gender-matched control group ( n = 501 ) derived from a r and om digital-dialing sample of a national cross-section not diagnosed with ADHD . RESULTS Statistically fewer subjects in the ADHD group achieved academic milestones beyond some high school ( P employed full time ( 34 % ) compared with controls ( 59 % ; P average household incomes were significantly lower among individuals with ADHD compared with controls , regardless of academic achievement or personal characteristics . On the basis of these findings , loss of workforce productivity associated with ADHD was estimated between $ 67 billion and $ 116 billion . CONCLUSIONS Decreased individual income among adults with ADHD contributes to substantial loss in US workforce productivity",
"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",
"The purpose of this study was to examine in a controlled trial the effects of atomoxetine on the management of attention deficit-hyperactivity disorder ( ADHD ) symptoms and functional impairments at school and at home . Participants were 153 children ( age 8 to 12 years ) diagnosed with attention-deficit hyperactivity disorder who were r and omized to double-blind treatment with either atomoxetine ( n = 101 ) or placebo ( n = 52 ) . Findings revealed significant improvements both for parent and teacher ratings of behavior for children receiving atomoxetine therapy . Children also were reported to evidence a trend toward better response to active medication than to placebo for health-related quality of life as rated by parents . No significant effects were revealed for the teacher ratings of academic productivity . Data were interpreted to provide support for the efficacy of atomoxetine on the symptoms associated with ADHD . The effects of atomoxetine on other functional outcomes including academic performance and health-related outcomes are of interest , albeit less compelling for this particular investigation , than for the effects on overt symptom display",
"Methylpheni date ( MPH ) often ameliorates attention-deficit/hyperactivity disorder ( ADHD ) behavioral dysfunction according to indirect informant reports and rating scales . The st and ard of care behavioral MPH titration approach seldom includes direct neuropsychological or academic assessment data to determine treatment efficacy . Documenting “ cool ” executive-working memory ( EWM ) and “ hot ” self-regulation ( SR ) neuropsychological impairments could aid in differential diagnosis of ADHD subtypes and determining cognitive and academic MPH response . In this study , children aged 6 to 16 with ADHD inattentive type ( IT ; n = 19 ) and combined type ( n = 33)/hyperactive-impulsive type ( n = 4 ) ( CT ) participated in double-blind placebo-controlled MPH trials with baseline and r and omized placebo , low MPH dose , and high MPH dose conditions . EWM/ SR measures and behavior ratings/classroom observations were rank ordered separately across conditions , with nonparametric r and omization tests conducted to determine individual MPH response . Participants were subsequently grouped according to their level of cool EWM and hot SR circuit dysfunction . Robust cognitive and behavioral MPH response was achieved for children with significant baseline EWM/SR impairment , yet response was poor for those with adequate EWM/ SR baseline performance . Even for strong MPH responders , the best dose for neuropsychological functioning was typically lower than the best dose for behavior . Findings offer one possible explanation for why long-term academic MPH treatment gains in ADHD have not been realized . Implication s for academic achievement and medication titration practice s for children with behaviorally diagnosed ADHD will be discussed",
"Twenty-two children with attention deficit-hyperactivity disorder underwent a double-blind , placebo-controlled , crossover evaluation of the efficacy of st and ard methylpheni date twice a day and comparable doses every morning of a sustained-release preparation of methylpheni date ( SR-20 Ritalin ) , a sustained-release form of dextroamphetamine ( Dexedrine Spansule ) , and pemoline . The children were participating in a summer treatment program in which they engaged in recreational and classroom activities . Dependent measures include evaluations of social behavior during group recreational activities , classroom performance , and performance on a continuous performance task . Results revealed generally equivalent and beneficial effects of all four medications . Dexedrine Spansule and pemoline tended to produce the most consistent effects and were recommended for 10 of the 15 children who were responders to medication . The continuous performance task results showed that all four medications had an effect within 2 hours of ingestion , and the effects lasted for 9 hours . The implication s of these results for the use of long-acting stimulant medication in children with attention deficit-hyperactivity disorder are discussed",
"OBJECTIVE The objective of this study was to evaluate differences in the pharmacodynamic ( PD ) profile of 2 second-generation extended-release ( ER ) formulations of methylpheni date ( MPH ) : Meta date CD ( MCD ; methylpheni date HCl , US Pharmacopeia ) extended-release capsules , CII , and Concerta ( CON ; methylpheni date HCl ) extended-release tablets , CII . Little empirical information exists to help the clinician compare the PD effects of the available ER formulations on attention and behavior . Previous studies have shown that the near-equal doses of MCD and CON provide equivalent , total exposure to MPH as measured by area under the plasma concentration time curve , yet their pharmacokinetic ( PK ) plasma concentration versus time profiles are different . We previously offered a theoretical PK/PD account of the similarities and differences among available ER formulations based on the hypothesis that all formulations produce effects related to MPH delivered by 2 processes : 1 ) an initial bolus dose of immediate-release ( IR ) MPH that is expected to achieve peak plasma concentration in the early morning and have rapid onset of efficacy within 2 hours of dosing , which for the MCD capsule is delivered by 30 % of the total daily dose as uncoated beads and for the CON tablet is delivered by an overcoat of 22 % of the total daily dose ; and 2 ) an extended , controlled delivery of ER MPH that is expected to achieve peak plasma concentrations in the afternoon to maintain efficacy for a programmed period of time after the peak of the initial bolus , which for the MCD capsule is delivered by polymer-coated beads and for the CON tablet by an osmotic-release oral system . According to this PK/PD model , clinical superiority is expected at any point in time for the formulation with the highest MPH plasma concentration . METHODS This was a multisite , double-blind , double-dummy , 3-way crossover study of 2 active treatments ( MCD and CON ) and placebo ( PLA ) . Children with confirmed diagnoses of attention-deficit/hyperactivity disorder were stratified to receive bioequivalent doses of MCD and CON that were considered to be low ( 20 mg of MCD and 18 mg of CON ) , medium ( 40 mg of MCD and 36 mg of CON ) , or high ( 60 mg of MCD and 54 mg of CON ) , and in a r and omized order each of the study treatments was administered once daily in the morning for 1 week . On the seventh day of each treatment week , children attended a laboratory school , where surrogate measures of response were obtained by using teacher ratings of attention and deportment and a record of permanent product of performance on a 10-minute math test at each of the 7 classroom sessions spread across the day at 1.5-hour intervals . Safety was assessed by patient reports of adverse events , parent ratings on a stimulant side-effects scale , and measurement of vital signs . RESULTS The analyses of variance revealed large , statistically significant main effects for the within-subject factor of treatment for all 3 outcome measures ( deportment , attention , and permanent product ) . The interactions of treatment x session were also highly significant for all 3 outcome measures . Inspection of the PD profiles for the treatment x session interactions suggested 4 patterns of efficacy across the day : 1 ) PLA > MCD approximately CON ( PLA superiority ) immediately after dosing ; 2 ) MCD > CON > PLA during the morning ( MCD superiority ) ; 3 ) MCD approximately CON > PLA during the afternoon ( PD equivalence of MCD and CON ) ; and 4 ) CON > MCD approximately PLA in the early evening ( CON superiority ) . The effect of site was significant , because some study centers had low and some high scores for behavior in the lab classroom , but both the low- and high-scoring sites showed similar PD patterns across the day . The interaction of dose x treatment was not significant , indicating that the pattern of treatment effects was consistent across each dose level . There were no statistically significant overall differences among the 3 treatments for the frequency of treatment-emergent adverse events , ratings of side effects , or vital signs . Two additional PK/PD questions were addressed : 1 . The a priori hypothesis called for a comparison of the average of sessions ( removing session as a factor ) during a time period that corresponds to the length of a typical school day ( from 1.5 through 7.5 hours after dosing ) . For the planned contrast of the 2 treatment conditions ( MCD versus CON ) , the difference was significant , confirming the a priori hypothesis of superiority of near-equal daily doses of MCD over CON for this predefined postdosing period . 2 . In the design of the study , the dose factor represented the total daily dose , consisting of 2 components : the initial bolus doses of IR MPH , which differ for the near-equal total daily doses of MCD and CON , and the reservoir doses of ER MPH , which were the same for the 2 formulations . To evaluate the moderating effects of the bolus component of dose on outcome , average effect size ( ES ) was calculated for the efficacy outcomes at the time of expected peak PK concentration times of the initial bolus component for each formulation at the 3 dose levels . The correlation ( r ) of ES with IR MPH bolus dose was significant for each of the 3 outcome measures ( r approximately .9 ) , indicating that the magnitude of effects in the early morning may be attributed to the dose administered by the IR MPH bolus of each formulation . For the 2 dose conditions with equal 12-mg IR MPH boluses ( MCD 40 and CON 54 ) , the ESs were large and indistinguishable ( eg , deportment ES approximately 0.75 for both ) . CONCLUSIONS Once-daily doses of MCD and CON produced statistically significantly different PD effects on surrogate measures of behavior and performance among children with attention-deficit/hyperactivity disorder in the laboratory school setting . As predicted by the PK/PD model , superiority at any point in time was achieved by the formulation with the highest expected plasma MPH concentration",
"The effects of methylpheni date on the academic performance and classroom behavior of 45 adolescents with attention deficit hyperactivity disorder were studied . During a 6-week , placebo-controlled medication assessment in the context of a summer treatment program , participants received a double-blind , crossover trial of 3 doses of methylpheni date . Dependent measures included note-taking quality , quiz and worksheet scores , written language usage and productivity , teacher ratings , on-task and disruptive behavior , and homework completion . Group data showed positive effects of methylpheni date on academic measures ; however , the greatest benefit came with the lowest dose . Although additional benefit did occur for some participants with higher doses , the largest increment of change usually occurred between the placebo and 10-mg dose . Many adolescents did not experience added benefit with increased dosages , and in some cases they experienced deterioration . Guidelines for assessment of medication effects are discussed",
"OBJECTIVE This study examined the effectiveness of stimulant medication on multiple domains of functioning in 36 young ( 5 to 6 years old ) children diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD Five- and 6-year-old children attending a summer treatment program between 1987 and 1997 underwent a r and omized clinical assessment of the effect of two doses of methylpheni date ( 0.3 mg/kg versus 0.6 mg/kg ) and placebo on social behavior and academic performance . RESULTS Methylpheni date had an effect on all four social behaviors and improved two of the three areas of academic functioning . Dose effects were present for three of the seven dependent measures . Individual analyses indicated a therapeutic response rate between 39 % and 100 % across dependent measures . Furthermore , individual analyses of response indicated that across several important dependent measures , 39 % to 98 % of children showed little incremental improvement with the higher dose compared with the lower dose of stimulant medication . CONCLUSIONS Stimulant medication is an effective treatment for young children diagnosed with ADHD ; however , multiple domains of functioning must be assessed to determine the most effective dose for young children with ADHD",
"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",
"Objective . To assess effects of OROS methylpheni date on cognitive and academic tasks in 9 to 12 year olds with attention-deficit/hyperactivity disorder ( ADHD ) . Methods . A double-blind , within-subject , crossover design was used to compare OROS methylpheni date with placebo in a laboratory classroom setting on several cognitive and academic tasks for 68 children who met r and omization criteria . Results . Performance on the following measures was significantly better when children received individually optimized OROS methylpheni date than placebo : math fluency and accuracy measured by the Permanent Product Math Test , ADHD symptoms observed in the laboratory setting , computerized indices of attention and impulsivity as measured by the Test of Variables of Attention ( TOVA ) , and visual — spatial working memory ( Finger Windows Backwards ) . Study medication was well tolerated ; adverse events were generally consistent with previous reports . Conclusions . OROS methylpheni date improves performance on measures of attention and vigilance , behavior , and working memory in a laboratory school setting in 9 to 12 year olds with ADHD",
"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 . Very little research has focused on the efficacy of Adderall ( Shire-Richwood Inc , Florence , KY ) in the treatment of children with attention-deficit/hyperactivity disorder ( ADHD ) , and no studies have compared it with st and ardized doses of Ritalin ( Novartis Pharmaceuticals , East Hanover , NJ ) . It is thought that Adderall has a longer half-life than Ritalin and might minimize the loss of efficacy that occurs 4 or 5 hours after Ritalin ingestion . We compared two doses of Ritalin and Adderall in the treatment of ADHD in children in an acute study and assessed the medications ' time courses . Design . Within-subject , double-blind , placebo-controlled , crossover design lasting 6 weeks . As in our previous work , medication changes occurred on a daily basis in r and om order over days . Setting . Eight-week , weekday ( 9 hours daily ) summer treatment program at the State University of New York at Buffalo , using an intensive behavioral treatment program including a point system and parent training . Study Participants . Twenty-five children ( 21 boys and 4 girls ) diagnosed as ADHD using st and ardized structured interview and rating scales , mean age 9.6 years , 88 % Caucasian , of average intelligence , with no medical conditions that would preclude a trial of stimulant medication . Thirteen were comorbid for opposi-tional-defiant disorder and another 8 for conduct disorder . Interventions . Children received 10 mg of Ritalin , 17.5 mg of Ritalin , 7.5 mg of Adderall , 12.5 mg of Adderall , or placebo , twice a day ( 7:45 am and 12:15 pm ) , in r and om order with conditions changing daily for 24 days . Outcome Measures . Daily rates of behaviors in recreational and classroom setting s , and st and ardized ratings from counselors , teachers , and parents , were averaged across days within condition within child and compared . Within-subject relative sizes of the medication effects were computed by taking the placebo-minus-drug mean difference divided by the placebo st and ard deviation for each child , and were compared hourly between first daily ingestion ( 7:45am ) and 5:00 pm to assess the time course of the two drugs . Measures were taken at 12:00 pm ( recess rule violations ) and at 5:00 pm ( parent behavior ratings ) to determine whether Adderall was still effective at times when the effects of Ritalin should have worn off . Parent ratings were also made for evening behavior to assess possible rebound , and side effects ratings were obtained from parents , counselors , and teachers . Parents , counselors , and teachers also rated their perceptions of medication status and whether they recommended the continued use of the medication given that day . Finally , a clinical team made recommendations for treatment taking into account each child 's individual response . Results . Both drugs were routinely superior to placebo and produced dramatic improvements in rates of negative behavior , academic productivity , and staff/parent ratings of behavior . The doses of Adderall that were assessed produced greater improvement than did the assessed doses of Ritalin , particularly the lower dose of Ritalin , on numerous but not all measures . This result suggests that the doses of Adderall used were functionally more potent than those for Ritalin . Adderall was generally superior to the low dose of Ritalin when the effects of Ritalin were wearing off at midday and late afternoon/early evening . The lower dose of Adderall produced effects comparable to those of the higher dose of Ritalin . Both drugs produced low and comparable levels of clinical ly significant side effects . Staff clinical recommendations for continued medication favored Adderall three to one . Almost 25 % of the study participants were judged to be nonresponders by the clinical team , presumably because of their large beneficial response to the concurrent behavioral intervention and minimal incremental benefit from medication . Conclusions . This is the first investigation to assess comparable doses of Adderall and Ritalin directly . Results showed that Adderall is at least as effective as Ritalin in improving acutely the behavior and academic productivity of children with ADHD . These results show clearly that Adderall should be added to the armamentarium of effective treatment for ADHD , particularly for children in whom the effects of Ritalin dissipate rapidly and a longer acting medication is desired . Measures taken at times of the day when Ritalin is expected to have worn off—4 to 5 hours after ingestion — generally showed that Adderall was more effective than Ritalin at these times . The 7.5-mg twice-a-day dose of Adderall and the 17.5-mg twice-a-day dose of Ritalin produced equivalent behavioral changes . This indicates that a 5-mg dose of Adderall ( or slightly less ) is equivalent to a 10-mg dose of Ritalin , indicating that Adderall is twice as potent ; this potency ratio is similar to the well-known 1:2 ratio between d-amphetamine and methylpheni date . A higher dose of Adderall did not produce incremental improvement beyond that of the 7.5-mg dose , and parents were less likely to desire the continuation of the higher Adderall dose than the other medication conditions . Three-quarters of the responders to medication were recommended the lower rather than higher of the doses assessed . These findings are similar to our previous reports that there is a diminishing incremental value with stimulant medications beyond low to moderate doses , particularly when a behavioral intervention is concurrently implemented . Time-course results indicated that the afternoon dose of medication seemed to have a larger effect than the morning dose , raising the possibility that afternoon doses of stimulant medication may be able to be reduced relative to the morning dose without a corresponding reduction in efficacy . Although this practice is commonly used with some cases in clinical setting s , it is almost never used in empirical investigations and no studies have systematic ally investigated the practice . Our results suggest that systematic studies of a reduced midday dose are indicated . Further studies of dose equivalence and dose-response , including mg/kg dosing rather than absolute dosing , are necessary to firmly establish the Adderall : Ritalin dosing ratio and guidelines for clinical practice . Studies comparing Adderall to d-amphetamine should be conducted to determine whether the compound is superior to d-amphetamine alone . Further examinations of time-course are necessary to determine the length of action of Adderall — for example , whether a single morning dose will be sufficient to provide coverage throughout the school day",
"Objective : ADHD is the most common childhood psychiatric disorder , with impairments seen in home and academic setting s. To investigate such impairments in a school-like setting , the laboratory school protocol ( LSP ) was developed at the University of California , Irvine . Method : This model provides a rigorously controlled environment to examine pharmacodynamic and pharmacokinetic aspects of responses to treatment . A key principle of this methodology is to exercise tight control of the timing and context of measurements by establishing a cycle of activities repeated across each study day . In addition , the LSP approach has been extended to both younger and older population s than the typically studied school-aged group . This extension requires corresponding modifications in measures to characterize drug efficacy and to allow evaluation of ADHD symptoms in a highly st and ardized setting . Results : This article provides guidelines for employing the LSP for the assessment of medication effects for both preschool and adolescent/adult population s. Conclusion : The LSP can be modified to form either an Adult Workplace Environment or a Preschool Assessment Laboratory",
"OBJECTIVE This was a r and omized , double-blind , crossover study of 30 children with attention-deficit/hyperactivity disorder ( ADHD ) that evaluated the time course effects of four doses of Adderall ( 5 , 10 , 15 , and 20 mg ) , an inactive control ( placebo ) , and a positive control ( clinical dose of methylpheni date ) . METHOD For each treatment condition , a capsule was administered in the morning and assessment s were performed in an analog classroom setting every 1.5 hours across the day . Subjective ( teacher ratings of deportment and attention ) and objective ( scores on math tests ) measures were obtained for each classroom session , and these measures were used to evaluate time-response and dose response effects of Adderall . RESULTS For doses of Adderall greater than 5 mg , significant time course effects were observed . Rapid improvements on teacher ratings and math performance were observed by 1.5 hours after administration , and these effects dissipated by the end of the day . The specific pattern of time course effects depended on dose : the time of peak effects and the duration of action increased with dose of Adderall . CONCLUSIONS This documentation of efficacy in a controlled study supports the addition of Adderall to the armamentarium of psychotropic medications for the treatment of ADHD . The differences in time-response patterns of Adderall and methylpheni date may help tailor treatment to meet specific clinical needs of different children with ADHD",
"Abstract Background Lisdexamfetamine dimesylate ( LDX ) is indicated for the treatment of attention-deficit/hyperactivity disorder ( ADHD ) in children 6 to 12 years of age and in adults . In a previous laboratory school study , LDX demonstrated efficacy 2 hours postdose with duration of efficacy through 12 hours . The current study further characterizes the time course of effect of LDX . Methods Children aged 6 to 12 years with ADHD were enrolled in a laboratory school study . The multicenter study consisted of open-label , dose-optimization of LDX ( 30 , 50 , 70 mg/d , 4 weeks ) followed by a r and omized , placebo-controlled , 2-way crossover phase ( 1 week each ) . Efficacy measures included the SKAMP ( deportment [ primary ] and attention [ secondary ] ) and PERMP ( attempted/correct ) scales ( secondary ) measured at predose and at 1.5 , 2.5 , 5 , 7.5 , 10 , 12 , and 13 hours postdose . Safety measures included treatment-emergent adverse events ( AEs ) , physical examination , vital signs , and ECGs . Results A total of 117 subjects were r and omized and 111 completed the study . Compared with placebo , LDX demonstrated significantly greater efficacy at each postdose time point ( 1.5 hours to 13.0 hours ) , as measured by SKAMP deportment and attention scales and PERMP ( P decreased appetite ( 47 % ) , insomnia ( 27 % ) , headache ( 17 % ) , irritability ( 16 % ) , upper abdominal pain ( 16 % ) , and affect lability ( 10 % ) , which were less frequent in the crossover phase ( 6 % , 4 % , 5 % , 1 % , 2 % , and 0 % respectively ) . Conclusion In school-aged children ( 6 to 12 years ) with ADHD , efficacy of LDX was maintained from the first time point ( 1.5 hours ) up to the last time point assessed ( 13.0 hours ) . LDX was generally well tolerated , result ing in typical stimulant AEs . Trial registration Official Title : A Phase IIIb , R and omized , Double-Blind , Multi-Center , Placebo-Controlled , Dose-Optimization , Cross-Over , Analog Classroom Study to Assess the Time of Onset of Vyvanse ( Lisdexamfetamine Dimesylate ) in Pediatric Subjects Aged 6–12 With Attention-Deficit/Hyperactivity Disorder . Clinical Trials.gov Identifier : NCT00500149 http:// clinical",
"Investigated the effect of methylpheni date ( MPH ) on the ability of children with Attention Deficit Disorder with Hyperactivity ( ADDH ) to learn both trained and untrained complex visual relationships and compared these findings to their school performance under identical dosage parameters . 26 children between the ages of 6 and 12 years with ADDH participated in a double-blind , placebo control , within-subjects design in which each child received four doses of MPH ( 5 , 10 , 15 , 20 mg ) and a placebo in a counterbalanced sequence . MPH enhanced children 's learning of both taught and untaught visual relationships , and most changes were similar to , albeit less dramatic than , those obtained for the children 's attention and academic performance in school . Results of group and single-subject analyses are presented and discussed with relevance to psychopharmacological research and underst and ing the complex relationship between learning and psychostimulants used in treating children with ADDH",
"INTRODUCTION This study compared two atomoxetine titration dosing schedules and two atomoxetine maintenance doses for treating adolescent attention-deficit/hyperactivity disorder ( ADHD ) inattention and hyperactivity/impulsivity . METHODS Adolescents ( N = 267 ) were r and omized to a slow or fast titration schedule . Patients who responded continued on a 40-week maintenance treatment , r and omized to either 0.8 or 1.4 mg/kg/day . RESULTS During the acute period , significant benefit was demonstrated with both titration schedules on the ADHD Rating Scale total score . Although patients in both groups maintained benefit relative to week 0 , statistically significant loss of benefit was found for patients maintained on 0.8 mg/kg/day but not on 1.4 mg/kg/day . A similar pattern was observed on the Clinical Global Impressions-ADHD-Severity scores and Life Participation Scale for ADHD-Child Version scores . Mean grade s for most subjects improved for patients in both maintenance treatment groups although most improvements were not statistically significant . CONCLUSIONS In adolescents with ADHD , treatment benefit at 8 weeks was better maintained long-term with 1.4 mg/kg/day than with 0.8 mg/kg/day . Improvement in adaptive functioning and age-appropriate developmental function was also demonstrated . Atomoxetine 0.8 and 1.4 mg/kg/day were equally well tolerated . CLINICAL TRIALS REGISTRY Maintenance of benefit with atomoxetine hydrochloride in adolescents with ADHD , NCT00191035",
"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",
"BACKGROUND Our objective was to estimate the lifetime prevalence of psychopathology in a sample of youth with and without attention deficit hyperactivity disorder ( ADHD ) through young adulthood using contemporaneous diagnostic and analytic techniques . METHOD We conducted a case-control , 10-year prospect i ve study of ADHD youth . At baseline , we assessed consecutively referred male , Caucasian children with ( n=140 ) and without ( n=120 ) DSM-III-R ADHD , aged 6 - 18 years , ascertained from psychiatric and pediatric sources to allow for generalizability of results . At the 10-year follow-up , 112 ( 80 % ) and 105 ( 88 % ) of the ADHD and control children , respectively , were reassessed ( mean age 22 years ) . We created the following categories of psychiatric disorders : Major Psychopathology ( mood disorders and psychosis ) , Anxiety Disorders , Antisocial Disorders ( conduct , oppositional-defiant , and antisocial personality disorder ) , Developmental Disorders ( elimination , language , and tics disorder ) , and Substance Dependence Disorders ( alcohol , drug , and nicotine dependence ) , as measured by blinded structured diagnostic interview . RESULTS The lifetime prevalence for all categories of psychopathology were significantly greater in ADHD young adults compared to controls , with hazard ratios and 95 % confidence intervals of 6.1 ( 3.5 - 10.7 ) , 2.2 ( 1.5 - 3.2 ) , 5.9 ( 3.9 - 8.8 ) , 2.5 ( 1.7 - 3.6 ) , and 2.0 ( 1.3 - 3.0 ) , respectively , for the categories described above . CONCLUSIONS By their young adult years , ADHD youth were at high risk for a wide range of adverse psychiatric outcomes including markedly elevated rates of antisocial , addictive , mood and anxiety disorders . These prospect i ve findings provide further evidence for the high morbidity associated with ADHD across the life-cycle and stress the importance of early recognition of this disorder for prevention and intervention strategies",
"There appear to be beneficial effects of stimulant medication on daily classroom measures of cognitive functioning for Attention Deficit Disorder ( ADD ) children , but the specificity and origin of such effects is unclear . Consistent with previous results , 0.3 mg/kg methylpheni date improved ADD children 's performance on a classroom reading comprehension measure . Using the Posner letting-matching task and four additional measures of phonological processing , we attempted to isolate the effects of methylpheni date to parameter estimates of ( a ) selective attention , ( b ) the basic cognitive process of retrieving name codes from permanent memory , and ( c ) a constant term that represented nonspecific aspects of information processing . Responses to the letter-matching stimuli were faster and more accurate with medication compared to placebo . The improvement in performance was isolated to the parameter estimate that reflected nonspecific aspects of information processing . A lack of medication effect on the other measures of phonological processing supported the Posner task findings in indicating that methylpheni date appears to exert beneficial effects on academic processing through general rather than specific aspects of information processing",
"OBJECTIVE The aim of this study was to assess changes in symptomatology of attention-deficit/ hyperactivity disorder ( ADHD ) with extended-release dexmethylpheni date ( d-MPHER ) versus placebo in a laboratory classroom setting . METHODS This double-blind , placebo-controlled , crossover study r and omized 54 children 6 - 12 years of age , stabilized on methylpheni date 20 - 40 mg/day . Patients participated in a practice day , then received 5 days of treatment with d-MPH-ER 20 mg/day or placebo . After a 1-day wash-out , they returned to the classroom and received 1 dose of their assigned treatment . Evaluations occurred predose and at postdose hours 1 , 2 , 4 , 6 , 8 , 9 , 10 , 11 , and 12 . Children were then crossed over to the alternate treatment , using identical protocol . Primary efficacy variable was the Swanson , Kotkin , Agler , M-Flynn , and Pelham rating scale (SKAMP)-Combined scores , and primary analysis time point was 1 hour postdose ; secondary efficacy variables over 12 hours included SKAMP-Attention and -Deportment scores and written math test results . Safety was assessed by adverse event ( AE ) recording following each period . Vital signs were recorded at each visit ; laboratory tests were conducted at screening and final visit . RESULTS D-MPH-ER 20 mg/day showed a significant advantage over placebo as early as 1 hour postdose on SKAMP-Combined scores ( p children , d-MPH-ER maintained significant superiority over placebo from hours 1 through 12 ( p-values ranged from D-MPH-ER was well tolerated , with no severe AEs reported . CONCLUSIONS D-MPH-ER is safe and effective and improves classroom attention , deportment , and performance in children with ADHD",
"The response of 23 children with attention deficit disorder ( ADD ) with hyperactivity ( + H ) and 17 children with ADD without hyperactivity ( -H ) to three doses of methylpheni date ( 5 , 10 , and 15 mg twice a day ) was evaluated in a triple-blind , placebo-controlled cross-over design using parent and teacher ratings of behavior , laboratory tests of ADD symptoms , and behavioral observations during academic performance . Results indicated that the children with ADD+H were rated as having more pervasive behavioral problems at home and more pervasive and severe conduct problems at school than the children with ADD-H. Laboratory tests found the children with ADD+H to be impaired in behavioral inhibition and vigilance whereas children with ADD-H were more impaired in the consistent retrieval of verbally learned material Drug effects were noted on the parent and teacher ratings and on most laboratory measures , with all three doses typically producing significant changes but rarely differing among themselves in effectiveness . The groups were not found to differ significantly on any measures in their response to methylpheni date . However , more children with ADD-H were clinical ly judged as having either no clinical response ( 24 % ) or responding best to the low dose ( 35 % ) of medication . In contrast , most ADD+H ( 95 % ) children were judged to be positive responders and most were recommended to receive the moderate to high dose ( 71 % )",
"OBJECTIVE To compare the efficacy and time course of single morning doses of Adderall , extended-release , and immediate-release dextroamphetamine sulfate . METHOD Thirty-five children with attention-deficit/hyperactivity disorder , combined type , were given Adderall , immediate-release dextroamphetamine , dextroamphetamine Spansules , and placebo in a r and omized , double-blind , crossover study . Behavior ratings , locomotor activity measurements , and academic measures were obtained over a period of 8 weeks . RESULTS All three drugs exhibited robust efficacy versus placebo on nearly all measures . The effects of dextroamphetamine Spansules were less robust in the morning , particularly compared with Adderall , but they lasted 3 to 6 hours longer , depending on the measure . Although parent behavior ratings and locomotor activity showed improvements up to 12 hours after single doses of all three drugs , the number of math problems attempted and completed correctly 4 hours after dosing were only robustly increased by Spansules . CONCLUSIONS Both immediate-release amphetamines demonstrated earlier onset of effects , but dextroamphetamine Spansules showed more sustained effects that were present on a wider range of measures",
"OBJECTIVES This investigation was conducted primarily to assess the safety and efficacy of SLI381 ( Adderall XR ) , developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder ( ADHD ) . Secondary objectives included examination of the time course , pharmacokinetic , and pharmacodynamic properties of SLI381 . METHOD This was a r and omized , double-blind , crossover study of three doses of SLI381 ( 10 , 20 , and 30 mg ) , placebo , and an active control ( Adderall 10 mg ) given once daily to 51 children with ADHD . Weekly assessment s in an analog classroom setting included blind ratings of attention and deportment and a performance measure ( math test ) obtained every 1.5 hours over a 12-hour period . RESULTS SLI381 was well tolerated . All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures . Dose-dependent improvements were evident for SLI381 . SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours , but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo . CONCLUSIONS These data provide support for the benefit of this novel , once-daily amphetamine preparation in the treatment of ADHD . The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing , thus reducing dose diversion and eliminating the need for in-school administration . SLI381 appears to be a useful treatment option for many children with ADHD",
"OBJECTIVE The aim of this study was to compare efficacy and safety of two long-acting formulations of methylpheni date ( MPH ) for attention-deficit/hyperactivity disorder ( ADHD ) in school-age children . METHODS Children 6 - 12 years of age diagnosed with ADHD and stabilized on MPH ( 20 - 40 mg/day ) participated in a five-way , r and omized , placebo-controlled , single-blind , crossover study conducted in a laboratory classroom setting . Children alternately received single doses of extended-release MPH ( ER-MPH ) 20 and 40 mg , modified-release MPH ( OROS-MPH ) 18 and 36 mg , and placebo over 6 consecutive weeks . Efficacy was assessed using SKAMP rating subscales and written math tests . Data were examined using between-treatment comparisons of area under the curve ( AUC ) for change from predose values during hours 0 - 4 , 0 - 8 , 8 - 12 , and 0 - 12 . Safety was assessed . RESULTS Fifty-three children completed the study . For all efficacy measures , improvements from predose were significantly greater with ER-MPH 40 mg than with OROS-MPH 36 mg in terms of AUC(0 - 4 ) ( p ER-MPH 20 mg was equivalent to both doses of OROS-MPH in AUC(0 - 4 ) , AUC(0 - 8 ) , and AUC(0 - 12 ) . No serious adverse events were reported . CONCLUSIONS The efficacy of ER-MPH 20 mg is similar to that of OROS-MPH 18 and 36 mg during the first 8 hours postdose . Statistically greater benefits are observed with ER-MPH 40 mg than with OROS-MPH 36 mg and persist through hour 8 . Active treatments show comparable efficacy from 8 to 12 hours postdose . Both doses of each MPH formulation are well tolerated",
"OBJECTIVE This was a multicenter , double-blind , r and omized , dose-ranging study of a methylpheni date ( MPH ) transdermal system ( MTS ) . Medication ( placebo , 0.45 , 0.9 , and 1.8 mg/h ) was crossed with application time ( 6 a.m. , 7 a.m. ) to evaluate MTS efficacy and influence of exposure time on morning effects . METHOD The study took place in a summer treatment program ( STP ) at three sites , with 36 children aged 7 - 12 years with attention-deficit/hyperactivity disorder . Each treatment was administered for 1 day in r and om order , for a total of 8 days . Behavioral and academic measures were taken as well as patch wear characteristics and side effects . RESULTS Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance . All MTS conditions were significantly different from placebo across measures . Time of application had no significant effect on daily behavior , and effects of application time on morning behavior were inconclusive . Consistent with previous results in this setting , the highest dose produced limited incremental benefit compared with the mid-range dose . The wear characteristics of the MTS were acceptable , and the formulation was well tolerated . CONCLUSIONS The MTS produced significant effects that were similar to those previously reported with comparable MPH doses . There does not appear to be a substantial effect of application time on total daily functioning in this setting ; further controlled time-course studies will be necessary to evaluate the question of morning onset fully",
"Methylpheni date ( Ritalin ) has been shown to have differential effects on hyperactive children 's behavior as a function of dose level . In the present investigation , a triple-blind , placebo-control , within-subject ( crossover ) experimental design was employed in which 12 hyperactive boys between 6 and 10 years received three different dosages of methylpheni date ( 5 , 10 , and 15 mg ) in a r and omly assigned sequence . Dosage effects were assessed on clinic(PAL-Paired Associates Learning test ) and school-(percent on task , teacher ratings , work completion rates , and accuracy ) related behaviors . For 10 of the children , classified as responders to medication by the PAL using the criteria of Swanson , Kinsbourne , and colleagues , a series of ANCOVAs with repeated measures showed significant dosage effects on teacher ratings ( p ⋖01 ) , percent on task ( p ⋖01 ) , academic accuracy ( p ⋖05 ) , and assignment completion rates ( p ⋖05 ) . PAL performance was also significantly enhanced ( p ⋖01 ) after optimal dose levels were considered . Subsequent trend analysis showed a significant positive linear relationship between dose and each of the dependent variables . A comparison of fixed-dose and miligram-per-kilogram plots showed that children 's performance across the different dosages were clearly individualistic and task-specific , even when similar body weights were compared . The implication s of using clinic-based testing to determine optimal medication responsivity were discussed",
"BACKGROUND Lisdexamfetamine dimesylate is a therapeutically inactive prodrug in which d-amphetamine is covalently bound to l-lysine , a naturally occurring amino acid . Pharmacologically active d-amphetamine is released from lisdexamfetamine following oral ingestion . METHODS This phase 2 , r and omized , double-blind , placebo- and active-controlled crossover study compared the efficacy and safety of lisdexamfetamine ( LDX : 30 , 50 , or 70 mg ) with placebo , with mixed amphetamine salts extended-release ( MAS XR : 10 , 20 , or 30 mg ) included as a reference arm of the study , in 52 children aged 6 to 12 years with attention-deficit/hyperactivity disorder ( ADHD ) in an analog classroom setting . The primary efficacy measure was the Swanson , Kotkin , Agler , M-Flynn , and Pelham ( SKAMP ) Rating Scale ; secondary efficacy measures included the Permanent Product Measure of Performance ( PERMP ) Derived Measures , and the Clinical Global Impression ( CGI ) Scale . RESULTS LDX treatment significantly improved scores on SKAMP-deportment , SKAMP-attention , PERMP-attempted , PERMP-correct , and CGI-improvement from baseline . Adverse events were similar for both active treatments . CONCLUSIONS In a laboratory classroom environment , LDX significantly improved ADHD symptoms versus placebo in school-age children with ADHD",
"Objective : This study evaluates the efficacy , duration of action , and tolerability of methylpheni date transdermal system ( MTS ) in children with ADHD . Method : Participants were dose optimized over 5 weeks utilizing patch doses of 10 , 16 , 20 , and 27 mg applied in the morning and worn for 9 hours . Following optimization , 80 participants were r and omized to 1 week of MTS or placebo followed by 1 week of the opposite treatment . Laboratory classroom sessions conducted after each r and omized week included blinded ratings of attention , behavior , and academic performance . Results : MTS was well tolerated and displayed significant improvement compared with placebo . Improvements were seen at the first postdose time point measured and continued through 12 hours . Conclusions : Treatment with MTS result ed in statistically significant improvements on all efficacy measures . Time course and therapeutic effects of MTS suggest that this novel methylpheni date delivery system is an efficacious once-daily treatment for ADHD",
"This study evaluated the effects of two doses of psychostimulants on nine ADHD students ' performance in a classroom design ed to be analogous to a junior high school American history class conducted during a summer treatment program . Double-bline , placebo-controlled assessment revealed significant and clinical ly important effects of psychostimulants on quiz and test performance , observations of attention and behavior during lectures , and teacher ratings , as well as accuracy on assignments completed during study hall . Analysis of individual differences revealed a 66 % positive response rate . The implication s for use of psychostimulants with ADHD young adolescents are discussed",
"Abstract Background Given the dosing limitations of methylpheni date short – acting preparations in treating ADHD , galenics with longer release of the substance were developed mainly to avoid drug intake during school hours . Objectives This investigation was conducted to assess the efficacy and the duration of action of a new extended-release formulation of methylpheni date ( Medikinet ® retard ) as a once – daily treatment for children with attention – deficit hyperactivity disorder ( ADHD ) . Method This was a r and omized , double – blind , crossover multicentre study with three treatment conditions : once – daily extended – release methylpheni date , twice – daily immediate – release methylpheni date and placebo given to 79 children ( 8–14 years old ) with ADHD . Daily assessment s in an analogue classroom setting included blind ratings of attention and deportment and a performance measure ( math test ) obtained 5 times over an 8–hour period . Secondary measures included an ADHD rating scale , based on DSMIV/ ICD–10 separately rated for the morning and the afternoon . Results Both active treatment conditions displayed significant time course effects and were superior to placebo in improving all efficacy measures . Once a day extended – release methylpheni date was not different from the same dose of twice daily immediate – release methylpheni date . Conclusions These data provide support for the benefit of this novel , once-daily methylpheni date preparation in the treatment of ADHD . The longer duration of action of Medikinet Retard has the potential to simplify psychostimulant treatment , thus reducing dose diversion and eliminating the need for in – school administration",
"Behavioral and neuropsychological functioning in unmedicated children with attention-deficit/hyperactivity disorder ( ADHD ) who have a history of medication treatment ( Rx ) versus those who are treatment naïve ( TN ) has , to our knowledge , not been previously studied . Ninety-four children in four groups ( ADHD/Rx , ADHD/TN , learning disabilities [ LD ] , and controls ) were evaluated , while unmedicated , on measures of achievement , neuropsychological functioning , and behavior . The ADHD/Rx group performed significantly better than the TN group on writing , Stroop interference , and measures of attention , and performed as well as the control group on executive functioning , verbal working memory , and academics . Behaviorally , the ADHD groups showed more difficulty with mood and externalizing behaviors compared with the LD and control groups , with the ADHD/TN performing the most poorly . Findings suggest that the ADHD/Rx group shows better executive and academic functioning even when unmedicated",
"Six boys aged 9 to 12 years attended a tutoring class focusing on reading for 30 minutes each morning . The investigators employed a modified Latin-square design in which each child began with a 5-day baseline phase followed by six 10-day treatment phases that used drug placebo , noncontingent reinforcers , 0.3 mg/kg methylpheni date , 0.7 mg/kg methylpheni date , and self-re-inforcement in various combinations . Amount of academic performance was the major measure of outcome and the target behavior of self-reinforcement . Drug placebo and noncontingent reinforcers had no systematic impact . Methylpheni date had differential effects across the recorded behaviors . Self-reinforcement improved the target behavior ; the mean effect size for self-reinforcement was 2.66 . The combined effects of methylpheni date and self-reinforcement on academic performance were greater than either of the treatments given alone ( mean effect size = 2.89 )",
"Two studies were conducted to investigate the relative effects of sustained release methylpheni date ( Ritalin [ SR-20 ] ) and st and ard methylpheni date ( Ritalin , 10 mg , administered twice daily ) . In the first study , 13 boys with attention deficit disorder participating in a summer treatment program went through a double-blind , within-subject trial of each form of methylpheni date and placebo . Measures of social and cognitive behavior were gathered in classroom and play setting s. Although group analyses of the data showed that both drugs were effective and there were few differences between them , st and ard methylpheni date was superior to SR-20 on several important measures of disruptive behavior . Furthermore , analyses of individual responsivity showed clearly that most boys responded more positively to st and ard methylpheni date than to SR-20 . The second study involved a partially overlapping group of nine boys with attention deficit disorder participating in the same summer treatment program . Also double-blind , within-subject , and placebo controlled , this study tracked the time courses of the two forms of methylpheni date . Both were shown to have similar time courses on the Abbreviated Conners Rating Scale and other measures , but SR-20 had a slower onset than did the st and ard drug form on a continuous performance task . Effects of SR-20 were still evident eight hours after ingestion",
"The present study examined the degree to which methylpheni date ( MPH ) normalized the classroom behavior and academic functioning of 31 children with attention deficit disorder ( ADD ) . Subjects with ADD participated in a double-blind , placebo-controlled trial in which children received each of four doses ( 5 , 10 , 15 , and 20 mg ) of MPH and a placebo following baseline measures . Children with ADD were compared with a group of 25 normal control children on teacher ratings of social conduct , direct observations of on-task behavior , and academic efficiency . At a group level of analysis , MPH exerted a significant effect on classroom measures of attention and academic efficiency to a point where they were no longer statistically deviant from scores obtained by normal control children . Nevertheless , when examined at the individual level , 25 % of the sample failed to show normalized levels of classroom performance , thus implying the need for ancillary school-based interventions",
"Sixteen children meeting diagnostic criteria for Attention Deficit Disorder with Hyperactivity ( ADD-H ) were tested on methylpheni date ( 0.3 mg/kg ) and placebo on cognitive , learning , academic and behavioral measures in a double-blind study . Assessment s were carried out in the laboratory and in the children 's regular classrooms . Results indicate methylpheni date -induced improvements on a majority of the measures . Drug-induced changes reflected increased output , accuracy and efficiency and improved learning acquisition . There was also evidence of increased effort and self-correcting behaviours . It is argued that review ers have underestimated the potential of stimulants to improve the performance of ADD-H children on academic , learning and cognitive tasks",
"The present invention is for an improved st and ( 2 ) typically of the music variety . The improvements consist of a stabilizing cam ( 10 ) and a compact , central ly located , adjustable position memory element ( 16 ) . The stabilizing cam ( 10 ) may be used in a variety of structures to micro adjust the level of the st and ( 2 ) to provide better support and stability . The adjustable position memory element ( 16 ) may be used on a variety of devices as well including an articulable support st and such that the support st and can be returned upon reuse to a preselected position from a plurality of preselected available positions",
"OBJECTIVE 1 ) To compare st and ard twice-daily methylpheni date ( MPH ) dosing with a single morning dose of MPH and of Adderall during a typical school-day time period , and 2 ) to conduct a dose-response study of the effects of a late-afternoon ( 3:30 PM ) dose of MPH and Adderall on evening behavior and side effects . DESIGN Within-subject , placebo-controlled , crossover design . SETTING Intensive summer treatment program with a comprehensive behavioral approach . STUDY PARTICIPANTS Twenty-one children with attention-deficit/hyperactivity disorder ( 19 boys and 2 girls ) , between the ages of 6 and 12 years . INTERVENTIONS Children received , in r and om order with daily crossovers , each of the following conditions : 1 ) placebo , 2 ) 0.3 mg/kg of MPH received 3 times , 3 ) 0.3 mg/kg of MPH received twice ( 7:30 AM and 11:30 AM ) with 0.15 mg/kg received at 3:30 PM , 4 ) 0.3 mg/kg of MPH received once in the morning only , 5 ) 0.3 mg/kg of Adderall received at 7:30 AM and at 3:30 PM , 6 ) 0.3 mg/kg of Adderall once in the morning with 0.15 mg/kg received at 3:30 PM , 7 ) 0.3 mg/kg of Adderall received in the morning only . OUTCOME MEASURES Daily rates of behaviors in social and academic setting s , and st and ardized ratings from counselors and teachers , were assessed for the hours between 8:00 AM and 3:30 PM ( a typical school-day ) . Relative sizes of the medication effects were compared hourly between first daily ingestion ( 7:30 AM ) and 4:45 PM to assess the time course of the 2 drugs . Effects of the 3:30 PM doses on functioning in the evenings at home were evaluated using parent ratings of behavioral and side effects . RESULTS A single morning dose of Adderall produced equivalent behavioral effects to those of MPH received twice-daily and behavioral effects of that single morning dose lasted throughout the school-day period . One morning dose of MPH was less effective than either 2 daily doses of MPH or 1 dose of Adderall , and seemed to wear off in the early to mid-afternoon . For some children a single morning dose of MPH maintained their behavior for an entire school day in the context of the summer treatment program . On parent ratings of evening behavior , 0.3 mg/kg of MPH at 3:30 PM was superior to 0.15 mg/kg at 3:30 PM , but there was no difference between the 2 doses of Adderall . Compared with placebo at 3:30 PM , only the 0.3 mg/kg dose of MPH caused significant improvement in parent ratings . In placebo versus Adderall comparisons , all doses , even the condition that consisted of Adderall in the morning and placebo at 3:30 PM , produced a significant change in evening behavior . CONCLUSIONS The results show that , at least in the context of an intensive behavioral intervention , a single morning dose of Adderall had behavioral effects throughout an entire school day period that were equivalent to st and ard twice-daily MPH dosing . These results indicate that Adderall may be used as a long-acting stimulant for children for whom midday dosing is a problem . Further study including dose-response comparisons , effects in regular school setting s , and direct comparisons with comparable doses of MPH and d-amphetamine will help to clarify the time course and relative advantages of Adderall",
"The short-term , dose-response effects of methylpheni date hydrochloride were evaluated on academic and social classroom measures in 29 children with attention deficit disorder . In a double-blind , cross-over design with order r and omized , children received a placebo for two weeks and three doses of methylpheni date hydrochloride ( 0.15 mg/kg , 0.3 mg/kg , and 0.6 mg/kg ) for one week each . Dependent measures included the output and accuracy of performance in grade -appropriate reading comprehension workbooks and arithmetic problems , spelling word acquisition , and observations of disruptive and on-task behavior . Beneficial drug effects and linear dose-response curves on all dependent measures were found . The results suggest that beneficial methylpheni date effects on classroom behavior may be accompanied by enhanced academic achievement in some hyperactive children",
"OBJECTIVE To evaluate the magnitude and clinical significance of methylpheni date ( MPH ) effects on the classroom behavior and academic performance of 76 children with attention deficit disorder/hyperactivity ( ADDH ) . METHOD A double-blind , placebo controlled , within-subject ( crossover ) experimental design was used to evaluate acute MPH effects at four dose levels ( 5 mg , 10 mg , 15 mg , and 20 mg ) on children 's attention , academic functioning , and behavior in regular classroom setting s. Results were contrasted with a normal control sample . RESULTS St and ard statistical analysis revealed MPH effects on classroom functioning that were primarily linear . Analysis of the clinical significance of effects indicated that large proportions of treated children exhibited significantly improved or normalized classroom functioning ; however , a large subset of them failed to show improved academic functioning . Overall , children failing to respond at lower dose levels have a high probability of improving or becoming normalized as a function of increasing dose . CONCLUSIONS For a majority of children with ADDH , MPH results in significantly improved or normalized attention and classroom behavior . A significant subset , however , fail to realize gains in their academic functioning and will require supplemental interventions",
"The effects of 0.3 mg/kg methylpheni date were compared for 12 ADD boys and 12 ADD girls participating in a summer treatment program for children with behavior and /or learning problems . Previous investigations have suggested that ADD girls may differ from ADD boys in some important respects . No information exists regarding whether the effects of the most common treatment for these children , methylpheni date , has comparable effects on boys and girls . The boys and girls were matched for age and IQ . The results revealed equivalent and beneficial effects of methylpheni date for both boys and girls . Methylpheni date therefore would appear to be as useful a treatment for ADD girls as for ADD boys",
"Daily academic classroom performance was recorded in a day hospital school using a commonly employed reading and math series as part of an 11-week double-blind , placebo controlled , crossover comparison of dextroamphetamine ( d-AMPH ) and methylpheni date ( MPH ) in 33 hyperactive boys . Students attempted more math and reading tasks while on either active drug . The percent correct and the number of attempted problems of the reading series improved with both drugs while the percent correct for the math series occurred with d-AMPH only . No dose-response relationship was found for either stimulant . Moderate , transient adverse effects were common for both drugs"
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4116e250-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Turner syndrome ( TS ) affects about one in 1,500 to 2,500 live-born females . One of the most prevalent and salient features of the syndrome is extremely short stature . Untreated women are approximately 20 - 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 women who have Turner syndrome . OBJECTIVES To assess the effects of recombinant growth hormone on short-term growth and final height in children and adolescents with Turner syndrome . SEARCH STRATEGY Published and unpublished r and omised-controlled trials ( RCTs ) were sought by search ing the Cochrane Central Register of Controlled Trials ( Central ) ( 2002 , Issue 3 ) , Medline ( 1981 to July 2002 ) , Embase ( 1980 to June 2002 ) , PubMed ( search 30 July , 2002 for entries in last 180 days ) , Science Citation Index ( search 30 July , 2002 ) , BIOSIS ( search 30 July , 2002 ) and Current Controlled Trials ( search 30 July , 2002 ) . Article reference lists were assessed for trials and experts and pharmaceutical companies were contacted . SELECTION CRITERIA R and omised controlled trials were included if they were carried out in children with Turner Syndrome 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 . A growth or height outcome measure must have been assessed . In addition , in the context of a growth assessment other outcomes reflecting psychological adjustment were also included . DATA COLLECTION AND ANALYSIS Two review ers assessed studies for inclusion criteria and for method ological quality . Data were extracted by one review er and checked by a second . The main outcomes were final height ( in cm or st and ard deviation score ) , growth ( in velocity or velocity st and ard deviation score ) . Additional outcomes included bone age , quality of life , cognitive performance , and adverse effects . To estimate summary treatment effects , data were pooled using a r and om effects model ( when data were sufficient and appropriate to combine ) with calculation of weighted mean differences ( WMD ) for continuous outcomes . MAIN RESULTS Four RCTs that included 211 participants after one year of treatment were included . These were described in six publications . Three studies were included in the analyses of growth outcomes ( one study did not report any data ) . Only one trial reported results on final height . This trial reported that average final height in 40 treated women was 146.2 cm and 141.4 cm in 29 untreated women ( mean difference ( MD ) 4.8 cm , 95 % CI 2.2 to 7.4 ) . Short-term growth velocity was greater in treated than untreated girls after one year ( two trials , weighted mean difference ( WMD ) 3.3 cm/yr , 95 % CI 2.4 to 4.3 ) after 18 months ( one trial , MD 2.6 cm/yr , 95 % CI 2.1 to 3.1 ) and after two years ( one trial , MD 1.8 cm/yr , 95 % CI 1.3 to 2.3 ) . Results were similar when reported as growth velocity st and ard deviation scores . Skeletal maturity was not accelerated by treatment with recombinant growth hormone ( hGH ) . Bone age divided by chronological age was approximately one in both treated and untreated groups in one trial after both one and two years of treatment . One trial selectively reported psychological outcomes that suggested that psychological adjustment was better in girls treated with hGH , but selective reporting leaves these results in some doubt . Adverse effects were minimally reported . There is little evidence of serious short-term adverse effects in these trials , but they are underpowered to detect rare adverse effects . REVIEW ER 'S CONCLUSIONS Recombinant human growth hormone ( hGH ) doses between 0.3 - 0.375 mg/kg/wk increase short-term growth in girls with Turner Syndrome ( TS ) by approximately 3 cm in the first year of treatment and by approximately 2 cm per year after 2 years of treatment . There is little evidence on the effects of hGH on final height . Treatment in one trial increased final height by approximately 5 cm over an untreated control group . Despite this increase , the fated control group . Despite this increase , the final height of treated women was still outside the normal range ( more than two st and ard deviations below the normal population mean ) . 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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" 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",
"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",
"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",
"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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AIM This systematic review aim ed to provide a comprehensive description of the method ologies used in home telemonitoring interventions for Chronic Obstructive Pulmonary Disease ( COPD ) and to explore patients ' adherence and satisfaction with the use of telemonitoring systems . METHODS A literature search was performed from June to August and up date d until December of 2012 on Medline , Embase , Web of Science and B-on data bases using the following keywords : [ tele(-)monitoring , tele(-)health , tele(-)homecare , tele(-)care , tele-home health or home monitoring ] and [ Chronic Obstructive Pulmonary Disease or COPD ] . References of all articles were also review ed . RESULTS Seventeen articles were included , 12 of them published from 2010 to the present . The method ologies were similar in the training provided to patients and in the data collection and transmission processes . However , differences in the type of technology used , telemonitoring duration and provision of prompts/feedback , were found . Patients were generally satisfied and found the systems useful to help them manage their disease and improve healthcare provision . Nevertheless , they reported some difficulties in their use , which in some studies were related to lower compliance rates . CONCLUSIONS Telemonitoring interventions are a relatively new field in COPD research . Findings suggest that these interventions , although promising , present some usability problems that need to be considered in future research . These adjustments are essential before the widespreading of telemonitoring
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"Background Telehealth ( TH ) and telecare ( TC ) interventions are increasingly valued for supporting self-care in ageing population s ; however , evaluation studies often report high rates of non-participation that are not well understood . This paper reports from a qualitative study nested within a large r and omised controlled trial in the UK : the Whole System Demonstrator ( WSD ) project . It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial . Methods Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention ( n = 19 ) , or who withdrew from the intervention arm ( n = 3 ) . Participants were recruited from the four trial groups ( with diabetes , chronic obstructive pulmonary disease , heart failure , or social care needs ) ; and all came from the three trial areas ( Cornwall , Kent , east London ) . Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home . Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes . Results Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes : requirements for technical competence and operation of equipment ; threats to identity , independence and self-care ; expectations and experiences of disruption to services . Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderst and ings . Respondents ’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance , and views that interventions could undermine self-care and coping . Finally , participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued . Conclusions These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake . These insights have implication s for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction . It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation",
"AIMS To investigate the feasibility , acceptance and potential effectiveness of delivering a telecare service on the health outcomes and hospital service utilization of community-dwelling patients with chronic obstructive pulmonary disease . METHODS Eligible participants were older people , with moderate or severe chronic obstructive pulmonary disease , and who had been admitted to hospital at least once for exacerbation during the previous year . The participants were r and omly assigned to the intervention or control group . Participants in the intervention group received a telecare device kit and they were asked to monitor their oxygen saturation , pulse rate and respiration rate using the device and to transmit the data to an online network platform . A medication and purse-lip breathing reminder with a feedback function is also provided in the device kit . A community nurse monitors changes in the physiological parameters and takes immediate action to address the patients ' needs . Participants in the control group received no other extra care . Study outcomes include user satisfaction , health-related quality of life , pulmonary function , hospital re-admission and use of emergency room services . RESULTS Twenty-two participants in the intervention group and 18 in the control group were included in the analysis . The mean age of all 40 participants was 72.93 years . Overall , the participants in the intervention group expressed satisfaction with the telecare service . Some patients reported difficulty in reading the screen of the mobile phone and manipulating the tiny key-in buttons . No significant differences were found between the two time points ( baseline and post-test period ) with regard to health-related quality of life . No significant differences in pulmonary function and in the number of emergency department visits and hospital re-admissions between the study groups were found . CONCLUSION The high level of user satisfaction indicated the feasibility of conducting a large-scale r and omized control trial to evaluate the effects of a telecare service on health outcomes of patients with chronic obstructive pulmonary disease",
"Hospital admissions due to chronic obstructive pulmonary disease ( COPD ) exacerbations have a major impact on the disease evolution and costs . The current authors postulated that a simple and well-st and ardised , low-intensity integrated care intervention can be effective to prevent such hospitalisations . Therefore , 155 exacerbated COPD patients ( 17 % females ) were recruited after hospital discharge from centres in Barcelona ( Spain ) and Leuven ( Belgium ) . They were r and omly assigned to either integrated care ( IC ; n = 65 ; age mean±sd 70±9 yrs ; forced expiratory volume in one second ( FEV1 ) 1.1±0.5 L , 43 % predicted ) or usual care ( UC ; n = 90 ; age 72±9 yrs ; FEV1 1.1±0.05 L , 41 % pred ) . The IC intervention consisted of an individually tailored care plan upon discharge shared with the primary care team , as well as accessibility to a specialised nurse case manager through a web-based call centre . After 12 months ’ follow-up , IC showed a lower hospitalisation rate ( 1.5±2.6 versus 2.1±3.1 ) and a higher percentage of patients without re-admissions ( 49 versus 31 % ) than UC without differences in mortality ( 19 versus 16 % , respectively ) . In conclusion , this trial demonstrates that a st and ardised integrated care intervention , based on shared care arrangements among different levels of the system with support of information technologies , effectively prevents hospitalisations for exacerbations in chronic obstructive pulmonary disease patients",
"OBJECTIVE To assess the impact of a home telemonitoring technology on patients with chronic obstructive pulmonary disease in terms of care satisfaction , patient empowerment , improved quality of life , and utilization of hospital and home care . DESIGN A quasi-experimental retrospective and prospect i ve design was developed with a matched control group to compare the effects of telemonitoring ( the experimental group , n = 23 ) with the traditional homecare offering ( the control group , n = 23 ) . MEASUREMENTS Satisfaction , patient empowerment , and quality of life were measured using vali date d Likert scales , whereas the data on care utilization were collected from the participating patients ' medical record . RESULTS Mixed results were observed . The clinical effects of home telemonitoring were very positive in terms of patients ' satisfaction and empowerment . The perceptions of care providers as well as those of patients were congruent in this respect . Also , the study suggests that telemonitoring may have a positive effect on quality of life for patients with chronic obstructive pulmonary diseases . In contrast , the results were disappointing in terms of re source savings for the use of both homecare and hospital care . CONCLUSION Capturing the full potential of these new technologies will require a much more fundamental reorganization of work than just a simple deployment of the technology",
"Self-management strategies improve a variety of health-related outcomes for patients with chronic obstructive pulmonary disease ( COPD ) . These strategies , however , are primarily design ed to improve chronic disease management and have not focused on early detection and early treatment of exacerbations . In COPD , the majority of exacerbations go unreported and treatment is frequently delayed , result ing in worsened outcomes . Therefore , a r and omised clinical trial was design ed to determine whether integration of self-management education with proactive remote disease monitoring would improve health-related outcomes . A total of 40 Global Initiative for Chronic Obstructive Lung Disease stage 3 or 4 COPD patients were r and omised to receive proactive integrated care ( PIC ) or usual care ( UC ) over a 3-month period . The primary and secondary outcomes were change in quality of life , measured by the St George ’s Respiratory Question naire ( SGRQ ) , and change in healthcare costs . PIC dramatically improved SGRQ by 10.3 units , compared to 0.6 units in the UC group . Healthcare costs declined in the PIC group by US$ 1,401 , compared with an increase of US$ 1,709 in the UC group , but this was not statistically significant . PIC uncovered nine exacerbations , seven of which were unreported . Therefore , proactive integrated care has the potential to improve outcomes in chronic obstructive pulmonary disease patients through effects of self-management , as well as early detection and treatment of exacerbations",
"BACKGROUND Remote in-home monitoring ( RM ) of symptoms and physiological variables may allow early detection and treatment of exacerbations of chronic obstructive pulmonary disease ( COPD ) . It is unclear whether RM improves patient outcomes or healthcare re source utilization . This study determined whether RM is feasible in patients with COPD and if RM reduces hospital admissions or length of stay ( LOS ) or improves health-related quality of life ( HRQOL ) . SUBJECTS AND METHODS Forty-four patients were r and omized to st and ard best practice care ( SBP ) ( n=22 ) or SBP+RM ( n=22 ) . RM involved daily recording of physiological variables , symptoms , and medication usage . RESULTS There were no differences ( mean±SD , SBP versus SBP+RM ) in age ( 68±8 versus 70±9 years ) , gender ( male : female 10:12 in both groups ) , or previous computer familiarity ( 59 % versus 50 % ) between groups . The SBP group had a lower forced expiratory volume in 1 s ( 0.66±0.24 versus 0.91±0.34 L , p in number of COPD -related admissions/year ( 1.5±1.8 versus 1.3±1.7 , p=0.76 ) , COPD -related LOS days/year ( 15.6±19.4 versus 11.4±19.6 , p=0.66 ) , total admissions/year ( 2.2±2.1 versus 2.0±2.3 , p=0.86 ) , total LOS days/year ( 22.1±29.9 versus 21.6±30.4 , p=0.88 ) , or HRQOL between the two groups . CONCLUSIONS The addition of RM to SBP was feasible but did not reduce healthcare utilization or improve quality of life in this group of patients already receiving comprehensive respiratory care",
"This article describes a pilot telehealth project in Swansea where patients with heart failure and chronic obstructive pulmonary disease were provided with telehealth monitoring equipment . While early evaluation points to some potential economic benefits , supporting patient empowerment was a significant outcome",
"We conducted a six-month r and omised controlled trial of home telemonitoring for patients with chronic obstructive pulmonary disease ( COPD ) . A total of 40 stable patients with moderate to severe COPD who had completed pulmonary rehabilitation took part . They were r and omised to receive st and ard care ( controls ) or st and ard care plus home telemonitoring ( intervention ) . During the monitoring period , patients in the telemonitoring group recorded their symptoms and physical observations twice daily . The data were transmitted automatically at night via the home telephone line . Nurses could access the data through a website and receive alerting email messages if certain conditions were detected . The patients completed the St George 's Respiratory Question naire , Hospital Anxiety and Depression and the EuroQoL EQ-5D quality of life scores before and after pulmonary rehabilitation , and then periodically during the trial . There were significant and clinical ly important improvements in the scores immediately following pulmonary rehabilitation , but thereafter there were no differences in quality of life scores between the groups at any time , or consistently within either group over time . The study showed that telemonitoring was safe but , despite being well used , it was not associated with changes in quality of life in patients who had stable COPD",
"We studied whether preventive home monitoring of patients with chronic obstructive pulmonary disease ( COPD ) could reduce the frequency of hospital admissions and lower the cost of hospitalization . Patients were recruited from a health centre , general practitioner ( GP ) or the pulmonary hospital ward . They were r and omized to usual care or tele-rehabilitation with a telehealth monitoring device installed in their home for four months . A total of 111 patients were suitable for inclusion and consented to be r and omized : 60 patients were allocated to intervention and three were lost to follow-up . In the control group 51 patients were allocated to usual care and three patients were lost to follow-up . In the tele-rehabilitation group , the mean hospital admission rate was 0.49 per patient per 10 months compared to the control group rate of 1.17 ; this difference was significant ( P = 0.041 ) . The mean cost of admissions was € 3461 per patient in the intervention group and € 4576 in the control group ; this difference was not significant . The Kaplan-Meier estimates for time to hospital admission were longer for the intervention group than the controls , but the difference was not significant . Future work requires large-scale studies of prolonged home monitoring with more extended follow-up",
"The objective of this study was to determine the effects of a homebased telemonitoring device , The Health Buddy ( HB ) , on health consumption and health-related quality of life ( HRQoL ) in patients with moderate to severe chronic obstructive pulmonary disease ( COPD ) . The HB provides daily symptom-surveillance by a case manager and education to enhance disease knowledge and self-management . A nonr and omized controlled multicenter study was established comparing the effectiveness of telemonitoring as an add-on to care as usual with a follow-up of 6 months . Four hospitals took part in the experimental group and 2 hospitals formed an equivalent control group with 59 and 56 patients , respectively . HRQoL was measured by the Clinical COPD Question naire . Healthcare consumption was assessed using medical records in the 6 months preceding study entry and during the study . Compared with the control group , the HB group showed a significant decrease in hospital admission rates ( HB -0.11 + /- 1.16 vs. control + 0.27 + /- 1.0 , p = 0.02 ) and in the total number of exacerbations ( HB -0.35 + /- 1.4 vs. control + 0.32 + /- 1.2 , p = 0.004 ) . There was a tendency toward decreased hospital days and outpatient visits . No significant changes in HRQoL were observed at follow-up between both study groups . Despite inherent limitations of the study , these findings suggest that adopting telemonitoring in everyday clinical practice is feasible and can substantially improve care and decrease healthcare utilization of patients with moderate to severe COPD",
"OBJECTIVE The present study seeks to conduct cost-utility analysis ( CUA ) of the Danish TELEKAT ( Telehomecare , Chronic Patients and the Integrated Healthcare System ) project . The TELEKAT project seeks to test and develop a preventive home monitoring concept across sectors for chronic obstructive pulmonary disease ( COPD ) patients . The concept of the TELEKAT project is to reduce admissions by enabling the COPD patients to conduct self-monitoring and maintain rehabilitation activities in their own home . COPD patients with severe and very severe COPD were included in the study . SUBJECTS AND METHODS This economic evaluation follows international guidelines for the conduction of a CUA alongside a clinical r and omized controlled trial . The analysis is based on a health sector perspective . RESULTS The mean incremental cost efficiency ratio , located in the southeast quadrant , shows that telerehabilitation is less costly and more effective than the rehabilitation given to the control group . The telerehabilitation program produces more value for money and generates savings on healthcare budgets . CONCLUSIONS The telerehabilitation program appears to be more cost-effective than the conventional rehabilitation program for COPD patients . Further studies of cost-effectiveness with a focus on large-scale studies are needed",
"ABSTRACT Aim . To see if home telemonitors reduce healthcare use in those with optimized chronic obstructive pulmonary disease ( COPD ) . Methods . We r and omized 40 stable patients with moderate to severe COPD , who had completed at least 12 sessions of outpatient pulmonary rehabilitation ( PR ) , to receive st and ard care ( Controls ) for 52 weeks or st and ard care plus Docobo HealthHUB monitors at home for 26 weeks followed by 26 weeks st and ard care ( Tm Group ) . During the monitoring period , the Tm Group completed symptoms and physical observations twice daily which were stored and then uploaded at 2 am through a freephone l and line . Nurses could access the data through a secure web site and received alerting e-mails if certain combinations of data occurred . Results . There were fewer primary care contacts for chest problems ( p emergency room visits , hospital admissions , days in hospital or contacts to the specialist COPD community nurse team , during the monitoring period . After the monitors were removed , there were no differences between the groups for any of the health care contacts ( p > 0.20 throughout ) . Conclusion . In stable , optimized COPD patients who have already completed PR , telemonitoring in addition to best care , reduces primary care chest contacts but not hospital or specialist team utilization",
"BACKGROUND Continuity of care is widely regarded as an important marker of quality in the management of patients with long-term conditions . New services that integrate telemonitoring into care pathways have potential to change aspects of continuity in both positive and negative ways . AIMS A telemonitoring service for patients with chronic obstructive pulmonary disease ( COPD ) was introduced in Lothian , Scotl and , in 2009 . A qualitative study , nested within the TELESCOT COPD r and omised control trial , was undertaken to explore the views of patients and professionals on telemonitoring . The perceived impact of telemonitoring on continuity of care was investigated as part of the research . METHODS Semi-structured interviews were undertaken with 38 patients ( 47 % male , mean age 67.5 years ) . A maximum variation sample in relation to age , sex , socio-economic background , disease severity , and compliance with telemonitoring was recruited . Thirty-two stakeholders ( healthcare professionals and managers ) were interviewed . Transcribed coded data were analysed thematically using the framework approach . Interpretation was supported by multidisciplinary discussion . RESULTS Patients and healthcare professionals considered that relationship-based continuity of care was important in the delivery of telemonitoring services . Managers placed emphasis on improved continuity of clinical management as a means of reducing healthcare costs . However , professionals described many operational challenges arising from the ' bolting-on ' of telemonitoring provision to existing usual care provision which , they considered , result ed in the proliferation of additional managerial discontinuities . CONCLUSIONS Managers and healthcare professionals face major challenges in meeting dem and s for both relationship continuity and continuity of clinical management in the development of telemonitoring services"
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4116e2d2-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Financial incentive interventions have been suggested as one method of promoting healthy behaviour change . OBJECTIVES To conduct a systematic review of the effectiveness of financial incentive interventions for encouraging healthy behaviour change ; to explore whether effects vary according to the type of behaviour incentivised , post-intervention follow-up time , or incentive value . DATA SOURCES Search es were of relevant electronic data bases , research registers , www.google.com , and the reference lists of previous review s ; and requests for information sent to relevant mailing lists . ELIGIBILITY CRITERIA Controlled evaluations of the effectiveness of financial incentive interventions , compared to no intervention or usual care , to encourage healthy behaviour change , in non- clinical adult population s , living in high-income countries , were included . STUDY APPRAISAL AND SYNTHESIS The Cochrane Risk of Bias tool was used to assess all included studies . Meta- analysis was used to explore the effect of financial incentive interventions within groups of similar behaviours and overall . Meta-regression was used to determine if effect varied according to post-intervention follow up time , or incentive value . RESULTS Seventeen papers reporting on 16 studies on smoking cessation ( n = 10 ) , attendance for vaccination or screening ( n = 5 ) , and physical activity ( n = 1 ) were included . In meta-analyses , the average effect of incentive interventions was greater than control for short-term ( ≤ six months ) smoking cessation ( relative risk ( 95 % confidence intervals ) : 2.48 ( 1.77 to 3.46 ) ; long-term ( > six months ) smoking cessation ( 1.50 ( 1.05 to 2.14 ) ) ; attendance for vaccination or screening ( 1.92 ( 1.46 to 2.53 ) ) ; and for all behaviours combined ( 1.62 ( 1.38 to 1.91 ) ) . There was not convincing evidence that effects were different between different groups of behaviours . Meta-regression found some , limited , evidence that effect sizes decreased as post-intervention follow-up period and incentive value increased . However , the latter effect may be confounded by the former . CONCLUSIONS The available evidence suggests that financial incentive interventions are more effective than usual care or no intervention for encouraging healthy behaviour change . TRIAL REGISTRATION PROSPERO CRD42012002393
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"This study determined the effects on smoking behavior of providing contingent reinforcement for nonsmoking versus reduced smoking afternoon breath carbon monoxide ( CO ) target levels . Twenty-eight hired chronic smoker volunteers were r and omly assigned to one of three experimental conditions during a 10-day intervention : ( a ) 8 ppm target CO , $ 5 per day incentive ( n = 11 ) ; ( b ) 16 ppm target CO , $ 4 per day incentive ( n = 8) ; or ( c ) 8 ppm target CO , no incentive ( n = 9 ) . Both payment groups showed significantly lower CO levels and greater amounts of daytime smoking reduction than the no-pay group . A specific effect of CO target was also seen ; 45 % of subjects in the 8 ppm group compared with 0 % of subjects in the 16 ppm target and no-pay groups produced average afternoon CO levels of 8.5 ppm or lower during the intervention . Average levels of CO and smoking reduction did not differ for the two paid groups , however , because some subjects in the 8 ppm group failed to reduce CO sufficiently to contact the reinforcer . Contingent reinforcement based on expired air CO levels can exercise powerful and precise ( target-specific ) control over smoking behavior , but there may be individual differences in ability to meet reinforcement contingencies if difficult targets are introduced abruptly",
"BACKGROUND Smoking is the leading preventable cause of premature death in the United States . Previous studies of financial incentives for smoking cessation in work setting s have not shown that such incentives have significant effects on cessation rates , but these studies have had limited power , and the incentives used may have been insufficient . METHODS We r and omly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs ( 442 employees ) or to receive information about programs plus financial incentives ( 436 employees ) . The financial incentives were $ 100 for completion of a smoking-cessation program , $ 250 for cessation of smoking within 6 months after study enrollment , as confirmed by a biochemical test , and $ 400 for abstinence for an additional 6 months after the initial cessation , as confirmed by a biochemical test . Individual participants were stratified according to work site , heavy or nonheavy smoking , and income . The primary end point was smoking cessation 9 or 12 months after enrollment , depending on whether initial cessation was reported at 3 or 6 months . Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs . RESULTS The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment ( 14.7 % vs. 5.0 % , P Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program ( 15.4 % vs. 5.4 % , P completion of a smoking-cessation program ( 10.8 % vs. 2.5 % , P smoking cessation within the first 6 months after enrollment ( 20.9 % vs. 11.8 % , P financial incentives for smoking cessation significantly increased the rates of smoking cessation . ( Clinical Trials.gov number , NCT00128375 .",
"BACKGROUND In a prior study , we reported that monetary incentives were effective in increasing return for tuberculosis ( TB ) skin test reading . The purpose of this study was to compare the effects of monetary versus nonmonetary incentives and a theory-based educational intervention on return for TB skin test reading in a sample of newly recruited active injection and crack cocaine users , and to determine the prevalence of TB infection in this sample . METHODS Active injection drug and /or crack cocaine users ( n = 1,078 ) , recruited using street outreach techniques , were skin tested for TB . They were r and omly assigned to 1 of 5 experimental treatment conditions : $ 10 cash , grocery store coupons , bus tokens/fast-food coupons , motivational education , or usual encouragement to return . Nonmonetary incentives had a $ 10 value , and all incentives were provided at return for skin test reading . RESULTS Ninety-five percent of those who received $ 10 returned for skin test reading compared to 86 % of those who received grocery store coupons and 83 % of those who received either bus tokens or fast-food coupons . In contrast , only 47 % of those who received the educational session and only 49 % of those who received usual encouragement returned for skin test reading . The prevalence of a positive tuberculin test was 21 % , and was similar for crack cocaine and injection drug users . CONCLUSIONS Nonmonetary and monetary incentives dramatically increased the return rate for TB skin test reading among drug users who are at high risk of TB infection . Nonmonetary incentives were somewhat less effective than monetary incentives",
"Vaccines represent a new and promising avenue of treatment for drug abuse but pose new medication adherence challenges due to prolonged and widely spaced administration schedules . This study examined effects of prize-based incentives on retention and medication adherence among 26 cocaine users involved in a 6-month hepatitis B vaccination series . Participants could meet with research staff weekly for 24 weeks and receive 7 injections containing either the Hepatitis B vaccine or a placebo . All participants received $ 10 at each weekly visit ( maximum of $ 240 ) . Those r and omly assigned to the incentive program received additional monetary payments on an escalating schedule for attendance at weekly monitoring and vaccination visits with maximum possible earnings of $ 751 . Group attendance diverged after study week 8 with attendance better sustained in the incentive than control group ( group by time interaction , p=.035 ) . Overall percent of weekly sessions attended was 82 % for incentive versus 64 % for control ( p=.139 ) . Receiving all scheduled injections were 77 % of incentive versus 46 % of control participants ( p=.107 ) . A significantly larger percentage ( 74 % versus 51 % ; p=.016 ) of injections were received by incentive versus control participants on the originally scheduled day . Results suggest that monetary incentives can successfully motivate drug users to attend sessions regularly and to receive injected medications in a more reliable and timely manner than may be seen under usual care procedures . Thus , incentives may be useful for addressing adherence and allowing participants to reap the full benefits of newly developed medications",
"This study evaluated the impact of a year-long incentives-based worksite smoking-cessation program . Nineteen moderate-sized worksites , employing a total of approximately 1100 smokers , were r and omized to Incentive or No Incentive conditions . All identified smokers in the worksite were considered as subjects , whether or not they participated in the intervention . Analyses were conducted at both the worksite and individual level , and using both self-reported and biochemically vali date d cessation as endpoints . The incentive program did not significantly improve cessation rates at either the 1-year or 2-year follow-up assessment s. We conclude that more broadly focused interventions that also address worksite smoking policies , skills training , and cessation re sources , or programs that target additional risk factors are needed to substantially enhance quit rates",
"Smoking cessation interventions have posed significant challenges for health professionals , particularly when directed at high risk , low income , pregnant smokers . Typical quit rates for pregnant women who receive publicly financed obstetrical care have rarely exceeded 12–16%.1 As many as 70 % of women who quit smoking during pregnancy relapse within one year of delivery.2 Two areas that have received particular attention as possible adjuncts to behaviour change are the use of reinforcements and social supports . Reinforcement in the form of incentives/rewards for positive behaviours has been controversial as an intervention strategy . Some argue that the “ overjustification effect ” of external rewards may cause subjects to lose internal motivation to modify behaviour over the long term.3 However , results of several studies , including two meta-analyses on reinforcement , provide compelling evidence that positive reinforcement provides positive behavioural changes.4 - 8 A second area of study that has been explored in the behaviour change research is the role of social support in motivating and sustaining selected behaviour change . Recent studies have empirically linked tobacco quit rates with daily interaction with a supportive “ other , ” preferably one who did not smoke.9 10 The primary objective of our intervention was to determine whether the combination of bolstered social support and financial incentives had an effect in significantly reducing smoking behaviour among low income , high risk , pregnant and postpartum women who participate in Oregon 's Women , Infants , and Children ( WIC ) program . The Significant Other Supporter ( SOS ) program was a r and omised , experimentally design ed smoking cessation study implemented in four Oregon WIC program sites . Criteria for entry into the study included the following : age 15 years or older ; self reported smoker ( “ even a puff in the last seven days ” ) ; English speaker/reader ; WIC eligible ; and 28 weeks gestation or less . Eligible subjects were r and omised into one of two groups , and were",
"OBJECTIVES This study assessed the independent and combined effects of different levels of monetary incentives and a theory-based educational intervention on return for tuberculosis ( TB ) skin test reading in a sample of active injection drug and crack cocaine users . Prevalence of TB infection in this sample was also determined . METHODS Active or recent drug users ( n = 1004 ) , recruited via street outreach techniques , were skin tested for TB . They were r and omly assigned to 1 of 2 levels of monetary incentive ( $ 5 and $ 10 ) provided at return for skin test reading , alone or in combination with a brief motivational education session . RESULTS More than 90 % of those who received $ 10 returned for skin test reading , in comparison with 85 % of those who received $ 5 and 33 % of those who received no monetary incentive . The education session had no impact on return for skin test reading . The prevalence of a positive tuberculin test was 18.3 % . CONCLUSIONS Monetary incentives dramatically increase the return rate for TB skin test reading among drug users who are at high risk of TB infection ",
"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",
"Sixty-three companies in the Chicago area were recruited to participate in a worksite smoking cessation program . Participants in each worksite received a television program and newspaper supplement ( part of a community-wide media campaign ) , and one of three conditions : ( 1 ) self-help manuals alone ( M ) , ( 2 ) self-help manuals and incentives for 6 months ( IM ) or ( 3 ) maintenance manuals , incentives and cognitive-behavioral support groups for 6 months ( GIM ) . Results at the 2 year assessment are examined using a r and om-effects regression model . In addition , various definitions of quit-rate commonly used in smoking cessation research are explored and the advantages of using a public health approach in the worksite are examined",
"OBJECTIVE Less than half of all U.S. adults meet public health recommendations for physical activity , and even fewer older adults ( aged 50 years and over ) are sufficiently active . Because inactivity increases the risk of costly medical complications , successful efforts to increase physical activity among older adults may potentially be cost-effective . We sought to test if financial incentives for walking could increase physical activity among sedentary older adults . METHODS We conducted a 4-week r and omized controlled study using pedometers . A total of 51 adults age 50 + from the Raleigh-Durham area of North Carolina participated in the study in April-May 2007 . Individuals were r and omized into one of two arms . The control group received a fixed payment of $ 75 ; the intervention group received a fixed payment of $ 50 plus up to $ 25 more per week depending on the number of weekly aerobic minutes , defined as 10 + minutes of continuous walking or jogging . RESULTS The control group logged 2.3 h per week , on average . The intervention group logged 4.1 h per week and received an additional weekly payment of $ 17.50 , on average . CONCLUSION Modest financial incentives tied to aerobic minutes are an effective , and potentially cost-effective , approach for increasing physical activity among sedentary older adults ",
"BACKGROUND To minimize absenteeism result ing from influenza , employers frequently offer on-site influenza vaccination to employees . Yet the level of uptake of vaccine is low among working adults . This study was design ed to increase workplace influenza vaccination rates by offering both a choice of intranasal ( LAIV ) and injectable ( TIV ) influenza vaccines to eligible employees , and an incentive for being vaccinated , and by increasing awareness of the vaccine clinic . DESIGN This study used a stratified r and omized cluster trial . SETTING / PARTICIPANTS A total of 12,222 employees in 53 U.S. companies with previous influenza vaccine clinics were examined . INTERVENTIONS Control sites advertised and offered vaccine clinics as previously done . Choice sites offered LAIV or TIV and maintained their previous advertising level but promoted the choice of vaccines . Choice Plus sites increased advertising and promoted and offered a choice of vaccines and a nominal incentive . MAIN OUTCOME MEASURES These included vaccination rates among eligible employees . Hierarchic linear modeling ( HLM ) was used to determine factors associated with vaccination . RESULTS The overall vaccination rate increased from 39 % in 2007 - 2008 to 46 % in 2008 - 2009 ( p difference in vaccination rates for LAIV was 6.5 % for Choice versus Control and 9.9 % for Choice Plus versus Control ( both p Rates of TIV increased by 15.9 percentage points in the Choice Plus arm versus Control for workers aged > or = 50 years ( p=0.024 ) . Rates of TIV did not change in workers aged 18 - 49 years in either intervention arm or in workers aged > or = 50 years in the Choice arm . In HLM analyses , factors significantly associated with increased vaccination were older age , female gender , previous company vaccination rate , and the Choice Plus intervention . CONCLUSIONS An incentive for vaccination , an intensified advertising campaign , and offering a choice of influenza vaccines improved vaccination rates in the workplace",
"Mailed invitations to participate in weight loss and /or smoking cessation correspondence programs to 31,400 households in a suburban community . Two programs were offered to r and omized subsets of households , a 6-month correspondence program costing + 5 and the same program for free but requiring a + 60 deposit to be refunded based on success in weight loss or smoking cessation . Overall , sign-up included 1,304 people for weight loss and 142 for smoking cessation . The + 5 program was about 5 times as popular as the incentive program . Vali date d weight change after 6 months averaged about 4 lb for the + 5 program and 8 lb for the incentive program . Corresponding rates of smoking cessation were about 9 % and 20 % , respectively . We conclude that correspondence programs for the promotion of weight control and smoking cessation are potentially cost-effective methods for reaching individuals in the community at large , many of whom would not be interested in clinic-based programs . Issues meriting further research include recruitment , especially of smokers , and evaluation of the relative trade-offs in recruitment success versus efficacy of differing treatment approaches"
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4116e30e-06ff-11f0-808a-c43d1ab1c353
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UNLABELLED The aim of this systematic review is to describe participation in social and physical leisure activities among children and adolescents with JIA , as well as identify potential determinants of leisure participation . METHODS Electronic data bases were systematic ally search ed for articles published up until June 2013 pertaining to participation in leisure activities among youth with JIA and other rheumatic diseases . Studies were included if they measured involvement in either social or physical leisure activities . Selection and quality appraisal of articles were completed independently by two authors . RESULTS Eight hundred and ninety-three articles were found through electronic and reference search . One hundred and nine full articles were review ed to assess for eligibility . Twelve articles met inclusion criteria and findings were review ed . Most focused on describing participation in physical rather than social activities . Results suggest that youth with JIA participated less in both social and physical leisure activities as compared to healthy peers , and those with JIA did not meet national recommendations for physical activity . Potential determinants of leisure participation were socio-demographic ( age , sex ) , anthropometric ( height , weight ) and disease-related ( JIA subtype , disease duration , pain , number of swollen or painful joints , stiffness , fatigue , well-being ) factors . CONCLUSION Characterization of leisure activity remains limited and mostly focused on physical activity in JIA . Assessment of more comprehensive outcome measures is warranted to obtain a better description of leisure in this population . Evidence of the influence of context ual factors as potential determinants of involvement in leisure among children with pediatric rheumatologic diseases is needed
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"OBJECTIVE To investigate the effects of an 8-week , 24-session weight-bearing physical conditioning program on disease signs and symptoms in children with chronic arthritis . METHODS In a within-subjects , repeated measures design , 25 subjects , ages 8 - 17 years , with chronic polyarticular juvenile rheumatoid arthritis ( JRA ) , were assessed at study entry , after an 8-week control period , and after an 8-week exercise period , for 1 ) disease status , based on joint count ( JC ) and articular severity index ( ASI ) ( sum of scores for joint swelling , pain on motion , tenderness , and limitations of motion ) ; 2 ) worst pain during the past week , using a 10-cm visual analog scale ( VAS ) , and 3 ) aerobic endurance , using the 9-minute run-walk test of the Health Related Physical Fitness Test battery . The 60-minute conditioning program included warm-up ( 10 minutes ) , low-impact aerobics ( 25 minutes ) , strengthening ( 15 minutes ) , and cool-down and flexibility exercises ( 10 minutes ) . Subjects exercised twice a week at their rheumatology center and once a week at home , using a commercial exercise video-tape supplied by the investigator . RESULTS Significant improvement was found in the ASI ( Friedman analysis of variance [ ANOVA ] ) , JC , and 9-minute run-walk test ( repeated measures ANOVA ) from the pre- to post-exercise tests . Mean VAS pain scores decreased 16 % from study entry to the post-exercise test . Statistically significant improvement ( reliable change index > 1.96 ) occurred in 80 % of subjects on the ASI and 72 % on the JC . CONCLUSION Children and adolescents with chronic polyarticular JRA can improve their aerobic endurance through participation in weight-bearing physical conditioning programs without disease exacerbation or increased pain , and may achieve decreased joint signs and symptoms through increased physical activity",
"OBJECTIVE To examine the effectiveness of high-intensity aerobic training compared with low-intensity training in terms of energy cost of locomotion , peak oxygen uptake , peak power , and self-reported physical function in children with juvenile idiopathic arthritis ( JIA ) . METHODS Eighty children with JIA , ages 8 - 16 years , were enrolled in a r and omized , single-blind controlled trial . Both groups participated in a 12-week , 3-times-weekly training program consisting of high-intensity aerobics in the experimental group and qigong in the control group . Subjects underwent exercise testing measuring submaximal oxygen uptake at 3 km/hour ( VO(2submax ) ) as the primary outcome , maximal oxygen uptake , and peak power at the beginning and end of the program . Physical function was measured using the Child Health Assessment Question naire ( C-HAQ ) . RESULTS The exercise program was well tolerated in both groups . There was no difference in VO(2submax ) or any other exercise testing measures between the groups through the study period and no indication of improvement . Both groups showed significant improvements in C-HAQ with no difference between the groups . Adherence was higher in the control group than the experimental group . CONCLUSION Our findings suggest that activity programs with or without an aerobic training component are safe and may result in an important improvement in physical function . The intensity of aerobic training did not seem to provide any additional benefits , but higher adherence in the qigong program may suggest that less intensive regimens are easier for children with JIA to comply with , and provide a degree of benefit equivalent to more intensive programs",
"BACKGROUND AND OBJECTIVE Search ing for nonr and omized studies in electronic data bases is complicated because there is a variety of study design s and lack of st and ardization in the terminology . The purpose of this study was to develop and evaluate a method to limit search strategies according to study design of comparative nonr and omized studies ( cNRSs ) . METHODS Four up date d Cochrane systematic review s that included nonr and omized studies ( cohort , case-control , and cross-sectional studies ) of the effects of health care interventions were selected . Search strategies limited to study design were devised for each one of these topic areas in two electronic data bases ( MEDLINE and EMBASE ) . A progressive method ( PM ) and a fixed method for selecting the most appropriate search terms associated with study design of nonr and omized studies are suggested . RESULTS The results showed that the sensitivity of search strategies ( in two data bases combined ) limited to study design were between 90 % and 100 % for the PM using both controlled vocabulary ( CV ) and textwords ( TWs ) and between 95 % and 100 % for a fixed set of controlled vocabulary and TWs . CONCLUSIONS It is possible and acceptable to use search strategies limited to study design of cNRSs of health care interventions ",
"OBJECTIVE To 1 ) assess the safety and feasibility of laboratory-based exercise testing in juvenile idiopathic arthritis ( JIA ) , 2 ) test the safety and feasibility of a 3-month exercise program in JIA , 3 ) assess pain during exercise in JIA , 4 ) compare ratings of perceived effort ( RPE ) with heart rate ( HR ) achieved , and 5 ) estimate the training effect on metabolic efficiency of gait as measured by submaximal exercise testing . METHODS Nine children with JIA were enrolled in a 12-week circuit training program involving pool , stationary bicycle , treadmill , and Fitball . They underwent formal exercise testing before and after the program , underwent a full joint assessment , were administered the Childhood Health Assessment Question naire and Juvenile Arthritis Functional Status Index , and were assessed for overall quality of life and health-related quality of life . A visual analog scale was used to assess pain during testing and training , and the Borg scale was used to measure RPE . RESULTS Children with JIA were able to participate in exercise testing without any significant problems . Children with severe hip disease dropped out of the exercise program due to pain during the exercise sessions and worsened arthritis symptoms . Target HR was achieved and correlated with RPE in the bicycle and treadmill sessions . Submaximal exercise testing showed an improvement with a small to moderate effect size . CONCLUSION This study suggests that it is safe , feasible , and acceptable for children with arthritis , in the absence of severe hip involvement , to participate in formal exercise testing and structured fitness programs",
"OBJECTIVE To explore early changes and predictors of bone mass in children with juvenile idiopathic arthritis ( JIA ) in order to identify patients who will develop bone mass reductions . METHODS We conducted a prospect i ve cohort study of 108 children with early JIA ( ages 6 - 18 years ; mean disease duration 19.3 months ) who were individually matched with 108 healthy children for age , sex , race , and county of residence . Bone mass and changes in total body , spine , femur , and forearm bone mineral density and bone mineral content ( BMC ) , body composition , growth , and biochemical parameters of bone turnover were examined at baseline and at followup a mean of 24 months later . Low bone mass was defined as a Z score > 1 SD below the reference population . RESULTS Of the 200 children evaluated at followup , the 100 healthy children had greater gains in total body BMC ( P = 0.035 ) , distal radius BMC ( P total body lean mass ( P 100 JIA patients . Low or very low total body BMC was observed in 24 % of the patients and 12 % of the healthy children . Bone formation , bone resorption , and weight-bearing activities were reduced in the patients compared with the healthy children . Multiple regression analysis showed that in patients with JIA , serum bone-specific alkaline phosphatase , serum C-telopeptide of type I collagen , and weight-bearing activities were independent predictors of changes in total body BMC . Total body BMC was lower in patients with polyarticular onset than in those with oligoarticular disease onset . CONCLUSION Patients with JIA have moderate reductions in bone mass gains , bone turnover , and total body lean mass early in the disease course",
"OBJECTIVE To evaluate the effects of an aquatic training programme for JIA patients . METHODS Fifty-four patients with JIA ( age range 5 to 13 yr ) participated in this study and were r and omized into an experimental ( n = 27 ) and a control ( n = 27 ) group . The children in the experimental group received a training programme consisting of a 1 h per week supervised training programme in a local pool of approximately 20 sessions . Effects were analysed on the following domains : functional ability , health-related quality of life , joint status and physical fitness . RESULTS Although all measures improved more in the experimental group than the control group , none of the differences was statistically significant . CONCLUSIONS The current research found no significant effect of an aquatic fitness training programme in children with JIA . Since there were no signs of worsening in health status , one can conclude that this was a safe exercise programme",
"OBJECTIVE To analyze patterns of daily pain , stiffness , and fatigue related to juvenile arthritis ; to examine the relationships of demographics , disease severity , and psychological adjustment to daily disease symptoms ; and to examine daily disease symptoms as predictors of reduced participation in school and social activity . METHODS For a 2-month period , 41 children with polyarticular juvenile arthritis completed daily diaries that included measures of symptoms and function . Children also underwent an initial evaluation and 4 followup evaluations that included a joint count , laboratory testing , and completion of question naires assessing physical and psychosocial functioning . RESULTS Children reported having pain an average of 73 % of days , with the majority of children ( 76 % ) reporting pain on > 60 % of all days . On average , children described the intensity of their daily pain as being in the mild to moderate range ; however , a significant subgroup ( 31 % ) reported pain in the severe range . Higher physician global assessment ratings , increased functional disability , and increased anxiety were significantly associated with increased daily pain and other daily symptoms . Multilevel r and om-effects analyses indicated that increased daily symptoms of pain , stiffness , and fatigue were significant predictors of reduced participation in school and social activities . CONCLUSION Physicians should consider treating pain more aggressively in children with arthritis , in order to preserve function in school and social domains , as well as physical function . Moreover , optimal pain management in children with arthritis should include therapeutic regimens addressing anxiety as well as st and ard pharmacologic interventions"
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4116e34a-06ff-11f0-808a-c43d1ab1c353
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Objective The present systematic review aim ed at assessing data from the literature on endodontic and prosthetic complications in endodontically treated teeth restored with fiber posts and single crowns ( SCs ) or fixed dental prostheses ( FDPs ) . Material s and methods Available r and omized controlled clinical trials evaluating endodontic and prosthetic complications in the teeth treated with fiber posts and restored with different prosthetic restorations were review ed . PubMed , Evidence -Based Dentistry , BMJ Clinical Evidence , Embase , DynaMed , and gray literature restricted to scientific literature were analyzed ; also , manual research es were performed . English language and time filters ( from 1990 to 2015 ) were used . Results The data base search produced 4230 records , many of which were duplicates . The manual research did not produce any other relevant article . After duplications were removed , all the selected data bases produced 3670 records . Reading titles and abstract s , two independent review ers excluded 3664 reports . The full-texts of the remaining six reports were read . Only four studies met the inclusion criteria and were included in this systematic review . Conclusions The most frequently reported failures in the available studies were as follows : fiber post debonding , loss of retention of single crowns , and marginal gaps . Less frequently , chippings and fractures were recorded in SCs . No studies about complications related to FDPs were found . Clinical relevance A correlation between the failure rates of fiber posts and the type of prosthetic restorations just like SCs and FDPs can not be found to date . Further r and omized controlled clinical studies are required to achieve evidence -based conclusions , particularly about the use of fiber posts with FDPs
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"The purpose of this study was to assess the fracture resistance of roots that were prosthetically restored with intra-radicular posts of different lengths . Forty-five bovine incisors were sectioned 17 mm from their apices , endodontically treated and r and omly divided into three experimental groups : GI , fibreglass posts luted at a depth of 12 mm ; GII , 8 mm and GIII , 4 mm . All posts were luted with dual resin cement . Resin composite cores were prepared with st and ardized measurements , and all teeth were restored with metal crowns . The sample s were su bmi tted to the fracture resistance test in a universal testing machine , at an angle of 135 degrees and speed of 0.5 mm min(-1 ) , until fracture occurred . The data , in MPa , were su bmi tted to the analysis of variance ( anova ) followed by Tukey 's test ( alpha = 0.01 ) . No statistically significant difference ( P > 0.01 ) was found between GI ( 129.72 + /- 12.14 ) and GII ( 154.3 + /- 12.08 ) , which presented the highest fracture resistance values . Group GIII ( 100.5 + /- 8.07 ) showed lower fracture resistance ( P fracture resistance of prosthetically restored roots . These results suggest that it is not necessary to perform excessive intra-radicular post-space preparation to improve the fracture resistance of roots",
"STATEMENT OF PROBLEM Crowns have been considered the restoration of choice for endodontically treated teeth , but their selection has been based primarily on anecdotal evidence . PURPOSE This study tested the hypothesis that crown placement ( coronal coverage ) is associated with improved survival of endodontically treated teeth when preaccess , endodontic , and restorative factors are controlled . MATERIAL AND METHODS A University of Iowa College of Dentistry treatment data base was used to identify permanent teeth that had undergone initial obturation between July 1 , 1985 , and December 31 , 1987 . Study patients were restricted to persons with at least 1 dental visit in each 2-year interval from 1985 to 1996 ; a simple r and om sample of 280 patients ( n = 400 teeth ) was selected . Dental charts , radiographs , and computerized data bases were examined to ascertain variables of interest and to verify study inclusion criteria . Kaplan-Meier survival estimates were generated for the 203 teeth that satisfied study inclusion criteria . Multivariate Cox proportional hazards regression models were developed , with st and ard errors adjusted to account for clustering of teeth within patients . RESULTS When tooth type and radiographic evidence of caries at access were controlled , the final Cox model showed that endodontically treated teeth not crowned after obturation were lost at a 6.0 times greater rate than teeth crowned after obturation ( 95 % confidence interval : 3.2 to 11.3 ) . CONCLUSION Within the limitations of this study , a strong association between crown placement and the survival of endodontically treated teeth was observed . These results may impact treatment planning if long-term tooth retention is the primary goal",
"PURPOSE To determine , in a 3-year clinical trial , whether tooth type and ferrule significantly affect the survival of pulpless teeth restored with fiber posts . METHODS A sample of 87 teeth in 87 patients ( 32 men and 55 women , age ranged from 23 to 78 ) were restored using Snowpost : 34 incisors , 12 canines , 25 premolars and 16 molars . The posts were cemented with RelyXUnicem and the core was made with a resin composite ( Dentocore Automix ) . Every tooth was covered with a metal-ceramic or all ceramic crown . Two experimental groups , according to the presence or absence of ferrule , were defined : A ) 45 teeth with ferrule ( > 2 mm height ) ; and B ) 42 teeth without ferrule ( failed ( 16.1 % ) . The failure modes were caries ( n=4 ) , post fracture ( n=4 ) , root fracture ( n=2 ) , and marginal gap , post cement failure , crown cement failure , and periapical lesion ( n= 1 respectively ) . In Group A the failure observed was 6.67 % and in Group B it was 26.20 % . The log-rank test showed statistically significant differences between both groups . According to the type of tooth , the incisors were the teeth with the highest failure rate ( 73.52 % ) , but Chi-square test showed no statistically significant differences among the four tooth types , perhaps because of the low number of the sample",
"OBJECTIVE To assess the survival rate of two different post systems after 5 years of service with a prospect i ve r and omized controlled trial . METHOD AND MATERIAL S One hundred patients in need of a post were studied . Half of the patients received long glass fiber-reinforced posts , while the other half received long metal screw posts . The posts were assigned r and omly . After at least 5 years ( mean , 61.37 months ) , follow-ups were established . When a complication occurred prior to this recall , the type and time of the complication was documented . Statistical analysis was performed using the log-rank test and Kaplan-Meier analysis . Additionally , a Cox regression was performed to analyze risk factors . RESULTS The survival rate of fiber-reinforced posts was 71.8 % . In the metal screw post group , the survival rate was significantly lower , 50.0 % ( log-rank test , P = .026 ) . Metal posts result ed more often in more unfavorable complications ( eg , root fractures ) ; consequently , more teeth ( n = 17 ) had to be extracted . The Cox regression identified the following risk factors : position of the tooth ( anterior vs posterior teeth ) , degree of coronal tooth destruction , and the post system ( fiber-reinforced post vs metal screw post ) . Fiber-reinforced restorations loosened in several patients ; in some of these cases ( n = 6 ) , patients did not notice this , leading to the extraction of teeth . CONCLUSION Long metal screw posts should be used with great care in endodontically treated teeth . Besides the selection of the post system , other factors influence the survival of the restoration",
"STATEMENT OF PROBLEM Little information exists regarding the outcome of crown build-ups on endodontically treated teeth restored with metal-ceramic crowns or with only a direct-placed composite . PURPOSE The aim of this study was to evaluate the clinical success rate of endodontically treated premolars restored with fiber posts and direct composite restorations and compare that treatment with a similar treatment of full-coverage with metal-ceramic crowns . MATERIAL AND METHODS Subjects included in this study had one maxillary or m and ibular premolar for which endodontic treatment and crown build up was indicated and met specific inclusion /exclusion criteria . Only premolars with Class II carious lesions and preserved cusp structure were included . Subjects were r and omly assigned to 1 of the following 2 experimental groups : ( 1 ) teeth endodontically treated and restored with adhesive techniques and composite or ( 2 ) teeth endodontically treated , restored with adhesive techniques and composite , and then restored with full-coverage metal-ceramic crowns . Sixty teeth were included in the first group and 57 in the second . All restorations were performed by one operator . Causes of failure were categorized as root fracture , post fracture , post decementation , clinical and /or radiographic evidence of marginal gap between tooth and restoration , and clinical and /or radiographic evidence of secondary caries contiguous with restoration margins . Subjects were examined for the listed clinical and radiographic causes of failure by 2 calibrated examiners at intervals of 1 , 2 , and 3 years . Exact 95 % confidence intervals for the difference between the 2 experimental groups were calculated . RESULTS At the 1-year recall , no failures were reported . The only failure modes observed at 2 and 3 years were decementations of posts and clinical and /or radiographic evidence of marginal gap between tooth and restoration . There was no difference in the failure frequencies of the 2 groups ( 95 % confidence interval , -17.5 to 12.6 ) . There was no difference between the number of failures caused by post decementations and the presence of marginal gaps observed in the 2 groups ( 95 % confidence intervals , -9.7 to 16.2 and -17.8 to 9.27 ) . CONCLUSION Within the limitations of this study , the results upheld the research hypothesis that the clinical success rates of endodontically treated premolars restored with fiber posts and direct composite restorations after 3 years of service were equivalent to a similar treatment of full coverage with metal-ceramic crowns",
"INTRODUCTION This is the first clinical long-term pilot study that tested the biomimetic concept of using more flexible , dentine-like ( low Young modulus ) glass fiber-reinforced epoxy resin posts ( GFREPs ) compared with rather rigid , stiff ( higher Young modulus ) titanium posts ( TPs ) in order to improve the survival rate of severely damaged endodontically treated teeth . METHODS Ninety-one subjects in need of postendodontic restorations in teeth with 2 or less remaining cavity walls were r and omly assigned to receive either a tapered TP ( n = 46 ) or a tapered GFREP ( n = 45 ) . The posts were adhesively luted using self-adhesive resin cement . The composite core build-ups were prepared ensuring a circumferential 2-mm ferrule . The primary endpoint was a loss of restoration for any reason . To study group differences , the log-rank test was calculated ( P failed ( ie , 4 GFREPs and 3 TPs ) . The failure modes were as follows : GFREP : root fracture ( n = 3 ) , core fracture ( n = 1 ) and TP : endodontic failure ( n = 3 ) . No statistical difference was found between the survival rates ( GFREPs = 90.2 % , TPs = 93.5 % , P = .642 ) . The probability of no failure was comparable for both post material s ( risk ratio ; 95 % confidence interval , 0.965 - 0.851/1.095 ) . CONCLUSIONS When using self-adhesive luted prefabricated posts in severely destroyed abutment teeth with 2 or less cavity walls and a 2-mm ferrule , postendodontic restorations achieved high long-term survival rates irrespective of the post material used ( ie , glass fiber vs titanium )"
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4116e386-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND This is the first systematic review and meta- analysis of the large body of data describing the Swedish adjustable gastric b and ( SAGB ) and Lap-B and ( LB ) . METHODS A systematic review was performed that included screening of studies published in any language ( January 1 , 1998 through April 30 , 2006 ) identified through MEDLINE , Current Contents , or the Cochrane Library . Studies with > or = 10 SAGB or LB patients reporting > or = 30-day efficacy or safety outcomes were eligible for review ; the data were extracted from the accepted studies . A weighted means analysis and r and om-effects meta- analysis of efficacy outcomes of interest were conducted . RESULTS A total of 4592 bariatric surgery studies met the initial criteria . Of these studies , 129 ( 28,980 patients ) were accepted ( 33 SAGB and 104 LB studies ) ; most had a retrospective single-center design . For 4273 patients ( 36 treatment groups ) in 33 SAGB studies and 24,707 patients ( 111 groups ) in 104 LB studies , the mean baseline age ( 39.1 - 40.2 yr ) , body mass index ( 43.8 - 45.3 kg/m2 ) , and gender ( women 79.2 - 82.5 % ) were similar . A laparoscopic technique was used in > or = 88 % and a pars flaccida technique in > or = 41 % of both groups . Early mortality was equivalent for SAGB/LB ( SAGB and LB excess weight loss ( 56.36 % and 50.20 % , respectively ) and body mass index reduction ( -11.99 and -11.81 kg/m2 , respectively ) from baseline were statistically significant ( P resolution of diabetes ( 61.45 % and 60.29 % , respectively ) and hypertension ( 62.95 % and 43.58 % , respectively ) . Although scant and inconsistently reported data precluded direct statistical comparisons , the complication rates for the 2 devices appeared comparable . In 8 directly comparative studies , meta- analysis found a significantly greater absolute weight loss ( P excess weight loss or change in body mass index . CONCLUSION In a systematic review of the published world SAGB and LB data , at 1 , 2 , and 3 years , the weight loss , resolution of diabetes and hypertension , and complications appeared comparable
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"Background : Laparoscopic gastric b and ing is the most common operation in Europe for morbid obesity . Many devices from different companies are now available . The aim of this study was to compare the results over a 2-year period of 2 types of b and : the Lap-B and ® and the Minimizer ® b and . Methods : In a non-r and omized study , 2 consecutive groups were prospect ively analyzed . Group A consisted of 120 patients who received the Lap-B and ® , and group B consisted of 68 patients who received the Minimizer b and which contains eyelets . All the b and s were placed above the lesser sac by the perigastric approach . Results : 4 early complications were observed in group A ( 1 phlebitis , 1 pneumopathy and 2 early displacements of the b and ) ; and 1 in group B ( 1 retention of urine ) . After a follow-up of 2 years , the displacement rate of the b and was 10.8 % in group A and 0 % in group B. One gastric erosion was observed in group B , but not in group A. After 2 years , the average loss of excess weight was 50 % in both groups . Conclusion : With the Minimizer b and , we did not observe any slipping , and the efficacy with respect to weight loss was equivalent to the Lap-B and",
"Background : To be certified for laparoscopic placement of adjustable gastric b and ing , surgeons must have advanced laparoscopic experience . Despite previous exposure to other kinds of laparoscopy , there may a learning curve specific to Lap-B and placement . Methods : Sixty consecutive patients were prospect ively separated into two groups : the first 30 patients operated on ( group 1 ) and the second 30 patients operated on ( group 2 ) . Results : Both groups were similar statistically in regard to gender , age , and body mass index . Operative time for group 1 was 79 ± 31.1 min . There were 11 ( 37 % ) complications in 10 patients . Operative time for group 2 was 59 ± 19.9 min . There were two complications ( 7 % ) . All operations were completed laparoscopically . Operative time was significantly lower in group 2 ( t-test ; p = 004 ) . Complications were also significantly lower ( chi-square ; p = 0.005 ) . The number of reoperations was also reduced and approached statistical significance ( chi-square ; p = 0.054 ) . Readmissions , although reduced , were not statistically significant . There were no deaths in either group . Conclusions : Despite a surgeon ’s history of advanced laparoscopic experience , there is a definite learning curve associated with the laparoscopically placed adjustable gastric b and",
"Abstract . We introduced open adjustable silicone gastric b and ing ( ASGB ) for treatment of morbid obesity in our institution in 1991 . It was done in a prospect i ve study comparing ASGB with vertical b and ed gastroplasty ( VBG ) with regard to weight loss . After 200 cases of open ASGB and 210 VBG procedures and the encouraging weight loss results , we started laparoscopic placement of the adjustable silicone b and . The initial work was done in an animal laboratory program where a new surgical protocol has been established . Details of the laparoscopic dissection around the stomach in a deep operative field and fatty atmosphere have been developed , and a laparoscopically implantable version of the adjustable silicone b and ( LAGB ) has been devised . The first human laparoscopic ASGB procedure was performed in our institution on September 1 , 1993 . Altogether 350 patients had undergone adjustable silicone gastric b and ing ( LASGB ) procedures by May 1997 ( 277 women , 73 men ) . All the patients were morbidly obese , with an average preoperative weight of 118 kg ( 92–200 kg ) . The mean BMI was 43 kg/m 2 ( 36–65 kg/m 2 ) . The conversion rate to laparotomy has been low ( 1.4 % ) . Early complications have been rare , and pouch dilatation and stomach slippage have been the only significant late complications . The rate of these complications has been considerably improved by reducing the pouch volume and using more gastrogastric sutures . Evaluation of postoperative weight loss of LASGB patients compared with our VBG and ASGB ( open ) patients showed a similar curve",
"Background : A body mass index of ≥40 kg/m2 represents clinical ly severe obesity and warrants operative treatment if requested . The adjustable silicone gastric b and and the Swedish adjustable gastric b and are recently produced laparoscopic gastric restrictive devices . The aim of this study was to assess all complications linked to both the available gastric b and s in a long-term follow-up . Methods : In a prospect i ve study , the effects , complications , and outcomes of this procedure were analyzed . The complications found were divided into early and general complications , and complications correlated to the b and s. The technique of laparoscopic adjustable gastric b and ing is described . Follow-up was performed by the operating team . Results : Between July 1994 and August 1998 , the authors operated on 158 patients and performed 102 adjustable silicone gastric b and ings and 54 Swedish adjustable gastric b and ings . The mean age at surgery was 36 years ( range 17 - 72 ) . The mean preoperative weight was 136 kg ( 89 - 230 ) . Of 158 patients who underwent laparoscopic procedures , 156(98 % ) could be followed up ( mean 28 months ; duration of follow-up , 6 weeks to 46 months ) . In early postoperative complications that required operation , one trocar wound hematoma ( 0.6 % ) and one wound infection of the port site ( 0.6 % ) were observed . The late complications that required reoperation were two pouch dilatations ( 1.3 % ) , three b and leakages ( 2 % ) , one b and migration ( 0.6 % ) , and one late infection of the port ( 0.6 % ) . A deb and ing operation was necessary in one patient because of esophageal dysmotility disorder . No early or late postoperative mortality was registered . The overall reoperation rate is currently about 7 % . Conclusion : The operation is safe and effective . Moreover , adjustable gastric b and ing is fully reversible and is adjustable to the patient 's needs . This study verifies the importance of correct operating technique . The authors ' study and experience clearly indicate that laparoscopic adjustable gastric b and ing is an attractive alternative in the surgical treatment of morbid obesity",
"Background : The advantages of laparoscopy over open surgery are well known . The aim of this study was to compare our results with Swedish adjustable gastric b and ing ( SAGB ) with other laparoscopically performed bariatric procedures ( gastric bypass , LapB and ® , vertical b and ed gastroplasty ) . Methods : Between January 1996 and December 2001 , 454 patients ( 381 women , 73 men ) underwent laparoscopic SAGB . All data ( demographic and morphologic , co-morbidities , operative , and follow-up ) were prospect ively collected in a computerized data bank . Results : Mean follow-up was 30 months ( range 1 - 66 ) . Average total weight loss was 35.5 kg after 1 year , reaching an average total of 54 kg after 3 years . Mean excess weight loss was 72 % after 3 years , and the BMI decreased from 46.7 to 28.1 kg/m2 . Patients with co-morbidities reported marked improvement of their accompanying diseases . Complications requiring reoperation occurred in 7.9 % . There was no mortality . The clinical outcome compared with the other laparoscopic bariatric procedures showed no significant difference . Conclusion : All laparoscopically performed bariatric procedures are very promising . The great advantage of laparoscopic adjustable gastric b and ing is that this operation is minimally invasive to the stomach , totally reversible and adjustable to the patients ' needs",
"BACKGROUND This prospect i ve study evaluated the effectiveness and safety of laparoscopic adjustable gastric b and ing ( LAGB ) for morbid obesity . METHODS Ninety-five consecutive patients ( 89 female ; median age 38 years , range 19 to 69 ) underwent LAGB for morbid obesity . Median weight and body mass index were 123.2 ( 88.9 to 228.6 ) kg and 45 ( 32.7 - 76.4 ) kg/m(2 ) respectively . Significant coexistent disease was present in 52 ( 55 % ) patients . RESULTS Median excess weight loss was 53 % ( range 96.9 % to 12.1 % ) and 62 % ( range 107.5 % to 32.3 % ) at 1 and 2 years respectively ( P Median operative time was 90 ( range 35 to 285 ) minutes and inpatient stay 2 ( range 1 to 10 ) days . Early complications were seen in 17 ( 18 % ) patients most commonly nausea/vomiting or dysphagia . Late complications were seen in 25 ( 26.3 % ) patients , most frequently vomiting or reflux due to b and slippage or pouch dilatation . There was 1 ( 1 % ) operative death . CONCLUSIONS LAGB is an effective operation for morbid obesity that results in equivalent weight loss to open surgical procedures",
"Background : Laparoscopic implantation of an adjustable gastric b and is being performed widely . One potential complication is the transgastric migration of the b and , that should be extracted . Methods : The authors report a series of 182 patients , followed prospect ively , October 1996 - April 2002 , who had undergone insertion of the Swedish adjustable gastric b and . All implantations had been completed by laparoscopy alone . Results : There were no deaths . 15 complications were detected , of which 7 were intragastric migrations of the b and ( 3.8 % ) at an average follow-up of 40 months . 6 were treated successfully by gastroscopy only , with a new cutter device and without complications . Conclusion : The endoscopic technique is beneficial even when the intraluminal migration is partial",
"Background : Laparoscopic adjustable gastric b and ing ( LAGB ) and open vertical b and ed gastroplasty ( VBG ) are treatment modalities for morbid obesity . However , few prospect i ve r and omized clinical trials ( RCT ) have been performed to compare both operations . Methods : 100 patients ( 50 per group ) were included in the study . Postoperative outcomes included hospital length of stay ( LOS ) , complications , percent excess weight loss ( % EWL ) , BMI and reduction in total comorbidities . Follow-up in all patients was 2 years . Results : LOS was significantly shorter in the LAGB group . 3 LAGB were converted to open ( 1 to gastric bypass ) . Directly after VBG , 3 patients needed relaparotomies due to leakage , of which one ( 2 % ) died . After 2 years , 100 % follow-up was achieved . BMI and % EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group ( 31.0 kg/m2 and 70.1 % vs 34.6 and 54.9 % respectively ) . Co-morbidities significantly decreased in both groups in time . 2 years after LAGB , 20 patients needed reoperation for pouch dilation/slippage ( n=12 ) , b and leakage ( n=2 ) , b and erosion ( n=2 ) and access-port problems ( n=4 ) . In the VBG group , 18 patients needed revisional surgery due to staple-line disruption ( n=15 ) , narrow outlet ( n=2 ) or insufficient weight loss ( n=1 ) . Furthermore , 8 VBG patients developed an incisional hernia . Conclusion : This RCT demonstrates that , despite the initial better weight loss in the VBG group , based on complication rates and clinical outcome , LAGB is preferred . It had a shorter LOS and less postoperative morbidity",
"Morbid obesity , commonly defined as a condition in which the weight exceed twice the ideal body weight , is a major public health concern , widely unrecognized in France whereas causing 55,000 deaths per year to compare to 8,000 deaths per year by traffic accidents . Its pathogenesis is discussed even if much attention in recent years has centered on genetic causes since the identification of the ob-gene and its protein product leptin . Due to the long term failure of medical treatments , the advent of laparoscopy had disrupted therapeutic and carried on exponential development of laparoscopic operations mainly by gastric b and ing using an adjustable ring not without complications . It is why we have performed a prospect i ve study by laparoscopy in 100 patients comparing 3 operations with the aim that each indication could be adapted to the alimentary behaviour . The short term results are extremely favourable and comparable to international literature data . Moreover , the study is a plea for a multidisciplinary approach of morbid obesity and a core for a public health action",
"Background : Laparoscopic adjustable gastric b and ing is the least invasive bariatric operation . However , just isolated attempts to perform this procedure as a Day Case have been published . This study highlights some aspects that might contribute to safe patient discharge within 23 hours after LAGB . Methods : Prospect i ve evaluation of 20 consecutive patients was carried out . Patients were indicated for laparoscopic Swedish adjustable gastric b and ing ( SAGB , Obtech , Ethicon Endo-Surgery ) in a private Bariatric center in the first 6 months of 2003 . The effect of extensive pre- and immediate postoperative education and psychological support , and information on postoperative health consequences delivered through a multi-disciplinary bariatric team effort , was evaluated , regarding the influence of these facilitators in shortening the length of hospital stay . Results : Mean preoperative BMI of the 20 patients entering the study was 42.3 . Mean operating-time was 91 minutes ( 58 - 112 min ) . Time spent on information and education of each patient was 60 minutes in total during the preoperative period . Average postoperative hospitalization was 21 hours . There were no intraoperative or early postoperative complications . Excess weight loss was 44 % at 12 months after surgery . Conclusion : SAGB performed on a Day Case basis in selected patients who are subjected to intensive pre- and immediate postoperative dedicated education appears to be a feasible alternative",
"Context Observational studies have shown sustained weight loss after surgery for extreme obesity . No r and omized trial of contemporary surgical methods has been performed . Contribution The authors r and omly assigned 80 mildly to moderately obese ( body mass index , 30 to 35 kg/m2 ) adults to laparoscopic placement of an adjustable gastric b and or to an intensive nonsurgical weight loss program . After 2 years , the surgical group had lost 21.6 % of initial weight , and the nonsurgical group had lost 5.5 % of initial weight . Four patients required laparoscopic revision of the gastric b and . Caution s The study was not design ed to detect uncommon adverse events . Implication s Laparoscopic gastric b and ing is effective treatment for mild to moderate obesity . The Editors The development of a safe and effective treatment for obesity is a leading challenge in health care today . Obesity is an increasing health problem across the world with a prevalence of more than 20 % among the adult population in Western countries and more than 30 % in the United States ( 1 , 2 ) . The increasing prevalence is associated with a parallel increase of several obesity-related diseases , in particular , the diseases of the metabolic syndrome ( 3 , 4 ) , which include type 2 diabetes , hypertension , and dyslipidemia , and are linked to nonalcoholic steatohepatitis , obstructive sleep apnea , and the polycystic ovary syndrome . For obese individuals , the options are limited . Behavioral therapies of reduced energy intake , improved eating practice s , and increased exercise and activity , supplemented by pharmacotherapy , generally achieve only modest and often transient effects ( 5 , 6 ) . Observational studies have shown that bariatric surgical therapies involving gastric restriction by various forms of stapling with or without diversion of the gut to generate malabsorption of food are effective in achieving major weight loss and clinical ly significant improvements in health and quality of life ( 7 - 11 ) . Strong direct evidence from r and omized , controlled trials of the relative benefits of nonsurgical and surgical therapies is lacking . We are aware of only a single study , performed in the 1980s , in which 60 morbidly obese patients were r and omly assigned , without informed consent , to diet plus an early form of gastric stapling or to diet alone ( 12 ) . The maximum weight losses did not differ between the groups . However , the weight regain was greater in the diet-only group . The advent of the laparoscopic adjustable gastric b and has provided a new bariatric surgical option , which has proved to be safe , minimally invasive in its application , gentle in its use through its adjustability and easy reversibility , and similarly effective to the other bariatric procedures ( 10 , 13 , 14 ) . Figure 1 shows the LAP-B AND System ( INAMED Health , Santa Barbara , California ) and demonstrates the key feature of adjustability of the area within the b and through which it induces satiety ( 15 ) . Patients require no more than an overnight hospital stay , and the procedure has been shown to be markedly safer than gastric bypass surgery ( 13 ) . Figure 1 . The laparoscopic adjustable gastric b and ( LAP-B AND System , INAMED Health , Santa Barbara , California ) with no added fluid ( top ) and with 2 mL of fluid added ( bottom ) . We hypothesized that surgical therapy would induce more weight loss , health benefit , and improvement in quality of life than nonsurgical therapy and have conducted a r and omized , controlled trial comparing the effectiveness of current nonsurgical therapy with laparoscopic adjustable gastric b and ing in a group of mildly to moderately obese adults ( body mass index , 30 kg/m2 to 35 kg/m2 ) . We did not study patients with a body mass index greater than 35 kg/m2 because current observational data suggest that outcomes after nonsurgical treatment were unlikely to be equal to those after surgical care for these patients . The principal outcome measures were weight change , health , quality of life , and complications of therapy . Methods Patient Recruitment We recruited patients for the study through a newspaper advertisement . All patient assessment s and outpatient treatments were conducted at a community clinic dedicated to obesity management or in the clinics of a university department of surgery . Surgical procedures were conducted at a private community hospital experienced in the care of bariatric surgical patients . Patients in both groups did not pay any medical costs generated by the study . The human ethics committees of The Alfred Hospital and The Avenue Hospital approved the study in accordance with the guidelines of the National Health and Medical Research Council ( www.nhmrc.gov.au/publications/synopses/e35syn.htm ) and with the Helsinki Declaration of 1975 , as revised in 2000 ( www.wma.net/e/ethicsunit/pdf/draft_historical_contemporary_perspectives.pdf ) . Inclusion Criteria We considered patients to be eligible if they were between 20 and 50 years of age ; had a body mass index of 30 kg/m2 to 35 kg/m2 ; had identifiable problems , including an obesity-related comorbid condition ( such as hypertension , dyslipidemia , diabetes , obstructive sleep apnea , or gastroesophageal reflux disease ) , severe physical limitations , or clinical ly significant psychosocial problems associated with their obesity ; had attempted to reduce weight over at least the previous 5 years ; could underst and the options offered and the r and omization process ; and were willing to comply with the requirements of each program . Exclusion Criteria We excluded c and i date s with a history of bariatric surgery or medical problems that contraindicated treatment in either study group , such as impaired mental status , drug or alcohol addiction , or portal hypertension . In addition , we excluded participants if they had undergone an intensive , physician-supervised program that used very-low-calorie diets or pharmacotherapy or if they did not attend the 2 initial patient information visits . Assessment We provided detailed information about the problems of obesity and about the 2 study groups through at least 2 discussion periods and a patient information booklet . Initial assessment included anthropometric measures ; identification of medical , physical , or psychosocial problems ( both weight-related and other ) ; and a discussion of previous weight loss efforts . The assessment included a detailed dietary history by the trial dietitian and a review by a specialist physician to determine the presence and severity of associated medical conditions . Initial investigations included measurements of fasting blood glucose level ; serum insulin level ; and a lipid profile , including HDL cholesterol and LDL cholesterol levels . After initial assessment , we instituted a program of advice on appropriate eating patterns and exercise and followed each patient on a monthly basis for 3 months . During this time , we assessed the patients ' fulfillment of tasks , such as completion of a food diary , and overall adherence to appointments . R and omization Process We r and omly allocated eligible patients to receive a conventional , intensive , nonsurgical program or laparoscopic adjustable gastric b and ing . A computer-derived r and om allocation sequence , without blocking or stratification , performed the r and omization . This was prepared at the trial office . The trial coordinator enrolled participants and informed them of the trial allocation . After assessment had confirmed a participant 's suitability for r and omization , the coordinator contacted the trial office by telephone for allocation . The study was not blinded . Description of Nonsurgical and Surgical Interventions Common Program We instructed and encouraged all patients to follow appropriate lifestyle behavior of good eating practice s and increased exercise and activity . We also encouraged them to exercise for at least 200 minutes per week . Nonsurgical Program This program centered on the use of behavioral modification , very-low-calorie diet , and pharmacotherapy with education and professional support on appropriate eating and exercise behavior . During the 2-year period , 3 trained physicians developed a program using all the available modalities for each individual on the basis of guidelines prepared and continually review ed by a panel of experienced bariatric physicians . The program began with an intensive 6-month period of very-low-calorie diet ( 500 to 550 kcal/d ) using 1 to 3 packets of Optifast ( Novartis , Fremont , Michigan ) daily for 12 weeks , followed by a transition phase over 4 weeks combining some very-low-calorie meals with 120 mg of orlistat before nonvery-low-calorie diet meals , and then 120 mg of orlistat before all meals until the completion of the intensive phase . This intensive 6-month program was followed by further courses of very-low-calorie diets or orlistat as tolerated , as well as continual behavioral , dietary , and exercise advice to assist the participant in maintaining weight loss over a prolonged period . Sibutramine was not approved for use in Australia during the first 12 months of the study and , therefore , was not incorporated into the medical program . The management program for each individual was design ed to reflect good clinical practice . A physician saw each patient every 2 weeks during the very-low-calorie diet program and every 4 to 6 weeks during the rest of the study . All patients were seen at least every 6 weeks . Surgical Program Two experienced surgeons performed the laparoscopic adjustable gastric b and ( LAP-B AND System ) procedure , by a st and ardized method ( 14 ) , within 1 month of r and omization . The b and was placed along the perigastric pathway in all cases ( 16 ) . The treating surgeon review ed patient progress every 4 to 6 weeks during the study period and made adjustments to the volume of saline within the b and in the office by using st and ard clinical criteria ( 17 ) . Adverse Events All patients in the study were question ed about the occurrence of adverse events at each consultation , and physicians recorded the",
"Background : Laparoscopically inserted adjustable gastric b and s are an effective means of weight reduction for obese patients",
"Background : This study is a trial to compare the effects and outcomes of three different bariatric procedures performed in two centers . St and ard Roux-en-Y gastric bypass was performed by Dr. Norman Samuels in Fort Lauderdale ( Florida ) ; vertical b and ed gastroplasty and laparoscopic adjustable silicone gastric b and ing were done in Hallein ( Salzburg ) by Dr. Emanuel Hell and Dr. Karl Miller . Methods : In a prospect i ve comparative study 30 matched patients from each group were followed to assess post-operative improvement in health status and quality of life , to compare the three different techniques . The Bariatric Analysis and Reporting Outcome System ( BAROS ) as described by Oria and Moorehead has been used for evaluation . Results : The observation time was at least 3 years ( 3 to 8 years ) in each individual case . A significant increase in quality of life and health status in 75 % of the surgically-treated patients was observed when compared with a non-operated control group of morbidly obese patients . Conclusions : By utilizing BAROS it has been found possible to compare the results of different procedures done by different surgeons with different techniques , utilizing patients from different cultures and with different language s. The results of this comparative study favor the st and ard gastric bypass for the treatment of morbid obesity . This operation is superior to purely gastric restrictive procedures in weight loss and improvement of quality of life",
"OBJECTIVE Personality characteristics are assumed to underlie health behaviors and , thus , a variety of health outcomes . Our aim was to examine prospect ively whether personality traits predict short- and long-term weight loss after laparoscopic adjustable gastric b and ing . RESEARCH METHODS AND PROCEDURES Of patients undergoing laparoscopic adjustable gastric b and ing , 168 ( 143 women , 25 men , 18 to 58 years old , mean 37 years , preoperative BMI 45.9 + /- 5.6 kg/m(2 ) ) completed the Dutch Personality Question naire on average 1.5 years before the operation . The relationship between preoperative personality and short- and long-term postoperative weight loss was determined using multilevel regression analysis . RESULTS The average weight loss of patients progressively increased to 10 BMI points until 18 months after surgery and stabilized thereafter . A lower baseline BMI , being a man , and a higher educational level were associated with a lower weight loss . None of the personality variables was associated with weight outcome at short-term follow-up . Six of seven personality variables did not predict long-term weight outcome . Egoism was associated with less weight loss in the long-term postoperative period . The effect sizes of the significant predictions were small . DISCUSSION None of the personality variables predicted short-term weight outcome , and only one variable showed a small and unexpected association with long-term weight outcome that needs confirmation . This suggests that personality assessment as intake psychological screening is of little use for the prediction of a poor or successful weight outcome after bariatric surgery",
"Background : In 2001 a new device for surgical weight loss was approved by the Food and Drug Administration ( Lap-B and , Inamed Health ) . We describe initial results of laparoscopic gastric b and ing for morbid obesity in two American academic centers . Methods : Prospect i ve data was collected on consecutive morbidly obese patients undergoing laparoscopic adjustable gastric b and ing , and evaluated retrospectively . Results : Four hundred forty-five consecutive patients underwent Lap-B and from May 2001 through December 2002 . The 103 men and 341 women had an average age of 42.1 years ( range 17–72 years ) and an average body mass index ( BMI ) of 49.6 kg/m2 ( range 35.2–92.2 kg/m2 ) . One operation required conversion to laparotomy due to bleeding ; the rest were completed laparoscopically . Mean length of stay was 1.1 days ( range 1–10 days ) . There was one death . Additional complications included b and slippage in 14 patients ( 3.1 % ) , gastric obstruction without slip in 12 ( 2.7 % ) , port migration in 2 ( 0.4 % ) , tubing disconnections in 3 ( 0.7 % ) , and port infection in 5 ( 1.1 % ) . Two b and s ( 0.4 % ) were removed due to intraabdominal abscess 2 months after placement . There was one b and erosion ( 0.2 % ) and no clinical ly significant esophageal dilation . Ninety-nine patients have 1-year follow-up and have lost an average of 44.3 % excess body weight . Conclusion : Laparoscopic gastric b and ing has much to offer the morbidly obese . We present data showing weight loss rivaling gastric bypass and acceptably low complications . These results parallel success with this device outside America",
"Objective : To define whether laparoscopic reb and ing or Roux-en-Y gastric bypass represents the best approach for failed laparoscopic gastric b and ing in patients with morbid obesity . Summary Background Data : Countless laparoscopic gastric b and ings have been implanted during the recent years worldwide . Despite excellent short-term results , long-term failures and complications have been reported in more than 20 % of patients . Which rescue procedures should be used remains controversial . Therefore , we analyzed our experience with the use of laparoscopic reb and ing versus laparoscopic Roux-en-Y gastric bypass after failed gastric b and ing . Methods : Using a prospect ively collected data base , we analyzed the feasibility , safety , and effectiveness of laparoscopic reb and ing versus laparoscopic conversion to Roux-en-Y gastric bypass after failed laparoscopic gastric b and ing . Results : A total of 62 consecutive patients were treated in our institution between May 1995 and December 2002 for failed primary laparoscopic gastric b and ing , including 30 laparoscopic reb and ings and 32 laparoscopic conversions to Roux-en-Y gastric bypass . Reb and ings were preferably done during the initial period of the study and Roux-en-Y gastric bypass in the last period . Both groups were comparable before the initial b and ing procedures . At the time of redo surgery , patients receiving a gastric bypass had more esophageal dysmotility ( 47 % vs. 7 % , P = 0.002 ) and higher body mass index ( BMI ) than those elected for reb and ing procedures ( BMI 42.0 vs. 38.4 kg/m2 , P = 0.015 ) . Feasibility and safety : Each procedure was performed laparoscopically . Mean operating time was 215 minutes for gastric bypass and 173 minutes for reb and ing ( P = 0.03 ) . Early complications occurred in one case in the reb and ing group and in 2 cases in the bypass group ; all underwent a laparoscopic reexploration without the need for open surgery . There was no mortality in this series . Effectiveness : BMI in the gastric bypass group decreased from 42.0 to 31.8 kg/m2 ( P = 0.02 ) within 1 year of surgery , while it remained unchanged in the reb and ing group . Conclusions : Laparoscopic conversion to a gastric bypass as well as laparoscopic reb and ing are feasible and safe . Conversion to gastric bypass offers a significant advantage in terms of further weight loss after surgery . Therefore , this procedure should be considered as the rescue therapy of choice after a failed laparoscopic gastric b and ing ",
"Background In morbid obesity conservative therapy often fails to reduce overweight permanently . As a consequence , several bariatric surgical procedures have been developed to achieve permanent excess weight loss . Among these , the laparoscopic restrictive procedures seem to be the least invasive . The aim of this prospect i ve study was to assess and analyze the effects , complications , and outcomes after the implantation of the Swedish adjustable gastric b and ( SAGB ) in long-term follow-up . Methods All consecutive patients with implantation of a SAGB between August 1996 and August 2002 were prospect ively investigated . The placement of the SAGB was done by laparoscopy in all cases . Success was rated by the reduction of body mass index ( BMI ) excess weight loss ( EWL ) , and reduction of comorbidities . “ Nonresponders ” to SAGB were defined as EWL after a 3-year follow-up . B and -related complications were recorded and classified . Patient ’s outcome was assessed after 6 months and subsequently each year postoperatively . Results A total of 190 patients received a SAGB , 97 % of whom could be followed up with a mean follow-up period of 39.4 months ( duration of follow-up , 6–72 ) . During follow-up , a significant reduction or improvement of BMI , EWL , and comorbidities were found . Nineteen percent of patients were identified as nonresponders . Early intraoperative and postoperative complications related to SAGB were one perforation of the gastric fundus ( 0.5 % ) , one conversion ( 0.5 % ) , one bleeding ( 0.5 % ) , and two b and infections ( 1.1 % ) . The SAGB-related complications encountered during long-term follow-up were three port problems ( 1.6 % ) , four b and migrations ( 2.1 % ) , five slipping/pouch dilatations ( 2.6 % ) , and two b and leakages ( 1.1 % ) . All intra- and postoperative SAGB-related complications accounted for a total morbidity of 10.5 % . Operative mortality was 0 % . The overall reoperation rate was 8.5 % . Conclusions In long-term follow-up , SAGB is safe and effective . Our results demonstrate a significant EWL of 50 % during the first 24 months . However , patient selection has to be improved to reduce the nonresponder rate . SAGB leads to a significant reduction of obesity-related comorbidities . SAGB is an attractive alternative in the surgical treatment of morbid obesity",
"OBJECTIVE To compare the clinical results of adjustable gastric b and ing and vertical b and ed gastroplasty for morbid obesity . DESIGN Prospect i ve r and omised trial . SETTING University hospital , Sweden . PATIENTS 59 morbidly obese patients , listed for obesity surgery . INTERVENTIONS Adjustable gastric b and ing ( n = 29 ) or vertical b and ed gastroplasty ( n = 30 ) . MAIN OUTCOME MEASURES Weight loss , complications , need for revisional surgery , reflux symptoms and the patient 's own evaluation . RESULTS Five years after surgery the mean ( SEM ) weight reduction for adjustable gastric b and ing was 43 ( 3.0 ) kg and for vertical b and ed gastroplasty 35 ( 4.8 ) kg . One patient in each group died of unrelated causes during follow-up and 3 and 2 patients , respectively , were lost to follow-up . One patient in the vertical b and ed group required reoperation for an anastomotic leak on the third postoperative day . A total of 3 patients in the adjustable group required reoperation and 11 in the vertical b and ed group . CONCLUSIONS Adjustable gastric b and ing carries a smaller risk of reoperation than vertical b and ed gastroplasty and the weight reduction is in the same order of magnitude",
"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",
"Objective : To define whether laparoscopic gastric b and ing or laparoscopic Roux-en-Y gastric bypass represents the better approach to treat patients with morbid obesity . Summary Background Data : Two techniques , laparoscopic gastric bypass or gastric b and ing , are currently widely used to treat morbid obesity . Since both procedures offer certain advantages , a strong controversy exists as to which operation should be proposed to these patients . Therefore , data are urgently needed to identify the best therapy . Methods : Since r and omized trials are most likely not feasible because of the highly different invasiveness and irreversibility of these procedures , a matched-pair design of a large prospect ively collected data base appears to be the best method . Therefore , we used our prospect i ve data base including 678 bariatric procedures performed at our institution since 1995 . A total of 103 consecutive patients with laparoscopic gastric bypass were r and omly matched to 103 patients with laparoscopic gastric b and ing according to age , body mass index , and gender . Results : Both groups were comparable regarding age , gender , body mass index , excessive weight , fat mass , and comorbidites such as diabetes , heart disease , and hypertension . Feasibility and safety : All gastric b and ing procedures were performed laparoscopically , and one gastric bypass operation had to be converted to an open procedure . Mean operating time was 145 minutes for gastric b and ing and 190 minutes for gastric bypass ( P Hospital stay was 3.3 days for gastric b and ing and 8.4 days for gastric bypass . The incidence of early postoperative complications was not significantly different , but late complications were significantly more frequent in the gastric b and ing group ( pouch dilatation ) . There was no mortality in both groups . Efficiency : Body mass index decreased from 48.0 to 36.8 kg/m2 in the gastric b and ing group and from 47.8 to 31.9 kg/m2 in the gastric bypass group within 2 years of surgery . These differences became significant from the first postoperative month until the end of the follow-up ( 24 months ) . The gastric bypass procedure achieved a significantly better reduction of comorbidities . Conclusions : Laparoscopic gastric b and ing and laparoscopic gastric bypass are feasible and safe . Pouch dilatations after gastric b and ing are responsible for more late complications compared with the gastric bypass . Laparoscopic gastric bypass offers a significant advantage regarding weight loss and reduction of comorbidities after surgery . Therefore , in our h and s , laparoscopic Roux-en-Y gastric bypass appears to be the therapy of choice",
"Background : Laparoscopic adjustable gastric b and ing ( LAGB ) has usually been performed as an inpatient procedure with an average hospital stay of 2 - 4 days . The aim of this study was to assess the feasibility of LAGB as an ambulatory procedure in selected patients . Methods : Potential c and i date s for ambulatory LAGB were recruited from patients consulting for obesity surgery . The main inclusion criteria were BMI > 35 kg/m2 with co-morbid conditions , living within a reasonable distance from the hospital , and adult company at home . The patients were admitted at 0700 hours on the day of surgery , underwent laparoscopic placement of a Lap-B and ® system and were discharged home that evening . Results : 9 women and 1 man underwent outpatient LAGB . Mean age was 36 ( range 18 - 52 ) years and mean BMI was 38.4 kg/m2 ( range 35.1 - 43.3 ) . Co-morbidities included functional dyspnea ( 6 ) , osteoarthritis ( 4 ) , arterial hypertension ( 4 ) , type 2 diabetes ( 2 ) and dyslipidemia ( 1 ) . 7 patients had undergone previous abdominal surgery : cesarian section ( 4 ) , appendectomy ( 3 ) , cholecystectomy ( 1 ) and hysterectomy ( 1 ) . All patients had an American Society of Anesthesiologists ( ASA ) classification of II . The average operating time was 87 minutes ( range 65 - 115 ) . The mean time lapse between the end of the operation and discharge from hospital was 9.6 hours . There were no readmissions , and no complications were noticed at 1 month postoperatively . The patients ' satisfaction with the ambulatory LAGB procedure was high . Conclusion : The present study demonstrates that LAGB for obesity may be performed on an ambulatory basis without complications",
"Objective : To compare , in a prospect i ve , r and omized , single-institution trial laparoscopic adjustable silicone gastric b and ing ( LASGB ) with laparoscopic vertical b and ed gastroplasty ( LVBG ) in morbidly obese patients . Summary Background Data : LASGB is a simple and safe procedure , but some reports have suggested disappointing long-term results . Despite the recent widespread use of LASGB , there are no prospect i ve nor r and omized trials comparing LASGB with other laparoscopic procedures . Methods : A total of 100 morbidly obese patients , with body mass index ( BMI ) 40 to 50 kg/m2 , without compulsive eating , were r and omized to either LASGB ( n = 49 ) or LVBG ( n = 51 ) . Minimum follow-up was 2 years ( mean 33.1 months ) . Results : There were no deaths or conversions in either group . Mean operative time was 94.2 minutes in LVBGs and 65.4 in LASGBs ( P Early morbidity rate was lower in LASGBs ( 6.1 % ) versus LVBGs ( 9.8 % ) ( P = 0.754 ) . Mean hospital stay was shorter in LASGBs versus LVBGs : 3.7 days versus 6.6 ( P Late complications rate in LVBGs was 14 % ( 7 of 50 ) and in LASGBs 32.7 % ( 16 of 49 ) ( P slippage of the b and ( 18 % ) . Late reoperations rate in LVBGs was 0 % ( 0 of 50 ) versus 24.5 % ( 12 of 49 ) in LASGBs ( P Excess weight loss in LVBGs was , at 2 years , 63.5 % and , at 3 years , 58.9 % ; in LASGBs , excess weight loss , respectively , was 41.4 % and 39 % . BMI in LVBGs was , at 2 years , 29.7 kg/m2 and , at 3 years , 30.7 kg/m2 ; in LASGBs , BMI was 34.8 kg/m2 at 2 years and 35.7 kg/m2 at 3 years . According to Reinhold 's classification , a residual excess weight LASGB ( P patients with BMI 40 to 50 kg/m2 , LASGB requires shorter operative time and hospital stay but LVBG is more effective in terms of late complications , reoperations , and weight loss",
"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",
"Background : The goal of surgery for morbid obesity is to achieve a good and durable loss of weight and improve health . Previous studies have demonstrated a significant weight loss for the Swedish adjustable gastric b and ( SAGB ) . Patients and Methods : Between November 1996 and April 1998 , 18 morbidly obese patients underwent SAGB laparoscopically . Their mean age at surgery was 35 years . The mean preoperative weight was 128 kg ( range 89 - 163 ) , and the mean body mass index was 50.4 ± 9 . Comorbidity was present in 13 patients . Results : One gastric perforation occurred , and in one patient it was not possible to create the pneumoperitoneum . Regarding late morbidity , one intragastric migration and one slippage of the b and occurred . There was no mortality . Conclusion : The low morbidity , the good results with weight loss , and the improvement in comorbidity lead the authors to believe that Swedish adjustable gastric b and ing for the treatment of morbidly obese patients is a successful means of losing weight and improving general health",
"Intragastric prosthesis ( Lap-B and , BioEnterics Co. , Carpinteria , CA , U.S.A. ) migration is one of the major long-term complications of laparoscopic adjustable silicone gastric b and ing . The causes , clinical signs , timing , and overall incidence of b and entrapment have not been prospect ively investigated in a large series . The purpose of this study was to assess prospect ively the incidence of Lap-B and intragastric migration and to establish the safety and effectiveness of minimally invasive b and removal . Between January 1996 and June 2000 , 148 consecutive patients enrolled in a multidisciplinary bariatric program underwent laparoscopic adjustable silicone gastric b and ing . In the follow-up treatment , gastrointestinal endoscopy was performed routinely . One hundred twenty-three patients with a minimum follow-up period of 12 months were entered into the study group . Eleven ( 9.2 % ) patients had long-term major complications . Intragastric b and migration was observed in nine ( 7.5 % ) patients . The diagnosis was established by routine endoscopy between 10 and 41 months after surgery . Five erosions occurred in the first 30 cases ( learning curve period ) . In six patients , the b and was removed by an intragastric endoscopic-assisted approach avoiding laparotomy . The remaining three patients are under endoscopic surveillance . The results of this study show that routine upper gastrointestinal endoscopy can discover asymptomatic b and migrations early . B and erosion did not require emergency treatment and can be removed safely by a minimally invasive approach",
"Background : Severe obesity is associated with type 2 diabetes and hypertension . Improvement in these comorbidities after surgically-induced weight loss has been documented , and laparoscopic adjustable gastric b and ing ( LAGB ) is an effective weight loss operation . Methods : Of 840 patients who underwent Lap-B and ® , data are available in 402 out of 413 patients whose surgery took place at ≥ 1 year ago . Preoperative and follow-up data were studied retrospectively to examine the effect of Lap-B and ® -induced weight loss on diabetes and hypertension . Results : Of 413 patients with at least 1 year postoperative follow-up , 53 ( 12.8 % ) were taking medications for type 2 diabetes preoperatively and 189 ( 45.7 % ) were on antihypertensive medications . 66 % ( n=35 ) of diabetic patients were also hypertensive . Resolution of diabetes was observed in 66 % at 1-year and 80 % at 2-year follow-up . HbA1c dropped from 7.25 % ( 5.6 - 11.0 , n=53 ) preoperatively to 5.58 % ( 5.0 - 6.2 , n=15 ) at 2 years after surgery . Hypertension resolved in 59.8 % and 74 % at 1 and 2 years , respectively . Percent excess weight loss ( % EWL ) was lower for diabetic patients than for our cohort population ( 39.2 % vs 41.2 % at 1 year , 46.7 % vs 54.2 % at 18 months , and 52.6 % vs 63.3 % at 2 years , respectively ) . Patients in whom diabetes was improved but not resolved had lower % EWL than did those whose diabetes went into remission ( 27.0 % at 1 year and 26.5 % at 2 years ) . Patients with the shortest duration of diabetes ( better weight loss after surgery achieved higher resolution rates . Conclusions : Dramatic improvement in – and frequent resolution of – diabetes and hypertension have been observed as a result of weight loss after Lap-B and ® surgery",
"Abstract Obesity is an increasing problem in Scotl and and Laparoscopic Adjustable Gastric B and s ( LAGB ) are an effective method of weight reduction . Most outcome data are reported from high volume units with extensive experience or dedicated bariatric practice . We aim ed to assess an experienced laparoscopic surgeon 's outcome working outwith a dedicated bariatric practice in the west of Scotl and . Methods All LAGB procedures performed by a single surgeon were prospect ively assessed from 1997 to 2004 . LAGB were inserted using pars flaccida approach . Patient selection was based on BMI > 35 or significant obesity related co-morbidities . Outcomes included percentage excess weight loss ( % EWL ) and excess BMI loss ( EBL ) . We assessed total operating time to assess the learning curve for LAGB placement . Results 125 patients were assessed ( 107 F:18 M ) . 123 patients were in regular follow-up ( 98 % ) . Median age was 44 years ( range 25 - 63 ) . Mean follow-up was 34 months ( range 11 - 91 ) . Median initial BMI was 49 ( range 37 - 73 ) . 31 % were BMI 35 - 45 , 36 % were BMI 45 - 50 and 33 % were BMI > 50 . % EWL at 1,3 and 5 years was 45 , 58 and 74 , respectively . EBL at 1 , 3 and 5 years was 11.7 , 16.1 , and 21.7 , respectively . Complications included 4 converted procedures , 1 failed b and insertion after conversion and reoperation for removal in five . Eight patients had tubing access port problems requiring intervention . The median overall total operation time was 80 minutes ( range 50 - 160 ) . Conclusions In this cohort LAGB insertion by an experienced laparoscopic surgeon is safe with few re-operations . Satisfactory weight loss is obtained and patient compliance with follow-up is high",
"Background : Laparoscopy is believed to reduce recovery time and patient discomfort following bariatric surgical operations . This study tests that hypothesis . Methods : 60 r and omly selected bariatric surgery patients , consisting of 20 open Roux-en-Y gastric bypass ( RYGBP ) , 19 lap RYGBP , and 21 laparoscopic adjustable b and ing , were studied . Outcome measures including hospital length of stay ( LOS ) , days to return to normal activity , days to surgical recovery , and pain medication usage were defined by the patients ' subjective responses to a retrospective question naire . Overall differences among the three surgeries were first determined using the Kruskal-Wallis test , and then individual comparisons were made between each of the three pairs of operations using a Wilcoxon rank-sum test when a significant difference existed . Results : Patients reported an average LOS of 3.45 days following open RYGBP , 2.47 days following lap RYGBP , and 1.33 days following Lap-B and ® surgery . There was little difference in return to normal activity , with open RYGBP patients reporting a 17.55 day delay in return to normal activity , and lap RYGBP reporting an 18.16 day delay . In contrast , Lap-B and ® patients responded that the delay was only 7.24 days . Days to recovery were reported to be 29.05 for open RYGBP patients , 21.68 for lap RYGBP patients and 15.81 for Lap-B and ® patients . Hospital days ( P=0.0002 ) , days to normal activity ( P=0.0115 ) , and days to recovery ( P regarding days to resumption of normal activities . Open RYGBP and b and ing differed significantly regarding days to recovery ( P < 0.001 ) . Conclusions : Lap-B and ® patients returned to normal activity levels earlier than gastric bypass patient 's irrespective of approach . Lap-B and ® patients also reported recovering from surgery significantly sooner than open RYGBP patients . Perceived differences in recovery time between open and laparoscopic RYGBP patients did not affect their time to resumption of normal activity",
"Background : No study has surveyed the factors that influence morbidly obese patients ' preference for a particular bariatric operation . Method : 469 consecutive patients in 2 major bariatric surgery centers in the United States ( US , 124 ) and Australia ( AU , 345 ) were prospect ively studied to determine referral pattern and reason for their choice of operation . Results : The predominant operation was laparoscopic adjustable gastric b and ing ( LAGB ) in both US ( 75 % ) and AU ( 83 % ) centers . Gender ( 70 % female ) , BMI ( 45 kg/m2 ) and age ( 42.5 years ) were similar in both cohorts . In Australia , 53 % had referral initiated by primary doctors and 25 % by another patient , while in the US , 43 % by another patient and 27 % by the Internet . Safety of the operation ( 43 % ) was the highest-rated factor in choosing LAGB . LAGB being \" least invasive \" was most significant in the US ( 46 % ) , and \" surgical safety \" in Australia ( 45 % ) . In the US , Rouxen-Y gastric bypass was preferred due to \" lack of a foreign body \" ( 31 % ) and \" inability to cheat \" ( 28 % ) , while in Australia , \" dumping \" was the most significant reason ( 50 % ) . Duodenal switch ( BPD/DS ) was selected in 11 % of patients , primarily because of \" durability of the weight loss \" ( 51 % ) . Surprisingly , only 1 patient in the US group selected BPD/DS because the pylorus remains intact . Conclusion : Safety and invasiveness had the greatest impact on patient choice for bariatric operation in two different countries . This information may help clinicians better underst and their patients ' concerns , and their treatment choices",
"Background : Concerns still exist about the long-term effectiveness and rate of retention of the laparoscopic adjustable gastric b and ( LAGB ) . Furthermore , esophageal dilatation has been suggested as a long-term complication for LAGB . We therefore sought to objective ly analyze our follow-up results in patients with LAGB performed in 1998 by perigastric technique and 2000 by pars flaccida technique . We also offered patients for 1998 a barium esophagram to assess dilatation . Methods : Data on all 2,300 LAGBs performed since 1996 have been prospect ively collected in LapBase . This data was accessed for 1998 and 2000 , for follow-up complication , b and removal , weight loss and comorbidity reduction . Patients were offered barium esophagrams . Results : 123 patients ( mean weight 127 kg , mean BMI 44.5 kg/m2 ) had LAGB in 1998 , and 162 patients ( mean weight 123 kg , mean BMI 44 ) had LAGB in 2000 . Follow-up was a mean 67 months in 88 % for 1998 and 94 % at 34 months for 2000 . Mean % EWL for 1998 was 51.2 % with mean BMI 31.9 . Slippage occurred in 9.5 % in 1998 compared to 4.3 % in 2000 ( P 20 of 23 diabetics are off all treatment . 1 of 34 patients had esophageal dilatation on barium esophagram , which resolved on b and deflation . Conclusion : LAGB is a safe and effective at midterm follow-up . Less slippage occurred after the pars flaccida technique . No evidence of permanent esophageal dilatation was found on barium studies",
"Objective : The objective of this study was to evaluate the results of laparoscopic gastric b and ing using 2 different b and s ( the Lapb and [ Bioenterics , Carpinteria , CA ] and the SAGB [ Swedish Adjustable Gastric B and ; Obtech Medical , 6310 Zug , Switzerl and ] ) in terms of weight loss and correction of comorbidities , short- and long-term complications , and improvement of quality of life in morbidly obese patients Summary Background Data : During the past 10 years , gastric b and ing has become 1 of the most common bariatric procedures , at least in Europe and Australia . Weight loss can be excellent , but it is not sufficient in a significant proportion of patients , and a number of long-term complications can develop . We hypothesized that the type of b and could be of importance in the outcome . Methods : One hundred eighty morbidly obese patients were r and omly assigned to receive the Lapb and or the SAGB . All the procedures were performed by the same surgeon . The primary end point was weight loss , and secondary end points were correction of comorbidities , early- and long-term complications , importance of food restriction , and improvement of quality of life . Results : Initial weight loss was faster in the Lapb and group , but weight loss was eventually identical in the 2 groups . There was a trend toward more early b and -related complications and more b and infections with the SAGB , but the study had limited power in that respect . Correction of comorbidities , food restriction , long-term complications , and improvement of quality of life were identical . Only 55 % to 60 % of the patients achieved an excess weight loss of at least 50 % in both groups . There was no difference in the incidence of long-term complications . Conclusions : Gastric b and ing can be performed safely with the Lapb and or the SAGB with similar short- and midterm results with respect to weight loss and morbidity . Only 50 % to 60 % of the patients will achieve sufficient weight loss , and close to 10 % at least will develop severe long-term complications",
"BACKGROUND Several surgical treatment options for morbid obesity exist . Currently , there are no studies that objective ly compare complication rates after laparoscopic bariatric operations performed at a single institution . We objective ly classify and compare complications result ing from laparoscopic adjustable gastric b and ing ( LABG ) , Roux-en-Y gastric bypass ( RYGB ) , and biliopancreatic diversion ( BPD ) with duodenal switch ( DS ) . STUDY DESIGN A retrospective review of a prospect i ve data base of all patients undergoing laparoscopic bariatric operation was performed . Complications were categorized according to severity score using a well-described classification system and compared between procedures . RESULTS From September 2000 to July 2003 , 780 laparoscopic bariatric operations were performed : 480 LAGB , 235 RYGB , and 65 BPD+/-DS . There was one late death . Total complication rates were : 9 % for LAGB , 23 % for RYGB , and 25 % for BPD+/-DS . Complications result ing in organ resection , irreversible deficits , and death ( grade s III and IV ) occurred at rates of 0.2 % for LAGB , 2 % for RYGB , and 5 % for BPD+/-DS . LAGB group had a statistically significant lower overall complication rate , both by incidence and severity , as compared with other groups ( p complication compared with the RYGB group ( odds ratio , 3.4 ; 95 % CI , 2.2 - 5.3 , p complication compared with the BPD with DS group ( odds ratio , 3.6 ; 95 % CI , 1.8 - 7.1 , p complication rates of RYGB and BPD+/-DS . CONCLUSIONS Bariatric operation complication rates range from 9 % to 25 % ; very few complications are serious . Laparoscopic adjustable gastric b and ing is the safest operation in terms of complication rate and severity when compared with laparoscopic Roux-en-Y gastric bypass or laparoscopic malabsorptive operations",
"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 The overall long-term results of medical treatment for morbid obesity are poor . Surgery is the only treatment option to obtain long-term weight reduction . Analysis of risk factors for treatment success of laparoscopically placed gastric b and ing ( LGB ) has not been available until now . METHODS Prospect i ve study with 99 patients with LGB between January 1997 and July 2003 . The parameters assessed as risk factors included onset of obesity , feeling of postpr and ial satiety , and initial body mass index ( BMI ) . RESULTS Median follow-up was 36 months ( 3 to 72 ) . Independent prognostic factors of excess body weight reduction ( > 25 % ) were for the first postoperative year : onset of obesity as an adolescent ( relative risk [ RR ] 0.21 ) , an initial BMI feeling of postpr and ial satiety ( RR 5.26 ) and an initial BMI LGB is suitable to achieve intermediate weight reduction in patients with morbid obesity . To obtain the best results , patients should be treated before they achieve a BMI > 45 kg/m(2 ) . Additionally a postpr and ial feeling of satiety after LGB is m and atory for good long-term results",
"Abstract .Laparoscopic gastric bypass ( LGBP ) is the gold st and ard operation for long-term weight control in the United States . Laparoscopic adjustable silicone gastric b and ing ( LASGB ) is the preferred operative method for morbid obesity worldwide . Limited data are available comparing the two procedure in the United States . This study compares weight loss , complications , and early outcome of comorbidity resolution in patients who underwent LGBP versus LASGB . A review of prospect ively collected data was performed on 392 patients undergoing primary LGBP ( n = 232 ) and LASGB ( n = 160 ) procedures between February 2001 and July 2004 . Differences in percentage excess weight lost ( % EWL ) at 3 , 6 , 12 , 18 , and 24 months postop , improvement or resolution of comorbidities , and complications across procedure types were evaluated . Mean initial body mass index between groups was not significantly different ( LGBP 47.2 vs LASGB 47.1 , p sweet-eating behavior between operative groups . There was a significantly greater % EWL in patients who underwent LGBP compared to patients of the LASGB groups 3 , 6 , 12 , and 18 months after surgery . There were no significant differences in resolution or improvement of comorbidities between the groups . Although LGBP patients experienced more complications compared to LASGB patients ( 5.6 vs 4.3 % , respectively ; p lose more weight than LASGB patients but have similar improvements in comorbidities . Further follow-up is needed to determine the relative long-term efficacy of these procedures",
"Background : We present our results from the \" B \" trial ( the 2nd U.S. FDA -approved clinical trial ) with the laparoscopic adjustable gastric b and ( LAGB ) or Lap-B and ® System , regarding weight loss , complications , and effect on co-morbidities with up to 3-year follow-up . Methods : Between March 1999 and June 2001 , 63 morbidly obese patients underwent LAGB following accepted ASBS/SAGES guidelines and protocol requirements . All b and s were placed via the classic high peri-gastric dissection above the lesser sac , corresponding to the equator of the calibration-tube balloon . Frequent follow-up by a multidisciplinary program was maintained . Results : All procedures were performed laparoscopically with no conversion to laparotomy . Operative time decreased from a mean of 197 minutes for the first 10 patients to 120 minutes for the last group . Average hospital stay was 1.4 days . Perioperative complications included 1 intraoperative gastric perforation , which was closed and did not prevent b and placement , and 5 port problems . Gastric slippage occurred in 9 patients ( 14.2 % ) , 3 of whom were revised to a gastric bypass and 6 who had the b and removed . Three additional b and s were removed due to infection ( 1 ) , b and erosion ( 1 ) and a cluster of gastric symptoms ( 1 ) . Percent excess weight loss averaged 27.2 at 6 months ( range 1 - 68 ) , 38.3 at 1 year ( range 10 - 77 ) , 46.6 at 2 years ( range 16- 89 ) , and 53.6 at 3 years ( range 21 - 94 ) . Before surgery , 46 of 63 patients ( 73 % ) suffered from a serious comorbidity . Following LAGB , all categories showed marked improvement . Conclusions : In this study up to 3 years , LAGB provided a safe and sustainable weight loss . Significant resolution of serious co-morbidities was common . A U.S. bariatric practice achieved results comparable to those in the international literature . The primary requisites to achieve optimal results include careful patient selection , the refined surgical technique , and a comprehensive long-term patient management program",
"BACKGROUND Many short-term follow-up reports on the efficacy of the adjustable silicone gastric b and ( ASGB ) and its modification for laparoscopic insertion ( Lap-B and ) for the surgical treatment of morbid obesity have been reported in the surgical literature . However , long-term studies are lacking . METHODS Between March 17 , 1992 , and January 7 , 1997 , 45 females and 17 males consecutively entered this prospect i ve study . Forty ASGB and 22 Lap-B and were implanted . Mean age was 34 years ( range 19 - 51 ) ; mean height was 171 cm ( range 152 - 190 ) ; mean weight was 145 kg ( range 100 - 214 ) . Weight loss and adverse events associated with the device were observed over time . RESULTS There was no operative mortality . Thirty intra-abdominal reoperations were necessary to correct complications related to the implanted ASGB and the Lap-B and . In the ASGB cohort , the body mass index ( BMI ) decreased from 50 to 36 over a 3-year period and then increased to 44 at 8 years after operation . In the Lap-B and cohort the BMI decreased from 47 to 40 at 1 year and then increased to 43 at 6 years after operation . Twenty-seven implantable devices ( 18 ASGB , 9 Lap-B and ) have been removed to date . CONCLUSION The results of this study do not support the use of ASGB devices for the surgical treatment of morbid obesity . The Lap-B and is less effective than ASGB",
"OBJECTIVE To perform the first prospect i ve trial of laparoscopic versus open adjustable silicone gastric b and ing ( ASGB ) in patients with morbid obesity . SUMMARY BACKGROUND DATA Vertical b and ed gastroplasty has been used for many years to treat morbid obesity , but the size of the stoma has remained a source of failure after the procedure . ASGB has the advantages of maintaining gastric integrity and the potential for readjustment of the b and , if needed . It has been suggested that laparoscopic ASGB , recently introduced to reduce postoperative complications and hospital stay , has a negative impact on outcome . METHODS Fifty patients with morbid obesity of > 5 years ' duration and a body-mass index ( BMI ) > 40 kg/m2 were r and omized to undergo laparoscopic or open ASGB . The difficulty of the procedure , surgical time , postoperative complications , and hospital stay were assessed . Stoma adjustments , long-term complications , readmissions , weight loss , and BMI were determined . RESULTS All procedures were successfully carried out . Of 25 patients assigned to laparoscopic ASGB , 2 were converted to an open procedure . Surgical time was significantly longer for laparoscopic ASGB ( 150 minutes vs. 76 minutes for open ASGB ) . There was no difference in complications . Mean hospital stay was 5.9 days for the laparoscopic procedure versus 7.2 days for open ASGB ( p total number of readmissions ( 6 vs. 15 ) and overall hospital stay in the first year ( 7.8 vs. 11.8 days ) were lower after laparoscopic ASGB ( p Weight and BMI were reduced significantly in both groups , but there was no difference between the groups . CONCLUSION Laparoscopic and open ASGB were equally effective in terms of early ( first-year ) weight loss , reduction of BMI , and postoperative complications . The laparoscopic procedure was associated with a shorter initial hospital stay and fewer readmissions during follow-up and is therefore the preferred treatment in morbidly obese patients undergoing ASGB",
"In a prospect i ve study of 188 patients with morbid obesity , the time-dependent changes in the quality of life of individual patients were analyzed following laparoscopic gastric b and ing ( LGB ) . These 188 patients ( 148 females and 40 males ; age 19 to 59 years ; body mass index 33 to 72 kg/m(2 ) ) underwent evaluation of the LGB according to a strict protocol that included psychological testing using st and ardized instruments , detailed medical evaluation , upper gastrointestinal function studies , and evaluation of quality of life using the Gastrointestinal Quality of Life Index ( GIQLI ) . Following this evaluation , 73 patients ( 57 females and 16 males ; age 37 years [ range 19 to 59 years ] ; body mass index 48 kg/m(2 ) [ range 37 to 72 kg/m(2 ) ] ) underwent LGB and were followed up for 2 years focusing on weight loss , postoperative morbidity , weight-related comorbidity , and quality of life . The results demonstrate that LGB is well able to allow for a significant loss of excess weight and a significant improvement in patients ' quality of life , both after a rather short period of time after surgery and at a continuous rate throughout the follow-up . The price for this success that was found in approximately 90 % of patients is a complication rate of 38 % ; 85 % of these patients , almost one third of all patients , must undergo some type of revision surgery . However , once the complications are resolved , these patients achieve the same level of weight loss and improvement in quality of life as patients with an uncomplicated postoperative course",
"Background : Laparoscopic adjustable gastric b and ing is a popular bariatric operation in Europe . However , the long-term complication rate and weight loss are still unclear . Methods : 824 patients underwent a laparoscopic Swedish Adjustable Gastric B and ing ( SAGB ) in a 5-year period . Preoperative data , postoperative weight loss and long-term complications were prospect ively obtained for analysis . Results : Mean age of the 824 patients was 43 ± 1 years , with mean preoperative BMI 43 ± 1 kg/m2 . No intra- or postoperative death occurred in the first 30 postoperative days . Intraoperative conversion rate was 5.2 % . Peri-operative complication rate was 1.2 % . 97 % of the patients were available for follow-up ( maximum 5 years ) . Long-term complications occurred in 191 patients ( 23.2 % ) . 135 complications ( 16.4 % ) were related to the b and , and 56 ( 6.8 % ) to the access-port or to the tube . Mean excess weight loss was 30 , 41 , 49 , 55 and 57 % after 1 , 2 , 3 , 4 and 5 years respectively . 82.9 % of the patients obtained > 50 % EWL after initial treatment . Conclusions : The results of this study suggest that laparoscopic SAGB can achieve an effective weight loss , with an acceptable mortality and morbidity rate ",
"Background : The purpose of this study was to assess factors of clinical importance in morbidly obese patients having a laparoscopically adjustable gastric b and ( LAP-B AND ® ) implanted in order to achieve weight loss . Methods : Preoperative evaluation of hiatus hernia and esophageal (dys)motility were compared with the need for reoperation . Results are presented for the first 50 consecutive patients entered . Results : Nine of the first 50 patients required reoperation ( 18 % ) . Five ( 10 % ) were for LAP-B AND slippage on the stomach . Of these five , reoperation was required in four of 12 ( 33 % ) with hiatus hernia ( P = 0.0093 ) ; three of nine ( 33 % ) with a motility disorder ( P = 0.025 ) ; and three of six ( 50 % ) with both hiatus hernia and a motility disorder ( P = 0.0076 ) . Conclusions : We identify two factors , hiatus hernia and esophageal dysmotility , which are associated , both independently as well as in combination , with reoperation for LAP-B AND ® slippage . Both patients and their physicians should consider these data when considering the LAP-B AND ® as possible therapy for morbid obesity",
"BACKGROUND The use of LAP-B AND adjustable gastric b and ing ( LAGB ) has gained tremendous popularity , but creation of the retrogastric tunnel is a considerable challenge , especially in the surgeon 's early experience , and is associated with up to 10 % b and slippage and occasional gastric perforation . The two-step technique involves a crural dissection toward the angle of His through a pars flaccida approach . The technique facilitates passage of the b and with no extensive posterior gastric wall dissection . METHODS A prospect i ve study investigated 250 patients ( 207 women and 43 men ) who underwent LAGB from January 1999 to May 2002 using a two-step dissection technique . The mean age of these patients was 37 years ( range , 18 - 58 years ) . Their mean preoperative weight was 120 kg ( range , 90 - 169 kg ) , and their mean body mass index was 44 kg/m2 ( range , 36 - 68 kg/m2 ) . RESULTS All the procedures except two were completed laparoscopically , and there were no deaths . The mean operative time was 61 min ( range , 35 - 150 min ) , and the mean hospital stay was 1.2 days ( range , 1 - 5 days ) . At 3 years , the mean body mass index had decreased from 44 kg/m2 to means of 39.9 , 37.3 , 34.4 , 32.4 , and 31.7 kg/m2 at 3 , 6 , 12 , 24 , and 36 months , respectively . The mean excess weight loss was 42.1 % at 1 year , 51.4 % at 2 years , and 55.5 % at 3 years . There were four b and slippages ( 1.6 % ) , no b and erosion , and no major morbidity . CONCLUSIONS The use of LAGB with the two-step technique is technically simple , avoids intimate posterior gastric wall dissection , and facilitates tight posterior b and support . It therefore is associated with only minimal perioperative complications and a low slippage rate",
"Background : Since its introduction about 10 years ago , and because of its encouraging early results regarding weight loss and morbidity , laparoscopic gastric b and ing ( LGB ) has been considered by many as the treatment of choice for morbid obesity . Few long-term studies have been published . We present our results after up to 8 years ( mean 74 months ) of follow-up . Methods : Prospect i ve data of patients who had LGB have been collected since 1995 , with exclusion of the first 30 patients ( learning curve ) . Major late complications are defined as those requiring b and removal ( major reoperation ) , with or without conversion to another procedure . Failure is defined as an excess weight loss ( EWL ) of reoperation . Results : Between June 1997 and June 2003 , LGB was performed in 317 patients , 43 men and 274 women . Mean age was 38 years ( 19 - 69 ) , mean weight was 119 kg ( 79 - 179 ) , and mean BMI was 43.5 kg/m2 ( 34 - 78 ) . 97.8 % of the patients were available for follow-up after 3 years , 88.2 % after 5 years , and 81.5 % after 7 years . Overall , 105 ( 33.1 % ) of the patients developed late complications , including b and erosion in 9.5 % , pouch dilatation/slippage in 6.3 % , and catheter- or port-related problems in 7.6 % . Major reoperation was required in 21.7 % of the patients . The mean EWL at 5 years was 58.5 % in patients with the b and still in place . The failure rate increased from 13.2 % after 18 months to 23.8 % at 3 , 31.5 % at 5 , and 36.9 % at 7 years . Conclusions : LGB appeared promising during the first few years after its introduction , but results worsen over time , despite improvements in the operative technique and material . Only about 60 % of the patients without major complication maintain an acceptable EWL in the long term . Each year adds 3 - 4 % to the major complication rate , which contributes to the total failure rate . With a nearly 40 % 5-year failure rate , and a 43 % 7-year success rate ( EWL > 50 % ) , LGB should no longer be considered as the procedure of choice for obesity . Until reliable selection criteria for patients at low risk for long-term complications are developed , other longer lasting procedures should be used",
" The authors present the results of a prospect i ve study regarding their 1st year experience in laparoscopic adjustable gastric b and ing ( LABG ) , which included 21 patients ( 5 males , 16 females ) , with an average age of 39 ( between 20 - 53 years ) . The follow up was made at one and six months postoperative . The medium weight was 138 kg ( between 95 - 172 kg ) , with a medium excess of body mass of 66.89 kg ( extremes between 27.75 and 104 kg ) . The medium BMI ( body mass index ) was 48.9 ( extremes : 34.5 - 66 ) , 8 patients being superobese ( BMI > 50 ) . The average operating time was 120 min , all operations were finished laparosopically . Postoperative complications were : total disfagia ( 1 case ) , parietal suppuration ( 2 cases ) and partial intragastric migration of the prosthesis ( 1 case ) . There were no deceased patients . The medium excess of body mass at 6 months after surgery was 46.57 ( only 13 patients evaluated in this interval ) . After 6 months postoperative the comorbidities were healed at half of the patients . Although we do not benefit of a long time follow up , the favorable initial results permits us to state that LABG must find its place in the efforts of struggling against obesity and its consequences",
"Background : Quality of life ( QoL ) was tested in a 2- year postoperative study using the Medical Outcome Study Short Form 36 ( MOS SF-36 ) to assess preoperative and 1 and 2 year postoperative QoL among one group of female patients ( group 1 , n = 42 ) and a 2 year postoperative QoL study in a second group of female patients ( group 2 , n = 9 ) who underwent a stomach reduction operation involving open surgical placement of a Lap-B and during the year 1997 . Methods : The QoL of 42 patients ( group 1 ) was assessed at most 20 hours before surgery and 1 and 2 years ( 12 and 24 months ) postoperatively using a r and omized pre-test/post-test design . The QoL of 9 patients ( group 2 ) was assessed 2 years ( 24 months ) postoperatively using a r and omized post-test design only . The results were compared with the st and ardized Dutch norm data scale . Statistical data were analyzed with SPSS versions 10.0 . Results : The placement of a Lap-B and in group 1 result ed in a significant reduction in Body Mass Index ( BMI ) in the first and second-year follow-up . Mean BMI declined significantly from 40.7 kg/m2 preoperatively to 33.1 kg/m2 at the 1-year follow-up , to 31.3 kg/m2 at 2-year follow-up . In group 2 BMI also declined significantly from 43.0 kg/m2 preoperatively to 34.2 kg/m2 at 1-year follow-up to 32.1 kg/m2 at the 2-year follow-up . Compared to the MOS SF-36 st and ardized Dutch norm data , a significant improvement in the QoL was seen on the effect variable bodily pain , mental health and general health perceptions in group 1 . Although the bodily pain , general health and mental health perceptions increased significantly 2 years postoperatively ( group 1 ) com pared with the Dutch st and ardized norm data , the preoperative general health and mental health perceptions of morbidly obese patients were , like all other preoperative effect variables , not significantly different from the scores on the Dutch st and ardized norm scale . Conclusion : Although other authors found that QoL improves after surgical-induced weight loss , showing significant improvements on patients ' perception of their health status , these findings were not confirmed in the present study . The findings show only a significant difference in bodily pain , general health and mental health perception before and after surgical intervention and preoperatively in group 1 compared to the Dutch st and ardized norm data . Because of small sample size ( n = 9 ) , no significant results were found in group 2 compared to the Dutch St and ardized norm data . Based on earlier and present findings , further study is recommended to ascertain whether the MOS SF-36 is valid in morbidly obese patients and whether the response set has an influence on QoL studies of these patients",
"Background : Early experience with 400 consecutive patients who underwent laparoscopic adjustable gastric b and ing ( LAGB ) is reported . Methods : From Nov 2002 to Aug 2004 , prospect i ve data were collected on 400 consecutive LAGB patients and evaluated retrospectively . Results : There were 354 ( 88.5 % ) females and 46 males ( 11.5 % ) , with mean age 43.6 years and mean BMI 46.2 kg/m 2 . For out patients ( freest and ing ambulatory surgery center ) , mean OR time was 55.4 min in 208 patients ( 52 % ) , compared to mean inpatient OR time of 70.5 min in 192 patients . In patients had a higher BMI ( 48.2 ± 9.3 SD ) than out patients ( 43.9 ± 5.7 SD ) ( P slipped b and s ( 2.3 % ) that were surgically repositioned , 6 port problems ( 1.5 % ) that were successfully repaired , 17 patients with temporary stoma occlusion ( 4.3 % ) that spontaneously resolved , and 2 bowel perforations ( 0.5 % ) that required surgical repair and b and removal . One patient died of pneumonia 2 weeks after an uneventful procedure . Average 1-year percent excess weight loss ( % EWL ) in 138 patients was 48.2 % . Patients who had ≤50 kg initial excess weight ( n=37 , 27 % ) had a significantly higher % EWL ( 55.2 % ) at 1 year than patients who had > 50 kg initial excess weight ( P=0.0011 ) . Conclusions : LAGB has been safe and effective thus far for the surgical treatment of morbid obesity , and can be performed as an outpatient in select patients",
"Background : Individual b and -filling on dem and of the morbidly obese patient is a major advantage of adjustable gastric b and ing . An increasing number of patients results in an enormous amount of outpatient follow-up visits , which inspired us to compare a stepwise b and -filling strategy with a single bolus injection 4 weeks after the operative procedure . Methods : 40 consecutive patients were prospect ively r and omized in 2 groups . 20 patients ( Group A ) had stepwise b and -filling during 6 monthly ambulant visits . 20 patients ( Group B ) had a bolus-filling 4 weeks postoperatively and had the next follow-up after another 5 months . Weight loss , complications and procedural costs during follow-up were compared . Results : Patients of both groups did not differ in age , gender or preoperative BMI .There was no significant difference postoperatively in excess weight lost ( EWL ) after 9 months . Postoperative complications did not differ significantly . By means of bolus-filling , a 60 % and 53 % reduction in outpatient clinical work was achieved within the 6 and 9 months , respectively . Conclusion : Postoperative management after gastric b and ing takes advantage of a single bolus-filling during the first postoperative 6 months due to sufficient weight loss , low complication rate but significant reduction of personal , financial and logistic efforts",
"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",
"Gastric bypass has been reported to be associated with markedly suppressed plasma ghrelin levels , suggesting that it is one of the possible weight-reducing factors related to this procedure . The aim of this study was the evaluation of plasma ghrelin levels in patients who had undergone laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) and laparoscopic adjustable silicone gastric b and ing ( LASGB ) . Normoweight , obese subjects and patients who had undergone total gastrectomy were used as controls . In this cross-sectional study , we selected 10 subjects who underwent LASGB , 11 subjects with LRYGBP , 10 obese subjects , eight patients with total gastrectomy , and eight normoweight subjects . Plasma ghrelin , insulin , and glucose profiles were determined before and after breakfast and lunch . Obese subjects showed a ghrelin plasma level significantly lower than normoweight subjects ( 407.3 + /- 21.6 vs. 813 + /- 72.4 pg/ml , P Patients with LRYGBP showed baseline ghrelin levels lower than LASGB ( 213.5 + /- 73.9 vs. 314.2 + /- 84.3 pg/ml , P = 0.04 ) . Both groups of patients who underwent bariatric surgical procedures also had ghrelin lower than normoweight and obese subjects ( P Patients with total gastrectomy showed plasmatic ghrelin levels extremely lower than those in all other groups ( 32.6 + /- 18.7 pg/ml , P ghrelin profile in both groups of subjects who underwent LRYGBP and LASGB did not show any meal-related changes as observed in obese and normoweight control groups . Significant difference in plasma ghrelin levels between LRYGBP and LASGB was found , suggesting that both procedures could induce weight loss by different mechanisms in which ghrelin could be involved",
"UNLABELLED Morbid obesity is associated with cholesterol gallstone formation , a risk compounded by rapid weight loss . Laparoscopic gastric b and ing allows for a measured rate of weight loss , but the subsequent risk for developing gallstones is unknown . METHOD Twenty-six normal-weight volunteers ( body mass index [ BMI ] less than 30 ) were compared with 14 morbidly obese patients ( BMI greater than 40 ) . Gallbladder volumes were measured ultrasonographically , after fasting and following stimulation with intravenous cholecystokinin-octapeptide ( CCK-8 ) RESULTS Preoperatively , fasting gallbladder volume and residual volume after CCK stimulation were both two times greater in the obese group ( P Per cent gallbladder emptying was not different . Gallbladder refilling was four times higher in the obese patients ( P Gallbladder emptying decreased 18.4 % ( 80.3+/-3.9 % to 65.5+/-6.9 % ; P residual volume rose one-third ( not significant ) , and refilling fell 60.5 % ( 0.43+/-0.09 to 0.26+/-0.04 mL/min ; P=0.07 ) . Three patients with weight losses of greater than 1.7 % per week developed gallstones ; gallbladder emptying fell outside the 95 percentile . By six months , weight loss slowed to 0.5+/-0.1 % per week ; gallbladder motility improved modestly . No further stones developed . CONCLUSION Rapid weight loss following laparoscopic gastric b and ing impairs gallbladder emptying and when pronounced , gallstones form by six weeks postoperatively . The accompanying reduction in gallbladder emptying , increased gallbladder residual volume and decreased refilling promote gallbladder stasis and hence stone formation",
"Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) and laparoscopic adjustable gastric b and ing ( LAGB ) are common surgical procedures for morbid obesity , but few studies have compared LRYGB and LAGB . All patients who underwent LRYGB and LAGB by a single surgeon at Legacy Health System were identified from a prospect ively maintained data base . Preoperatively , most patients were allowed to choose between LRYGB and LAGB . Age , sex , body mass index ( BMI ) , complications , mortality , and weight loss were examined . From October 2000 to November 2003 , 219 patients underwent LRYGB and 154 patients underwent LAGB . Mean preoperative BMI was 49.5 ± 6.6 and 50.9 ± 9.4 kg/m2 , respectively ( P = 0.10 ) . Mean age was 42 ± 9 and 47 ) . The LAGB group had a higher proportion of male patients ( 21 % versus 7 % , P Patients undergoing LRYGB had longer operative times ( 134 versus 76 minutes , P 0.001 ) , more blood loss ( 43 versus 28 ml , P ) , and longer hospital stays ( 2.6 versus 1.3 days , P was 35 % for LRYGB versus 19 % for LAGB at 3-month follow-up ( P ( P = 0.85 ) . Major complications occurred in 7 % and 6 % ( P 0.58 ) and minor complications occurred in 18 % and 20 % ( P = 0.65 ) of patients , respectively . Reoperation occurred in 21 patients ( 10 % ) after LRYGB and 31 ( 20 % ) patients after LAGB ( P undergoing reoperation , eight ( 38 % ) LRYGB patients and one ( 3 % ) LAGB patient required open laparotomy . One death occurred in each group . Patients undergoing laparoscopic adjustable gastric b and ing have shorter operative times , less blood loss , and shorter hospital stays compared with laparoscopic gastric bypass patients . The incidence of major and minor complications is similar ; however , morbidity after LRYGB is potentially greater and the reoperation rate is higher in the LAGB group . Early weight loss is greater with gastric bypass , but the difference appears to diminish over time",
"Background : Laparoscopic gastric b and ing is effective in surgical treatment of morbid obesity , but has had the drawback of specific complications , like slippage and gastric erosion . To prevent such complications , modifications have been used , including high retrogastric positioning above the bursa omentalis , complete anterior fixation by gastro-gastric stitches over the b and , and reduction of the pouch volume to ≤ 15 ml . These technical variants may induce dysphagia . Methods : We adopted a different technique , consisting of placement of the b and ( 9.75 cm BioEnterics Lap-B and ® ) around the esophagus just above the cardia , to induce an amplification of the dysphagic mechanism . No fixation stitches were used . Results : From January 1999 to March 2001 , 80 consecutive patients ( 16 males , 64 females , mean age 41 years , average BMI 45 ) were operated this way . All operations were completed laparoscopically . However , in 1 patient the procedure had to be interrupted for bleeding from a large fatty liver injury by the retractor . Complications included 2 cases of slippage : an early one after 24 h , requiring surgical removal , and a late one after 9 months , treated by laparoscopic repositioning . The third complication , a reactive esophageal stenosis , occurred in a transsexual male on estrogen treatment , that needed replacement with a wider Swedish b and . B and adjustment was required in 28 patients , one time in 22 cases and twice in the other 6 . Mean BMI decreased from 45 to 38 after 6 months , remaining at 37 after 24 months , while excess weight was reduced by 50 % at 24 months . Conclusions : The technique has a re-educational function , in that patients are induced to chew thoroughly , to introduce small morsels of food and to prolong the mastication time , in order to avoid dys phagia . Laparoscopic adjustable esophagogastric b and ing gave no problem if well positioned , and promoted new alimentary habits through a dysphagic mechanism , inducing significant excess weight loss ",
"BACKGROUND Despite impressive results with the Lap-B and in Europe and Australia , the early Food and Drug Administration A trial in the United States showed fairly poor results . This prospect i ve study attempts to determine if the Lap-B and can produce effective weight loss in morbidly obese Americans . METHODS Five hundred four consecutive patients have undergone placement of the Lap-B and ( Inamed ) . Four hundred fourteen patients were women ( 82 % ) and 90 were men ( 18 % ) . The median preoperative weight was 138 kg , and the preoperative median body mass was 49 kg/m(2 ) . RESULTS Five hundred two b and s were placed laparoscopically . One was converted to an open procedure because of lack of exposure , and one was placed open because of multiple previous abdominal surgeries . Median operating time was 50 minutes , and median length of stay was 1.8 days . Percent excess weight loss at 6 , 12 , 24 , and 36 months for all patients was 36 % , 50 % , 61 % , and 65 % , respectively . Complications occurred in 96 patients ( 19 % ) primarily consisting of port tubing separations , slips , postoperative dysphagia , and port infections . There was one ( .2 % ) mortality . CONCLUSIONS The Lap-B and system is an effective tool for weight loss surgery in morbidly obese patients in the United States",
"Background : A study was performed to assess the usefulness and efficacy of a new type of b and ( Heliogast ® ) for laparoscopic adjustable gastric b and ing ( LAGB ) for the treatment of morbid obesity , compared with the Lap-B and ® . Method : From January to May 2001 , a prospect i ve r and omized study of 60 LAGB procedures was conducted : group I ( n=30 ) , the Lap-B and ® system ( INAMED ) ; group II ( n=30 ) , the Heliogast ® b and ( Hélioscopie ) . We implanted the devices using the 2-step technique ( pars flaccida to peri-gastric ) by laparoscopy . Port systems were placed on the rectus sheath and were fixed by non-absorbable sutures . Follow-up of all patients was a minimum of 12 months . Results : There were no differences in operating-time , intra-operative complications , or weight loss during the first 4 weeks after surgery . However , with increasing time , more complications with the Heliogast ® b and and differences in weight loss favoring the Lap-B and ® became significant . Conclusion : Based on the results of this study , we recommend that new b and s have independent clinical evaluation before commercialization",
"Background : The Swedish adjustable gastric b and ( SAGB ) has been in use since 1985 . The aim of this study was to analyze short and long-term complications linked to the SAGB . Material s and Methods : Between August 1990 and December 1996 , we operated on a series of 326 patients ( 78 men and 248 women ) at the Huddinge University Hospital and the Norra Älvsborg County Hospital . The mean age of patients at surgery was 40 years ( range 19 - 62 ) . The mean preoperative weight was 125 kg ( range 81 - 181 ) . The mean excess weight was 80 % . Results : The mean time of follow-up was 28 months ( range 6 - 76 ) . Complications requiring reoperation included two ( 0.6 % ) b and dislocations , six ( 1.8 % ) b and leakages , and 16 ( 4.6 % ) b and migrations-erosions . The most common reason for abdominal reoperation , b and migration , was attributed to overfilling of the b and system . In the patients in whom migration occurred , the b and s had been filled with a mean volume of 12.6 ml fluid . In the remaining patients , the mean volume was 8.7 ml . The most common complication not requiring reoperation was reflux disease ( 4.7 % ) . In cases with a small pouch , this complication did not seem to be a serious problem . The mean excess weight loss in the 296 patients without complications was 68 % . Conclusion : The overall long-term complication rate following SAGB is reasonable . With improved operating technique and closer follow-up , it should be possible to reduce the complication rate further . Reoperation because of b and migration appears to be related to overfilling of the system and should therefore be avoidable in most cases"
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Appendicectomy has been accepted as the gold st and ard for the management of appendicitis over the years , but there has been an increasing evidence and trend toward the conservative approach to the management of appendicitis . The aim of this review is to search existing literature and to evaluate and compare the conservative and operative approaches to the management of appendicitis . An electronic search of published literature was conducted through Pubmed , Google Scholar , Embase , and Medline using a variety of search items to find relevant observational studies , r and omized clinical trials , systematic review s , and meta-analyses . Bibliographies of selected articles were also analyzed for publications of interest relevant to the scope of the topic . The articles that reported primary outcomes after the management of appendicitis , complications , economic implication s , and duration of follow-up were review ed in detail . The major primary outcomes show a high recurrence rate and failed treatment associated with the conservative management of appendicitis . The other outcomes obtained show that there is an increased incidence of complications associated with operative management . Economic implication s and cost-effectiveness analysis show that conservative treatment may be preferred . The length of hospital stay was significantly higher in conservative approach to management ; however , shorter time off activities was observed . In general , the conservative management of appendicitis is still regarded as safe , effective , and efficacious , and further research with well-constructed study design , and larger sample size is required
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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",
"An increasing amount of evidence supports antibiotic therapy for treating uncomplicated acute appendicitis . The objective of this study was to compare the costs of antibiotics alone versus appendicectomy in treating uncomplicated acute appendicitis within the r and omized controlled APPAC ( APPendicitis ACuta ) trial",
"Background Although the st and ard treatment of acute appendicitis ( AA ) consists of an early appendectomy , there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA . However , the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial . Methods / design The APPAC trial is a r and omized prospect i ve controlled , open label , non-inferiority multicenter trial design ed to compare antibiotic therapy ( ertapenem ) with emergency appendectomy in the treatment of uncomplicated AA . The primary endpoint of the study is the success of the r and omized treatment . In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year ( treatment efficacy ) . Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100 % . Secondary endpoints are post-intervention complications , overall morbidity and mortality , the length of hospital stay and sick leave , treatment costs and pain scores ( VAS , visual analoque scale ) . A maximum of 610 adult patients ( aged 18–60 years ) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and r and omized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem ( 1 g per day ) for three days continued by oral levofloxacin ( 500 mg per day ) plus metronidazole ( 1.5 g per day ) for seven days . Follow-up by a telephone interview will be at 1 week , 2 months and 1 , 3 , 5 and 10 years ; the primary and secondary endpoints of the trial will be evaluated at each time point . Discussion The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85 % of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity , also result ing in major cost savings . Trial registration Clinical",
"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 ",
"Study objective R and omized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics‐first is safe . No trial has evaluated outpatient treatment and no US r and omized trial has been conducted , to our knowledge . This pilot study assessed feasibility of a multicenter US study comparing antibiotics‐first , including outpatient management , with appendectomy . Methods Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were r and omized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole . Stable antibiotics‐first‐treated participants older than 13 years could be discharged after greater than or equal to 6‐hour emergency department ( ED ) observation with next‐day follow‐up . Outcomes included 1‐month major complication rate ( primary ) and hospital duration , pain , disability , quality of life , and hospital charges , and antibiotics‐first appendectomy rate . Results Of 48 eligible patients , 30 ( 62.5 % ) consented , of whom 16 ( 53.3 % ) were r and omized to antibiotics‐first and 14 ( 46.7 % ) to appendectomy . Median age was 33 years ( range 9 to 73 years ) , median WBC count was 15,000/&mgr;L ( range 6,200 to 23,100/&mgr;L ) , and median computed tomography appendiceal diameter was 10 mm ( range 7 to 18 mm ) . Of 15 antibiotic‐treated adults , 14 ( 93.3 % ) were discharged from the ED and all had symptom resolution . At 1 month , major complications occurred in 2 appendectomy participants ( 14.3 % ; 95 % confidence interval [ CI ] 1.8 % to 42.8 % ) and 1 antibiotics‐first participant ( 6.3 % ; 95 % CI 0.2 % to 30.2 % ) . Antibiotics‐first participants had less total hospital time than appendectomy participants , 16.2 versus 42.1 hours , respectively . Antibiotics‐first‐treated participants had less pain and disability . During median 12‐month follow‐up , 2 of 15 antibiotics‐first‐treated participants ( 13.3 % ; 95 % CI 3.7 % to 37.9 % ) developed appendicitis and 1 was treated successfully with antibiotics ; 1 had appendectomy . No more major complications occurred in either group . Conclusion A multicenter US trial comparing antibiotics‐first to appendectomy , including outpatient management , is feasible to evaluate efficacy and safety",
"PURPOSE The purpose of this study was to determine if early , acute appendicitis in children can be safely and effectively managed with antibiotics alone . METHODS A retrospective review was performed of children ( non-operatively ( NOM ) for early , acute appendicitis since May 2012 . These were compared to patients treated with appendectomy between January 2011 and October 2011 ( OM ) . Inclusion criteria included : ( a ) symptoms . RESULTS Twelve patients ( 66 % female , mean age 12.2,SD=4.2 yrs ) were treated non-operatively , while 12 ( 50 % female , mean age 12.5,SD=3.2 yrs ) were treated operatively . Two NOM children ( 16.7 % ) required initial appendectomy . One patient developed recurrent appendicitis requiring appendectomy 7 months post-discharge . Four other NOM patients returned with symptoms but did not require admission or surgery . Two OM patients ( 8.3 % ) had hospital visits and admissions related to surgical site infections . Mean length of stay ( LOS ) for the first visit was 1.5 days ( SD=1.0d ) ( NOM ) vs. 1.3 days ( SD=0.5d ) ( OM ) ( p=0.61 ) . Including first and subsequent admissions , mean LOS was 1.8 days ( SD=1.1d ) ( NOM ) vs. 1.7 days ( SD=1.5d ) ( OM ) ( p=0.97 ) . CONCLUSION Early acute appendicitis in appropriately selected children can be successfully treated non-operatively . R and omized trials with longer follow-up are required",
"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",
"BACKGROUND Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults ; so far , not much is known about the safety and efficacy of this treatment in children . The aims of this study were to investigate the feasibility of a r and omized controlled trial ( RCT ) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and to evaluate the safety of this approach . METHODS In a multicenter , prospect i ve cohort study patients aged 7 - 17 years with a radiologically confirmed simple appendicitis were eligible . Intravenous antibiotics ( amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily ; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily ) were administered for 48 - 72 hours . Clinical reevaluation every 6 hours , daily blood sample s , and ultrasound follow-up after 48 hours was performed . In case of improvement after 48 hours , oral antibiotics were given for a total of 7 days . At any time , in case of clinical deterioration or non-improvement after 72 hours , an appendectomy could be performed . Follow-up continued until 8 weeks after discharge . Adverse events were defined as major complications of antibiotic treatment , such as allergic reactions , perforated appendicitis , and recurrent appendicitis . RESULTS Of 44 eligible patients , 25 participated ( inclusion rate , 57 % ; 95 % CI , 42%-70 % ) . Delayed appendectomy was performed in 2 , and the other 23 were without symptoms at the 8 weeks follow-up . Minor complications occurred in three patients . None of the patients suffered from an adverse event or a recurrent appendicitis . CONCLUSION Our study shows that an RCT comparing initial antibiotic treatment strategy with urgent appendectomy is feasible in children ; the intervention seems to be safe",
"BACKGROUND Appendiceal mass may be treated in several ways . However , no r and omized trial has been conducted to find the best option . OBJECTIVE To compare the three most commonly used methods for treating appendiceal mass . METHODS Over a three-year period , 60 consecutive patients with appendiceal mass were r and omly allocated to three groups : Group A -- initial conservative treatment followed by interval appendectomy six weeks later ; Group B -- appendectomy as soon as appendiceal mass resolved using conservative means ; Group C -- conservative treatment alone . Short-term outcome measures included operative time , operative difficulty , postoperative complications , length of hospital stay , and duration of time away from work . Long-term outcome measures were : number of hospital visits made , presence of severe incisional pain , scar appearance , and patients with recurrent appendicitis . RESULTS Baseline characteristics were comparable in the three groups . In patients in Group A , operative time was less , adhesions were encountered less frequently , the incision had to be extended less often and post-operative complications were fewer , as compared to Group B. Patients in Group C had the shortest hospital stay and duration of work-days lost ; only 2 of 20 patients in this group developed recurrent appendicitis during a follow-up period of 24 - 52 ( median 33.5 ) months . CONCLUSION Of the three treatment modalities compared , conservative treatment without subsequent appendectomy appears to be the best",
"Objective To define risk factors that predict adverse outcomes after the surgical treatment of appendicitis in Department of Veterans Affairs Medical Centers . Summary Background Data Risk factors for adverse outcomes after the surgical treatment of appendicitis in adults are poorly defined . Accurate presurgical assessment of the risk of perioperative complications and death is important in planning surgical therapy . Methods The VA National Surgical Quality Improvement Program contains prospect ively collected and extensively vali date d data on ∼1,000,000 major surgical operations . All patients undergoing surgical intervention for appendicitis from 1991 to 1999 registered in this data base were selected for study . Independent variables examined included 68 putative preoperative risk factors and 12 intraoperative process measures . Dependent variables were 21 specific adverse outcomes , including death . Stepwise logistic regression analysis was used to construct models predicting 30-day morbidity rate and the 30-day postoperative mortality rate . Results There were 4163 patients identified . The mean age was 50 years ; 96 % were male . Sixteen percent of patients had 1 or more complications after surgical intervention . Prolonged ileus , failure to wean from the ventilator , pneumonia , and both superficial and deep wound infection were the most frequently reported complications , accounting for the majority of the morbidity . The 30-day mortality rate was 1.8 % ( 74 deaths ) . For > 50 % of the complications reported , the 30-day mortality rates were significantly higher ( P . Thirty-day mortality rates for several complications exceeded 30 % , including cardiac arrest , coma > 24 hours , myocardial infa rct ion , acute renal failure , bleeding requiring > 4 units of red cells , and systemic sepsis . Four preoperative factors predicted a high risk of 30-day mortality in the logistic regression analysis : “ completely dependent ” functional status , bleeding disorder , steroid usage , and current pneumonia . “ Threat to life ” or “ moribund ” American Society of Anesthesiologists classification and more than a 10 % weight loss in the 6 months before surgery were associated with a high risk of complications . Conclusions Morbidity and mortality rates after the surgical treatment of appendicitis in VA hospitals are comparable with those reported in other large series . Most postsurgical complications are associated with an increased 30-day mortality rate . The models presented here are the most robust available in predicting 30-day morbidity and mortality for VA patients with appendicitis . Furthermore , they provide a starting point for the design of similar models to evaluate non-VA patients with appendicitis using the data the National Surgical Quality Improvement Program is currently gathering from private hospitals",
"Importance Short-term results support antibiotics as an alternative to surgery for treating uncomplicated acute appendicitis , but long-term outcomes are not known . Objective To determine the late recurrence rate of appendicitis after antibiotic therapy for the treatment of uncomplicated acute appendicitis . Design , Setting , and Participants Five-year observational follow-up of patients in the Appendicitis Acuta ( APPAC ) multicenter r and omized clinical trial comparing appendectomy with antibiotic therapy , in which 530 patients aged 18 to 60 years with computed tomography – confirmed uncomplicated acute appendicitis were r and omized to undergo an appendectomy ( n = 273 ) or receive antibiotic therapy ( n = 257 ) . The initial trial was conducted from November 2009 to June 2012 in Finl and ; last follow-up was September 6 , 2017 . This current analysis focused on assessing the 5-year outcomes for the group of patients treated with antibiotics alone . Interventions Open appendectomy vs antibiotic therapy with intravenous ertapenem for 3 days followed by 7 days of oral levofloxacin and metronidazole . Main Outcomes and Measures In this analysis , prespecified secondary end points reported at 5-year follow-up included late ( after 1 year ) appendicitis recurrence after antibiotic treatment , complications , length of hospital stay , and sick leave . Results Of the 530 patients ( 201 women ; 329 men ) enrolled in the trial , 273 patients ( median age , 35 years [ IQR , 27 - 46 ] ) were r and omized to undergo appendectomy , and 257 ( median age , 33 years , [ IQR , 26 - 47 ] ) were r and omized to receive antibiotic therapy . In addition to 70 patients who initially received antibiotics but underwent appendectomy within the first year ( 27.3 % [ 95 % CI , 22.0%-33.2 % ] ; 70/256 ) , 30 additional antibiotic-treated patients ( 16.1 % [ 95 % CI , 11.2%-22.2 % ] ; 30/186 ) underwent appendectomy between 1 and 5 years . The cumulative incidence of appendicitis recurrence was 34.0 % ( 95 % CI , 28.2%-40.1 % ; 87/256 ) at 2 years , 35.2 % ( 95 % CI , 29.3%-41.4 % ; 90/256 ) at 3 years , 37.1 % ( 95 % CI , 31.2%-43.3 % ; 95/256 ) at 4 years , and 39.1 % ( 95 % CI , 33.1%-45.3 % ; 100/256 ) at 5 years . Of the 85 patients in the antibiotic group who subsequently underwent appendectomy for recurrent appendicitis , 76 had uncomplicated appendicitis , 2 had complicated appendicitis , and 7 did not have appendicitis . At 5 years , the overall complication rate ( surgical site infections , incisional hernias , abdominal pain , and obstructive symptoms ) was 24.4 % ( 95 % CI , 19.2%-30.3 % ) ( n = 60/246 ) in the appendectomy group and 6.5 % ( 95 % CI , 3.8%-10.4 % ) ( n = 16/246 ) in antibiotic group ( P length of hospital stay , but there was a significant difference in sick leave ( 11 days more for the appendectomy group ) . Conclusions and Relevance Among patients who were initially treated with antibiotics for uncomplicated acute appendicitis , the likelihood of late recurrence within 5 years was 39.1 % . This long-term follow-up supports the feasibility of antibiotic treatment alone as an alternative to surgery for uncomplicated acute appendicitis . Trial Registration Clinical Trials.gov Identifier :"
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OBJECTIVE To present a summary of the 2013 version of the European Association of Urology ( EAU ) guidelines on the treatment of advanced , relapsing , and castration-resistant prostate cancer ( CRPC ) . EVIDENCE ACQUISITION The working panel performed a literature review of the new data ( 2011 - 2013 ) . The guidelines were up date d , and levels of evidence and /or grade s of recommendation were added to the text based on a systematic review of the literature that included a search of online data bases and bibliographic review s. EVIDENCE SYNTHESIS Luteinising hormone-releasing hormone ( LHRH ) agonists are the st and ard of care in metastatic prostate cancer ( PCa ) . LHRH antagonists decrease testosterone without any testosterone surge , and they may be associated with an oncologic benefit compared with LHRH analogues . Complete and rogen blockade has a small survival benefit of about 5 % . Intermittent and rogen deprivation results in noninferior oncologic efficacy when compared with continuous and rogen-deprivation therapy ( ADT ) in well-selected population s. In locally advanced and metastatic PCa , early ADT does not result in a significant survival advantage when compared with delayed ADT . Relapse after local therapy is defined by prostate-specific antigen ( PSA ) values > 0.2 ng/ml following radical prostatectomy ( RP ) and > 2 ng/ml above the nadir and after radiation therapy ( RT ) . Therapy for PSA relapse after RP includes salvage RT ( SRT ) at PSA levels 0.5 ng/ml and SRP or cryosurgical ablation of the prostate in radiation failures . Endorectal magnetic resonance imaging and 11C-choline positron emission tomography/computed tomography ( PET/CT ) are of limited importance if the PSA is 20 ng/ml . Follow-up after ADT should include analysis of PSA and testosterone levels , and screening for cardiovascular disease and metabolic syndrome . Treatment of CRPC includes sipuleucel-T , abiraterone acetate plus prednisone ( AA/P ) , or chemotherapy with docetaxel at 75mg/m(2 ) every 3 wk . Cabazitaxel , AA/P , enzalutamide , and radium-223 are available for second-line treatment of CRPC following docetaxel . Zoledronic acid and denosumab can be used in men with CRPC and osseous metastases to prevent skeletal-related complications . CONCLUSIONS The knowledge in the field of advanced , metastatic , and castration-resistant PCa is rapidly changing . These EAU guidelines on PCa summarise the most recent findings and put them into clinical practice . A full version is available at the EAU office or at www.uroweb.org . PATIENT SUMMARY We present a summary of the 2013 version of the European Association of Urology guidelines on treatment of advanced , relapsing , and castration-resistant prostate cancer ( CRPC ) . Luteinising hormone-releasing hormone ( LHRH ) agonists are the st and ard of care in metastatic prostate cancer ( PCa ) . LHRH antagonists decrease testosterone without any testosterone surge , and they might be associated with an oncologic benefit compared with LHRH analogues . Complete and rogen blockade has a small survival benefit of about 5 % . Intermittent and rogen deprivation results in noninferior oncologic efficacy when compared with continuous and rogen-deprivation therapy ( ADT ) in well-selected population s. In locally advanced and metastatic PCa , early ADT does not result in a significant survival advantage when compared with delayed ADT . Relapse after local therapy is defined by prostate-specific antigen ( PSA ) values > 0.2 ng/ml following radical prostatectomy ( RP ) and > 2 ng/ml above the nadir and after radiation therapy . Therapy for PSA relapse after RP includes salvage radiation therapy at PSA levels . Multiparametric magnetic resonance imaging and 11C-choline positron emission tomography/computed tomography ( PET/CT ) are of limited importance if the PSA is 20 ng/ml . Follow-up after ADT should include analysis of PSA and testosterone levels , and screening for cardiovascular disease and metabolic syndrome . Treatment of castration-resistant CRPC includes sipuleucel-T , abiraterone acetate plus prednisone ( AA/P ) , or chemotherapy with docetaxel 75 mg/m(2 ) every 3 wk . Cabazitaxel , AA/P , enzalutamide , and radium-223 are available for second-line treatment of CRPC following docetaxel . Zoledronic acid and denosumab can be used in men with CRPC and osseous metastases to prevent skeletal-related complications . The guidelines reported should be adhered to in daily routine to improve the quality of care in PCa patients . As we have shown recently , guideline compliance is only in the area of 30 - 40 %
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"BACKGROUND Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive and rogen-independent prostate cancer . We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic , hormone-independent prostate cancer . METHODS We r and omly assigned 770 men to one of two treatments , each given in 21-day cycles : 280 mg of estramustine three times daily on days 1 through 5 , 60 mg of docetaxel per square meter of body-surface area on day 2 , and 60 mg of dexamethasone in three divided doses before docetaxel , or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily . The primary end point was overall survival ; secondary end points were progression-free survival , objective response rates , and post-treatment declines of at least 50 percent in serum prostate-specific antigen ( PSA ) levels . RESULTS Of 674 eligible patients , 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone . In an intention-to-treat analysis , the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone ( 17.5 months vs. 15.6 months , P=0.02 by the log-rank test ) , and the corresponding hazard ratio for death was 0.80 ( 95 percent confidence interval , 0.67 to 0.97 ) . The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone ( P PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients , respectively ( P objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease , respectively ( P=0.30 ) . Grade 3 or 4 neutropenic fevers ( P=0.01 ) , nausea and vomiting ( P cardiovascular events ( P=0.001 ) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone . Pain relief was similar in both groups . CONCLUSIONS The improvement in median survival of nearly two months with docetaxel and estramustine , as compared with mitoxantrone and prednisone , provides support for this approach in men with metastatic , and rogen-independent prostate cancer",
"PURPOSE To assess whether the risk of death is associated with the time to testosterone recovery ( TTR ) after radiotherapy ( RT ) and hormonal therapy ( HT ) for prostate cancer ( PCa ) . PATIENTS AND METHODS Between 1995 and 2001 , 206 men with localized , unfavorable-risk PCa were r and omized to receive RT or RT plus 6 months of HT . A multivariate postr and omization Cox regression analysis was used to assess whether the TTR in years was associated with the risk of death after adjusting for the known prognostic factors , age , Adult Comorbidity Evaluation-27 score , and the use of HT for recurrence . RESULTS Of the 102 men r and omized to receive RT and HT , 57 ( 56 % ) had a TTR of > 2 years , and none of these men had died of PCa after a median follow-up of 7.6 years . As the TTR increased , the risk of death decreased significantly ( adjusted hazard ratio , 0.60 ; 95 % confidence interval , 0.43 - 0.84 ; p = .003 ) . A significant interaction was noted between the TTR and the comorbidity score ( p = .002 ) . The survival estimates were similar ( p = 0.17 ) across the TTR values in men with moderate to severe comorbidity ; however , these estimates increased significantly ( p PCa-specific mortality ( p = .006 ) as the TTR increased in men with no or minimal comorbidity . CONCLUSION The results of our study have shown that a longer TTR after RT plus 6 months of HT for unfavorable-risk PCa is associated with a lower risk of death in men with no or minimal comorbidity",
"We conducted a r and omized clinical trial in men with stage D2 prostate cancer to test whether and rogen priming potentiates the efficacy of cytotoxic chemotherapy . Eighty-five men with progressive prostate cancer refractory to orchiectomy were treated continuously with aminoglutethimide and hydrocortisone to lower adrenal and rogen secretion and were administered cyclic intravenous ( IV ) chemotherapy . The patients were r and omized to receive either and rogen priming or no additional treatment for three days before and on the day of chemotherapy . Median duration of follow-up was 43 months . Response rate ( remission plus disease stabilization ) was not significantly different between the stimulation and control arm when the analysis was restricted to evaluable patients ( 79 % v 73 % , respectively ) or when it was extended to all patients ( 46 % v 61 % ) . Median duration of response was similar for the stimulation and control arm ( 9 and 10 months , respectively ) . Median survival was 10 months in the stimulation and 15 months in the control group ( P = .0047 ) . The and rogen sensitivity of the tumors was supported by the greater toxicity in the stimulation arm associated with and rogen administration . Factors found to be independently associated with improved clinical outcome included a high Karnofsky score and hematocrit , long duration of response to the initial castration , and normalization of an elevated serum acid phosphatase on treatment . We conclude that in this group of patients with advanced disease , and rogen priming does not potentiate the efficacy of chemotherapy and is actually associated with a worse outcome . Furthermore , our data emphasize the heterogeneity of biologic behavior of prostate cancer",
" To evaluate the efficacy and safety of degarelix , a new gonadotrophin‐releasing hormone ( GnRH ) antagonist ( blocker ) , vs leuprolide for achieving and maintaining testosterone suppression in a 1‐year phase III trial involving patients with prostate cancer",
"PURPOSE Few patients with locally recurrent prostate cancer after external beam ( EB ) or interstitial ( I ) radiotherapy ( RT ) are considered c and i date s for salvage radical prostatectomy ( RP ) due to high reported rates of major complications and urinary incontinence . We report the morbidity associated with salvage RP in 100 consecutive patients . MATERIAL S AND METHODS From 1984 to 2003 salvage RP was performed for recurrent prostate cancer following EBRT in 58 cases , and IRT in 42 ( 28 retropubic ) and ( 14 transperineal ) . Clinical information was obtained from a prospect i ve data base . RESULTS Since 1993 , the major complication rate has decreased significantly ( 13 % vs 33 % , p = 0.02 ) , including the rectal injury rate ( 2 % vs 15 % , p = 0.01 ) . Compared with retropubic IRT and /or pre-radiotherapy pelvic lymph node dissection the risk of major complications following EBRT or transperineal IRT was significantly less ( OR 0.2 , p = 0.006 ) . At 5 years an estimated 39 % of patients were dry and 68 % required 1 pad daily or less . A total of 23 patients with moderate-severe incontinence underwent artificial sphincter placement . The anastomotic stricture rate was 30 % . The 5-year potency rate was 28 % following unilateral or bilateral nerve sparing RP and 45 % in previously potent patients . CONCLUSIONS Due to patient selection the major complication rate after salvage RP has improved significantly with time and it is similar to that of st and ard RP . Rates of anastomotic stricture and moderate to severe incontinence are higher than those observed after st and ard RP . However , most patients recover reasonable urinary continence and a substantial number of select patients recover potency . The acceptable morbidity profile of salvage RP following EBRT and transperineal IRT should persuade more physicians to consider patients for this potentially curative procedure",
"PURPOSE To up date eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone . METHODS A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by review ing previous criteria , Response Evaluation Criteria in Solid Tumors ( RECIST ) , and emerging trial data . RESULTS The Prostate Cancer Clinical Trials Working Group ( PCWG2 ) recommends a two- objective paradigm : ( 1 ) controlling , relieving , or eliminating disease manifestations that are present when treatment is initiated and ( 2 ) preventing or delaying disease manifestations expected to occur . Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory . Eligibility is defined using st and ard disease assessment s to authenticate disease progression , prior treatment , distinct clinical subtypes , and predictive models . Outcomes are reported independently for prostate-specific antigen ( PSA ) , imaging , and clinical measures , avoiding grouped categorizations such as complete or partial response . In most trials , early changes in PSA and /or pain are not acted on without other evidence of disease progression , and treatment should be continued for at least 12 weeks to ensure adequate drug exposure . Bone scans are reported as \" new lesions \" or \" no new lesions , \" changes in soft-tissue disease assessed by RECIST , and pain using vali date d scales . Defining eligibility for prevent/delay end points requires attention to estimated event frequency and /or r and om assignment to a control group . CONCLUSION PCWG2 recommends increasing emphasis on time-to-event end points ( ie , failure to progress ) as decision aids in proceeding from phase II to phase III trials . Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit",
"PURPOSE Prostate-specific antigen ( PSA ) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells . For patients with metastatic disease , changes in PSA will often ante date changes in bone scan . Furthermore , many but not all investigators have observed an association between a decline in PSA levels of 50 % or greater and survival . Since the majority of phase II clinical trials for patients with and rogen-independent prostate cancer ( AIPC ) have used PSA as a marker , we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting . We held a consensus conference with 26 leading investigators in the field of AIPC to define these parameters . RESULT We defined four patient groups : ( 1 ) progressive measurable disease , ( 2 ) progressive bone metastasis , ( 3 ) stable metastases and a rising PSA , and ( 4 ) rising PSA and no other evidence of metastatic disease . The purpose of determining the number of patients whose PSA level drops in a phase II trial of AIPC is to guide the selection of agents for further testing and phase III trials . We propose that investigators report at a minimum a PSA decline of at least 50 % and this must be confirmed by a second PSA value 4 or more weeks later . Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period . Some investigators may want to report additional measures of PSA changes ( ie , 75 % decline , 90 % decline ) . Response duration and the time to PSA progression may also be important clinical end point . CONCLUSION Through this consensus conference , we believe we have developed practical guidelines for using PSA as a measurement of outcome . Furthermore , the use of common st and ards is important as we determine which agents should progress to r and omized trials which will use survival as an end point",
"BACKGROUND Sipuleucel-T , an autologous active cellular immunotherapy , has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer . METHODS In this double-blind , placebo-controlled , multicenter phase 3 trial , we r and omly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T ( 341 patients ) or placebo ( 171 patients ) administered intravenously every 2 weeks , for a total of three infusions . The primary end point was overall survival , analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen ( PSA ) and lactate dehydrogenase . RESULTS In the sipuleucel-T group , there was a relative reduction of 22 % in the risk of death as compared with the placebo group ( hazard ratio , 0.78 ; 95 % confidence interval [ CI ] , 0.61 to 0.98 ; P=0.03 ) . This reduction represented a 4.1-month improvement in median survival ( 25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group ) . The 36-month survival probability was 31.7 % in the sipuleucel-T group versus 23.0 % in the placebo group . The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test ( hazard ratio , 0.77 ; 95 % CI , 0.61 to 0.97 ; P=0.02 ) and after adjustment for use of docetaxel after the study therapy ( hazard ratio , 0.78 ; 95 % CI , 0.62 to 0.98 ; P=0.03 ) . The time to objective disease progression was similar in the two study groups . Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills , fever , and headache . CONCLUSIONS The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer . No effect on the time to disease progression was observed . ( Funded by Dendreon ; Clinical Trials.gov number , NCT00065442 .",
"PURPOSE This multinational , double-blind , r and omized , placebo-controlled , phase III trial assessed the efficacy and tolerability of the oral platinum analog satraplatin in patients with metastatic castrate-refractory prostate cancer ( CRPC ) experiencing progression after one prior chemotherapy regimen . PATIENTS AND METHODS Nine hundred fifty patients were r and omly assigned ( 2:1 ) to receive oral satraplatin ( n = 635 ) 80 mg/m(2 ) on days 1 to 5 of a 35-day cycle and prednisone 5 mg twice daily or placebo ( n = 315 ) and prednisone 5 mg twice daily . Primary end points were progression-free survival and overall survival ( OS ) . The secondary end point was time to pain progression ( TPP ) . RESULTS A 33 % reduction ( hazard ratio [ HR ] = 0.67 ; 95 % CI , 0.57 to 0.77 ; P risk of progression or death with satraplatin versus placebo . This effect was maintained irrespective of prior docetaxel treatment . No difference in OS was seen between the satraplatin and placebo arms ( HR = 0.98 ; 95 % CI , 0.84 to 1.15 ; P = .80 ) . Compared with placebo , satraplatin significantly reduced TPP ( HR = 0.64 ; 95 % CI , 0.51 to 0.79 ; P Satraplatin was generally well tolerated , although myelosuppression and GI disorders occurred more frequently with satraplatin . CONCLUSION Oral satraplatin delayed progression of disease and pain in patients with metastatic CRPC experiencing progression after initial chemotherapy but did not provide a significant OS benefit . Satraplatin was generally well tolerated . These results suggest activity for satraplatin in patients with CRPC who experience progression after initial chemotherapy",
"OBJECTIVES To evaluate the efficacy , tolerability , endocrinological effects and the pharmacokinetics of Casodex , when given as monotherapy during daily dosing of 10 - 200 mg to patients with advanced prostate cancer . METHODS A total of 390 patients with advanced prostate cancer were treated for a minimum of 12 weeks with a daily monotherapy dose of Casodex . The doses ranged from 10 to 200 mg . Objective assessment s of efficacy included : review of measurable metastases , prostate dimension , prostatic acid phosphatase and prostate-specific antigen ( PSA ) levels . Subjective assessment s of efficacy included review of urological symptoms , performance status , bone scan and analgesic requirement . Pharmacokinetic sample s were taken at various time points up to 3 months , and assayed using an achiral HPLC method . RESULTS Clear objective responses were observed , particularly at doses of 50 mg and above . Specifically , the median percentage decrease in PSA at 50 mg was 90.0 % , and at 100 and 200 mg it was 93.4 and 94.8 % , respectively . Up to 53 % of symptomatic patients demonstrated a subjective response at 3 months . Casodex was well tolerated at all doses with no effect on haematological or cardiovascular parameters and no effect on renal function . The expected pharmacological effects of potent anti and rogen therapy , such as breast tenderness ( 58 % ) , gynaecomastia ( 48 % ) , and hot flushes ( 17 % ) , were reported , but these incidences reflected the direct eliciting of these events . The intrinsic efficacy of Casodex was demonstrated despite increases of 60 % in testosterone levels . However , this increase reached a plateau after 4 - 12 weeks of therapy , but the majority of values remained within the normal range . Casodex has a half-life of approximately 1 week , enabling once-daily dosing with no effect of age or renal impairment on its pharmacokinetics . CONCLUSION Casodex has a favourable side effect profile compared with the known safety profiles of other anti and rogens and has demonstrated intrinsic efficacy . Casodex warrants further investigation as a monotherapy for the management of advanced prostate cancer",
"PURPOSE A phase I/II study was done to evaluate the efficacy and complications of salvage cryotherapy as a treatment for locally recurrent prostate cancer following full dose radiation therapy and /or systemic therapy . The efficacy of single and double freeze-thaw cycles was compared using posttreatment prostate specific antigen ( PSA ) levels and prostate biopsies as end points . MATERIAL S AND METHODS A total of 150 patients with locally recurrent prostate cancer following radiation , hormonal therapy and /or systemic chemotherapy underwent salvage cryotherapy using a single ( 71 men , mean followup 17.3 months ) or double ( 79 men , mean followup 10.0 months ) freeze-thaw cycle . PSA was measured approximately every 3 months postoperatively and sextant biopsies were repeated 6 months postoperatively . Complications were assessed by retrospective chart review and a mailed quality of life survey . RESULTS Overall , 45 patients ( 31 % ) had persistently undetectable PSA . Patients with a history of radiation therapy only who underwent a double freeze-thaw cycle had a higher negative biopsy rate ( 93 versus 71 % , p biochemical failure rate ( defined as an increase in serum PSA of 0.2 ng./ml . above the nadir value , 44 versus 65 % , p salvage cryotherapy were urinary incontinence ( 73 % of the patients ) , obstructive symptoms ( 67 % ) , impotence ( 72 % ) and severe perineal pain ( 8 % ) . CONCLUSIONS Salvage cryotherapy impacts local tumor control as evident by the high frequency of negative posttreatment biopsies . A double freeze-thaw cycle appears more effective than a single cycle . Like salvage prostatectomy , salvage cryotherapy causes significant morbidity",
"CONTEXT Biochemical disease recurrence after radical prostatectomy often prompts salvage radiotherapy , but no studies to date have had sufficient numbers of patients or follow-up to determine whether radiotherapy improves survival , and if so , the subgroup of men most likely to benefit . OBJECTIVES To quantify the relative improvement in prostate cancer-specific survival of salvage radiotherapy vs no therapy after biochemical recurrence following prostatectomy , and to identify subgroups for whom salvage treatment is most beneficial . DESIGN , SETTING , AND PATIENTS Retrospective analysis of a cohort of 635 US men undergoing prostatectomy from 1982 - 2004 , followed up through December 28 , 2007 , who experienced biochemical and /or local recurrence and received no salvage treatment ( n = 397 ) , salvage radiotherapy alone ( n = 160 ) , or salvage radiotherapy combined with hormonal therapy ( n = 78 ) . MAIN OUTCOME MEASURE Prostate cancer-specific survival defined from time of recurrence until death from disease . RESULTS With a median follow-up of 6 years after recurrence and 9 years after prostatectomy , 116 men ( 18 % ) died from prostate cancer , including 89 ( 22 % ) who received no salvage treatment , 18 ( 11 % ) who received salvage radiotherapy alone , and 9 ( 12 % ) who received salvage radiotherapy and hormonal therapy . Salvage radiotherapy alone was associated with a significant 3-fold increase in prostate cancer-specific survival relative to those who received no salvage treatment ( hazard ratio [ HR ] , 0.32 [ 95 % confidence interval { CI } , 0.19 - 0.54 ] ; P hormonal therapy to salvage radiotherapy was not associated with any additional increase in prostate cancer-specific survival ( HR , 0.34 [ 95 % CI , 0.17 - 0.69 ] ; P = .003 ) . The increase in prostate cancer-specific survival associated with salvage radiotherapy was limited to men with a prostate-specific antigen doubling time of less than 6 months and remained after adjustment for pathological stage and other established prognostic factors . Salvage radiotherapy initiated more than 2 years after recurrence provided no significant increase in prostate cancer-specific survival . Men whose prostate-specific antigen level never became undetectable after salvage radiotherapy did not experience a significant increase in prostate cancer-specific survival . Salvage radiotherapy also was associated with a significant increase in overall survival . CONCLUSIONS Salvage radiotherapy administered within 2 years of biochemical recurrence was associated with a significant increase in prostate cancer-specific survival among men with a prostate-specific antigen doubling time of less than 6 months , independent of other prognostic features such as pathological stage or Gleason score . These preliminary findings should be vali date d in other setting s , and ultimately , in a r and omized controlled trial",
"BACKGROUND MDV3100 is an and rogen-receptor antagonist that blocks and rogens from binding to the and rogen receptor and prevents nuclear translocation and co-activator recruitment of the lig and -receptor complex . It also induces tumour cell apoptosis , and has no agonist activity . Because growth of castration-resistant prostate cancer is dependent on continued and rogen-receptor signalling , we assessed the antitumour activity and safety of MDV3100 in men with this disease . METHODS This phase 1 - 2 study was undertaken in five US centres in 140 patients . Patients with progressive , metastatic , castration-resistant prostate cancer were enrolled in dose-escalation cohorts of three to six patients and given an oral daily starting dose of MDV3100 30 mg . The final daily doses studied were 30 mg ( n=3 ) , 60 mg ( 27 ) , 150 mg ( 28 ) , 240 mg ( 29 ) , 360 mg ( 28 ) , 480 mg ( 22 ) , and 600 mg ( 3 ) . The primary objective was to identify the safety and tolerability profile of MDV3100 and to establish the maximum tolerated dose . The trial is registered with Clinical Trials.gov , number NCT00510718 . FINDINGS We noted antitumour effects at all doses , including decreases in serum prostate-specific antigen of 50 % or more in 78 ( 56 % ) patients , responses in soft tissue in 13 ( 22 % ) of 59 patients , stabilised bone disease in 61 ( 56 % ) of 109 patients , and conversion from unfavourable to favourable circulating tumour cell counts in 25 ( 49 % ) of the 51 patients . PET imaging of 22 patients to assess and rogen-receptor blockade showed decreased (18)F-fluoro-5alpha-dihydrotestosterone binding at doses from 60 mg to 480 mg per day ( range 20 - 100 % ) . The median time to progression was 47 weeks ( 95 % CI 34-not reached ) for radiological progression . The maximum tolerated dose for sustained treatment ( > 28 days ) was 240 mg . The most common grade 3 - 4 adverse event was dose-dependent fatigue ( 16 [ 11 % ] patients ) , which generally resolved after dose reduction . INTERPRETATION We recorded encouraging antitumour activity with MDV3100 in patients with castration-resistant prostate cancer . The results of this phase 1 - 2 trial vali date in man pre clinical studies implicating sustained and rogen-receptor signalling as a driver in this disease . FUNDING Medivation , the Prostate Cancer Foundation , National Cancer Institute , the Howard Hughes Medical Institute , Doris Duke Charitable Foundation , and Department of Defense Prostate Cancer Clinical Trials Consortium",
"OBJECTIVE EORTC trial 30891 compared immediate versus deferred and rogen-deprivation therapy ( ADT ) in T0 - 4 N0 - 2 M0 prostate cancer ( PCa ) . Many patients r and omly assigned to deferred ADT did not require ADT because they died before becoming symptomatic . The question arises whether serum prostate-specific antigen ( PSA ) levels may be used to decide when to initiate ADT in PCa not suitable for local curative treatment . METHODS PSA data at baseline , PSA doubling time ( PSADT ) in patients receiving no ADT , and time to PSA relapse ( > 2 ng/ml ) in patients whose PSA declined to ADT were analyzed in 939 eligible patients r and omly assigned to immediate ( n=468 ) or deferred ADT ( n=471 ) . RESULTS In both arms , patients with a baseline PSA>50 ng/ml were at a>3.5-fold higher risk to die of PCa than patients with a baseline PSA risk of PCa death was approximately 7.5-fold higher in patients with PSADT12 mo . Time to PSA relapse after response to immediate ADT correlated significantly with baseline PSA , suggesting that baseline PSA may also reflect disease aggressiveness . CONCLUSIONS Patients with a baseline PSA>50 ng/ml and /or a PSADT risk to die from PCa and might have benefited from immediate ADT , whereas patients with a baseline PSA 12 mo ) were likely to die of causes unrelated to PCa , and thus could be spared the burden of immediate ADT",
"PURPOSE This study ( EORTC 30891 ) attempted to demonstrate equivalent overall survival in patients with localized prostate cancer not suitable for local curative treatment treated with immediate or deferred and rogen ablation . PATIENTS AND METHODS We r and omly assigned 985 patients with newly diagnosed prostate cancer T0 - 4 N0 - 2 M0 to receive and rogen deprivation either immediately ( n = 493 ) or on symptomatic disease progression or occurrence of serious complications ( n = 492 ) . RESULTS Baseline characteristics were well balanced in the two groups . Median age was 73 years ( range , 52 to 81 ) . At a median follow-up of 7.8 years , 541 of 985 patients had died , mostly of prostate cancer ( n = 193 ) or cardiovascular disease ( n = 185 ) . The overall survival hazard ratio was 1.25 ( 95 % CI , 1.05 to 1.48 ; noninferiority P > .1 ) favoring immediate treatment , seemingly due to fewer deaths of nonprostatic cancer causes ( P = .06 ) . The time from r and omization to progression of hormone refractory disease did not differ significantly , nor did prostate-cancer specific survival . The median time to the start of deferred treatment after study entry was 7 years . In this group 126 patients ( 25.6 % ) died without ever needing treatment ( 44 % of the deaths in this arm ) . CONCLUSION Immediate and rogen deprivation result ed in a modest but statistically significant increase in overall survival but no significant difference in prostate cancer mortality or symptom-free survival . This must be weighed on an individual basis against the adverse effects of life-long and rogen deprivation , which may be avoided in a substantial number of patients with a deferred treatment policy",
"BACKGROUND Appropriate timing of and rogen deprivation treatment ( ADT ) for prostate cancer is controversial . Our aim was to determine whether immediate ADT extends survival in men with node-positive prostate cancer who have undergone radical prostatectomy and pelvic lymphadenectomy compared with those who received ADT only once disease progressed . METHODS Eligible patients from 36 institutes in the USA were r and omly assigned in 1988 - 93 to receive immediate ADT ( n=47 ) or to be observed ( n=51 ) , with ADT to be given on detection of distant metastases or symptomatic recurrences . Patients were followed up every 3 months for the first year and every 6 months thereafter . The primary endpoint was progression-free survival ; secondary endpoints were overall and disease-specific survival . Analysis was by intention to treat . To ensure that the treatment groups were comparable , we did a retrospective central pathology review of slides and re grade d the Gleason scores for available sample s. This trial pre date s the requirement for clinical trial registration . FINDINGS At median follow-up of 11.9 years ( range 9.7 - 14.5 for surviving patients ) , men assigned immediate ADT had a significant improvement in overall survival ( hazard ratio 1.84 [ 95 % CI 1.01 - 3.35 ] , p=0.04 ) , prostate-cancer-specific survival ( 4.09 [ 1.76 - 9.49 ] , p=0.0004 ) , and progression-free survival ( 3.42 [ 1.96 - 5.98 ] , p ADT , 30 observation ) , 16 were down grade d from the original Gleason score ( between groups or = 8) and five were up grade d. We recorded similar proportions of score changes in each group ( p=0.68 ) , and no difference in score distribution by treatment ( p=0.38 ) . After adjustment for score , associations were still significant between treatment and survival ( overall , p=0.02 ; disease-specific , p=0.002 ; progression-free survival , p ADT benefits patients with nodal metastases who have undergone prostatectomy and lymphadenectomy , compared with those who receive deferred treatment . The beneficial effects of early ADT , rather than an imbalance in risk factors , are likely to explain the differences in outcomes between treatments",
"PURPOSE To determine the impact of adjuvant and rogen deprivation therapy ( ADT ) for patients who have node-positive prostate cancer in the prostate-specific antigen ( PSA ) era . PATIENTS AND METHODS We used linked Surveillance , Epidemiology and End Results -Medicare data to construct a cohort of men who underwent radical prostatectomy ( RP ) between 1991 and 1999 and who had positive regional lymph nodes . We classified men as receiving adjuvant ADT if they received ADT within 120 days of RP , and we compared them to the men who had not received adjuvant ADT . We used propensity scores to balance potential confounders of receiving adjuvant ADT ( ie , tumor characteristics , extent of nodal disease , demographics , receipt of radiation therapy ) and Cox proportional hazard methods to measure the impact of adjuvant ADT on overall survival ( OS ) , stratified by propensity score quintile . We conducted a sensitivity analysis that used 90 , 150 , 180 , and 365 days as the definition for adjuvant ADT . RESULTS A total of 731 men were identified , 209 of whom received ADT within 120 days of RP . There was no statistically significant difference in OS between the adjuvant ADT and non-ADT group ( HR , 0.97 ; 95 % CI , 0.71 to 1.27 ) . There was no statistically significant survival difference with 90 , 150 , 180 , and 365 days as the adjuvant ADT definition . CONCLUSION Deferring immediate ADT in men with positive lymph nodes after RP may not significantly compromise survival . Because observational studies should be considered hypothesis-generating studies , these results should be vali date d in a prospect i ve fashion in a similar patient population",
"PURPOSE Hormonal therapy ( HT ) is the current mainstay of systemic treatment for prostate specific antigen ( PSA ) only recurrence ( PSAR ) , however , there is virtually no published literature comparing HT to observation in the clinical setting . The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational data base to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach . MATERIAL S AND METHODS Of 5,382 men in the data base who underwent primary radical prostatectomy ( RP ) , 4,967 patients were treated in the PSA-era between 1988 and December 2002 . Of those patients 1,352 men who had PSAR ( PSA after surgery greater than 0.2 ng/ml ) and had postoperative followup greater than 6 months were used as the study cohort . These patients were further divided into an early HT group in which patients ( 355 ) received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients ( 997 ) who received no HT before clinical metastasis or by current followup . The primary end point was the development of clinical metastases . Of the 1,352 patients with PSAR clinical metastases developed in 103 ( 7.6 % ) . Patients were also stratified by surgical Gleason sum , PSA doubling time and timing of recurrence . Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome . RESULTS Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less ( Hazards ratio = 2.12 , p = 0.01 ) . However , in the overall cohort early HT did not impact clinical metastases . Race , age at RP and PSA at diagnosis had no effect on metastasis-free survival ( p > 0.05 ) . CONCLUSIONS The retrospective observational multicenter data base analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current followup . Further study with longer followup and r and omized trials are needed to address this important issue",
"PURPOSE This was an exploratory analysis of a trial of intermittent and rogen deprivation ( IAD ) in men with biochemical relapse ( BR ) to establish first cycle characteristics prognostic for progression to castration-resistant prostate cancer ( CRPC ) and death . PATIENTS AND METHODS Men with BR of prostate cancer after radical prostatectomy ( RP ) or radiation ( RT ) were treated with and rogen deprivation therapy ( ADT ) comprised of leuprolide and flutamide . After 9 months on treatment , ADT was stopped , and monthly prostate-specific antigen ( PSA ) levels were observed during the off-treatment interval . When the PSA reached a threshold value ( 1 ng/mL for RP , 4 ng/mL for RT ) , ADT was resumed in a new cycle . Patients were treated intermittently in this manner until CRPC , which was defined as > or = two consecutive increasing PSA values while on ADT with castrate testosterone levels . RESULTS Seventy-two of 100 patients enrolled onto the study met criteria for this analysis . The duration of the first off-treatment interval ( 40 weeks ) was associated with shorter time to CRPC ( hazard ratio = 2.9 ; 95 % CI , 1.1 to 7.7 ; P = .03 ) and death ( hazard ratio = 3.8 ; 95 % CI , 1.1 to 13.6 ; P = .04 ) after adjusting for age , stage , grade , and PSA at diagnosis . CONCLUSION In patients who completed the first cycle of IAD , a duration of the first off-treatment interval of < or = 40 weeks defines a subset of patients at higher risk of CRPC and death . Conversely , patients with an off-treatment interval of more than 40 weeks have a significantly better long-term prognosis",
"The aim of this study was to compare the efficacy of total intermittent and rogen deprivation ( IAD ) versus total continuous and rogen deprivation ( CAD ) for treating patients with advanced prostate cancer in a phase III r and omized trial . A total of 68 evaluable patients with hormone-naive advanced or relapsing prostate cancer were r and omized to receive combined and rogen blockade according to a continuous ( n = 33 ) or intermittent ( n = 35 ) regimen . Therapeutic monitoring was assessed by use of serum prostate-specific antigen ( PSA ) measurements . Patients in the CAD and IAD groups were equally stratified for age , biopsy Gleason score , and baseline serum PSA levels . The outcome variable was time to and rogen-independence of the tumor , which was defined as increasing serum PSA levels despite and rogen blockade . Mean follow-up was 30.8 months . The 35 IAD-treated patients completed 91 cycles , and 19 of them ( 54.3 % ) completed > or = 3 cycles . Median cycle length and percentage of time off therapy were 9.0 months and 59.5 , respectively . The estimated 3-year progression rate was significantly lower in the IAD group ( 7.0 % + /- 4.8 % ) than in the CAD group ( 38.9 % + /- 11.2 % , P = 0.0052 ) . Our data suggest that IAD treatment may maintain the and rogen-dependent state of advanced human prostate cancer , as assessed by PSA measurements , at least as long as CAD treatment . Further studies with longer follow-up times and larger patient cohorts are needed to determine the comparative impacts of CAD and IAD on survival",
"The results of a large r and omized prospect i ve clinical trial conducted by the Veterans Administration Co-operative Urological Research Group ( VACURG ) in 1968 are up date d and reevaluated . In this study , placebo , diethylstilbestrol ( DES , 5 mg/day ) , orchiectomy plus placebo , and orchiectomy plus DES were compared in patients whose conditions were initially diagnosed as stage III and IV carcinoma of the prostate . Results showed that orchiectomy alone or in combination with estrogen did not improve overall survival rates in stage III and IV carcinoma of the prostate . In the two treatment groups receiving estrogen , however , there were fewer deaths due to cancer of the prostate , but this effect tended to be offset by an increased number of deaths due to cardiovascular causes . Deaths from other causes showed no particular pattern with respect to treatment . These studies showed that estrogen is more effective than orchiectomy in preventing deaths from cancer and that the addition of orchiectomy to estrogen does not offer any clear-cut advantage over estrogen therapy alone . If cancer symptoms necessitate treatment , initial therapy with estrogen is preferred . Orchiectomy should be reserved for those circumstances in which a patient is not reliable , can not tolerate estrogens , or has severe cardiovascular disease",
"To test the hypothesis that maximal and rogen blockade improves the effectiveness of the treatment of prostatic cancer , we conducted a r and omized , double-blind trial in patients with disseminated , previously untreated prostate cancer ( stage D2 ) . All 603 men received leuprolide , an analogue of gonadotropin-releasing hormone that inhibits the release of gonadotropins , in combination with either placebo or flutamide , a nonsteroidal anti and rogen that inhibits the binding of and rogens to the cell nucleus . As compared with the 300 patients receiving leuprolide and placebo , the 303 patients r and omly assigned to receive leuprolide and flutamide had a longer progression-free survival ( 16.5 vs. 13.9 months ; P = 0.039 ) and an increase in the median length of survival ( 35.6 vs. 28.3 months ; P = 0.035 ) . The differences between the treatments were particularly evident for men with minimal disease and good performance status ; however , further studies should be conducted in this subgroup . Symptomatic improvement was greatest during the first 12 weeks of the combined and rogen blockade , when leuprolide alone often produces a painful flare in the disease . We conclude that in patients with advanced prostate cancer , treatment with leuprolide and flutamide is superior to treatment with leuprolide alone",
"PURPOSE Persistence of lig and -mediated and rogen receptor signaling has been documented in castration-resistant prostate cancers ( CRPCs ) . Abiraterone acetate ( AA ) is a potent and selective inhibitor of CYP17 , which is required for and rogen bio synthesis in the testes , adrenal gl and s , and prostate tissue . This trial evaluated the efficacy and safety of AA in combination with prednisone to reduce the symptoms of secondary hyperaldosteronism that can occur with AA monotherapy . PATIENTS AND METHODS Fifty-eight men with progressive metastatic CRPC who experienced treatment failure with docetaxel-based chemotherapy received AA ( 1,000 mg daily ) with prednisone ( 5 mg twice daily ) . Twenty-seven ( 47 % ) patients had received prior ketoconazole . The primary outcome was > or = 50 % prostate-specific antigen ( PSA ) decline , with objective response by Response Evaluation Criteria in Solid Tumors ( RECIST ) criteria , and changes in Eastern Cooperative Oncology Group ( ECOG ) performance status ( PS ) and circulating tumor cell ( CTC ) numbers . Safety was also evaluated . RESULTS A > or = 50 % decline in PSA was confirmed in 22 ( 36 % ) patients , including 14 ( 45 % ) of 31 ketoconazole-naïve and seven ( 26 % ) of 27 ketoconazole-pretreated patients . Partial responses were seen in four ( 18 % ) of 22 patients with RECIST-evaluable target lesions . Improved ECOG PS was seen in 28 % of patients . Median time to PSA progression was 169 days ( 95 % CI , 82 to 200 days ) . CTC conversions with treatment from > or = 5 to AA-related adverse events were grade 1 to 2 , and no AA-related grade 4 events were seen . CONCLUSION AA plus prednisone was well tolerated , with encouraging antitumor activity in heavily pretreated CRPC patients . The incidence of mineralocorticoid-related toxicities ( hypertension or hypokalemia ) was reduced by adding low-dose prednisone . The combination of AA plus prednisone is recommended for phase III investigations",
"BACKGROUND Recent data suggest prostate-specific antigen ( PSA ) progression may predict overall survival in prostate cancer patients . OBJECTIVE To compare the activity of degarelix and leuprolide regarding PSA recurrence-free survival . DESIGN , SETTING , AND PARTICIPANTS Phase 3 , 1-yr , multicentre , r and omised , open-label trial comparing the efficacy and safety of degarelix at 240 mg for 1 mo , and then 80 mg monthly ( 240/80 mg ) ; degarelix at 240 mg for 1 mo , and then 160 mg monthly ; and leuprolide at 7.5 mg/mo . Overall , 610 patients with histologically confirmed prostate cancer ( all stages ) , for whom and rogen deprivation therapy was indicated , were included . The primary end point of this trial has been reported previously ; the protocol led and exploratory subgroup analyses reported in this paper focus on degarelix at 240/80 mg ( dose approved by the US Food and Drug Administration and the European Medicine Evaluation Association for the treatment of patients with hormone-naive advanced prostate cancer ) . MEASUREMENTS PSA progression-free survival ( two consecutive increases in PSA of 50 % compared with nadir and ≥ 5 ng/ml on two consecutive measurements at least 2 wk apart or death ) and change in PSA were review ed . Effects of baseline disease stage ( localised , locally advanced , and metastatic ) and PSA level ( 20 - 50 , and > 50 ng/ml ) were analysed . RESULTS AND LIMITATIONS Patients receiving degarelix showed a significantly lower risk of PSA progression or death compared with leuprolide ( p=0.05 ) . PSA recurrences occurred mainly in patients with advanced disease and exclusively in those with baseline PSA > 20 ng/ml . Patients with PSA > 20 ng/ml had a significantly longer time to PSA recurrence with degarelix ( p=0.04 ) . The relatively low number of patients in each subgroup is a limitation of this study . CONCLUSIONS These results generate the hypothesis that degarelix at 240/80 mg offers improved PSA control compared with leuprolide . PSA recurrences occurred almost exclusively in patients with metastatic prostate cancer or high baseline PSA during this 1-yr study . Further studies are warranted to confirm these findings"
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Previous studies have reported that steroids may reduce the risk of atrial fibrillation ( AF ) recurrence after catheter ablation , but data regarding this issue have been controversial . Therefore , we conducted a meta- analysis of r and omized clinical trials ( RCTs ) and observational studies to ascertain the association of steroids and AF recurrence after ablation . PubMed , Embase , and Cochrane online data bases were search ed from inception to December 2017 . The primary outcome of the meta- analysis was short-term or long-term AF recurrence following a single ablation procedure with or without the use of steroids . Both fixed- and r and om-effects models were used to calculate the overall effect estimates . Eight studies ( four RCTs and four observational studies ) , with a total 992 patients , were included in the present study . Our meta- analysis shows that steroid use was associated with reduced AF occurrence at 3 months ( odd ratio ( OR ) = 0.53 , 95 % confidence interval ( CI ) = 0.31 - 0.90 , P=0.02 ) and 12 - 14 months ( OR = 0.67 , 95 % CI = 0.47 - 0.95 , P=0.02 ) after radiofrequency ( RF ) catheter ablation ( RFCA ) . No clear benefit was observed for AF recurrence at 2 - 3 days , 1 or 24 months of follow-up . Steroid use was associated with decreased risk of early AF recurrence 3 and 12 - 14 months after ablation . No clear relationship was observed for 2 - 3 days , 1 and 24 months of follow-up and further data are needed to clarify these results
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[
"Background —Early recurrence ( ER ) of atrial tachyarrhythmias during the first 3 months ( blanking period ) after atrial fibrillation ablation can be highly symptomatic , often requiring emergency treatment . Short-term steroid therapy may suppress ER during the blanking period . Methods and Results —We prospect ively enrolled 138 patients who were r and omly assigned to 2 groups ( steroid group and control group ) . An intravenous bolus of 0.5 mg/kg of methylprednisolone for 2 days followed by 12 mg daily of oral methylprednisolone for 4 days was given to the steroid group patients . The primary end point was ER during the blanking period ( 3 months post ablation ) . During the blanking period , 51 of the 138 ( 37.0 % ) patients experienced ER after atrial fibrillation ablation . The steroid group had a lower rate of ER than the control group ( 15/64 [ 23.4 % ] versus 36/74 [ 48.6 % ] , P=0.003 ) . There was no difference between the 2 groups about late recurrence during a 24-month follow-up ( log-rank test , P=0.918 ) . In a multivariate analysis , short-term steroid therapy was independently associated with a lower rate of ER during the blanking period ( adjusted OR , 0.45 ; 95 % confidence interval , 0.25–0.83 ; P=0.01 ) . Conclusions —Periprocedural short-term moderate intensity steroid therapy reduces ER ( ≈3 months ) after catheter ablation of atrial fibrillation . It is not effective in preventing late ( 3≈24 m ) atrial fibrillation recurrence . Clinical Trial Registration —URL : www.who.int/ictrp ; Unique identifier : KCT0000107",
"BACKGROUND Atrial arrhythmias are associated with inflammation . The cause and effect of the association are unknown . OBJECTIVE The purpose of this study was to test the hypothesis that atrial tachyarrhythmias contribute to inflammation . METHODS We performed a prospect i ve observational study wherein C-reactive protein ( CRP ) and interleukin-6 ( IL-6 ) levels from the femoral vein and coronary sinus ( CS ) were compared before curative ablation for atrial flutter ( AFL ; n = 59 ) and paroxysmal supraventricular tachycardia ( SVT ; n = 110 ) . Follow-up levels were obtained at 1 and 6 months . RESULTS Peripheral levels of both biomarkers were significantly higher in the AFL group . After multivariate adjustment , only those in the AFL group who presented in AFL or atrial fibrillation ( AF ) had significantly elevated CRP levels ( odds ratio 1.26 ; P = .033 ) . Levels of each marker were similar in the CS and peripheral blood in the SVT group ; in the AFL group , both CRP and IL-6 were significantly lower in the CS than in the periphery ( P = .0076 and P = .0021 , respectively ) . CRP was significantly lower a median of 47 days after AFL ablation ( from a median of 6.28 mg/L to a median of 2.92 mg/L ; P = .028 ) and remained reduced at second follow-up . IL-6 decreased across three time points after AFL ablation ( P = .002 ) . No reduction in inflammatory biomarkers was observed after SVT ablation . CONCLUSIONS CRP and IL-6 levels are elevated in patients presenting in AFL . Given the lower CS values in these patients , their origin appears to be systemic rather than cardiac . Because these levels significantly fall after ablation of AFL , the atrial tachyarrhythmia appears to be the cause ( not the effect ) of the inflammation",
"OBJECTIVES We sought to clarify the efficacy of corticosteroid therapy for preventing atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) . BACKGROUND The inflammatory process may cause acute AF recurrence after PVI . However , no studies have examined the relationship between corticosteroid administration and AF recurrence after PVI . METHODS A total of 125 patients with paroxysmal AF were r and omized to receive either corticosteroids ( corticosteroid group ) or a placebo ( placebo group ) . In the corticosteroid group , intravenous hydrocortisone ( 2 mg/kg ) was given the day of the procedure , and oral prednisolone ( 0.5 mg/kg/day ) was administered for 3 days after the PVI . The body temperature and high-sensitivity C-reactive protein level were measured before and on each of the first 3 days after ablation . RESULTS The prevalence of immediate AF recurrence ( ≤3 days after the PVI ) was significantly lower in the corticosteroid group ( 7 % ) than in the placebo group ( 31 % ) . The maximum body temperature and C-reactive protein during the initial 3 days after ablation and the increase in the body temperature and C-reactive protein level from baseline were significantly lower in the corticosteroid group than in the placebo group . Corticosteroid treatment did not decrease AF recurrences between 4 and 30 days after ablation . The AF-free rate at 14 months post-ablation was greater in the corticosteroid group ( 85 % ) than in the placebo group ( 71 % , p=0.032 by the log-rank test ) . CONCLUSIONS Transient use of small amounts of corticosteroids shortly after AF ablation may be effective and safe for preventing not only immediate AF recurrences but also AF recurrences during the mid-term follow-up period after PVI",
"BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . OBJECTIVE The purpose of this study was to prospect ively determine if the use of intraprocedural corticosteroids to limit the extent of tissue edema and /or inflammation alters the prevalence of spontaneous and adenosine-induced acute PV reconnection after PVI . METHODS Prior to wide circumferential PVI , 45 patients received a single intravenous ( IV ) bolus of hydrocortisone 250 mg immediately after transseptal access ( steroid group ) . Another 45 consecutive patients underwent st and ard PVI without IV hydrocortisone ( nonsteroid group ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed at 3 , 6 , and 12 months . RESULTS Dormant conduction was unmasked in a significantly higher proportion of PVs in the steroid group compared with the nonsteroid group ( 32.8 % of PVs [ 60/183 ] vs 21.1 % of PVs [ 37/175 ] , P = .03 ) . On multivariate generalized estimating equation analysis , steroid use remained independently associated with dormant PV conduction ( P = .03 ) . There was no difference in the segmental distribution of reconnection between the 2 groups . The 1-year freedom from recurrent AF did not differ between groups ( P = .37 ) . Radiofrequency time was significantly longer in the steroid group ( 58 ± 21 minutes vs 48 ± 18 minutes , P whereas procedure duration and fluoroscopy time were comparable ( P = .55 and P = .44 , respectively ) . CONCLUSION A single bolus of hydrocortisone 250 mg IV prior to PVI results in greater radiofrequency requirements for PVI and a higher prevalence of dormant PV conduction unmasked by adenosine . The utility of these approaches requires evaluation in a long-term prospect i ve r and omized study",
"Background Use of corticosteroids before and after atrial fibrillation ( AF ) ablation can decrease acute inflammation and reduce AF recurrence . Purpose To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation and its effect on inflammatory cytokine . Methods A total of 60 patients with paroxysmal AF undergoing radiofrequency ablation were r and omized ( 1:1 ) to receive either 3 doses of 60 mg daily of oral prednisone or a placebo . Inflammatory cytokine levels ( TNF-α , IL-1 , IL6 , IL-8 ) were measured at baseline , prior to ablation , immediately after ablation , and 24 hours post ablation . Patients underwent 30 day event monitoring at 3 months , 6 months and 12 months post procedure . Results Immediate post ablation levels of inflammatory cytokines were lower in the steroid group when compared to the placebo group ; IL-6 : 9.0 ±7 vs 15.8 ±13 p=0.031 ; IL-8 : 10.5 ±9 vs 15.3 ±8 ; p=0.047 respectively . Acute PV reconnection rates during the procedure ( 7/23 % vs 10/36 % ; p = 0.39 ) , and RF ablation time ( 51±13 vs 56±11 min , p = 0.11 ) trended to be lower in the placebo group than the steroid group . There was no difference in the incidence of early recurrence of AF during the blanking period and freedom from AF off AAD at 12 months between both groups ( 5/17 % vs 8/27 % ; p = 0.347 and 21/70 % vs 18/60 % ; p=0.417 in placebo and steroid groups respectively ) . Conclusion Although oral corticosteroids have significant effect in lowering certain cytokines , it did not impact the clinical outcomes of AF ablation",
"CONTEXT Atrial fibrillation ( AF ) is the most common arrhythmia to occur after cardiac surgery . An exaggerated inflammatory response has been proposed to be one etiological factor . OBJECTIVE To test whether intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery . DESIGN , SETTING , AND PATIENTS A double-blind , r and omized multicenter trial ( study enrollment August 2005-June 2006 ) in 3 university hospitals in Finl and of 241 consecutive patients without prior AF or flutter and scheduled to undergo first on-pump coronary artery bypass graft ( CABG ) surgery , aortic valve replacement , or combined CABG surgery and aortic valve replacement . INTERVENTION Patients were r and omized to receive either 100-mg hydrocortisone or matching placebo as follows : the first dose in the evening of the operative day , then 1 dose every 8 hours during the next 3 days . In addition , all patients received oral metoprolol ( 50 - 150 mg/d ) titrated to heart rate . MAIN OUTCOME MEASURE Occurrence of AF during the first 84 hours after cardiac surgery . RESULTS The incidence of postoperative AF was significantly lower in the hydrocortisone group ( 36/120 [ 30 % ] ) than in the placebo group ( 58/121 [ 48 % ] ; adjusted hazard ratio , 0.54 ; 95 % confidence interval , 0.35 - 0.83 ; P = .004 ; number needed to treat , 5.6 ) . Compared with placebo , patients receiving hydrocortisone did not have higher rates of superficial or deep wound infections , or other major complications . CONCLUSION Intravenous hydrocortisone reduced the incidence of AF after cardiac surgery . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00442494",
"BACKGROUND Atrial fibrillation ( AF ) has been linked to an inflammatory process detected through various biomarkers , including C-Reactive Protein ( CRP ) . Early recurrence of AF within the first 3 months after curative AF ablation is not felt to reflect success or failure of the procedure . We hypothesized that this early recurrence is due to an inflammatory response to the ablation itself . We therefore sought to evaluate levels of CRP after AF ablation . METHODS We prospect ively enrolled subjects undergoing AF ablation . A control group of patients undergoing ablation for supraventricular tachycardia ( SVT ) was also enrolled . Each patient had CRP drawn on the day of the procedure ( prior to ablation ) and during their first follow-up ( median 49 days , interquartile range [ IQR ] 37 - 93 ) and second follow-up ( median 147 days , IQR 141 - 257 ) clinic visits . Patient interviews were performed and medical histories review ed for evidence of recurrent AF prior to the first follow-up . RESULTS CRP levels significantly increased from baseline to first follow-up in the AF ablation group ( P = 0.0017 ) . CRP did not significantly change after SVT ablation ( P = 0.92 ) . Seventeen ( 45 % ) of the AF subjects exhibited recurrence of AF prior to first follow-up . After adjusting for multiple potential confounders , AF ablation patients with recurrent AF prior to their first follow-up had a statistically significant greater odds of having an increase in CRP ( OR 21 , 95 % CI 1.1 - 417 , P = 0.045 ) . CONCLUSIONS AF ablation generates an inflammatory response that persists for several weeks . This inflammation may explain early recurrence of AF after curative ablation",
"BACKGROUND The transient use of corticosteroid shortly after atrial fibrillation ( AF ) ablation might prevent immediate and mid-term AF recurrence ; however , the effective dosage for preventing AF recurrence has not been determined . In this study , we evaluated whether low-dose hydrocortisone is effective for the prevention of AF recurrence after radiofrequency catheter ablation ( RFCA ) . METHODS AND RESULTS We enrolled 89 AF patients ( 70 males , 55.8 ± 10.9 years ) who underwent RF ablation and were treated with single bolus injection of 100 mg hydrocorticosteroid ( corticosteroid group ) . For the control group , we enrolled 120 sex- and age-matched AF patients ( 94 males , 55.4 ± 10.5 years ) . Pericarditis occurred in 3 ( 2.5 % ) and 1 ( 1.1 % ) patients in the control and corticosteroid groups , respectively . The number of patients with immediate AF recurrence ( ≤ 2 days ) was 17 ( 14.5 % ) and 11 ( 12.4 % ) in the control and steroid groups , respectively ( P=0.687 ) . Treatment with low-dose steroid did not decrease early ( 3 - 30 days ) AF recurrence ( 13 [ 11.1 % ] vs. 11 [ 12.5 % ] , P=0.829 ) or late ( ≥ 31 days ) AF recurrence after ablation ( 26 [ 22.2 % ] vs. 13 [ 14.6 % ] , P=0.209 ) . There was no difference in cumulative survival free of late AF recurrence between the corticosteroid and control groups ( P=0.57 by log-rank test ) . White blood cell count , C-reactive protein concentration and maximum body temperature also were unchanged by low-dose steroid . CONCLUSIONS Single bolus injection of low-dose hydrocortisone after AF ablation is not effective for preventing AF recurrence during the mid-term follow-up period",
"Catheter ablation ( CA ) is a procedure commonly used to restore sinus rhythm in patients with atrial fibrillation ( AF ) . However , AF recurrence after CA remains a relevant clinical issue . We tested the effects of an oral antioxidant treatment ( alpha lipoic acid [ ALA ] ) on AF recurrence post-CA . Patients with paroxysmal AF have been enrolled in a r and omized , prospect i ve , double-blind , controlled placebo trial . After CA , patients have been r and omly assigned to receive ALA oral supplementation ( ALA group ) or placebo ( control group ) and evaluated at baseline and after a 12-month follow-up : 73 patients completed the 12-month follow-up ( ALA : 33 and control : 40 ) . No significant difference has been detected between the 2 groups at baseline . Strikingly , 1 year after CA , ALA therapy significantly reduced serum markers of inflammation . However , there was no significant difference in AF recurrence events at follow-up comparing ALA with placebo group . Multivariate analysis revealed that the only independent prognostic risk factor for AF recurrence after CA is age . In conclusion , ALA therapy reduces serum levels of common markers of inflammation in ablated patients . Nevertheless , ALA does not prevent AF recurrence after an ablative treatment",
"OBJECTIVES The purpose of the present study was to test the potential of colchicine , an agent with potent anti-inflammatory action , to reduce atrial fibrillation ( AF ) recurrence after pulmonary vein isolation in patients with paroxysmal AF . BACKGROUND Proinflammatory processes induced by AF ablation therapy have been implicated in postablation arrhythmia recurrence . METHODS Patients with paroxysmal AF who received radiofrequency ablation treatment were r and omized to a 3-month course of colchicine 0.5 mg twice daily or placebo . C-reactive protein ( CRP ) and interleukin (IL)-6 levels were measured on day 1 and on day 4 of treatment . RESULTS In the 3-month follow-up , recurrence of AF was observed in 27 ( 33.5 % ) of 80 patients of the placebo group versus 13 ( 16 % ) of 81 patients who received colchicine ( odds ratio : 0.38 , 95 % confidence interval : 0.18 to 0.80 ) . Gastrointestinal side-effects were the most common symptom among patients receiving active treatment . Diarrhea was reported in 7 patients in the colchicine group ( 8.6 % ) versus 1 in the placebo group ( 1.3 % , p = 0.03 ) . Colchicine led to higher reductions in CRP and IL-6 levels : the median difference of CRP and IL-6 levels between days 4 and 1 was -0.46 mg/l ( interquartile range : -0.78 to 0.08 mg/l ) and -0.10 mg/l ( -0.30 to 0.10 pg/ml ) , respectively , in the placebo group versus -1.18 mg/l ( -2.35 to -0.46 mg/l ) and -0.50 pg/ml ( -1.15 to -0.10 pg/ml ) in the colchicine group ( p Colchicine is an effective and safe treatment for prevention of early AF recurrences after pulmonary vein isolation in the absence of antiarrhythmic drug treatment . This effect seems to be associated strongly with a significant decrease in inflammatory mediators , including IL-6 and CRP"
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BACKGROUND Benign prostatic hyperplasia ( BPH ) is a common condition in ageing men that may cause lower urinary tract symptoms ( LUTS ) . Treatment aims are to relieve symptoms and prevent disease-related complications . Naftopidil is an alpha-blocker ( AB ) that has a high affinity for the A1d receptor that may have advantages in treating LUTS in this setting . This is an up date of a Cochrane Review first published in 2009 . Since that time , several large r and omised controlled trials ( RCTs ) have been reported , making this up date relevant . OBJECTIVES To evaluate the effects of naftopidil for the treatment of LUTS associated with BPH . SEARCH METHODS We performed a comprehensive search using multiple data bases ( the Cochrane Library , MEDLINE , Embase , Scopus , LILAC , and Web of Science ) , trials registries , other sources of grey literature , and conference proceedings with no restrictions on the language of publication or publication status up to 31 May 2018 SELECTION CRITERIA : We included all parallel RCTs . We also included cross-over design trials . DATA COLLECTION AND ANALYSIS Two review authors independently classified and abstract ed data from the included studies . We performed statistical analyses using a r and om-effects model and interpreted them according to the Cochrane H and book for Systematic Review s of Interventions . Primary outcomes were urological symptom scores , quality of life ( QoL ) and treatment withdrawals for any reason ; secondary outcomes were treatment withdrawals due to adverse events , acute urinary retention , surgical intervention for BPH , and cardiovascular and sexual adverse events . We considered outcomes measured up to 12 months after r and omisation as short term , and later than 12 months as long term . We rated the certainty of the evidence according to the GRADE approach . MAIN RESULTS We included 22 RCTs with 2223 r and omised participants across four comparisons for short-term follow-up . This abstract focuses on only two of four comparisons for which we found data since two comparators ( i.e. propiverine and Eviprostat ( phytotherapy ) ) are rarely used . One study comparing naftopidil to placebo did not report any relevant outcomes and was therefore excluded . There were no trials that compared to combination therapy with naftopidil or any 5-alpha reductase inhibitors ( 5-ARIs ) to combination therapy with other ABs and any 5-ARIs . All included studies were conducted in Asian countries . Study duration ranged from four to 12 weeks . Mean age was 67.8 years , prostate volume was 35.4 mL , and International Prostate Symptom Score was 18.3 . We were unable to perform any of the preplanned subgroup analyses based on age and baseline symptom score . Naftopidil versus tamsulosinBased on 12 studies with 965 r and omised participants , naftopidil may have result ed in little or no difference in urological symptom score ( mean difference ( MD ) 0.47 , 95 % confidence interval ( CI ) -0.09 to 1.04 measured on a scale from 0 to 35 with higher score representing increased symptoms ) , QoL ( MD 0.11 , 95 % CI -0.09 to 0.30 ; measured on a scale from 0 to 6 with higher scores representing worse QoL ) , and treatment withdrawals for any reason ( risk ratio ( RR ) 0.92 , 95 % CI 0.64 to 1.34 ; corresponding to 7 fewer per 1000 participants , 95 % CI 32 fewer to 31 more ) . Naftopidil may have result ed in little to no difference in sexual adverse events ( RR 0.54 , 95 % CI 0.24 to 1.22 ) ; this would result in 26 fewer sexual adverse events per 1000 participants ( 95 % CI 43 fewer to 13 more ) . We rated the certainty of evidence as moderate for urological symptom score and low for the other outcomes .Naftopidil versus silodosinBased on five studies with 652 r and omised participants , naftopidil may have result ed in little or no difference in the urological symptom scores ( MD 1.04 , 95 % CI -0.78 to 2.85 ) , QoL ( MD 0.21 , 95 % CI -0.23 to 0.66 ) , and treatment withdrawals for any reason ( RR 0.80 , 95 % CI 0.52 to 1.23 ; corresponding to 26 fewer per 1000 participants , 95 % CI 62 fewer to 32 more ) . We rated the certainty of evidence as low for all these outcomes . Naftopidil likely reduced sexual adverse events ( RR 0.15 , 95 % CI 0.06 to 0.42 ; corresponding to 126 fewer sexual adverse events per 1000 participants , 95 % CI 139 fewer to 86 fewer ) . We rated the certainty of evidence as moderate for sexual adverse events . AUTHORS ' CONCLUSIONS Naftopidil appears to have similar effects in the urological symptom scores and QoL compared to tamsulosin and silodosin . Naftopidil has similar sexual adverse events compared to tamsulosin but has fewer compared to silodosin
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"In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials",
"BACKGROUND Tadalafil improved lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ; LUTS/BPH ) in clinical studies but has not been evaluated together with an active control in an international clinical study . OBJECTIVE Assess tadalafil or tamsulosin versus placebo for LUTS/BPH . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , international , placebo-controlled , parallel-group study assessed men ≥45 yr of age with LUTS/BPH , International Prostate Symptom Score ( IPSS ) ≥13 , and maximum urinary flow rate ( Q(max ) ) ≥4 to ≤15ml/s . Following screening and washout , if needed , subjects completed a 4-wk placebo run-in before r and omisation to placebo ( n=172 ) , tadalafil 5 mg ( n=171 ) , or tamsulosin 0.4 mg ( n=168 ) once daily for 12 wk . MEASUREMENTS Outcomes were assessed using analysis of covariance ( ANCOVA ) or ranked analysis of variance ( ANOVA ) ( continuous variables ) and Cochran-Mantel-Haenszel test or Fisher exact test ( categorical variables ) . RESULTS AND LIMITATIONS IPSS significantly improved versus placebo through 12 wk with tadalafil ( -2.1 ; p=0.001 ; primary efficacy outcome ) and tamsulosin ( -1.5 ; p=0.023 ) and as early as 1 wk ( tadalafil and tamsulosin both -1.5 ; p Index significantly improved versus placebo at first assessment ( week 4 ) with tadalafil ( -0.8 ; p ( tadalafil -0.8 , p=0.003 ; tamsulosin -0.6 , p=0.026 ) . The IPSS Quality -of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil ( both p0.1 ) . The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil ( 4.0 ; p ) increased significantly versus placebo with both tadalafil ( 2.4ml/s ; p=0.009 ) and tamsulosin ( 2.2ml/s ; p=0.014 ) . Adverse event profiles were consistent with previous reports . This study was limited in not being powered to directly compare tadalafil versus tamsulosin . CONCLUSIONS Monotherapy with tadalafil or tamsulosin result ed in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max ) . However , only tadalafil improved erectile dysfunction . TRIAL REGISTRATION Clinical trials.gov ID NCT00970632",
"This was a multicenter r and omized trial to investigate the clinical efficacy and the impact on sexual function of alpha-1A selective silodosin and alpha-1D selective naftopidil for treatment of benign prostatic hyperplasia . A total of 97 patients with lower urinary tract symptoms/benign prostatic hyperplasia who had an International Prostate Symptom Score of 8 or more were r and omly assigned to receive silodosin ( 8 mg/day , n = 53 ) or naftopidil ( 75 mg/day , n = 44 ) . Before and 4 , 8 and 12 weeks after treatment , International Prostate Symptom Score and its quality of life score were used to assess lower urinary tract symptoms . Also , International Index of Erectile Function-5 , and an original question naire were used to evaluate erectile function and ejaculation for sexually active patients , respectively . The silodosin group showed advantages in terms of voiding symptoms and quality of life of International Prostate Symptom Score when compared with the naftopidil group . Both silodosin and naftopidil showed no significant effect on International Index of Erectile Function-5 . A total of 23 sexually active patients in the silodosin group experienced more ejaculatory impairment than 21 patients in the naftopidil group , with a decrease of ejaculation volume ( 87 % vs 40 % , P = 0.003 ) , prolonged time to ejaculation ( 56 % vs 33 % , P = 0.027 ) and decrease of orgasm ( 50 % vs 39 % , P = 0.027 ) . These results suggest that alpha-1A selective blockers are more effective for voiding symptoms , whereas alpha-1D selective blockers offer a minor degree of ejaculatory dysfunction",
"To compare the efficacy and safety of two α1a/α1d adrenoceptor ( AR ) antagonists with different affinity for the α1AR subtypes , tamsulosin and naftopidil , in the treatment of benign prostatic hyperplasia ( BPH )",
"We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) secondary to benign prostatic hyperplasia ( BPH ) . Thirty one patients were enrolled in a r and omized crossover study . Fourteen patients were initially prescribed naftopidil 75 mg ( N ) for 8 weeks , followed by tamsulosin 0.2 mg and solifenacin 5 mg ( TS ) for 8 weeks ( group N ) ; another 17 were initially prescribed TS , followed by N ( group TS ) . The efficacy variables were the changes in international prostate symptom score ( I-PSS ) , quality of life ( QOL ) score , overative bladder symptom score ( OABSS ) , and post-void residual ( PVR ) urine volume . After the study , a question naire survey was carried out about the choice of treatment . After treatment with each agent , total I-PSS , storage symptom score , QOL score and OABSS except for the daytime frequency were significantly improved from baseline . PVR was significantly increased after TS treatment . There were no significant differences between the two treatments except for PVR . As a result of the question naire survey , 13 patients chose N and 17 chose TS . In conclusion , N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy",
"Naftopidil , approved only in Japan , is an α1-adrenergic receptor antagonist ( α1-blocker ) used to treat lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Different from tamsulosin hydrochloride and silodosin , in that it has higher and extremely higher affinity respectively , for the α1A-adrenergic receptor subtype than for the α1D type , naftopidil has distinct characteristics because it has a three times greater affinity for the α1D-adrenergic receptor subtype than for the α1A subtype . Although well- design ed large-scale r and omized controlled studies are lacking and the optimal dosage of naftopidil is not always completely determined , previous reports from Japan have shown that naftopidil has superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin . On the other h and , the incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may be lower than for tamsulosin and silodosin having high affinity for the α1A-adrenergic receptor subtype . However , it remains unknown if the efficacy and safety of naftopidil in Japanese is applicable to white , black and Hispanic men having LUTS/BPH in western countries",
"OBJECTIVE To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia ( BPH ) in order to ensure the optimal indication for different BPH patients . METHODS A r and omized , parallel-controlled , multicenter clinical trial was conducted . From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups , including selective-adrenoceptor antagonist ( terazosin , doxazosin tamsulosin and naftopidil ) , 5 alpha-reductase inhibitor ( finasteride and epristeride ) and natural product ( cernilton ) . International Prostate Symptom Score ( IPSS ) and Quality of Life ( QOL ) , uroflowmetry , total prostatic volume ( TPV ) and transitional zone volume and residual urine were used as efficacy criteria . RESULTS According to the baseline , the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume ( P IPSS , QOL , Qmax and residual urine volume were observed in each therapeutic group , and no difference in IPSS improvement was found among the groups . Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups ( P Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group ( P , doxazosin and naftopidil group . In each group , the improvement of symptom were more significant in patients with IPSS higher than 20 points ( P BPH patients , especially for patients with higher IPSS baseline . When using 5alpha-reductase inhibitor , prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3",
"We compared the efficacy of naftopidil with that of tamsulosin hydrochloride for benign prostatic hyperplasia patients . Eighty-five patients without improvement of quality of life ( QOL ) score by the administration of 50 - 75 mg naftopidil for more than four weeks were assigned to receive doses of 0.1 - 0.2 mg tamsulosin hydrochloride and 89 patients without improvement of QOL score by the administration of 0.1 - 0.2 mg tamsulosin hydrochloride for more than four weeks were assigned to receive doses of 50 - 75 mg naftopidil once a day for 8 weeks . International prostate symptom score , maximum flow rate , residual urine volume and side effect profile were determined before the administration of the first medicine , before the administration of the second medicine and after 8 weeks of treatment with the second medicine . In the group without improvement of QOL score by naftopidil , significant improvements in symptoms of urgency , weak stream and straining were observed after 8 weeks of treatment with tamsulosin hydrochloride . In the group without improvement of QOL score by tamsulosin hydrochloride , significant improvements in symptoms of incomplete emptying , intermittency and nocturia were observed after 8 weeks of treatment with naftopidil . In conclusion , improvement of symptoms by each alpha 1-blocker differs symptom by symptom . Tamsulosin hydrochloride was superior to naftopidil for the symptoms of urine flow and naftopidil was superior to tamsulosin hydrochloride for the symptom of nocturia",
"PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of BPH progression was significantly greater in patients on placebo with a baseline TPV of 31 ml or greater vs less than 31 ml ( p the placebo arm , baseline TPV , PSA , Qmax , PVR and age were important predictors of the risk of clinical progression of BPH",
"Background No study has compared the bothersomeness of all lower urinary tract symptoms ( LUTS ) using a population -based sample of adults . Despite this lack of evidence , investigators have often cited their LUTS of interest as the “ most bothersome ” or “ one of the most bothersome . ” Objective To compare the population - and individual-level burden of LUTS in men and women . Design , setting , and participants In this population -based cross-sectional study , question naires were mailed to 6000 individuals ( 18–79 yr of age ) r and omly identified from the Finnish Population Register . Outcome measurements and statistical analysis The vali date d Danish Prostatic Symptom Score question naire was used for assessment of bother of 12 different LUTS . The age-st and ardized prevalence of at least moderate bother was calculated for each symptom ( population -level burden ) . Among symptomatic individuals , the proportion of affected individuals with at least moderate bother was calculated for each symptom ( individual-level bother ) . Results and limitations A total of 3727 individuals ( 62.4 % ) participated ( 53.7 % female ) . The LUTS with the greatest population -level burden were urgency ( 7.9 % with at least moderate bother ) , stress urinary incontinence ( SUI ) ( 6.5 % ) , nocturia ( 6.0 % ) , postmicturition dribble ( 5.8 % ) , and urgency urinary incontinence ( UUI ) ( 5.0 % ) . Burden from incontinence symptoms was higher in women than men , and the opposite was true for voiding and postmicturition symptoms . At the individual level , UUI was the most bothersome for both genders . Although the response proportion was high , approximately a third did not participate . Conclusions Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS . At the population level , the most prevalent bothersome symptoms are urgency , SUI , and nocturia . Patient summary Urinary urgency was the most common troubling symptom in a large population -based study ; however , for individuals , urgency incontinence was the most likely to be rated as bothersome",
"We compared the efficacy , safety , and patient preferences for two α1-adrenoceptor ( AR ) antagonists with different affinity for AR subtypes , naftopidil ( Naf ) and silodosin ( Silo ) , for the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia ( male LUTS/BPH ) . New patients diagnosed with male LUTS/BPH were r and omly divided into either the Naf-Silo group or the Silo-Naf group ( Naf : 50 - 75 mg once daily for 2 weeks followed by 75 mg once daily for 4 weeks ; Silo : 2 - 4 mg twice daily for 2 weeks followed by 4 mg twice daily for 4 weeks ) . A survey was conducted to evaluate patient drug preferences after completion of the study and the reasons for the preferences . Naf and Silo improved the total International Prostate Symptom Score ( IPSS ) compared with baseline . There was no significant difference between Naf and Silo in improvement in the IPSS total score . Adverse effects were more frequent with Silo than with Naf ( P=0 . 002 ) . No significant difference in patient preference for the drugs was observed . These findings indicate that Naf and Silo provide similar clinical efficacy , with no difference in patient preference for the drugs , although adverse effects were significantly more frequent with Silo than with Naf ",
"AIM The aim of this study was to compare the efficacy and safety of alpha1-adrenoceptor ( alpha1-AR ) antagonist monotherapy with combination therapy using alpha1-AR antagonist and anticholinergic agent for benign prostatic hyperplasia ( BPH ) with storage symptoms as the chief complaint . METHODS In this prospect i ve comparative study , either 25 - 75 mg/day of naftopidil monotherapy ( monotherapy group ) or combination therapy using 25 - 75 mg/day of naftopidil and an anticholinergic agent ( 10 - 20 mg/day of propiverine hydrochloride or 2 - 6 mg/day of oxybutynin hydrochloride ; cotherapy group ) were administered for 12 weeks to 101 BPH patients with storage symptoms . RESULTS International prostate symptom score ( IPSS ) and quality of life ( QOL ) index improved significantly in both groups , with no marked differences between groups . Maximum flow rate ( Qmax ) and residual urine volume ( RUV ) tended to improve in both groups , again with no marked differences between groups . However , median post-therapeutic RUV was significantly worse for the cotherapy group ( 45.0 mL ) than for the monotherapy group ( 13.5 mL ; P = 0.0210 ) . Ratio of patients with increased RUV was also significantly worse for cotherapy ( 22.9 % ) than for monotherapy ( 5.0 % ; P = 0.038 ) . CONCLUSIONS Although the anticholinergic dosage was low , the present results suggest that naftopidil monotherapy was as useful as combination therapy of naftopidil and an anticholinergic agent . Therefore , naftopidil is a useful agent as the first choice in BPH patients with storage symptoms",
"BACKGROUND The present study investigated the efficacy , safety , and utility of starting an alpha(1d)-selective antagonist , naftopidil , at 75 or 25 mg/day in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . METHODS In this prospect i ve comparative study , the subjects comprised 153 patients with LUTS associated with BPH . Patients were r and omized to receive either 25 mg/day ( Group LD ) or 75 mg/day ( Group HD ) of naftopidil for 4 weeks . The lower urinary tract disease symptom score ( LUTDSS ) , the International Prostate Symptom Score ( IPSS ) , the Quality of life assessment index , the maximum flow rate ( Q(max ) ) , and the residual urine volume were compared between the groups . RESULTS In both groups , the LUTDSS and the IPSS were significantly improved at the endpoint and no significant intergroup differences were identified . However , the improvement in the Q(max ) was significantly better for Group HD than for Group LD . The overall efficacy did not differ significantly between the groups . The degree of improvement in voiding symptoms and LUTDSS among patients with moderate symptoms was significantly greater for Group HD than for Group LD . The frequency of adverse reactions did not differ significantly between the groups . CONCLUSIONS Starting administration at 75 mg/day rather than 25mg/day is helpful for LUTS associated with BPH for patients with moderate symptoms , particularly in improving voiding symptoms . The 75 mg/day administration was considered to be a recommendable therapeutic dose in some patients",
"There is no consensus on the evaluated efficacy of individual alpha(1)-blockers in the treatment of lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . This study compared the clinical benefits of tamsulosin hydrochloride with those of naftopidil in BPH . Men aged 54 - 84 years with a main complaint of BPH were r and omly assigned to receive consecutive treatment with tamsulosin then naftopidil ( T-N group , 25 patients ) , or naftopidil then tamsulosin hydrochloride ( N-T group , 20 patients ) . The therapeutic effects were compared in a crossover design . Administration was continued for 28 days in each treatment period . Both groups showed similar improvements during the first treatment period . However , during the second treatment period after crossover , therapeutic effects were greater in the N-T group . Tamsulosin was more effective than naftopidil on intermittency , nocturia and quality of life scores . Tamsulosin and naftopidil have different efficacy profiles for LUTS associated with BPH",
"A prospect i ve r and omized controlled study was performed to compare the clinical effects of naftopidil and tamsulosin . Men complaining of lower urinary tract symptoms due to benign prostatic hyperplasia were r and omized into two groups : one receiving 50 mg naftopidil once daily ( Naf group , n=36 patients ) , and the other receiving 0.2 mg tamsulosin once daily ( Tam group , n=32 patients ) . In the Naf group at 12 weeks , 7 items of the International Prostate Symptom Score ( IPSS ) , storage and voiding symptoms , total IPSS , quality of life ( QOL ) index ( QOLI ) and Qmax were improved significantly . In the Tam group at 12 weeks , 6 items of IPSS except urgency , storage and voiding symptoms , total IPSS , QOLI and Qmax were improved significantly . Improvement of residual urine volume ( PVR ) was insignificant in both groups . In intergroup comparison between the Naf and the Tam groups , variations of 7 items of IPSS , storage and voiding symptoms , total IPSS , QOLI , Qmax and PVR at 4 and 12 weeks after treatment were not statistically significant . There was almost no difference in clinical efficacy between Naf and Tam",
"BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P doxazosin ( P risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P finasteride ( P doxazosin . Doxazosin ( P finasteride ( P=0.001 ) , and combination therapy ( P scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy",
"Purpose : We investigated the efficacy of 2 & agr;1‐blockers with different affinities for the & agr;1‐adrenoceptor subtypes silodosin and naftopidil in the treatment of benign prostatic enlargement complicated by overactive bladder . Material s and Methods : This was a prospect i ve , open label , r and omized , multicenter study of 350 out patients with untreated benign prostatic enlargement associated with urinary urgency at least once per week and an OABSS ( Overactive Bladder Symptom Score ) of 3 or greater . Patients were r and omly assigned to receive silodosin 8 mg per day or naftopidil 75 mg per day . Changes in parameters from baseline to 4 and 12 weeks were assessed based on I‐PSS ( International Prostate Symptom Score ) , I‐PSS quality of life , OABSS and voiding functions measured by uroflowmetry . Results : On efficacy analysis a total of 314 patients were included in the 2 groups . No significant difference in adverse effects was observed between the groups . Mean I‐PSS and I‐PSS quality of life scores , and OABSS significantly improved in both groups . Statistically significantly greater improvement in the silodosin group than in the naftopidil group was observed in total OABSS ( p = 0.03 ) , I‐PSS quality of life score ( p = 0.005 ) and OABSS urgency score ( p regard to voiding function the maximum urinary flow rate showed significant improvements in both groups but the change in the maximum flow rate in the silodosin group at 12 weeks was significantly greater than in the naftopidil group ( 3.6 vs 2.1 ml per second ) . Conclusions : Silodosin , a pure & agr;1A‐adrenoceptor blocker , showed greater improvement in overactive bladder symptoms along with the urinary flow rate in patients with benign prostatic enlargement complicated by overactive bladder compared to naftopidil , an & agr;1D > A‐adrenoceptor blocker",
"AIM The aim of our study was to examine the efficacy of naftopidil in terms of the international prostate symptom score ( IPSS ) and urodynamic parameters in the treatment of benign prostatic hyperplasia ( BPH ) . Eviprostat was used as a control to study the efficacy of naftopidil . METHODS Forty-nine patients with BPH ( mean age 67.9 + /- 7.8 years ) were involved in the study . Patients were r and omly assigned either to the naftopidil group , which was treated with the alpha-blocker naftopidil ( 50 - 75 mg daily , 36 patients ) , or the eviprostat group , which was treated with phytotherapy ( six tablets of eviprostat daily , 13 patients ) . RESULTS The mean total IPSS , the total storage and voiding symptom scores , and the quality of life score decreased significantly ( P naftopidil group , but not in the eviprostat group . In the naftopidil group , analyses showed significant increases in average and maximum flow rate and bladder capacity at first desire to void ( P postvoid residual , the percent of residual and the Abrams-Griffiths number ( P = 0.009 , P = 0.008 and P = 0.042 , respectively ) . However , in the eviprostat group , no significant changes were noted in terms of these symptomatic and urodynamic parameters . In the pressure/flow study , an improvement in the International Continence Society nomogram grade was noted in 29 % of the naftopidil group , but in only 16 % of the eviprostat group . Among the 14 patients in the naftopidil group , detrusor overactivity disappeared in 21 % and cystometric capacity increased in 36 % , but no improvement in detrusor overactivity was noted in the eviprostat group . CONCLUSIONS Naftopidil appears to have been effective in this short-term treatment of BPH",
"Introduction : We examined the tolerability of dosage methods of naftopidil in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH/male LUTS ) . Patients and Methods : A total of 80 patients with BPH/male LUTS who had an International Prostate Symptom Score ( IPSS ) ≧8 and IPSS quality of life ( QoL ) ≧2 were enrolled and r and omly administered naftopidil for 8 weeks at either 75 mg once daily ( OD ) in the evening ( group O ; n = 41 ) or 25 mg thrice daily ( TID ) in the morning , afternoon and evening ( group T ; n = 39 ) . Results : IPSS total score , IPSS-QoL and BPH impact index ( BII ) were significantly improved for both groups at 8 weeks after starting treatment compared to baseline . IPSS total score and daytime and 24-hour voiding frequencies were significantly improved at 8 weeks after starting treatment for group O in comparison to group T. Group O showed a significantly better degree of change in BII in comparison to group T. Conclusions : Naftopidil 75 mg OD in the evening was better tolerated than naftopidil 25 mg TID for the objective parameter and BII",
"Introduction : To investigate the incidence of ejaculatory disorders caused by naftopidil and tamsulosin in patients with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Material s and Methods : Ninety-five patients with LUTS/BPH who had International Prostate Symptom Scores ( IPSS ) of 8 or more were r and omly assigned to receive naftopidil ( 50 mg/day , n = 48 ) or tamsulosin ( 0.2 mg/day , n = 47 ) . Before and 12 weeks after treatment , a question naire was used to evaluate ejaculation . Results : Among men who had sexual activity during the 12 weeks , the proportion who reported an abnormal feeling on ejaculation was higher in the tamsulosin group ( 16.7 % ) than in the naftopidil group ( 7.4 % ) , although the difference was not significant ( p = 0.402 ) . The proportion of men who reported reduced ejaculatory volume after treatment was significantly higher in the tamsulosin group ( 96.0 % ) than in the naftopidil group ( 73.1 % , p = 0.0496 ) . On the other h and , the improvements in IPSS and the quality of life index were significantly higher in the tamsulosin group than in the naftopidil group . Conclusions : Tamsulosin may cause a higher incidence of ejaculatory disorders than naftopidil , although the efficacy of 0.2 mg tamsulosin may be better than that of 50 mg naftopidil",
"PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve",
"OBJECTIVES In order to compare the clinical efficacy of naftopidil ( Naf ) and tamsulosin hydrochloride ( Tam ) , which differ in their selectivity to alpha receptor subtypes , we performed a multi-center prospect i ve r and omized controlled study . METHODS Men complaining of lower urinary tract symptoms due to benign prostatic hypertrophy , were r and omized into two treatment groups : one receiving 50 mg Naftopidil daily ( Naf group , n = 31 pts ) , and one receiving 0.2 mg Tam once daily ( Tam group , n = 28 pts ) . Baseline symptom scores were compared to those at 2 weeks and at the end of the observation period ( 6 - 8 weeks ) . RESULTS In the Naf group at 2 weeks , the score of the daytime frequency significantly improved from 3.5 to 2.2 ( P = 0.03 ) , and the score of nocturia improved significantly from 3.5 to 2.2 ( P = 0.0004 ) , respectively . In the Tam group at 2 weeks , however , no significant improvement was noted in the increased score of daytime frequency ( P = 0.1 ) or nocturia ( P = 0.2 ) . At 2 weeks , the storage symptom score of the frequency to the combined score of daytime frequencies and the score of nocturia was better in the Naf group ( improved from 7.0 to 4.4 , P = 0.0017 ) than in the Tam group ( from 6.8 to 4.9 , P = 0.08 ) ( P lower urinary tract symptoms were comparable . CONCLUSIONS Naf demonstrated a significant early response to improve storage symptoms at 2 weeks , including daytime frequency and nocturia , compared with Tam",
"BACKGROUND The aim of the study presented here was to stratify drug therapy for patients with benign prostatic hyperplasia ( BPH ) displaying various voiding symptoms . METHODS Two different alpha1-adrenoceptor antagonists ; tamsulosin hydrochloride ( Tam ) and naftopidil ( Naf ) , were administered to 96 patients with BPH for 8 weeks in a crossover study . RESULTS With the administration of both drugs , the International Prostate Symptom Score ( I-PSS ) significantly decreased and the maximum urinary flow significantly increased . Whereas Naf monotherapy decreased the I-PSS for storage symptoms , Tam monotherapy decreased the I-PSS for voiding symptoms . In both the Naf-to-Tam and Tam-to-Naf groups , crossover was effective when the initial drug was judged subjectively and objective ly to have been ineffective . Compliance was acceptable with both drugs . CONCLUSION Our results show that either Naf or Tam can be used to treat patients on the basis of objective and subjective assessment of voiding symptoms . Our findings should be helpful for patient guidance and treatment of BPH",
"A total of 100 patients with benign prostatic hyperplasia ( BPH ) and overactive bladder ( OAB ) symptoms ( BPH/OAB ) , enrolled between June 2006 to March 2008 , were r and omly divided into 2 groups of morning medication ( M ) and evening medication ( E ) groups , then 50 mg of naftopidil was given once a day after breakfast or supper for 8 weeks . Data were available for efficacy analysis on 80 patients ( M group ; 43 , E group ; 37 ) . Naftopidil significantly improved the overall international prostatic symptom score ; from 19.2±7.9 to 11.7±5.8 in the M group and from 19.4±6.4 to 12.3±6.8 in the E group ( p QOL score from 4.9±0.8 to 3.2±1.4 in the M group and from 5.0±0.8 to 3.6±1.3 in the E group ( p symptom score from 7.8±2.6 to 5.0±2.5 in the M group ( p difference in the incidence of adverse effects between the M group ( 6.1 % ) and E group ( 2.2 % ) . These results suggest that naftopidil improves storage symptoms as well as voiding symptoms regardless of timing of administration",
"OBJECTIVES Silodosin is a novel drug that is highly selective to subtype alpha 1A and , since 2006 , has been used in Japan for treating benign prostatic hyperplasia . This study aim ed to compare the clinical effects of the alpha-adrenoceptor antagonist , silodosin , with those of naftopidil in patients presenting lower urinary tract symptoms associated with benign prostatic hyperplasia . METHODS This was a r and omized , open-label , controlled multicenter study carried out in Japan . Overall , 121 participants with lower urinary tract symptoms associated with benign prostatic hyperplasia were r and omized to receive silodosin ( 4 mg twice daily ) or naftopidil ( 50 mg once daily ) for 4 or 8 weeks . Patients were divided into four groups : the alpha-blocker-naive groups received silodosin ( 35 patients ) or naftopidil ( 33 patients ) and the drug-switching groups changed from tamsulosin to silodosin ( 26 patients ) or naftopidil ( 27 patients ) . The outcomes parameters were the International Prostate Symptom Score , quality of life , maximum urinary flow rate and post-void residual urine volume . P naftopidil significantly improved the total International Prostate Symptom Score and quality of life . However , silodosin obtained significantly better improvement in total International Prostate Symptom Score in the alpha-blocker-naive patients at 4 and 8 weeks . The maximum urinary flow rate and residual urine did not change significantly in all the treatment groups . CONCLUSIONS The present study confirms the clinical usefulness of silodosin in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia",
"Objective . To assess the efficacy and safety of propiverine hydrochloride ( antimuscarinic ) , naftopidil ( α1-adrenoceptor antagonist ) or both in patients with male lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia and concomitant overactive bladder ( OAB ) . Material and methods . Men aged at least 50 years who had a total International Prostate Symptom Score ( IPSS ) of 8 or higher and bladder dairy documenting micturition frequency ( more than eight micturitions/24 h ) and urgency ( more than one episode/24 h ) , with or without urgency urinary incontinence were r and omized into three groups : group N , naftopidil ( 50 mg once daily ) only ; group P , propiverine hydrochloride ( 20 mg once daily ) ; and group NP , naftopidil ( 50 mg once daily ) plus propiverine hydrochloride ( 20 mg once daily ) for a 4-week treatment regimen . Results . A total of 66 men , including 20 in group N , 23 in group P and 23 in group NP , were treated and 58 ( 87.9 % ) completed the 4 weeks of treatment . IPSS improved significantly in groups N and NP . Urinary frequency improved significantly in groups P and NP . Postvoid residual urine volume increased significantly in groups P and NP . Significant improvements in urgency episodes were noted in each group . One patient in group P required catheterization owing to acute urinary retention and another stopped medication because of difficulty in voiding . Conclusion . These results suggest that each treatment showed effectiveness for male LUTS with OAB . However , there are some possibilities of adverse effects with propiverine hydrochloride monotherapy",
"OBJECTIVE To compare the efficacies of naftopidil and tamsulosin in terms of reducing storage symptoms in patients with benign prostatic hyperplasia . MATERIAL S AND METHODS This prospect i ve r and omized study was performed at 10 centers . Ninety-four patients that had been taking tamsulosin for more than 8 weeks , but had an Overactive Bladder Symptom Score ( OABSS ) of greater than 3 points , were initially enrolled . After a 1-week washout period , patients were divided into 2 groups . Forty-five patients were treated with tamsulosin 0.2 mg daily , and 49 patients were treated with naftopidil 75 mg daily for 8 weeks . Total International Prostate Symptoms Score ( IPSS ) , storage symptom scores , nocturia times , OABSS , maximal flow rates ( Qmax ) , and postvoid residual volumes were checked before and after the 8-week treatment period . RESULTS Mean patient ages in the tamsulosin and naftopidil groups were 64.8 and 66.0 years , respectively . Baseline characteristics were not significantly different . In the tamsulosin group , mean total IPSS decreased from 19.1 to 15.1 after the 8-week treated period ( P = .001 ) , and in the naftopidil group , mean total IPSS decreased from 16.9 to 13.1 ( P = .001 ) . Mean storage symptom scores were reduced in the tamsulosin and naftopidil groups from 8.0 to 6.6 ( P = .002 ) and from 7.6 to 6.1 ( P = .001 ) , respectively . Mean nocturia times in the naftopidil groups decreased significantly from 2.5 to 1.9 ( P = .001 ) , and mean OABSSs were reduced from 7.7 to 6.0 ( P = .001 ) and from 7.4 to 6.0 ( P = .001 ) , respectively . CONCLUSION Total IPSS , storage symptom scores , nocturia times , and OABSS were significantly reduced by naftopidil and tamsulosin . Moreover , the naftopidil group showed better improvements in nocturia than the tamsulosin group",
"Introduction : Lower urinary tract symptoms in men , over age of 50 years is suggestive of benign prostatic enlargement ( BPE ) . Different alpha-blockers have been evaluated for the treatment of benign prostatic hyperplasia for over last 30 years . This study was conducted in a tertiary care institution during the period of year between June 2011 and August 2013 to compare the effect of naftopidil and tamsulosin in reducing the obstructive and irritable symptoms of BPE . Subjects and Methods : A prospect i ve r and omized comparative study was carried on 60 patients of BPE by assigning half of them to treatment with tamsulosin and rest with naftopidil . Pre- and post-treatment uroflowmetry ( UFM ) , post-void residue ( PVR ) , International Prostate Symptoms Score ( IPSS ) , were obtained at 15 and 30 days after starting treatment . Results : The age of patients ranged from 51 to 78 . At base line there was no statistical difference between UFM parameter , PVR and IPSS in the two groups . UFM and PVR showed significantly better response at both intervals with naftopidil . Comparison of IPSS showed better improvement in Group A both at 15 and 30 days . It was seen that the obstructive symptoms showed a significantly better response with tamsulosin and symptoms of irritability was seen better response with naftopidil . Conclusion : It was seen that during the period of follow-up of 30 days naftopidil had a better effect on UFM , PVR , IPSS compared with tamsulosin . In general , obstructive symptoms showed better improvement in tamsulosin and irritative symptoms showed better improvement in naftopidil"
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Background No previous systematic review has quantitatively examined the association between muscular fitness during childhood and adolescence and health parameters later in life . Objective The aim was to systematic ally review and meta-analyze the current evidence for a prospect i ve association between muscular fitness in childhood and adolescence and future health status . Methods Two authors systematic ally search ed MEDLINE , EMBASE and SPORTD iscus electronic data bases and conducted manual search ing of reference lists of selected articles . Relevant articles were identified by the following criteria : apparently healthy children and adolescents aged 3–18 years with muscular fitness assessed at baseline ( e.g. , h and grip , st and ing long jump , sit-ups , among others ) , and a follow-up period of ≥ 1 year . The outcome measures were anthropometric and adiposity measurements and cardiometabolic , bone and musculoskeletal health parameters . Two authors independently extracted data . Results Thirty studies were included in the meta- analysis , yielding a total of 21,686 participants . The meta- analysis found a significant , moderate-large ( p between muscular fitness at baseline and body mass index ( r = − 0.14 ; 95 % confidence interval ( CI ) − 0.21 to − 0.07 ) , skinfold thickness ( r = − 0.32 ; 95 % CI − 0.40 to − 0.23 ) , homeostasis model assessment estimated insulin resistance ( r = − 0.10 ; 95 % CI − 0.16 to − 0.05 ) , triglycerides ( r = − 0.22 ; 95 % CI − 0.30 to − 0.13 ) , cardiovascular disease risk score ( r = − 0.29 ; 95 % CI − 0.39 to − 0.18 ) , and bone mineral density ( r = 0.166 ; 95 % CI 0.086 to 0.243 ) at follow-up . Conclusion A prospect i ve negative association was observed between muscular fitness in childhood/adolescence and adiposity and cardiometabolic parameters in later life , together with a positive association for bone health . There is inconclusive evidence for low back pain benefits
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"OBJECTIVES To assess whether childhood cardiorespiratory fitness ( CRF ) and muscular fitness phenotypes ( strength , power , endurance ) predict adult glucose homeostasis measures . DESIGN Prospect i ve longitudinal study . METHODS Study examining participants who had physical fitness measured in childhood ( aged 7 - 15 years ) and who attended follow-up clinics approximately 20 years later and provided a fasting blood sample which was tested for glucose and insulin . Physical fitness measurements included muscular strength ( right and left grip , shoulder flexion , shoulder and leg extension ) , power ( st and ing long jump distance ) and endurance ( number of push-ups in 30s ) , and CRF ( 1.6 km run duration ) . In adulthood , fasting glucose and insulin levels were used to derive glucose homeostasis measures of insulin resistance ( HOMA2-IR ) and beta cell function ( HOMA2-β ) . RESULTS A st and ard deviation increase in childhood CRF or muscular strength ( males ) was associated with fasting glucose ( CRF : β=-0.06mmol/L ) , fasting insulin ( CRF : β=-0.73mU/L ; strength : β=-0.40mU/L ) , HOMA2-IR ( CRF : β=-0.06 ; strength : β=-0.05 ) and HOMA2-β ( CRF : β=-3.06 % ; strength : β=-2.62 % ) in adulthood , independent of the alternative fitness phenotype ( all p muscular strength ( males ) and statistical significance remained for all associations expect between CRF , fasting glucose and HOMA2-β ( p>0.06 ) . CONCLUSIONS CRF and muscular fitness in childhood were inversely associated with measures of fasting insulin , insulin resistance and beta cell function in adulthood . Childhood CRF and muscular fitness could both be potential independent targets for strategies to help reduce the development of adverse glucose homeostasis ",
"OBJECTIVES Low muscular fitness levels have previously been reported as an independent risk factor for chronic disease outcomes . Muscular fitness tracking , the ability to maintain levels measured at one point in time to another point in time , was assessed from youth to adulthood to provide insight into whether early identification of low muscular fitness in youth is possible . DESIGN Prospect i ve longitudinal study . METHODS Study including 623 participants who had muscular fitness measures in 1985 ( aged 9 , 12 or 15 years ) and again 20 years later in young adulthood . Measures of muscular fitness were strength ( right and left grip , leg , shoulder extension and flexion measured by dynamometer , and a combined strength score ) and power ( st and ing long jump distance ) . RESULTS Strength and power were relatively stable between youth and adulthood ; the strongest tracking correlations were observed for the combined strength score ( r=0.47 , p≤0.001 ) , right grip strength ( r=0.43 , p≤0.001 ) and st and ing long jump ( r=0.43 , p≤0.001 ) . Youth in the lowest third of muscular fitness had an increased risk of remaining in the lowest third of muscular fitness in adulthood ( strength : relative risk (RR)=4.70 , 95 % confidence interval ( CI ) ( 3.19 , 6.92 ) ; power : RR=4.06 ( 2.79 , 5.90 ) ) . CONCLUSIONS Youth with low muscular fitness are at increased risk of maintaining a low muscular fitness level into adulthood . These findings warrant investigation into the long term effects of early interventions that focus on improving low muscular fitness levels in youth which could potentially improve adult muscular fitness and reduce future chronic disease outcomes",
"Aims : To investigate how physical activity , physical performance and sociodemographic characteristics at the age of 16 are related to adult health habits ( physical activity , dietary intake , smoking ) and biological risk factors for cardiovascular diseases ( being overweight , low aerobic fitness , unfavorable levels of serum lipids , high blood pressure ) . Methods : A r and omly selected group of 220 male and 205 female students at 16 years of age was tested in 1974 , and reinvestigated 18 years later . Results : The predictive health profiles for adult lifestyle and biological risk factors were different in men and women . Leisure sports activity along with high performance in the nine-minute run among the boys and in the two-h and lift test among the girls were significant predictors of adult physical activity . A positive attitude to aerobic exercise and high performance in the nine-minute run test among the boys and high marks in physical education among the girls decreased the risk of smoking . Leisure sports activities together with body mass index at young ages were the most powerful predictors of adult biological risk factors , but attitudes to sports and educational level were also significant determinants . Conclusion : These results contribute to the knowledge of which factors at young ages may promote adult healthy habits in particular physical activities ",
"Background Whether muscle strength in youth is related to cardiovascular risk later in life independent of cardiorespiratory fitness is unclear . Methods We examined the independent association of isometric muscle strength in youth with cardiovascular risk factors in young adulthood using data from the Danish European Youth Heart Study ; a population -based prospect i ve cohort study among boys and girls ( n=332 ) followed for up to 12 years . In youth maximal voluntary contractions during isometric back extension and abdominal flexion were determined using a strain-gauge dynamometer and cardiorespiratory fitness was obtained from a maximal cycle ergometer test . Cardiovascular risk factors were obtained in youth and in young adulthood . Associations were examined using multivariable-adjusted regression models including major confounding factors . Results Each 1 SD difference in isometric muscle strength in youth ( 0.17 N/kg ) was inversely associated with body mass index ( BMI ; −0.60 kg/m2 , 95 % CI −0.97 to −0.22 ) , triglyceride ( −0.09 mmol/l , 95 % CI −0.16 to −0.02 ) , diastolic blood pressure ( BP ) ( −1.22 mm Hg , 95 % CI −2.15 to −0.29 ) and a composite cardiovascular risk factor score ( −0.61 SD , 95 % CI −1.03 to −0.20 ) in young adulthood in multivariable-adjusted analyses including fitness . Associations to triglyceride , diastolic BP and the cardiovascular risk factor score remained with additional adjustment for waist circumference or BMI . Each 1 SD difference in isometric muscle strength in youth was significantly associated with 0.59 ( 95 % CI 0.40 to 0.87 ) lower odds of general overweight/obesity in young adulthood ( p=0.007 ) and was marginally associated with incident raised BP , raised triglyceride and low high-density lipoprotein cholesterol . Conclusions This study suggests that greater isometric muscle strength in youth is associated with lower levels of cardiovascular risk factors in young adulthood independent of fitness , adiposity and other confounding factors",
"Objectives Musculoskeletal pain is highly prevalent throughout adulthood with a major impact on health , function and participation in the society . Still , the association between muscle strength and development of musculoskeletal pain is unclear . We aim ed to study whether overall muscle strength in adolescent men is inversely associated with self-reported musculoskeletal pain in adulthood . Design Cohort study with baseline data from the Swedish Conscription Register and outcome information from the r and om population -based Swedish Living Conditions Surveys . Setting Sweden , 1970–2005 . Participants 5489 men who at age 17–19 years tested their isometric muscle strength ( h and grip , arm flexion and knee extension ) during the compulsory conscription . Outcome measures The men were surveyed regarding self-reported musculoskeletal pain ; mean follow-up time of 17 ( range 1–35 ) years . Our primary outcome was a self-report of musculoskeletal pain , and secondary outcomes were a report of ‘ severe pain ’ , ‘ pain in back/hips ’ , ‘ pain in neck/shoulders ’ or ‘ pain in arms/legs ’ , respectively . We categorised muscle strength into three groups : low , average and high , using the 25th–75th percentile to define the reference category ( average ) . We estimated relative risks using log binomial regression with adjustment for smoking , body mass index , education and physical activity . Results In the adjusted model , men with low overall muscle strength had decreased risk of self-reported musculoskeletal pain ( 0.93 , 95 % CI 0.87 to 0.99 ) . We observed no such association in men with high strength ( 0.99 , 0.93 to 1.05 ) . Furthermore , no statistically significant increase or decrease in risk was observed for any of the secondary outcomes . Conclusions In men , low overall isometric muscle strength in youth was not associated with an increased risk of future musculoskeletal pain . Contrarily , we observed a slightly decreased risk of self-reported musculoskeletal pain in adulthood . Our results do not support a model in which low muscle strength is a risk factor for future musculoskeletal pain",
"This study evaluates the effect of physical activity on the bone content ( BMC ) and density ( BMD ) in 51 girls ( 14.2+/-0.4 yr ) . Twenty-four were placed in the h and ball group as they have been playing h and ball for at least 1 year ( 3.9+/-0.4 ) . The other 27 who did not perform in any kind of regular physical activity other than that programmed during the compulsory physical education courses comprised the control group . Bone mass and areal density were measured by dual-energy X-ray absorptiometry ( DXA ) . The maximal leg extension isometric force in the squat position with knees bent at 90 degrees and the peak force , mean power , and height jumped during vertical squat jump were assessed with a force plate . Additionally , 30-m run ( running speed ) and 300-m run ( as an estimate of anaerobic capacity ) tests were also performed . Maximal aerobic capacity was estimated using the 20-m shuttle-run tests . Compared to the controls , h and ballers attained better results in the physical fitness tests and had a 6 % and 11 % higher total body and right upper extremity lean mass ( all P h and ballers showed enhanced BMC and BMD in the lumbar spine , pelvic region , and lower extremity ( all P greater BMC in the whole body and enhanced BMD in the right upper extremity and femoral neck than the control subjects ( all P total lean mass strongly correlated with total and regional BMC and BMD ( r=0.79 - 0.91 P BMC and BMD variables ( r=0.59 - 0.67 and r=0.60 - 0.70 , respectively ; all P whole-body BMC and BMD ( R=0.93 and R=0.90 , P h and ball participation is associated with improved physical fitness , increased lean and bone masses , and enhanced axial and appendicular BMD in young girls . The combination of anthropometric and fitness-related variables may be used to detect girls with potentially reduced bone mass",
"PURPOSE The present population study is conducted to examine the extent to which lifetime physical activity and lifestyle parameters contribute to bone mass . METHODS The design of the project is a 27-yr prospect i ve follow-up study . Subjects are 126 males gathered from the Leuven Longitudinal Study on Lifestyle , Physical Fitness and Health , and aged 13 yr at the onset of the study and 40 at the end of the follow-up . Physical activity and lifestyle parameters are obtained with question naires . Bone mass is measured by means of dual-energy x-ray absorptiometry ( DXA ) . RESULTS Results from correlation and regression analyses show that the body mass index ( BMI ) is the most important parameter in relation to cortical and trabecular bone mass at every examination period . Longitudinally , static arm strength , running speed , and upper muscular endurance contribute significantly to the prediction of adult bone mass . The parameter \" change in motor fitness \" between 18 and 13 yr old was used to control for hereditary influences . The score for static arm strength and trunk muscle strength demonstrates a significant correlation with adult total bone mineral content ( BMC ) and lumbar bone mineral density ( BMD ) , respectively . At the age of 40 , the Baecke sports index is almost equally important as BMI in explaining the variance in BMD , and static arm strength is the most important parameter ( after BMI ) for BMC . CONCLUSION Lifetime physical activity , physical fitness , and BMI all contribute to adult bone mass . The clinical relevance of these findings is emphasized by the fact that the observed patterns of physical activity and motor fitness pertain to customary lifestyle and are thus feasible targets",
"Study Design . This study comprised a cross-sectional part and a prospect i ve part . Objective . To study whether low lumbar extension strength , high lumbar mobility , and high mobility – extension strength ratios are related to current and future low back pain in adolescents . Summary of Background Data . Knowledge is sparse about the significance of lumbar mobility and strength for low back pain in adolescents . Methods . The study population included all the adolescents in the eighth and ninth grade s of a rural municipality ( n = 44 ) and in an urban area ( n = 61 ) during the 1996–1997 school year . At baseline , 88 adolescents ( mean age , 14.7 years ) participated in the study , giving a response rate of 84 % . Low back pain was assessed by question naire as pain or discomfort in the low back during the preceding year . Sagittal lumbar mobility was tested by Schober ’s modified technique , and lumbar strength as static endurance extension strength . The follow-up part was conducted 3 years later , which included 98 % of the adolescents . Results . By bivariate and multivariate analyses in the cross-sectional part of the study , low back pain was found to be highly associated with low lumbar extension strength ( P = 0.004–0.02 ) , and high lumbar mobility – extension strength ratios ( P = 0.005–0.04 ) . Baseline low lumbar extension strength and high lumbar sagittal mobility – extension strength ratios ( P = 0.03 and P = 0.02 , respectively ) predicted low back pain at follow-up assessment in multivariate analyses when control was used for gender , previous low back pain , physical activity , and well-being . No associations were found between plain sagittal mobility and low back pain . Conclusion . The study findings support theories suggesting insufficient strength and stability in the low back as important factors for both concurrent and future low back pain in adolescents",
"OBJECTIVES We examined the relationship between comprehensive fitness tests and overweight using a school surveillance system in a racially diverse city in the United States . RESEARCH METHODS AND PROCEDURES Trained physical education teachers measured weight , height , and fitness annually from 2001 to 2003 . We compiled data for a cross-sectional analysis ( 11,845 measurements on 6297 students , 5 to 14 years of age ) and a 1-year prospect i ve analysis ( 4215 measurements on 2927 students not overweight at baseline , 5 to 13 years of age ) . Overweight was defined as a BMI > or = 95th percentile ( Centers for Disease Control and Prevention 2000 growth charts ) , and underfit was defined as failing at least one of five fitness tests : endurance run , abdominal strength , flexibility , upper body strength , and agility ( Amateur Athletic Union and Fitnessgram ) . Associations between fitness and overweight were examined using multivariate logistic regression models , adjusting for sociodemographic status and repeated measurements over time . RESULTS The mean number of fitness tests passed was lower among students with a BMI above the 80th percentile . Overweight incidence over 1 year was 7 % and 2 % for underfit and fit girls , respectively ( odds ratio , 3.3 ; 95 % confidence interval , 2.0 to 5.6 ) . Not passing either the endurance run or upper body strength test was associated with overweight incidence in both boys and girls . After adjusting for baseline BMI , the endurance run remained a significant predictor of incident overweight among girls ( odds ratio , 2.0 ; 95 % confidence interval , 1.1 to 3.5 ) . DISCUSSION Findings support a cross-sectional inverse relationship between physical fitness and overweight among school-aged children . The direction of causation between fitness and overweight is not clearly established and merits further study",
"Strength training represents an alternative to endurance training for patients with type 2 diabetes . Little is known about the effect on insulin action and key proteins in skeletal muscle , and the necessary volume of strength training is unknown . A total of 10 type 2 diabetic subjects and 7 healthy men ( control subjects ) strength-trained one leg three times per week for 6 weeks while the other leg remained untrained . Each session lasted no more than 30 min . After strength training , muscle biopsies were obtained , and an isoglycemic-hyperinsulinemic clamp combined with arterio-femoral venous catheterization of both legs was carried out . In general , qualitatively similar responses were obtained in both groups . During the clamp , leg blood flow was higher ( P arterio-venous extraction glucose did not decrease in trained legs . Thus , leg glucose clearance was increased in trained legs ( P . Strength training increased protein content of GLUT4 , insulin receptor , protein kinase B-alpha/beta , glycogen synthase ( GS ) , and GS total activity . In conclusion , we found that strength training for 30 min three times per week increases insulin action in skeletal muscle in both groups . The adaptation is attributable to local contraction-mediated mechanisms involving key proteins in the insulin signaling cascade",
"This study investigates whether physical activity and physical performance in adolescence are positively related to adult bone mineral density ( BMD ) . In 1974 , physical activity , endurance , and muscular strength were measured in 204 r and omly selected female students , age 16.1 + /- 0.3 year ( range 15 - 17 years ) . Twenty years later , 36 of the women volunteered to undergo a measurement of their BMD . Women who were members in a sports club in adolescence had significantly higher adult BMD ( mean differences of 5 % to 17 % depending on site ) compared with subjects who were not engaged in a sports club . Furthermore , women with persistent weight-bearing activity in adulthood had significantly higher BMD compared with women who had stopped being active or had never been active . The differences ranged between 5 % and 19 % with the highest difference found in trochanter BMD . Stepwise regression analyses showed that membership in a sports club at baseline was a significant independent predictor of BMD in the total body , lumbar spine , legs , trochanter , and femoral neck , explaining 17 - 26 % of the variation in BMD . Change in body weight was a strong independent predictor of BMD of the total body and arms , explaining 8 % of the variation in both sites . In addition , running performance at baseline was an independent predictor of total body BMD , whereas the two-h and lift performance significantly predicted BMD of the total body , legs and trochanter . The hanging leg-lift and h and grip were both significant predictors of arm BMD . In conclusion , membership in a sports club and site-specific physical performance in adolescence together with the change in body weight were significantly associated with adult BMD in premenopausal women",
"Study Design . This was a prospect i ve 3-year follow-up study of r and omized matched subgroups of 15-year-old school children with or without low back pain initially . Objective . In addition to low back pain and leisure time physical activity , spinal mobility , trunk muscle strength , and early degenerative findings of the lumbar spine were evaluated . Summary of Background Data . Reliable epidemiologic studies on the prevalence of low back pain and development of early degenerative changes of the lumbar spine in young persons have been sparse . Along with several other characteristics , the relationship of these changes to frequent low back pain in young persons is not known . Methods . After a question naire-based survey was administered , subjects with or without low back pain were examined initially and at follow-up with special reference to leisure time physical activity , anthropometry , spinal mobility , trunk muscle strength , and magnetic resonance imaging findings of the lumbar spine . Results . At baseline and at follow-up , those subjects with initial low back pain were characterized by a low frequency of physical activity and decreased spinal function . During follow-up , the occurrence of disc degeneration increased significantly more in the original group with low back pain than among asymptomatic subjects . Furthermore , disc degeneration at baseline significantly predicted future frequent low back pain . Initial disc protrusion also predicted future frequent low back pain . Conclusion . After the rapid physical growth period , there seemed to be a causal relationship between the early evolution of the degenerative processes of the lower lumbar discs and frequent low back pain in several subjects",
"OBJECTIVES The mechanical environment is considered to be the most important determinant of bone strength . Local muscle force , in turn , is regarded as the largest source of loading applied to bones . However , the effect of weight-bearing on bone mineral accrual is unclear . Comparing the relationship between muscle force and bone mineral content ( BMC ) in the upper and lower limbs provides a means of investigating this issue . SUBJECTS AND METHODS The study group comprised 258 healthy girls aged 10 - 13 years old at baseline . BMC , lean body mass ( LM ) and fat body mass ( FM ) of total body were assessed by dual-energy X-ray absorptiometry at baseline and 2 years after . The maximal isometric voluntary contraction ( MVC ) of left elbow flexors and knee extensors was evaluated by a dynamometer . A hierarchical linear statistical model with r and om effects was used to analyze the relationship between BMC and limb-matched MVC . Fisher 's z-transformation was used to compare the correlation coefficients between arms and legs . The ratio of BMC to MVC ( BMC /MVC ) in upper and lower limbs was compared using Student 's t-test . RESULTS BMC was highly correlated with MVC in arms and legs ( r(2)=0.54 and 0.50 , respectively ) , and the correlation coefficients did not differ between upper and lower limbs . On the other h and , BMC /MVC was significantly ( 30 % ) higher in leg than in arm . CONCLUSIONS The results indicate that local muscle contraction and weight-bearing exert an additive effect on bone mass accretion in the lower limbs . Exercise regimes combining resistance and impact training should provide larger bone response than either one of them alone in growing children",
"Purpose Sports have different effects on bone development and effective interventions to improve bone health of adolescent athletes are needed . The purpose of the study was to investigate the effect of a 9-month jumping intervention on bone geometry and metabolism in adolescent male athletes . Methods Ninety-three adolescent ( 14.1 yr old ) male swimmers ( SWI ) , footballers ( FOO ) , and cyclists ( CYC ) were r and omized to intervention and sport ( INT-SWI = 19 , INT-FOO = 15 , and INT-CYC = 14 ) or sport only ( CON-SWI = 18 , CON-FOO = 15 , and CON-CYC = 12 ) groups . Cross-sectional area , cross-sectional moment of inertia ( CSMI ) , and section modulus ( Z ) at the femoral neck were assessed using hip structural analysis and trabecular texture of the lumbar spine using trabecular bone score . Bone mineral content ( BMC ) at femoral neck and lumbar spine was assessed using dual-energy x-ray absorptiometry . Serum N-terminal propeptide of procollagen type I , isomer of the carboxy-terminal telopeptide of type 1 collagen , total serum calcium , and 25-hydroxyvitamin D were analyzed . Results INT-CYC acquired significantly higher lumbar spine BMC ( 4.6 % ) and femoral neck BMC ( 9.8 % ) than CON-CYC . INT-CYC acquired significantly higher cross-sectional area ( 11.0 % ) , CSMI ( 10.1 % ) , and trabecular bone score ( 4.4 % ) than CON-CYC . INT-SWI acquired significantly higher femoral neck BMC ( 6.0 % ) and CSMI ( 10.9 % ) than CON-SWI . There were no significant differences between INT-FOO and CON-FOO in any bone outcomes . N-terminal propeptide of procollagen type I significantly decreased in CON-SWI , INT-FOO , CON-FOO , and CON-CYC . Carboxy-terminal telopeptide of type 1 collagen significantly decreased in CON-SWI and CON-CYC . The 25-hydroxyvitamin D significantly increased in INT-CYC , CON-CYC , INT-FOO , and CON-FOO . Conclusions A 9-month jumping intervention improved bone outcomes in adolescent swimmers and cyclists , but not in footballers . This intervention might be used by sports clubs to improve bone health of adolescent athletes",
"Background Although cardiorespiratory fitness ( CRF ) in childhood and adolescence may be linked to future cardiovascular health , there is currently limited evidence for a longitudinal association . Objectives To provide a systematic review on the prospect i ve association between CRF in childhood and adolescence and cardiovascular disease ( CVD ) risk factors at least 2 years later . Methods Using a systematic search of Medline , Embase , and SPORTD iscus , relevant articles were identified by the following criteria : generally healthy children and adolescents between 3 and 18 years of age with CRF assessed at baseline , and a follow-up period of ≥ 2 years . The outcome measures were CVD risk factors . We appraised quality of the included articles with STROBE and QUIPS checklists . Results After screening 7524 titles and abstract s , we included 38 articles , assessing 44,169 children and adolescents followed up for a median of 6 years . Eleven articles were of high quality . There was considerable heterogeneity in methodology , measurement of CRF , and outcomes , which hampered meta- analysis . In approximately half of the included articles higher CRF in childhood and adolescence was associated with lower body mass index ( BMI ) , waist circumference , body fatness and lower prevalence of metabolic syndrome in later life . No associations between CRF in childhood and adolescence and future waist-to-hip ratio , blood pressure , lipid profile , and glucose homeostasis were observed . Conclusion Although about half of the included articles reported inverse associations between CRF in childhood and adolescence and future BMI , body fatness , and metabolic syndrome , evidence for other CVD risk factors was unconvincing . Many articles did not account for important confounding factors such as adiposity . Recommendations for future research include st and ardizing the measurement of CRF , i.e. by reporting VO2max , using st and ardized outcome assessment s , and performing individual patient data meta-analyses"
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To systematic ally review available evidence related to the characteristics of bone changes post-stroke and the relationship between various aspects of muscle function ( e.g. , strength , spasticity ) and bone properties after stroke onset . An extensive online data base search was undertaken ( last search in January 2019 ) . Articles that examined the bone properties in stroke patients were included . The quality of the studies was evaluated with the National Institutes of Health ( NIH ) Study Quality Assessment Tools . Publication bias of meta-analyses was assessed using the Egger ’s regression asymmetry test . The selection and evaluation of the articles were conducted by two independent research ers . Fifty-nine studies were identified . In subacute and chronic stroke studies , the skeletal sites in the paretic limbs sustained a more pronounced decline in bone quality than did their counterparts in the non-paretic limbs . The rate of changes showed a decelerating trend as post-stroke duration increased , but the timing of achieving the steady rate differed across skeletal sites . The magnitude of bone changes in the paretic upper limb was more pronounced than the paretic lower limb . There was a strong relationship between muscle strength/mass and bone density/strength index . Muscle spasticity seemed to have a negative impact on bone integrity in the paretic upper limb , but its influence on bone properties in the paretic lower limb was uncertain . Substantial bone changes in the paretic limbs occurred particularly in the first few months after stroke onset . Early intervention , muscle strength training , and long-term management strategies may be important to enhance bone health post-stroke . This review has also revealed the knowledge gaps which should be addressed in future research
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"Transcranial direct current stimulation ( tDCS ) is used in a variety of disorders after stroke including upper limb motor dysfunctions , hemispatial neglect , aphasia , and apraxia , and its effectiveness has been demonstrated . Although gait ability is important for daily living , there were few reports of the use of tDCS to improve balance and gait ability . The supplementary motor area ( SMA ) was reported to play a potentially important role in balance recovery after stroke . We aim ed to investigate the effect of combined therapy body weight-supported treadmill training ( BWSTT ) and tDCS on gait function recovery of stroke patients . Thirty stroke in patients participated in this study . The two BWSTT periods of 1weeks each , with real tDCS ( anode : front of Cz , cathode : inion , 1mA , 20min ) on SMA and sham stimulation , were r and omized in a double-blind crossover design . We measured the time required for the 10 m Walk Test ( 10MWT ) and Timed Up and Go ( TUG ) test before and after each period . We found that the real tDCS with BWSTT significantly improved gait speed ( 10MWT ) and applicative walking ability ( TUG ) , compared with BWSTT+sham stimulation periods ( p feasibility and efficacy of tDCS in gait training after stroke . The facilitative effects of tDCS on SMA possibly improved postural control during BWSTT . The results indicated the implication s for the use of tDCS in balance and gait training rehabilitation after stroke",
"Purpose Bone fragility contributes to increased fracture risk , but little is known about the emergence of post-stroke bone loss . We investigated skeletal changes and relationships with physical activity , stroke severity , motor control and lean mass within 6 months of stroke . Methods This is a prospect i ve observational study . Participants were non-diabetic but unable to walk within 2 weeks of first stroke . Distal tibial volumetric bone mineral density ( vBMD , primary outcome ) , bone geometry and microstructure ( high-resolution peripheral quantitative computed tomography ) were assessed at baseline and 6 months , as were secondary outcomes total body bone mineral content and lean mass ( dual energy X-ray absorptiometry ) , bone metabolism ( serum osteocalcin , N-terminal propeptide of type 1 procollagen ( P1NP ) , C-terminal telopeptide of type 1 collagen ( CTX ) ) , physical activity ( PAL2 accelerometer ) and motor control ( Chedoke McMaster ) which were also measured at 1 and 3 months . Results Thirty-seven participants ( 69.7 years ( SD 11.6 ) , 37.8 % females , NIHSS 12.6 ( SD 4.7 ) ) were included . The magnitude of difference in vBMD between paretic and non-paretic legs increased within 6 months , with a greater reduction observed in paretic legs ( mean difference = 1.5 % ( 95 % CI 0.5 , 2.6 ) , p = 0.007 ) . At 6 months , better motor control was associated with less bone loss since stroke ( r = 0.46 , p = 0.02 ) . A trend towards less bone loss was observed in people who regained independent walking compared to those who did not ( p = 0.053 ) . Higher baseline daily count of st and ing up was associated with less change in bone turnover over 6 months : osteocalcin ( r = −0.51 , p = 0.01 ) , P1NP ( r = −0.47 , p = 0.01 ) , CTX ( r = −0.53 , p = 0.01 ) . Conclusion Better motor control and walking recovery were associated with reduced bone loss . Interventions targeting these impairments from early post-stroke are warranted . Clinical trial registration URL : http://www.anzctr.org.au . Unique identifier : ACTRN12612000123842",
"Ikai T , Uematsu M , Eun SS , Kimura C , Hasegawa C , Miyano S : Prevention of secondary osteoporosis postmenopause in hemiplegia . Am J Phys Med Rehabil 2001;80:169–174 . Objectives To study secondary osteoporosis postmenopause in women with hemiplegia and to show the therapeutic effects of etidronate and how osteoporotic conditions relate to the activities of daily living ( ADL ) . Design Eighty-one postmenopausal women with hemiplegia were admitted within 6 mo of their first cerebrovascular accident . The bone mineral density ( BMD ) and biochemical markers of bone turnover were measured at the time of admission . Forty women ( treatment group ) received a 2-wk administration of etidronate . Forty-one women ( control group ) were not administered etidronate . Results After completing a 3-mo rehabilitation program , BMD levels were remeasured . ADL was evaluated by FIMTM . The low ADL group had a larger decrease in BMD than the high ADL group . For the control group , the BMD rate of change on the paretic side of the femoral neck was −9.6%/3 mo for the low ADL group . BMD loss was reduced significantly by the administration of etidronate for the low ADL group . Conclusions Results indicate that ADL corresponds to the progression of osteoporosis in postmenopausal women with hemiplegia and that increasing the level of ADL will reduce the progression of osteoporosis . Use of etidronate has also been proven to have a suppressive effect on the BMD decrease in women",
"Muscle strength , usually measured as the peak torque during maximal contraction , is impaired in persons with stroke . Time-dependent properties of muscle contraction may also be altered but have not been quantified . We quantified both magnitude ( peak torque ) and time-dependent parameters ( times to develop and reduce torque ) in eight different isometric joint actions . Parameters were compared among the more and less affected arms of 20 persons with chronic stroke and the nondominant arms of 10 similarly aged healthy persons . Torque-generation parameters were independent from one another ( i.e. , low correlations ) and highly reliable between trials and days . All parameters were impaired in the more affected arm , whereas peak torque and time to develop torque were impaired in the less affected arm . Following stroke , torque-generation impairments include both magnitude and time-dependent properties and exist not only in the more affected but also in the less affected arm . Clinicians attempting to improve upper-extremity function should employ therapeutic exercises that challenge patients to improve both their strength and speed of muscle contraction",
"Background and Purpose — Stroke is a major risk factor for hip fracture . Patients with intermediate rather than severe or mild stroke deficits at the time of hospital discharge have the most fractures . This proof-of-concept study evaluated the efficacy of a single infusion of zoledronate , an intravenous bisphosphonate , in preserving hip bone density after stroke . Methods — In a 1-year r and omized , double-blind , placebo-controlled , clinical trial , 27 newly hemiplegic patients ( 6 females , 21 males ) with acute stroke were assigned to receive 4 mg of the intravenous zoledronate ( n=14 ) or placebo ( n=13 ) within 35 days . Strict inclusion criteria were followed-up to ensure recruited patients were likely to have residual functional impairment . Both groups received calcium and vitamin D supplementation . The primary outcome measure was the change in bone mineral density ( BMD ; Lunar Prodigy ) at the hemiplegic hip during the year of investigation . Results — The treatment was generally well tolerated . Mean total hip BMD was unchanged in the hemiplegic hip of the zoledronate group ( mean 0.0 % change ) , whereas in the placebo group the total hip BMD changed by −5.5 % , with the greatest bone loss observed in the trochanteric subregion ( mean , −8.1 % ) . On the unaffected side the mean change in total hip BMD was + 1.0 % with zoledronate versus a mean change of −2.7 % without . Repeated measures ANOVA confirmed the significance of the differences between groups at both hips ( hemiplegic , P Stroke patients were protected from the deleterious effects of hemiplegia on hip bone density for at least 1 year after a single infusion of zoledronate",
"Şahin L , Özoran K , Gündüz OH , Uçan H , Yücel M : Bone mineral density in patients with stroke . Am J Phys Med Rehabil 2001;80:592–596 . ObjectiveS troke is an acute neurologic dysfunction of vascular origin , characterized by loss of voluntary movement , sensory disturbances , and neurologic findings in the contralateral half of the body . Acute and long-term complications because of immobilization are seen in all organ systems . The aim of this study was to determine any differences between the affected and unaffected sides ’ bone mineral densities of acute and chronic stroke patients . Design In this study , we determined the bone mineral densities ( BMD ) of 30 male patients with acute ( 0 - 20 days ) and 30 male patients with chronic ( 6 months or longer ) stroke and compared the densities with the normal side . Upper and lower limb BMDs were measured by dual-energy x-ray absorptiometry . Additionally , patients were evaluated for the degree of spasticity , the phases of motor improvement , and the activities of daily living . Results In acute-phase stroke patients , BMD of the affected side was not significantly different from BMD of the normal side . BMD of both upper limbs of acute stroke patients was not different from normal side upper limb BMD of chronic stroke patients . In both acute and chronic stroke patients , affected and unaffected side lower limb BMDs ( femur total BMD scores ) were not significantly different . However , in chronic stroke patients , affected side BMD of Ward ’s region was significantly higher compared with the normal side . There is no correlation between BMD and Brunnstrom phases , Ashworth scales , and the degree of activities of daily living . Conclusions Higher BMD of the affected side Ward ’s region in chronic cerebrovascular accident patients may be related to spasticity and changes in walking pattern , which increase the mechanical stress loading of the Ward ’s region",
"Background and Purpose — Stroke patients may have an increased risk of fractures because of weak bones or an increased risk of falling . Our goal was to estimate the frequency of fracture after stroke and to identify those at greatest risk . Methods — This study incorporated 2 complementary strategies : a prospect i ve , single-center , cohort study and an analysis of Scottish routine hospital discharge data . Results — Eighty-eight fractures ( 30 % hip ) occurred in 2696 hospital-referred stroke patients . The proportions sustaining any fracture or hip fracture within 2 years were 4 % and 1.1 % , respectively , 1.4 ( 95 % CI , 0.92 to 2.07 ) times the rate of hip fracture in the general population ( ie , observed number divided by expected number or st and ardized morbidity ratio ) . Female sex , older age , low abbreviated mental test score , and prestroke dependence were associated with an increased hip fracture rate . Routine data identified 129 935 acute stroke patients admitted to Scottish hospitals . During 363 447 patient-years , 4528 patients had hip fractures , 2.0 % had fractures by 1 year , and 10.6 % had fractures by 10 years . This is 1.7 times the rate of hip fracture in the general population and 2.3 times that in patients with myocardial infa rct ion . Older patients predictably had the highest rate of poststroke hip fractures but a lower st and ardized morbidity ratio than younger patients . Conclusions — Fractures after stroke are probably frequent and serious enough to justify the development of preventive strategies , but the modest event rate would mean that r and omized , controlled trials to test these strategies specifically in stroke patients would need to enroll thous and s of patients ",
"OBJECTIVES To determine fracture risk in U.S. stroke patients and identify patient characteristics that predict highest fracture risk in two complementary cohorts . DESIGN Secondary analyses of two prospect i ve cohorts . SETTING Veterans Affairs ( VA ) Medical Centers . PARTICIPANTS The VA Acute Stroke ( VASt ) cohort includes 1,073 veterans admitted to nine VA hospitals for stroke between April 1995 and March 1997 . The Integrated Stroke Outcomes Data base ( ISOD ) includes 6,578 veterans who received inpatient rehabilitation for stroke at 121 VA facilities during fiscal years 2001 and 2002 . MEASUREMENTS Fractures detected using International Classification of Diseases , 9th Revision , codes in the VA computerized patient record system ; baseline patient characteristics and stroke features ; Functional Independence Measures scores in ISOD . RESULTS Estimated 2-year fracture rates after stroke in the VASt and ISOD cohorts were 6.1 % and 4.7 % , respectively . Longer hospitalizations for stroke ( P=.06 ) and new motor or sensory impairment ( P=.09 ) showed trends toward greater risk in the VASt cohort . Female sex ( P cognitive impairment ( P=.01 ) , and nonblack race ( P=.04 ) were associated with higher fracture risk in the ISOD . Intermediate functional impairment conferred higher fracture risk than mild or severe functional impairment . CONCLUSION Veterans who suffer a stroke are at high risk of subsequent fracture , which can lead to further disability . Women , nonblacks , and those with intermediate functional impairment were at particularly high risk of fracture . Future study should investigate therapies to decrease fracture risk in stroke patients",
"Hemiplegic patients are prone to bone loss and alterations in fat and lean mass , which ultimately affect their rehabilitation status and propensity in bone fractures . The present study aim ed to evaluate body composition and bone mineral density ( BMD ) in stroke patients within 1st year post-stroke . Fifty-eight hemiplegic patients ( 36 men and 22 women ) were enrolled in this prospect i ve study . Dual-energy X-ray absorptiometry was used to assess total-body and lower-extremity BMDs ( g/cm(2 ) ) , lean mass ( g ) , and fat mass ( g ) after 3 , 6 and 12 mo of stroke that led to hemiplegia . The Modified Ashworth Scale and the functional ambulation category were used to evaluate spasticity and ambulatory category of patients , respectively . Both sexes exhibited total-body and paretic lower-limb BMD loss , fat mass gain , and lean mass waste during the 1st 12 mo poststroke , and in most cases , statistically significant differences were found between 3 and 6 mo ; however , the pattern of changes was different between males and females . Therefore , it is suggested that disability because of hemiplegia led to alterations in muscle function , which triggered skeletal and body composition changes and rendered these patients particularly prone to increased fracture risk",
"Abstract : Fractures are a common and serious complication after stroke and the risk of hip fractures among stroke patients is 2 to 4 times greater than among other elderly people . The aim of this study was to investigate prospect ively the change in bone mineral density ( BMD ) after severe stroke and to study the association between motor impairment , disability and the development of hemiosteoporosis . The study comprised 24 stroke patients , with no persistent paresis from previous strokes or previous osteoporotic fractures , included 1 month after stroke onset . BMD , motor function , ambulation and activities of daily living ( ADL ) were assessed at 1 , 4 , 7 and 12 months after stroke onset . At inclusion , the patients ’ BMD was normal for their age . During the study , there was a significant loss of BMD in the total body ( −2.0 % ; p head or spine . BMD differed significantly between the paretic and the non-paretic arm at inclusion ( −4.8 % ; p Decrease in BMD was most pronounced in the affected humerus ( −17.4 % ; p ) . BMD decreased significantly in both lower extremities during follow-up , but the losses were more pronounced on the paretic side ( p increase in BMD from inclusion to the end of the study ( + 5.8 % ; p for hemiosteoporosis such as motor function , ability to perform ADL or ambulation . Two patients had fractures at follow-up , both on the paretic side . Loss of bone mineral density in the paretic extremities is thus pronounced and progressive during the first year after stroke , indicating that loss of BMD is probably an important risk factor for post-stroke fractures . Surprisingly , BMD in the nonaffected arm increased significantly during the first year after stroke , most likely due to increased physical activity , and perhaps a redistribution of bone minerals from the paretic extremities",
"Levendo&U01E7;lu F , U&U01E7;urlu H , Gürbilek M , Akkurt E , Karagözo&U01E7;lu E : Increased bone resorption in the proximal femur in patients with hemiplegia . Am J Phys Med Rehabil 2004;83:835–841 . Objectives : To investigate the relationship between the proximal femoral bone mineral density and bone resorption markers , determinants of calcium metabolism and vitamin D levels in elderly stroke patients . Design : A total of 80 patients and 20 controls were enrolled in the study . Bone mineral density measurements were obtained at the proximal femur . In all subjects , 25-hydroxyvitamin D , 1,25-dihydroxyvitamin D , intact parathyroid hormone , osteocalcin , deoxypyridinoline , and ionized calcium concentrations were measured . Barthel Index and Motricity Index Leg Score were recorded all patients . Results : The serum concentrations of deoxypyridinoline , intact parathyroid hormone , and the mean serum ionized calcium levels were significantly higher in patients with stroke than that of the control subjects . The mean serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentrations in patients were significantly lower than those of the control group ( P The bone mineral density of proximal femurs of paretic limbs was decreased significantly compared with those of the control group ( P and the patients ’ Barthel Index , Motricity Index Leg Score , 25-hydroxyvitamin D , 1,25-dihydroxyvitamin D , calcium , and deoxypyridinoline . Conclusions : This study provides clear evidence that decreased mobility , vitamin D status , and bone turnover variables in patients after stroke are important factors in the greater bone loss in the paretic leg",
"To evaluate the loss of trabecular and cortical bone mineral density ( BMD ) and geometric parameters of bone strength expressed by stress-strain index ( SSI ) in the proximal and distal forearm and the alterations of BMD in the hip of hemiplegic patient and 12 mo after stroke . Sixty-seven hemiplegic patients ( 43 men and 24 women ) with a history of single completed strokes associated with unilateral weakness were enrolled in this prospect i ve study . All patients underwent bone densitometry measurements at 3 , 6 , and 12 mo after the initial episode of stroke . Both paretic and normal forearms were examined by peripheral quantitative computed tomography ( pQCT ) at the 4 % and 20 % sites of the forearm length and both hips were examined by dual-energy X-ray absorptiometry ( DXA ) including the area of femoral neck and greater trochanter . The diagnosis of stroke was confirmed by cranial computed tomography . Motor function was assessed by the functional ambulation category ( FAC ) and spasticity by the modified Ashworth scale ( MAS ) . We found statistically significant trabecular and cortical bone density reductions during the course of our study in the forearm , which was more profound on the paretic side . Trabecular bone loss and SSI measured at 4 % of the paretic forearm in the male group represented a 12-mo decrease of 14.01 % and 28.61 % , respectively , and in the female group 9.29 % and 19.17 % , respectively . Cortical bone and SSI measured at the 20 % site of paretic forearm in the male group corresponded to a 12-mo decrease of 4.02 % and 7.43 % , respectively , and in the female group 2.59 % and 6.97 % , respectively . Paretic femoral neck and trochanter measurements in males showed a reduction of 11.76 % and 10.38 % , respectively , and in females 13.04 % and 12.6 % , respectively . A significant loss of BMD and bone strength was found during the first year after stroke in both trabecular and cortical bone at the forearm and at the neck and great trochanter on the paretic hip . Most prominent BMD reduction was evident in men compared with perimenopausal women in the same age",
"OBJECTIVES To examine the effects of a community-based group exercise program for older individuals with chronic stroke . DESIGN Prospect i ve , single-blind , r and omized , controlled intervention trial . SETTING Intervention was community-based . Data collection was performed in a research laboratory located in a rehabilitation hospital . PARTICIPANTS Sixty-three older individuals ( aged > or = 50 ) with chronic stroke ( poststroke duration > or = 1 year ) who were living in the community . INTERVENTION Participants were r and omized into intervention group ( n=32 ) or control group ( n=31 ) . The intervention group underwent a fitness and mobility exercise ( FAME ) program design ed to improve cardiorespiratory fitness , mobility , leg muscle strength , balance , and hip bone mineral density ( BMD ) ( 1-hour sessions , three sessions/week , for 19 weeks ) . The control group underwent a seated upper extremity program . MEASUREMENTS Cardiorespiratory fitness ( maximal oxygen consumption ) , mobility ( 6-minute walk test ) , leg muscle strength ( isometric knee extension ) , balance ( Berg Balance Scale ) , activity and participation ( Physical Activity Scale for Individuals with Physical Disabilities ) , and femoral neck BMD ( using dual-energy x-ray absorptiometry ) . RESULTS The intervention group had significantly more gains in cardiorespiratory fitness , mobility , and paretic leg muscle strength than controls . Femoral neck BMD of the paretic leg was maintained in the intervention group , whereas a significant decline of the same occurred in controls . There was no significant time-by-group interaction for balance , activity and participation , nonparetic leg muscle strength , or nonparetic femoral neck BMD . CONCLUSION The FAME program is feasible and beneficial for improving some of the secondary complications result ing from physical inactivity in older adults living with stroke . It may serve as a good model of a community-based fitness program for preventing secondary diseases in older adults living with chronic conditions",
"Background and Purpose — Osteoporosis and stroke share several risk factors , including age , smoking , low physical activity , and hypertension . Thus , low bone mineral density ( BMD ) and high stroke risk may be related . We examined the relationship between BMD and acute stroke in noninstitutionalized men and women aged ≥60 years . Methods — Sixty-three stroke patients ( 33 women and 30 men ) and 188 control subjects from the general population were included . BMD was measured by using dual-energy x-ray absorptiometry at both proximal femurs . The measurements of the stroke patients were performed 6 days after the onset of stroke . Results — The BMD at the femoral neck in the female stroke patients was 8 % lower than in the control subjects ( P = 0.007 ) . In men , no difference in BMD between the stroke patients and their controls was found . Women with BMD values in the lowest quartile had a higher risk of stroke than women with BMD values in the highest quartile ( OR 4.8 ) , and the probability value for linear trend over the quartiles was statistically significant ( P = 0.003 ) . The OR for stroke increased 1.9 per SD ( 0.13 g/cm2 ) reduction in BMD , and the association between low BMD and stroke in women remained significant when the analysis was adjusted for potential confounders . Conclusions — Female , but not male , stroke patients have lower BMD than population controls . Low BMD may predict stroke in women",
"Objective Prolonged immobilization in stroke is known to result in hypercalciuria , hypercalcemia , accelerated bone resorption , and osteoporosis . Furthermore , bone mineral loss accelerated with increasing duration of hemiplegia . Although stroke is a common disease that causes sudden immobilization , relatively few investigations of bone metabolism in stroke have been reported . The aim of this study was to investigate the changes in bone mineral density of the forearms and legs related to duration of hemiplegia-induced immobilization after stroke . Methods Forty-one hemiplegic patients with stroke were evaluated . The patients ’ age , gender and duration of hemiplegia-induced immobilization were recorded . The measurements of bone mineral density ( BMD ) in all patients were evaluated with DEXA using the Norl and apparatus . The BMD values ( g/cm2 ) were determined by measurements made in the lumbar vertebrae , both forearm and legs ( femoral neck and trochanter ) . Results We found that bone mineral density was decreased in the affected extremities relative to the intact contralateral side on measurements by dual energy x-ray absorptiometry in bones such as forearm , femoral neck and trochanter . There was a significant difference between bone mineral density of paretic and nonparetic forearms and legs . Bone mineral density of the upper limbs was lower than that of the lower limbs . There was a negative correlation between duration of hemiplegia and BMD values . Conclusions Bone mineral loss may be related to the duration of hemiplegia-induced immobilization . Bone mineral loss is accelerated when the duration of hemiplegia is prolonged",
"The aim of this 1-year prospect i ve study of acute stroke patients was to determine the effects of walking and asymmetrical weight bearing on the loss of bone mineral in the upper and lower femoral neck . Forty patients were followed . Eight remained unable to walk , whereas 32 relearned to walk independently within 7 months ( 12 shortly after the stroke , 15 by 2 months , 5 by 7 months ) . Bone mineral density ( BMD ) was measured in the proximal femur within the first week after stroke and 1 year later ; regional BMD changes were computed for the lower and upper femoral neck . The lower part of the femoral neck is mainly influenced by compressive stresses of the hip , the upper part by tensile stresses during walking . When comparing mean BMD loss in groups of patients according to when they relearned to walk , a statistically significant trend in BMD loss was found in the lower femoral neck on both the paretic and nonparetic sides ( p /= 0.1 ) . In addition , the body weight distribution during st and ing was assessed by use of a force-plate in 38 patients who could st and independently at the 7 month evaluation . The only significant correlation between changes in BMD and asymmetrical weight bearing was found in the lower femoral neck on the paretic side ( r = 0.6 , p reduction in BMD in the femoral neck occurs mainly in the lower part of the neck and on the paretic side . The BMD loss depended on when or if the patients relearned to walk , but also on the amount of body weight born on the paretic leg . Thus , measuring the lower part of the femoral neck gives a better estimate of the impact of gait and weight bearing than measuring the total femoral neck"
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4116e534-06ff-11f0-808a-c43d1ab1c353
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Purpose The primary objective was to describe anxiety measurement instruments used in children and adolescents with cancer or undergoing hematopoietic stem cell transplantation ( HSCT ) and summarize their content and psychometric properties . Methods We conducted search es of MEDLINE , Embase , PsycINFO , HAPI , and CINAHL . We included studies that used at least one instrument to measure anxiety quantitatively in children or adolescents with cancer or undergoing HSCT . Two authors independently identified studies and abstract ed study demographics and instrument characteristics . Results Twenty-seven instruments , 14 multi-item and 13 single-item , were used between 78 studies . The most commonly used instrument was the State-Trait Anxiety Inventory in 46 studies . Three multi-item instruments ( Children ’s Manifest Anxiety Scale — M and arin version , PROMIS Pediatric Anxiety Short Form , and the State-Trait Anxiety Inventory ) and two single-item instruments ( Faces Pain Scale-Revised and 10-cm Visual Analogue Scale , both adapted for anxiety ) were found to be reliable and valid in children with cancer . Conclusions We identified 14 different multi-item and 13 different single-item anxiety measurement instruments that have been used in pediatric cancer or HSCT . Only three multi-item and two single-item instruments were identified as being reliable and valid among pediatric cancer or HSCT patients and would therefore be appropriate to measure anxiety in this population
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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",
"Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved",
"This paper compares parent- and self-report health-related quality of life ( HRQL ) in children aged 2 - 16 years with brain tumours , one , six and twelve months after diagnosis with matched normal controls . HRQL was assessed using the PedsQL generic core scales . 37 tumour patients and 42 controls were included in analysis of parent-report , and 27 patients and 31 controls in self-report HRQL . Parent-report scores were significantly lower in patients than controls for all PedsQL scores at all time points ( max p=0.002 ) . Differences in self-report PedsQL between patients and controls were variable . The relationship between self- and parent-report in patients and controls was inconsistent ; varied over time ; and did not consistently correlate with parental depressive symptoms , suggesting parents and their children do not regard HRQL in a similar way . Prospect i ve , longitudinal assessment of HRQL is important , but should be supplemented with other outcome measures such as health status and behaviour in this population",
"The authors prospect ively assessed anxiety , depression , and behavior in children with st and ard‐risk acute lymphoblastic leukemia ( SR‐ALL ) during the first year of therapy and identified associated risk factors",
"Background A number of r and omized trial studies and longitudinal research es emphasize that despite problems in social adjustment and cognitive damages , children with cancer demonstrate good emotional adjustment . Methods Most of the research findings in this area are obtained using objective tools such as question naires . “ Vitality of children ” , as a drawing tool , was used as a basis to draw a comparison between children with cancer and healthy children in this study . Accordingly , 112 children with cancer ( 5 girls and 57 boys aged 3 to 12 years ) and 123 healthy children ( 77 girls and 46 boys aged 3 to 12 years ) participated in the study . Results Findings showed that the vitality of the two groups differed significantly . Perhaps , children with cancer repress negative emotions and avoid expressing their feelings . MANOVA was used to compare the vitality scores between groups and to explore the impact of different variables . Conclusion Making use of such tools that indirectly examine the emotional experience of children with cancer would be beneficial . Neglecting this issue can cause children with cancer to be deprived of r receiving supportive counselling",
"Hypnosis was compared with nonhypnotic behavioral techniques for efficacy in reducing pain and anxiety in 27 children and adolescents during bone marrow aspiration and in 22 children and adolescents during lumbar puncture . The patients and independent observers each rated ( scale of 1 to 5 ) pain and anxiety during one to three procedures prior to intervention and one to three procedures with intervention . Prior to intervention for both groups , pain during bone marrow aspiration was rated as more severe ( P less than 0.01 ) than pain during lumbar puncture . During bone marrow aspiration pain was reduced to a large extent by hypnosis ( P less than 0.001 ) and to a smaller but significant extent by nonhypnotic techniques ( P less than 0.01 ) , and anxiety was significantly reduced by hypnosis alone ( P less than 0.001 ) . During lumbar puncture only hypnosis significantly reduced pain ( P less than 0.001 ) ; anxiety was reduced to a large degree by hypnosis ( P less than 0.001 ) and to a smaller degree by nonhypnotic techniques ( P less than 0.05 ) . Thus hypnosis was shown to be more effective than nonhypnotic techniques for reducing procedural distress in children and adolescents with cancer",
"Background : Chemotherapy is frequently administered in repetitive cycles . Adolescents with cancer have multiple symptoms related to chemotherapy , but knowledge of symptom trajectories across a cycle is limited . Examining trajectories over a cycle may reveal key periods to manage symptoms . Objectives : The aims of this pilot were to describe the trajectory of symptoms ( pain , sleep , appetite , nausea , fatigue ) and biological and behavioral variables ( anxiety , stress , hematologic function ) across 1 cycle and examine relationships between variables . Methods : Nine adolescents with cancer within 6 months of diagnosis participated . Data were collected by surveys , chart review , and biologic measures on days 1 and 2 of the cycle , 1 week later ( nadir ) , and day 1 of the following cycle . To evaluate the trajectory , a simple r and om-effects repeated- measures analysis was computed . Results : The significant trajectories were fatigue ( P = .003 ) , difficulty sleeping ( P = .032 ) , and nausea ( P = .04 ) . Most of the adolescents reported some anticipatory anxiety about receiving chemotherapy . Significant correlations between symptoms and biobehavioral variables included anticipatory anxiety and nausea ( r = .86 , P = .003 ) , trait anxiety and fatigue ( r = −0.82 , P , and stress and pain ( r = 0.78 , P = .039 ) . Conclusions : Multiple symptoms were experienced across the cycle . Three symptoms displayed significant trajectories indicating that patterns of symptoms may be anticipated . Implication s for Practice : Pilot findings suggest that monitoring symptoms , stress , and anxiety across a cycle is important , not only during chemotherapy administration , but also prior to being admitted for chemotherapy"
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4116e570-06ff-11f0-808a-c43d1ab1c353
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Background Data comparing duloxetine with existing antidepressant treatments is limited . A comparison of duloxetine with fluoxetine has been performed but no comparison with venlafaxine , the other antidepressant in the same therapeutic class with a significant market share , has been undertaken . In the absence of relevant data to assess the place that duloxetine should occupy in the therapeutic arsenal , indirect comparisons are the most rigorous way to go . We conducted a systematic review of the efficacy of duloxetine , fluoxetine and venlafaxine versus placebo in the treatment of Major Depressive Disorder ( MDD ) , and performed indirect comparisons through meta-regressions . Methods The bibliography of the Agency for Health Care Policy and Research and the CENTRAL , Medline , and Embase data bases were interrogated using advanced search strategies based on a combination of text and index terms . The search focused on r and omized placebo-controlled clinical trials involving adult patients treated for acute phase Major Depressive Disorder . All outcomes were derived to take account for varying placebo responses throughout studies . Primary outcome was treatment efficacy as measured by Hedge 's g effect size . Secondary outcomes were response and dropout rates as measured by log odds ratios . Meta-regressions were run to indirectly compare the drugs . Sensitivity analysis , assessing the influence of individual studies over the results , and the influence of patients ' characteristics were run . Results 22 studies involving fluoxetine , 9 involving duloxetine and 8 involving venlafaxine were selected . Using indirect comparison methodology , estimated effect sizes for efficacy compared with duloxetine were 0.11 [ -0.14;0.36 ] for fluoxetine and 0.22 [ 0.06;0.38 ] for venlafaxine . Response log odds ratios were -0.21 [ -0.44;0.03 ] , 0.70 [ 0.26;1.14 ] . Dropout log odds ratios were -0.02 [ -0.33;0.29 ] , 0.21 [ -0.13;0.55 ] . Sensitivity analyses showed that results were consistent . Conclusion Fluoxetine was not statistically different in either tolerability or efficacy when compared with duloxetine . Venlafaxine was significantly superior to duloxetine in all analyses except dropout rate . In the absence of relevant data from head-to-head comparison trials , results suggest that venlafaxine is superior compared with duloxetine and that duloxetine does not differentiate from fluoxetine
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"OBJECTIVE This analysis assessed the incidence , severity , onset , and duration of nausea among patients with major depressive disorder ( MDD ) treated with the new antidepressant duloxetine . METHODS Data were pooled from 8 double-blind , r and omized , placebo- and active comparator-controlled trials employing patients with MDD that were su bmi tted to the US Food and Drug Administration to support duloxetine 's new drug application for treatment of MDD . RESULTS The numbers of patients receiving each regimen were as follows : placebo , n = 777 ; duloxetine 40 mg/d , n = 177 ; duloxetine 60 mg/d , n = 251 ; duloxetine 80 mg/d , n = 363 ; duloxetine 120 mg/d , n = 348 ; paroxetine 20 mg/d , n = 359 ; and fluoxetine 20 mg/d , n = 70 . In acute placebo-controlled trials of duloxetine 40 to 120 mg/d , treatment-emergent nausea was reported by more duloxetine-treated patients than those receiving placebo ( 19.9 % [ 227/1139 ] vs 6.9 % [ 154/777 ] , respectively ; P duloxetine-treated patients , the median time to onset of nausea was 1 day , and the median duration of nausea was 7 days . The incidence of nausea was similar to placebo rates after 1 week . In paroxetine-controlled studies , the incidence of treatment-emergent nausea in patients receiving duloxetine did not differ significantly from paroxetine ( 14.4 % vs 12.0 % , respectively ) . In head-to-head studies , the incidence of treatment-emergent nausea with duloxetine did not differ significantly from that with fluoxetine ( 17.1 % vs 15.7 % , respectively ) . Most duloxetine-treated patients reported nausea to be mild ( 52.9 % ) or moderate ( 41.4 % ) . Treatment discontinuation secondary to nausea occurred in more duloxetine-treated patients than those receiving placebo ( 1.4 % [ 16/1139 ] vs 0.1 % [ 1/777 ] , respectively ; P = 0.002 ) . Following abrupt discontinuation after acute treatment , 5.9 % of duloxetine-treated patients exhibited nausea compared with 0.3 % of patients receiving placebo ( P treatment-emergent nausea during 6-month continuation of duloxetine treatment ( 80 mg/d , 2.1 % ; 120 mg/d , 1.3 % ) was similar to placebo ( 1.6 % ) . Following abrupt discontinuation after 8 months of treatment , nausea was reported by 1.6 % of patients receiving duloxetine 120 mg/d compared with 0 % for those receiving duloxetine 80 mg/d and 0 % for placebo . CONCLUSIONS Duloxetine induced mild to moderate nausea in a subset of patients with MDD during treatment initiation . Nausea resolved rapidly with continued treatment . The incidence of duloxetine-induced nausea resembled that produced by paroxetine and fluoxetine",
"Pramipexole , a dopamine D2 receptor agonist , was tested in 174 patients with major depression , with or without melancholia and without psychotic features . Three daily dose levels ( 0.375 mg , 1.0 mg , and 5.0 mg ) were compared to fluoxetine ( Prozac ) at 20 mg and placebo in a r and omized , double-blind , parallel-group study . After a 1 week placebo run-in period , patients were treated for 8 weeks , had a post- study follow-up ( week 9 ) , and were evaluated primarily with the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Clinician 's Global Impressions-Severity of Illness scale ( CGI-SI ) . All patients who received one dose of study medication were included in the observed-case analysis ( no missing data were replaced ) . Results indicated that by endpoint ( week 8) , patients receiving pramipexole at the 1.0 mg per day dose had significant improvement over baseline compared to the placebo group by measure of the HAM-D , MADRS , and CGI-SI . Significant improvement in this dose group was seen at other timepoints as well . The most obvious improvement was seen in the pramipexole 5.0 mg group , although a substantial dropout rate for this group precluded statistical tests vs. placebo late in the study . Patients taking fluoxetine also showed significant improvements at endpoint on the MADRS and earlier in the study on the HAM-D. No new or unusual safety concerns were generated during this study . Pramipexole helped safely alleviate the symptoms of depression at 1.0 mg per day and especially in those patients who could tolerate the escalation to 5 mg per day",
"Fluoxetine , a selective serotonin reuptake inhibitor , was compared with mianserin and placebo in a double‐blind study . In total , 81 depressed patients were included . Patients were rated weekly on the Hamilton Depression Rating Scale ( HDRS ) and the Montgomery & Asberg Depression Rating Scale ( MADRS ) . The duration was 6 weeks , and 52 patients completed the study . Significantly more patients on fluoxetine improved than patients on placebo . For mianserin no significant differences were found with either fluoxetine or placebo . Mean HDRS at the end of the study was also statistically significantly lower for fluoxetine , but not for mianserin , than placebo . Subscores of the MADRS showed improved sleep on mianserin at weeks 2 and 3 . Suicidal feelings were reduced to a greater degree on fluoxetine than on mianserin and placebo at weeks 6 and 7 . Fluoxetine induced weight loss , while patients on mianserin gained weight . Side effects were present in most patients on the two active drugs ; those on fluoxetine experienced nausea and vomiting , and those on mianserin drowsiness",
"BACKGROUND We compared the efficacy and tolerability of venlafaxine XR with that of fluoxetine in a multicenter , r and omized , double-blind , placebo-controlled study in depressed out patients . METHODS Out patients , 18 years and older , who met DSM-IV criteria for major depressive disorder were included ( n = 301 r and omized ; 232 completed ) . Patients were r and omly assigned to eight weeks of treatment with either venlafaxine XR 75 - 225 mg/day ( n = 100 ) , fluoxetine 20 - 60 mg/day ( n = 103 ) , or placebo ( n = 98 ) . The primary efficacy outcome measures were the final ratings on the Hamilton Rating Scale for Depression ( HAM-D21 ) total score , HAM-D21 depressed mood item , Montgomery-Asberg Depression Rating Scale total score , and Clinical Global Impressions Scale . RESULTS Withdrawal from the study due to adverse events occurred in 6 % of the patients in the venlafaxine XR group and 9 % of the patients in the fluoxetine group . Patients treated with venlafaxine XR , but only rarely those treated with fluoxetine , had statistically significant improvements in their depression ratings compared with placebo at the end of the study . The percentages of patients who achieved full remission of their depression ( HAM-D21 total score venlafaxine XR , fluoxetine and placebo groups , respectively . The differences in remission rates between venlafaxine XR and the other groups were statistically significant ( p remission outcome observed with venlafaxine XR treatment needs to be replicated in additional studies . CONCLUSION Venlafaxine XR is a well-tolerated and efficacious treatment for depression . The results of this study suggest that venlafaxine XR is as well-tolerated as fluoxetine but may have some efficacy advantages over fluoxetine",
"BACKGROUND While emotional symptoms such as depressed mood and loss of interest have traditionally been considered to constitute the core symptoms of major depressive disorder ( MDD ) , the prevalence and importance of painful physical symptoms such as back pain , abdominal pain , and musculoskeletal pain is becoming increasingly appreciated . Antidepressants possessing dual serotonin/norepinephrine ( 5-HT/NE ) reuptake inhibition may demonstrate greater efficacy in the alleviation of pain . The efficacy of duloxetine , a balanced and potent dual reuptake inhibitor of 5-HT and NE , was evaluated within a cohort of depressed patients with associated painful physical symptoms . METHODS In this multicenter , double-blind , placebo-controlled study , patients meeting DSM-IV criteria for MDD were r and omized to receive placebo ( N=141 ) or duloxetine 60 mg QD ( N=141 ) . Patients were required to have a 17-item Hamilton Rating Scale for Depression ( HAMD17 ) total score 15 , a Clinical Global Impression of Severity ( CGI-S ) score 4 , and a Brief Pain Inventory ( BPI ) Average Pain score 2 at baseline . The primary efficacy measure was the BPI Average Pain score , while secondary measures included other BPI items , the HAMD17 total score , CGI-S , the Patient Global Impression of Improvement ( PGI-I ) scale , Visual Analog Scales ( VAS ) for pain , and the Symptom Question naire , Somatic Subscale ( SQSS ) . Safety was evaluated by recording treatment-emergent adverse events ( spontaneously reported ) , vital signs , and laboratory analytes . RESULTS Mean changes in BPI Average Pain for duloxetine- and placebo-treated patients differed significantly at most visits , but only approached significance at endpoint p=0.066 . For the main effect of treatment ( pooling all visits ) , significant advantages for duloxetine-treated patients were found in 10 of 11 assessed BPI pain severity and pain interference items , in addition to VAS overall pain and back pain . Mean changes in pain measures for duloxetine-treated patients corresponded to improvements of 25 - 50 % , compared with 19 - 39 % for placebo . Mean changes at endpoint in depression rating scales ( HAMD17 , CGI-S , PGI-I ) did not differ significantly between duloxetine and placebo treatment groups due to unusually high placebo response . The magnitude of placebo treatment effects ( as measured by HAMD17 total score and Maier subscale ) was significantly smaller in patients with 1 previous depressive episode , compared to those patients with no previous episodes . In patients with 1 previous depressive episode the advantage of duloxetine over placebo was similar to previous studies . Rates of discontinuation due to adverse events were 14.2 % vs. 2.1 % for duloxetine and placebo , respectively p nausea , dry mouth , fatigue , and decreased appetite . CONCLUSIONS In this study , duloxetine ( 60 mg QD ) was shown to be an effective treatment for the painful physical symptoms which are frequently associated with depression . Improvements in pain severity occurred independently of changes in depressive symptom severity",
"Existing therapies for major depressive disorder ( MDD ) have either limited efficacy and /or poor tolerability . The present study examined the effects of duloxetine , a potent and balanced dual reuptake inhibitor of serotonin ( 5-HT ) and norepinephrine ( NE ) , in patients with MDD . Adult patients ( N = 267 ) with MDD were r and omly assigned to receive duloxetine ( 60 mg/day ) or placebo in this 9-week , multi-center , double-blind , parallel-group clinical trial . Efficacy was evaluated using the 17-item Hamilton Depression Rating Scale ( HAMD(17 ) ) , Visual Analog Scales ( VAS ) for pain , Clinical Global Impression of Severity ( CGI-S ) , Patient 's Global Impression of Improvement ( PGI-I ) , and Quality of Life in Depression Scale ( QLDS ) . Safety was evaluated by assessing discontinuation rates , adverse event rates , vital signs , and laboratory tests . Duloxetine ( 60 mg QD ) significantly reduced the HAMD(17 ) total score compared with placebo at the end of 9-week therapy . Estimated probabilities of response and remission were 65 and 43 % , respectively , for duloxetine compared with 42 and 28 % for placebo . Duloxetine also reduced overall pain , back pain , shoulder pain and time in pain while awake significantly more than placebo . Global measures of improvement , including PGI-I and QLDS , were significantly improved by duloxetine compared with placebo . Discontinuations due to adverse events were more frequent for duloxetine-treated patients ( 12.5 % ) than for placebo-treated patients ( 4.3 % ) . Nausea , dry mouth , dizziness , and constipation were more frequent for duloxetine than placebo . There was no significant incidence of hypertension , nor any other safety issues . Duloxetine 60 mg administered once daily appears to be a safe and effective treatment for MDD",
"BACKGROUND Duloxetine is a balanced and potent dual reuptake inhibitor of serotonin ( 5-HT ) and norepinephrine ( NE ) that has previously been shown to be effective in the acute treatment of major depressive disorder ( MDD ) . This placebo-controlled study assesses the safety and efficacy of duloxetine ( 80 or 120 mg/day ) and paroxetine ( 20 mg QD ) during an initial 8-week acute phase and subsequent 6-month continuation phase treatment of MDD . METHOD In this r and omized , double-blind , placebo-controlled trial , adult out patients ( age > or= 18 years ) meeting DSM-IV criteria for MDD received placebo ( n = 93 ) , duloxetine 80 mg/day ( 40 mg BID ; n = 95 ) , duloxetine 120 mg/day ( 60 mg BID ; n = 93 ) , or paroxetine ( 20 mg QD ; n = 86 ) for 8 weeks . Patients who had a > or= 30 % reduction from baseline in HAMD(17 ) total score during the acute phase were allowed to continue on the same ( blinded ) treatment for a 6-month continuation phase . Efficacy measures included the 17-item Hamilton Rating Scale for Depression ( HAMD(17 ) ) total score , HAMD(17 ) subscales , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , the Hamilton Anxiety Rating Scale ( HAMA ) , Visual Analog Scales ( VAS ) for pain , the Clinical Global Impression of Severity ( CGI-S ) and Patient Global Impression of Improvement ( PGI-I ) scales , the 28-item Somatic Symptom Inventory ( SSI ) , and the Sheehan Disability Scale ( SDS ) . Safety and tolerability were assessed using treatment-emergent adverse events , discontinuations due to adverse events , vital signs , ECGs , laboratory tests , and the Arizona Sexual Experiences Scale ( ASEX ) . RESULTS During the acute phase , patients receiving duloxetine 80 mg/day , duloxetine 120 mg/day , or paroxetine 20 mg QD had significantly greater reductions in HAMD(17 ) total score compared with placebo . Both duloxetine ( 80 and 120 mg/day ) and paroxetine treatment groups had significantly greater improvement , compared with placebo , in MADRS , HAMA , CGI-S , and PGI-I scales . Estimated probabilities of remission at week 8 for patients receiving duloxetine 80 mg/day ( 51 % ) , duloxetine 120 mg/day ( 58 % ) , and paroxetine ( 47 % ) were significantly greater compared with those receiving placebo ( 30 % ) . The rate of discontinuation due to adverse events among duloxetine-treated patients ( 80 and 120 mg/day ) did not differ significantly from the rate in the placebo group . Treatment-emergent adverse events reported significantly more frequently by duloxetine-treated patients than by patients receiving placebo were constipation ( 80 and 120 mg/day ) , increased sweating ( 120 mg/day ) , and somnolence ( 120 mg/day ) . The incidence of acute treatment-emergent sexual dysfunction in duloxetine- and paroxetine-treated patients was 46.5 % and 62.8 % , respectively . During the 6-month continuation phase , duloxetine ( 80 and 120 mg/day ) and paroxetine treatment groups demonstrated significant improvement in HAMD(17 ) total score . Treatment-emergent adverse events occurring most frequently in each active treatment group during the continuation phase were viral infection ( duloxetine 80 mg/day ) , diarrhea ( duloxetine 120 mg/day ) , and headache ( paroxetine 20 mg QD ) . CONCLUSION These data support previous findings that duloxetine is safe , efficacious , and well tolerated in the acute treatment of MDD . Furthermore , these data provide the first demonstration under double-blind , placebo-controlled conditions that the efficacy and tolerability of duloxetine are maintained during chronic treatment",
"In a double-blind , placebo-controlled study the authors found that fluoxetine , a potent and selective inhibitor of serotonin reuptake , was an effective antidepressant in moderately depressed , ambulatory out patients . Typical adverse effects reported by patients treated with fluoxetine included agitation , nausea , fatigue , and insomnia . Compared to imipramine , fluoxetine was associated with fewer complaints of dry mouth , constipation , and dizziness",
"BACKGROUND We conducted a r and omized , double-blind , placebo-controlled study of the efficacy and safety of once-daily venlafaxine extended release ( XR ) and fluoxetine in out patients with major depression and concomitant anxiety . METHOD Patients who met DSM-IV criteria for major depressive disorder and satisfied eligibility criteria were r and omly assigned to once-daily venlafaxine XR , fluoxetine , or placebo for 12 weeks . Efficacy was assessed with the Hamilton Rating Scale for Depression ( HAM-D ) , Hamilton Rating Scale for Anxiety ( HAM-A ) , and Clinical Global Impressions scale . RESULTS Among 359 out patients , venlafaxine XR and fluoxetine were significantly superior ( p placebo on the HAM-D total score beginning at week 2 and continuing to the end of the study . Venlafaxine XR but not fluoxetine was significantly better than placebo at week 2 on the HAM-D depressed mood item . At week 12 , the HAM-D response rate was 43 % on placebo , 67 % on venlafaxine XR , and 62 % on fluoxetine ( p HAM-D remission rate was significantly higher ( p venlafaxine XR and at weeks 8 , 12 , and final evaluation with fluoxetine than with placebo . The HAM-A response rate was significantly higher ( p venlafaxine XR than with fluoxetine at week 12 . The incidence of discontinuation for adverse events was 5 % with placebo , 10 % with venlafaxine XR , and 7 % with fluoxetine . CONCLUSION Once-daily venlafaxine XR is effective and well tolerated for the treatment of major depression and concomitant anxiety and provides evidence for superiority over fluoxetine",
"We report results from a multicenter , placebo-controlled , r and omized , double-blind comparison of the efficacy and tolerability of paroxetine and fluoxetine in out patients with major depression . Across five U.S. sites , 128 out patients ( mean age : 41.3 + /- 12.6 ; 63 men and 65 women ) with moderate to moderately severe major depression without a history of mania or hypomania were recruited between 1993 and 1994 . All 128 patients completed a 1-week placebo washout period , and were then r and omized to 12 weeks of double-blind treatment with paroxetine up to 50 mg/day ( n = 55 ) , fluoxetine up to 80 mg/day ( n = 54 ) , or placebo ( n = 19 ) . Subjects were evaluated weekly for the first 4 weeks , then at weeks 6 , 9 , and 12 with the 21-item HAMD and the Covi Anxiety Scale . There were no significant differences among the three treatment groups in baseline and endpoint depression and anxiety severity , as well as in the degree of depression and anxiety improvement . There were no statistically significant differences in rates or mean numbers of adverse events between paroxetine-treated patients and fluoxetine-treated patients . In summary , our results , although limited by the lack of a significant difference from placebo in treatment outcome , suggest that the SSRIs paroxetine and fluoxetine have comparable antidepressant and antianxiety efficacies among depressed out patients , as well as similar safety and tolerability profiles",
"A 6-week double-blind trial of fluoxetine treatment of unipolar major depressive disorder in 49 patients was evaluated in terms of improvement in the Hamilton Depression Rating Scale ( HDRS ) and Clinical Global Improvement ( CGI ) scores . A relationship was found between change in HDRS ( absolute and percentage decrease from baseline ) and final CGI ratings . However , because of a few placebo-responders , endpoint analysis with both the HDRS and CGI showed no differences between active drug and placebo . Pattern analysis of persistent response did successively separate active drug from placebo ( < 0.05 )",
"The efficacy of fluoxetine was evaluated in depressed patients in double-blind imipramine- and placebo-controlled clinical trials . Fluoxetine produced greater improvement than placebo on all major efficacy parameters and was comparable to imipramine with respect to the primary indicators of depression . Fluoxetine had significantly less associated anticholinergic effects , dizziness , drowsiness , somatosensory disturbance , and excessive sweating than imipramine . Although nausea occurred more frequently in fluoxetine patients , it was generally mild and well tolerated . A significantly smaller percentage of fluoxetine than imipramine patients terminated therapy because of adverse experiences ",
"The efficacy and safety of fluoxetine were compared with those of imipramine and of placebo in a 6-week r and omized double-blind parallel study of patients with major depressive illness . Mean values for all efficacy measurements were improved over baseline with fluoxetine and imipramine treatment ( p less than .001 ) . More fluoxetine patients completed the study than did imipramine or placebo patients . Predominant adverse experiences reported by imipramine patients were dry mouth and dizziness/lightheadedness . Predominant adverse experiences reported by fluoxetine patients were drowsiness/sedation and excessive sweating . In a subsequent 48-week open-label study , the predominant adverse experience in the fluoxetine group was excessive sweating and in the imipramine group was still dry mouth . In this study , fluoxetine relieved the symptoms of major depressive illness effectively and significantly better than placebo and was better tolerated than imipramine",
"BACKGROUND Despite treatment advances , major depressive disorder ( MDD ) is still a significant cause of morbidity and mortality . Current therapies frequently fall short of providing full remission . In addition , physical symptoms are commonly seen in MDD patients , increasing overall morbidity and health care utilization . Duloxetine hydrochloride , a dual reuptake inhibitor of serotonin and norepinephrine , was evaluated for efficacy and tolerability/safety in the treatment of MDD and associated physical symptoms . METHOD In this multicenter , double-blind , parallel-group study , adult patients with DSM-IV MDD were r and omly assigned to receive placebo ( N = 122 ) or duloxetine ( 60 mg/day , N = 123 ) for 9 weeks . The primary efficacy measure was the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score . Painful physical symptoms were assessed using visual analog scales , and global illness and quality of life were evaluated using the Clinical Global Impressions-Severity scale , the Patient Global Impressions-Improvement scale , and the Quality of Life in Depression Scale . Safety and tolerability were determined by monitoring discontinuation rates , adverse events , vital signs , and laboratory results . RESULTS Duloxetine was significantly superior to placebo ( p HAM-D-17 total scores , starting at week 2 . The estimated probability of remission for duloxetine-treated patients ( 44 % ) was almost 3 times that of placebo patients ( 16 % ) . Duloxetine significantly reduced painful physical symptoms in comparison with placebo . Discontinuation due to adverse events for duloxetine-treated patients ( 13.8 % ) compared favorably with the rates reported for SSRIs in other studies . Nausea , dry mouth , and somnolence were the most common adverse events ; no significant incidence of hypertension was seen . CONCLUSION Duloxetine , 60 mg/day , is a well-tolerated and effective treatment for MDD that reduces painful physical symptoms . These findings suggest that duloxetine may be a first-line treatment for patients with MDD and associated painful physical symptoms",
"BACKGROUND This was a r and omized , double-blind , placebo-controlled evaluation of the efficacy and safety of once-daily venlafaxine extended release ( XR ) in out- patients with DSM-IV major depression . METHOD Patients were r and omly assigned to venlafaxine XR ( 75 - 225 mg ) once daily or placebo for up to 8 weeks . The primary efficacy variables were the 21-item Hamilton Rating Scale for Depression ( HAM-D ) total score and HAM-D depressed mood item , the Montgomery-Asberg Depression Rating Scale ( MADRS ) total scores , and the Clinical Global Impressions ( CGI ) Severity scale . Data were analyzed on a modified intent-to-treat basis using the last-observation-carried-forward method . RESULTS Venlafaxine XR ( N = 91 ) was significantly more effective than placebo ( N = 100 ) beginning at Week 2 on the CGI Severity scale , at Week 3 on the HAM-D depressed mood item , and at Week 4 on the HAM-D and MADRS ; this superiority was maintained through Week 8 . The most common treatment-emergent adverse events associated with venlafaxine XR were nausea , insomnia , and somnolence . The incidence of nausea was highest during the first week , decreased by 50 % during the second week , and was comparable to that of placebo from Week 3 onward . CONCLUSION These results demonstrate that venlafaxine XR is an effective and well-tolerated treatment of major depression",
"BACKGROUND Many antidepressants are associated with sexual dysfunction , a side effect that may lead to patients ' dissatisfaction and noncompliance with treatment . OBJECTIVE This study compared the efficacy , tolerability , and effects on sexual functioning of bupropion sustained release ( bupropion SR ) and the selective serotonin reuptake inhibitor fluoxetine . METHODS In this multicenter , r and omized , double-blind , double-dummy , parallel-group study , patients with recurrent major depression were treated with bupropion SR 150 to 400 mg/d , fluoxetine 20 to 60 mg/d , or placebo for up to 8 weeks . Depression and sexual-functioning status were assessed by site-specific trained investigators at weekly clinic visits ; tolerability was assessed primarily by monitoring adverse events . RESULTS Four hundred fifty-six patients participated in the study , 150 receiving bupropion SR , 154 fluoxetine , and 152 placebo . The majority of patients in each group completed the study ( 63 % each , bupropion SR [ n = 94 ] and fluoxetine [ n = 97 ] ; 67 % , placebo [ n = 102 ] ) . Bupropion SR and fluoxetine were similarly effective in the treatment of depressive symptoms . Beginning at week 2 and continuing throughout the study , significantly more fluoxetine-treated patients experienced orgasm dysfunction than did patients receiving bupropion SR or placebo ( P or = 50 % decrease from baseline in 21-item Hamilton Rating Scale for Depression [ HAM-D ] total score ) ( P worsened sexual functioning , sexual desire disorder , sexual arousal disorder , and dissatisfaction with sexual functioning in those satistied at baseline were more frequently associated with fluoxetine treatment than with bupropion SR or placebo . Both active treatments were well tolerated . CONCLUSIONS Bupropion SR and fluoxetine were similarly effective and well tolerated in the treatment of depression . Fluoxetine , however , was more frequently associated with sexual dysfunction compared with bupropion SR . Bupropion SR may be an appropriate initial choice for the treatment of depression in patients concerned about sexual functioning",
"Fluoxetine ( 20 mg/day ) and placebo were compared in 89 outpatient men and women with major depression with ( n = 52 ) or without ( n = 37 ) DSM-III-R melancholia in an 8-week double-blind study to determine predictors of treatment response . Fluoxetine was statistically superior to placebo both within the melancholic subtype and in the total patient group ( all measures ) . Response rate and mean decrease in 17-item Hamilton Depression Rating Scale total score approached statistical significance in favor of fluoxetine-treated melancholic patients compared with fluoxetine-treated non-melancholic patients . There were no statistically significant differences between fluoxetine-treated and placebo-treated non-melancholic patients . Results support DSM-III-R melancholia as a predictor of antidepressant response",
"OBJECTIVES To survey the frequency of use of indirect comparisons in systematic review s and evaluate the methods used in their analysis and interpretation . Also to identify alternative statistical approaches for the analysis of indirect comparisons , to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within review s. DATA SOURCES Electronic data bases . REVIEW METHODS The Data base of Abstract s of Review s of Effects ( DARE ) was search ed for systematic review s involving meta- analysis of r and omised controlled trials ( RCTs ) that reported both direct and indirect comparisons , or indirect comparisons alone . A systematic review of MEDLINE and other data bases was carried out to identify published methods for analysing indirect comparisons . Study design s were created using data from the International Stroke Trial . R and om sample s of patients receiving aspirin , heparin or placebo in 16 centres were used to create meta-analyses , with half of the trials comparing aspirin and placebo and half heparin and placebo . Methods for indirect comparisons were used to estimate the contrast between aspirin and heparin . The whole process was repeated 1000 times and the results were compared with direct comparisons and also theoretical results . Further detailed case studies comparing the results from both direct and indirect comparisons of the same effects were undertaken . RESULTS Of the review s identified through DARE , 31/327 ( 9.5 % ) included indirect comparisons . A further five review s including indirect comparisons were identified through electronic search ing . Few review s carried out a formal analysis and some based analysis on the naive addition of data from the treatment arms of interest . Few method ological papers were identified . Some valid approaches for aggregate data that could be applied using st and ard software were found : the adjusted indirect comparison , meta-regression and , for binary data only , multiple logistic regression ( fixed effect models only ) . Simulation studies showed that the naive method is liable to bias and also produces over-precise answers . Several methods provide correct answers if strong but unverifiable assumptions are fulfilled . Four times as many similarly sized trials are needed for the indirect approach to have the same power as directly r and omised comparisons . Detailed case studies comparing direct and indirect comparisons of the same effect show considerable statistical discrepancies , but the direction of such discrepancy is unpredictable . CONCLUSIONS Direct evidence from good- quality RCTs should be used wherever possible . Without this evidence , it may be necessary to look for indirect comparisons from RCTs . However , the results may be susceptible to bias . When making indirect comparisons within a systematic review , an adjusted indirect comparison method should ideally be used employing the r and om effects model . If both direct and indirect comparisons are possible within a review , it is recommended that these be done separately before considering whether to pool data . There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect . Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons . Research into how evidence from indirect comparisons compares to that from non-r and omised studies may also be warranted . Investigations using individual patient data from a meta- analysis of several RCTs using different protocol s and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful",
"Results are presented of the first double-blind , placebo-controlled trial of a novel antidepressant venlafaxine , which pre clinical ly has demonstrated serotonin , norepinephrine , and dopamine reuptake inhibiting effects . Sixty out patients meeting DSM-III-R criteria for major depression were r and omized to receive 6 weeks of treatment with one of three fixed doses of venlafaxine—25 mg three times a day , 75 mg three times a day , or 125 mg three times a day — or placebo . Significant improvement was observed in depression scores at all doses , with the high dose result ing in earlier improvement , by week 2 . For the combined venlafaxine treatment groups , 68 % achieved a moderate or marked improvement on the Clinical Global Impression scale , compared with only 31 % for the placebo group . Venlafaxine was well tolerated , and nervousness , sweating , and nausea were the only adverse effects observed more frequently with drug compared with placebo",
"In a multicentered study , 372 patients with mild major depressive disorder with a Hamilton Rating Scale for Depression ( HAM-D ) score of 15 to 19 were r and omly assigned to 6 weeks of treatment with placebo or 20 mg , 40 mg , or 60 mg/day of fluoxetine . Patients were rated weekly for improvement and the appearance of side effects . Pattern analysis of treatment response showed more patients in the active drug treatment groups having a persistent or a delayed persistent response , the types of response specifically associated with active treatment . Analyses of mean changes in treatment measures showed little difference among treatment groups . This may be explained in part by different distributions in outcome , placebo patients having had a higher frequency of mild improvement with fewer negative and very positive outcomes . Response rate analyses favor the active treatments numerically , but only one of the comparisons is statistically significant . These findings suggest a specific role for fluoxetine treatment in mildly depressed patients who do not respond promptly or who respond inconsistently to nonspecific treatment",
"BACKGROUND Duloxetine hydrochloride , a dual reuptake inhibitor of serotonin and norepinephrine , was evaluated for therapeutic efficacy and safety/tolerability in the treatment of major depression . METHOD In an 8-week multicenter , double-blind , placebo-controlled study , 173 patients ( aged 18 - 65 years ) with DSM-IV major depressive disorder were r and omly allocated to receive placebo ( N = 70 ) , duloxetine ( N = 70 ) , or fluoxetine , 20 mg q.d . ( N = 33 ) . Duloxetine dose was titrated in the first 3 weeks in a forced-titration regimen from 40 mg ( 20 mg b.i.d . ) to 120 mg/day ( 60 mg b.i.d . ) . Patients were required to have a Clinical Global Impressions (CGI)-Severity of Illness scale score of at least moderate severity ( > or = 4 ) and a 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score of at least 15 . Patients could not have had any current primary DSM-IV Axis I diagnosis other than major depressive disorder , or any anxiety disorder as a primary diagnosis within the past year , excluding specific phobias . The primary efficacy measurement was the HAM-D-17 total score , and secondary measures included the Montgomery-Asberg Depression Rating Scale , CGI-Severity of Illness and CGI-Improvement , and Patient Global Impression of Improvement . Safety was evaluated by recording the occurrence of discontinuation rates and treatment-emergent adverse events and by measurement of vital signs and laboratory analytes . RESULTS Duloxetine was superior to placebo in change on the HAM-D-17 ( p = .009 ) . Estimated probabilities of response and remission were 64 % and 56 % , respectively , for duloxetine , compared with 52 % and 30 % for fluoxetine and 48 % and 32 % for placebo . Duloxetine was numerically superior to fluoxetine on the primary and most of the secondary outcome measures . In general , duloxetine was well tolerated ; 76 % of patients achieved the maximum dose , and insomnia and asthenia were the only adverse events reported statistically significantly ( p duloxetine-treated patients compared with placebo-treated patients . CONCLUSION These data indicate that duloxetine is efficacious for the treatment of major depressive disorder and is well tolerated and safe",
"This paper aims to explore the potential usefulness and limitations of indirect comparisons in evaluating the relative efficacy of interventions . From a systematic review of antimicrobial prophylaxis in colorectal surgery , we identified 11 sets of r and omized trials that can be used to compare antibiotics both directly and indirectly . The discrepancy between the direct and the indirect comparison is defined as the absolute value of difference in log odds ratio . The adjusted indirect comparison has the advantages that the prognostic factors of participants in different trials can be partially taken into account and more uncertainty be incorporated into its result by providing a wider confidence interval . However , considerable discrepancies exist between the direct and the adjusted indirect comparisons . When there is no direct comparison , the adjusted indirect method may be used to obtain some evidence about the relative efficacy of competing interventions , although such indirect results should be interpreted with great caution . Further empirical and method ologic research is needed to explore the validity and generalizability of the adjusted indirect comparison for evaluating different interventions",
"Fixed daily doses of 20 mg , 40 mg , or 60 mg of fluoxetine , a highly specific serotonin reuptake inhibitor , were given to 84 depressed out patients in a double-blind , placebo-controlled , r and omized 6-week trial . The 20-mg dose produced improvement of depression in the moderate-severe depression group as expressed in significant reductions of scores on the Hamilton Rating Scale for Depression ( p greater than or equal to .007 ) and the Patient Global Impressions scale ( p greater than or equal to .011 ) , and the 20-mg dose caused fewer side effects than did the higher doses . A mildly depressed group of patients showed no improvement at any dose level of fluoxetine",
"BACKGROUND Venlafaxine is a new phenylethylamine antidepressant that exhibits monoamine reuptake inhibition . The current study evaluates the efficacy of venlafaxine compared to that of imipramine in out patients suffering from major depression of moderate-to-marked severity . METHOD We conducted a double-blind , placebo-controlled , 6-week treatment study of 224 out patients who met DSM-III-R criteria for major depression , and who had a score of at least 20 on the 21-item Hamilton Rating Scale for Depression ( HAM-D ) . Dosage was flexible and administered on a three-times-a-day schedule , with a mean maximum daily dose of 182 mg for venlafaxine and 176 mg for imipramine . RESULTS For patients completing 6 weeks of treatment with venlafaxine , the HAM-D total score improved by 16.6 + /- 4.9 points . Improvement at 6 weeks was 13.6 + /- 6.3 points for patients treated with imipramine and 10.6 + /- 7.8 points for patients treated with placebo ( p placebo ) . Ninety percent of venlafaxine completers were rated as \" much \" or \" very much \" improved on the Clinical Global Impression-Improvement scale , compared to 79 % treated with imipramine and 53 % treated with placebo ( p efficacy only for venlafaxine and not imipramine , probably because of the higher attrition for the latter drug . Overall , both venlafaxine and imipramine were well-tolerated , with venlafaxine having a somewhat lower attrition rate due to adverse effects than imipramine ( 16 % vs. 25 % ) . CONCLUSION These results , together with those of previously reported studies , suggest that venlafaxine has antidepressant efficacy comparable to that provided by available antidepressants",
"A double-blind , placebo-controlled trial was undertaken to compare the safety and efficacy of venlafaxine and trazodone in patients with major depression . Two hundred twenty-five patients entered an initial 6-week treatment phase , and 149 completed it . Ninety-six patients who were responders continued in a 1-year , double-blind , long-term phase during which they received the same medication and doses they had during the short-term phase . Both active treatments were significantly more effective than placebo on some measures during the short-term study , but venlafaxine produced more improvement in the cognitive disturbance and retardation factors on the Hamilton Rating Scale for Depression . Trazodone was more effective against the sleep disturbance factor . Patients on venlafaxine were most likely to enter the long-term phase and to remain in the trial longest . The side effect profiles of the three treatment groups were compared . Venlafaxine was most likely to cause nausea , whereas trazodone was associated with the most dizziness and somnolence",
"Venlafaxine is a structurally novel compound with a biochemical and pharmacological profile suggesting antidepressant properties . We report the results of a Phase II , double-blind , placebo-controlled clinical trial assessing the efficacy and safety of venlafaxine in a sample of 93 depressed out patients . Venlafaxine doses of 25 mg t.i.d . , 75 mg t.i.d . , and 125 mg t.i.d . were compared to placebo . Patients receiving venlafaxine showed a significantly greater improvement in their mood symptoms compared to those receiving placebo . Venlafaxine was well tolerated and the most common side effect was nausea . There was some evidence to suggest that venlafaxine may have antidepressant activity within the first 2 weeks of treatment",
"Fluoxetine is the first selective serotonin reuptake inhibitor antidepressant to be marketed in the U.S. In this double-blind trial fluoxetine was compared with imipramine and placebo among 198 out patients with DSM-III major depression , of whom 145 completed at least 2 weeks of active treatment and were evaluated for efficacy . Significantly fewer patients in each active drug group terminated early due to lack of efficacy compared to placebo . Both imipramine and fluoxetine were significantly superior to placebo on most measures . There were no consistently significant differences between the two active drugs although a trend favored imipramine on a number of measures . Fluoxetine was generally well tolerated . Significantly more imipramine than placebo patients terminated early due to side-effects while the fluoxetine-placebo difference was not significant . The results support previous studies which suggest fluoxetine 's superior side-effect profile and the approximate antidepressant equivalence of fluoxetine and TCAs"
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Objectives : The authors set out to systematic ally review the research literature in order to identify the anxiety measures most commonly used in the assessment of older adults . Once identified , the literature was review ed to determine the extent to which these instruments had age-relevant norms and psychometric data supporting their use with older adults . Method : Literature search es were conducted in PsycINFO and PubMed to identify research articles in which anxiety measures were completed by older adults . After screening for suitability , a total of 213 articles were review ed to determine the most commonly used anxiety measures with older adults to examine the psychometric properties of these instruments and to evaluate whether the instruments are appropriate for use with older adults . Results : A total of 91 different anxiety measures were used in the 213 included articles . Twelve anxiety measures were most commonly used in the literature and of those three were specifically developed for older adults . Conclusions : Of the most commonly used measures , the majority lacked sufficient evidence to warrant their use with older adults . Based on psychometric evidence , three measures ( Beck Anxiety Inventory , Penn State Worry Question naire , and Geriatric Mental Status Examination ) showed psychometric properties sufficient to justify the use of these instruments when assessing anxiety in older adults . In addition , two measures developed specifically for older adults ( Worry Scale and Geriatric Anxiety Inventory ) were also found to be appropriate for use with older adults
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"A recent special issue of the Journal of Pediatric Psychology included papers focused on evidence -based assessment across several broad domains of assessment in pediatric psychology ( e.g. , adherence , pediatric pain , and quality of life ) . In one of these papers , Holmbeck et al. ( 2008 ) review ed strengths and limitations of existing measures of psychosocial adjustment and psychopathology , concluding that many measures lacked supporting psychometric data ( e.g. , basic indices of reliability and validity ) that would permit a complete evaluation of these measures . Given that measure development and validation papers are frequently published in JPP ( Brown , 2007 ) , it is important that we attend to guiding psychometric principles when developing and disseminating data on new measures to be employed with pediatric population s ( Nunnally & Bernstein , 1994 ) . Thus , the purpose of this paper is to present and describe a checklist for authors to use when su bmi tting measure development papers to JPP . This checklist is included in the Appendix and is also included at the following link on the JPP website : http://www.oxfordjournals.org/our_journals/jpepsy/for _ authors /measure%20development%20checklist.pdf Findings presented by Holmbeck et al. ( 2008 ) indicated that 34 of the 37 measures review ed met pre-established “ evidence -based assessment ” ( EBA ) criteria for “ well-established ” measures ( Cohen et al. , 2008 ) . To be considered “ well-established , ” a measure had to have been presented in at least two peer- review ed journal articles by different investigatory teams , have demonstrated adequate levels of reliability and validity , and be accompanied by supporting information ( e.g. , a measure manual ) . Although most measures that we review ed met these criteria , we also found that most of the 34 “ well-established ” measures were hampered by at least one major psychometric flaw and /or lacked important psychometric data . We concluded that a more fine-grained EBA classification system is needed . One important distinction in this literature relates to differences between empirically supported assessment and evidence -based assessment . This type of distinction was first discussed in the literature on clinical interventions ( e.g. , Spring , 2007 ) . An empirically supported intervention is one that has demonstrated efficacy in r and omized clinical trials or clinic-based effectiveness trials . An evidence -based intervention has empirical support in the manner just described , but also “ integrates research evidence , clinical expertise , and patient preferences and characteristics … empirically-supported treatments ( ESTs ) are an important component of evidence -based practice ( EBP ) , but EBP can not be reduced to ESTs ” ( Spring , 2007 , p.611 ) . Applying these terms to the field of assessment and measure development efforts , an empirically supported assessment measure would be one that demonstrates satisfactory psychometric characteristics , broadly defined . To be evidence based , the measure should also demonstrate utility in clinical setting s , be useful in making diagnoses , be sensitive to treatment effects , and /or provide incremental validity above and beyond other similar measures . Although papers in the special issue of JPP frequently referred to “ evidence -based assessment ” ( Cohen et al. , 2009 ) , the articles included in the issue tended to evaluate the degree to which the measures were empirically-supported rather than evidence based . To be “ evidence -based , ” our review s would have needed to integrate an evaluation of clinical utility , diagnostic utility , and treatment sensitivity with the empirical psychometric data presented in each review . As noted , the published review s were more likely to focus on the latter rather than on the former . As suggested by Mash and Hunsley ( 2005 ) , detailed EBA profiles would provide a complete evaluation of evidence across each of several psychometric and clinical ly relevant dimensions , including : ( a ) internal consistency , ( b ) test – retest reliability , ( c ) the availability of normative data , ( d ) content validity , ( e ) construct validity , ( f ) convergent and discriminant validity , ( g ) criterion-related validity , ( h ) incremental validity , ( i ) clinical utility , ( j ) diagnostic utility , and ( k ) treatment sensitivity . The focus on incremental validity and clinical and diagnostic utility raises the bar from a focus on “ empirical support ” ( i.e. , where the focus would tend to be primarily on psychometric data ) to a broad focus on the “ evidence base ” for a measure . In developing the checklist that is the focus of this article , we attempted to provide a list of criteria relevant to establishing the evidence base ( and not just empirical support ) for a measure . In addition to shifting the focus from providing “ empirical support ” for a measure to providing an “ evidence base ” for our instruments , a checklist for measure development papers would permit JPP review ers to evaluate such papers in the same way that review ers of r and omized clinical trials make use of the Consoli date d St and ards of Reporting Trials ( CONSORT ) checklist and flowchart ( Altman et al. , 2001 ) . The CONSORT checklist contains reporting st and ards with respect to method ological features of and the manner in which results are reported in clinical trials . Moreover , authors are required to provide a flowchart that describes details of sample recruitment and attrition during the course of the study . Thus , a checklist for measure development papers would serve two interrelated purpose s : ( a ) it would provide guidance to authors as they embark on the measure development process and would provide a list of criteria authors can use as they develop an evidence base for their measures , and ( b ) it would begin to st and ardize the manner in which psychometric and other assessment -related data are presented in measure development papers for this journal . Before providing a more detailed overview of the checklist , it is important to note that this checklist is rather exhaustive ( see Appendix ) . As such , it represents what would “ ideally ” be expected for a measure development or validation manuscript rather than minimal criteria for such papers . No one paper can provide a complete evaluation of all important psychometric and clinical ly relevant dimensions that will establish once- and -for-all the evidence base for a measure . Instrument refinement is part of a measure development process that gradually builds an evidence base for a scale ( see Smith & McCarthy , 1995 , for suggestions on measure refinement ) . Indeed , the validation of any measure is a cumulative process that occurs across many different types of research studies and across research programs",
"BACKGROUND Although anxiety disorders are prevalent in older adults , r and omized controlled trials of treatment effectiveness for late-life anxiety are scarce and have focused primarily on the effectiveness of psychotherapeutic interventions . However , recent findings suggest that in some cases , pharmacological treatment may be more beneficial for late-life anxiety disorders . As yet , there have been no systematic studies investigating prognostic factors for the outcome of cognitive behavioral therapy ( CBT ) and pharmacotherapy for late-life anxiety . The objective of the present study was to study long-term treatment outcomes and to explore differential predictors for both short-term and long-term treatment outcomes of sertraline and CBT for late-life anxiety disorders . METHODS Participants of a r and omized controlled trial ( RCT ) comparing sertraline and CBT for the treatment of late-life anxiety were contacted one year after completing their treatment , so that predictors for both short-term and long-term treatment outcome could be established . RESULTS Sertraline showed a greater reduction of symptoms than CBT on anxiety ( Hamilton Anxiety Rating Scale ; HARS ) and worry ( Worry Domain Question naire ) ratings at one-year follow-up . The strongest predictor for short-term CBT outcome was poor perceived health , explaining 40 % of the variance in post-treatment residual gain scores on the HARS . The strongest predictor for long-term CBT outcome was neuroticism , explaining 20 % of the variance in residual gain scores at one-year follow-up . Analyses revealed no significant predictors for treatment outcome in sertraline participants . CONCLUSIONS Our study suggests that long-term use of sertraline might be more beneficial for late-life anxiety than a 15-week CBT program . Poor perceived health and neuroticism are predictive of less improvement after CBT in anxious older adults . Implication s of these findings are discussed",
"Older adults with generalized anxiety disorder ( GAD ; N = 75 ; M age = 67.1 years ) were r and omly assigned to cognitive-behavioral therapy ( CBT ) , a discussion group ( DG ) organized around worry-provoking topics , or a waiting period . Participants in both active conditions improved relative to the waiting list . Although CBT participants improved on more measures than DG participants , the authors found only I significant difference immediately after treatment and no differences at 6-month follow-up . Effect sizes were smaller than in younger sample s , but CBT showed large effects and DG showed medium-sized effects Overall , results indicate that brief treatment of late-life GAD is beneficial , but they provide only limited support for the superiority of CBT to a credible comparison intervention",
"BACKGROUND Although anxiety is quite prevalent in late life , its impact on disability , well-being , and health care utilization of older persons has not been studied . Older persons are a highly relevant age group for study ing the consequences of anxiety , since their increasing numbers put an extra strain on already limited health care re sources . METHODS Data of a large community-based r and om probability sample ( N = 659 ) of older subjects ( 55 - 85 year ) in the Netherl and s were used to select three groups : subjects with a diagnosed anxiety disorder , subjects with merely anxiety symptoms and a reference group without anxiety . These groups were compared with regard to their functioning , subjective well-being , and use of health care services , while controlling for potentially confounding variables . RESULTS Anxiety was associated with increased disability and diminished well-being . Older persons with a diagnosed anxiety disorder were equally affected in their functioning as those with merely anxiety symptoms . Although use of health services was increased in anxiety sufferers , their use of appropriate care was generally low . CONCLUSIONS Anxiety has a clear negative impact on the functioning and well-being of older subjects . The similarity of participants with an anxiety disorder and those having merely anxiety symptoms regarding quality of life variables and health care use was quite striking . Finally , in spite of its grave consequences for the quality of life , appropriate care for anxiety is seldom received . Efforts to improve recognition , disseminate effective treatments in primary care , and referring to specialized care may have positive effects on the management of anxiety in late life",
"BACKGROUND The object of this study was to develop an Iranian version of the General Health Question naire-28 ( GHQ-28 ) for use with elderly subjects . METHODS The GHQ-28 Farsi version was evaluated for face validity among 204 elderly subjects aged 59 years or older , chosen r and omly from residents of Tehran . The Composite International Diagnostic Interview ( CIDI ) was used to establish a gold st and ard diagnosis of mental disorders . RESULTS The GHQ-28 was an internally consistent measure . Cronbach 's alpha , split-half coefficients and test-retest reliability were 0.9 , 0.89 and 0.58 respectively . Four factors were extracted using factor analysis : \" depression , \" \" psychosocial activity , \" \" anxiety , \" and \" somatic . \" Using receiver operating curve ( ROC ) analysis , the optimum cutoff score for the GHQ-28 in this group was 19/20 ( sensitivity 0.83 , specificity 0.76 ) . Using a loading of 0.6 or greater , a short form of the instrument ( GHQ-15 ) ( alpha=0.9 ) was derived and correlated well with the longer form of the scale ( r=0.97 ) . Using ROC analysis , the optimum cutoff score was 10/11 ( sensitivity 0.83 , specificity 0.69 ) . CONCLUSIONS The short and long forms of the GHQ-28 are suitable screening instruments for elderly Iranian residents , particularly those living in urban areas",
"BACKGROUND This is the first report of results from the EURODEP Programme . AIMS To assess the prevalence of depression judged suitable for intervention in r and omised sample s of those aged > or = 65 in nine European centres . METHOD The GMS-AGECAT package . RESULTS Differences in prevalence are apparent , 8.8 % ( Icel and ) to 236 % ( Munich ) . When sub-cases and cases are added together , five high- and four low-scoring centres emerge . Women predominated over men . Proportions of sub-cases to cases revealed striking differences but did not explain prevalence . There was no constant association between prevalence and age . A meta- analysis ( n = 13,808 ) gave an overall prevalence of 12.3 % , 14.1 % for women and 8.6 % for men . CONCLUSIONS Considerable variation occurs in the levels of depression across Europe , the cause for which is not immediately obvious . Case and sub-case levels taken together show greater variability , suggesting that it is not a matter of case/sub-case selection criteria , which were st and ardised by computer . Substantial levels of depression are shown but 62 - 82 % of persons had no depressive level . Opportunities for treatment exist",
"OBJECTIVE Symptomatic anxiety has prognostic significance in major depression . In theory , the Hospital Anxiety and Depression Scale ( HADS ) should be a useful instrument for measuring the severity of symptomatic anxiety in late-life depression . However , the dimensional structure of the HADS has not been evaluated in elderly depressed patients ; it is not known whether the scale actually functions as a bidimensional measure of anxiety and depression in this population . The purpose of this exploratory study , therefore , was to examine the factor structure of the HADS in older patients with major depression . METHOD The HADS was completed by 213 patients , aged 60 years or older , with DSM-III-R unipolar major depression . Principal components analysis was performed on the full 14-item HADS and on each of its subscales . RESULTS Two distinct factors , which corresponded to the instrument 's depression and anxiety subscales , emerged . The two-factor structure proved reasonably stable when the study group was r and omly divided into two halves . Analysis of the subscales result ed in a single factor for each . The subscales had high internal reliability . CONCLUSIONS These findings confirm that the HADS functions as a bidimensional measure of depression and anxiety in older patients with major depression . The results suggest that the HADS is a valid instrument for measuring severity of anxiety , independent of other depressive symptoms , in this population",
"OBJECTIVE To study the prevalence and risk factors of anxiety disorders in the older ( 55 - 85 ) population of The Netherl and s. METHOD The Longitudinal Aging Study Amsterdam ( LASA ) is based on a r and om sample of 3107 older adults , stratified for age and sex , which was drawn from the community registries of 11 municipalities in three regions in The Netherl and s. Anxiety disorders were diagnosed using the Diagnostic Interview Schedule in a two-stage screening design . The risk factors under study comprise vulnerability , stress and network-related variables . Both bivariate and multivariate statistical methods were used to evaluate the risk factors . RESULTS The overall prevalence of anxiety disorders was estimated at 10.2 % . Generalized anxiety disorder was the most common disorder ( 7.3 % ) , followed by phobic disorders ( 3.1 % ) . Both panic disorder ( 1.0 % ) and obsessive compulsive disorder ( 0.6 % ) were rare . These figures are roughly similar to previous findings . Ageing itself did not have any impact on the prevalence in both bivariate and multivariate analyses . The impact of other factors did not change much with age . Vulnerability factors ( female sex , lower levels of education , having suffered extreme experiences during World War II and external locus of control ) appeared to dominate , while stresses commonly experienced by older people ( recent losses in the family and chronic physical illness ) also played a part . Of the network-related variables , only a smaller size of the network was associated with anxiety disorders . CONCLUSIONS Anxiety disorders are common in later life . The risk factors support using a vulnerability-stress model to conceptualize anxiety disorders . Although the prevalence of risk factors changes dramatically with age , their impact is not age-dependent . The risk factors indicate which groups of older people are at a high risk for anxiety disorders and in whom active screening and treatment may be warranted",
"BACKGROUND Interventions to promote prescribing of preventive therapies in patients with cardiovascular disease ( CVD ) or diabetes have reported variable success . OBJECTIVE ( i ) To evaluate the effect of prescribing feedback on GP practice using academic detailing compared to postal bulletin on prescribing of CVD preventive therapies in patients with CVD or diabetes at 3 and 6 months post intervention and ( ii ) to evaluate the intervention from a GP 's perspective . METHODS Volunteer GP practice s ( n = 98 ) were r and omized to receive individualized prescribing feedback via academic detailing ( postal bulletin plus outreach visit ) ( n = 48 ) or postal bulletin ( n = 50 ) . The proportion of CVD or diabetic patients on statins and antiplatelet agents/warfarin pre- and post-intervention was calculated for each GP practice . Multivariate regression with a r and om effects model was used to compare differences between the groups adjusting for GP clustering and confounding factors . beta-Coefficients and 95 % confidence intervals ( CIs ) are presented . RESULTS There was a 3 % increase in statin prescribing in CVD patients at 6 months post-intervention for both r and omized groups , but there was no statistical difference between the groups ( beta = 0.004 ; 95 % CI = -0.01 to 0.02 ) . Statin and antiplatelet/warfarin prescribing also increased in the diabetic population ; there was no significant differences between the groups . GPs participating in the project expressed a high level of satisfaction with both interventions . CONCLUSION Prescribing of preventive therapies increased in both r and omized groups over the study period . But academic detailing did not have an additional effect on changing prescribing over the postal bulletin alone",
"BACKGROUND Research on the dimensional structure and reliability of the Hospital Anxiety and Depression Scale ( HADS ) and its relationship with age is scarce . Moreover , its efficacy in determining the presence of depression in different patient groups has been question ed . METHODS Psychometric properties of the HADS were assessed in six different groups of Dutch subjects ( N = 6165 ) : ( 1 ) a r and om sample of younger adults ( age 18 - 65 years ) ( N = 199 ) ; ( 2 ) a r and om sample of elderly subjects of 57 to 65 years of age ( N = 1901 ) ; ( 3 ) a r and om sample of elderly subjects of 66 years or older ( N = 3293 ) ; ( 4 ) a sample of consecutive general practice patients ( N = 112 ) ; ( 5 ) a sample of consecutive general medical out- patients with unexplained somatic symptoms ( N = 169 ) ; and ( 6 ) a sample of consecutive psychiatric out- patients ( N = 491 ) . RESULTS Evidence for a two-factor solution corresponding to the original two subscales of the HADS was found , although anxiety and depression subscales were strongly correlated . Homogeneity and test-retest reliability of the total scale and the subscales were good . The dimensional structure and reliability of the HADS was stable across medical setting s and age groups . The correlations between HADS scores and age were small . The total HADS scale showed a better balance between sensitivity and positive predictive value ( PPV ) in identifying cases of psychiatric disorder as defined by the Present State Examination than the depression subscale in identifying cases of unipolar depression as defined by ICD-8 . CONCLUSIONS The moderate PPV suggests that the HADS is best used as a screening question naire and not as a ' case-identifier ' for psychiatric disorder or depression",
"Background : Effective management of heart failure relies on optimal use of non-pharmacological therapy alongside medical treatment . Yet , there is an inadequate use of non-pharmacological therapy in caring for older people with heart failure . Objective : To examine the effects of relaxation therapy and exercise training on psychological outcomes and disease-specific quality of life of older heart failure patients . Methods : Subjects undertook relaxation ( n = 59 ) , exercise training ( n = 32 ) or received attention placebo ( n = 62 ) for 12 weeks . The relaxation group attended two training sessions , one revision workshop , and continued with twice-daily taped-directed home relaxation practice , with support from the intervener through bi-weekly telephone contact , for 12 weeks . The exercise group undertook 12 weekly sessions of resistance training and aerobic exercise and thrice weekly home exercise . The control group received regular telephone calls for general ‘ greetings ’ . Results : The relaxation and exercise groups reported a significantly greater improvement in psychological [ F(2 , 149 ) = 6.69 , p = 0.002 ] and various disease-specific quality of life outcomes [ dyspnea : F(2 , 149 ) = 5.72 , p = 0.004 ; fatigue : F(2 , 149 ) = 3.78 , p = 0.25 ; emotion : F(2 , 149 ) = 6.68 , p = 0.001 ] , compared with those who received the attention placebo . While relaxation therapy was more effective to reduce psychological distress , with depression in particular ( p control fatigue symptoms ( p = 0.03 ) . Conclusion : Relaxation therapy and exercise training are effective to improve the psychological and physical health of older heart failure patients . They should be used as an individual treatment modality , or as care components of a disease management program",
"CONTEXT Generalized anxiety disorder ( GAD ) is one of the most common psychiatric disorders in older adults ; however , few data exist to guide clinicians in efficacious and safe treatment . Selective serotonin reuptake inhibitors ( SSRIs ) are efficacious for younger adults with GAD , but benefits and risks may be different in older adults . OBJECTIVE To examine the efficacy , safety , and tolerability of the SSRI escitalopram in older adults with GAD . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial in primary care practice s and related specialty clinics in Pittsburgh , Pennsylvania , of 177 participants aged 60 years or older with a principal diagnosis of GAD r and omized to receive either escitalopram or placebo and conducted between January 2005 and January 2008 . INTERVENTIONS Twelve weeks of 10 to 20 mg/d of escitalopram ( n = 85 ) or matching placebo ( n = 92 ) . MAIN OUTCOME MEASURES Cumulative response defined by Clinical Global Impressions-Improvement score of much or very much improved ; time to response ; and anxiety and role functioning changes measured by the Clinical Global Impressions-Improvement scale , Hamilton Anxiety Rating Scale , Penn State Worry Question naire , Late-Life Function and Disability Instrument activity limitations subscale , and the role-emotional impairment and social function subscales of the Medical Outcome Survey 36-item Short Form . RESULTS In the primary analytic strategy in which participants ( n = 33 ) were censored at the time of dropout , mean cumulative response rate for escitalopram was 69 % ( 95 % confidence interval [ CI ] , 58%-80 % ) vs 51 % ( 95 % CI , 40%-62 % ) for placebo ( P = .03 ) . A conservative intention-to-treat analysis showed no difference in mean cumulative response rate between escitalopram and placebo ( 57 % ; 95 % CI , 46%-67 % ; vs 45 % ; 95 % CI , 35%-55 % ; P = .11 ) . Participants treated with escitalopram showed greater improvement than with placebo in anxiety symptoms and role functioning ( Clinical Global Impressions-Improvement scale : effect size , 0.93 ; 95 % CI , 0.50 - 1.36 ; P Penn State Worry Question naire : 0.30 ; 95 % CI , 0.23 - 0.48 ; P = .01 ; activity limitations : 0.32 ; 95 % CI , 0.01 - 0.63 ; P = .04 ; and the role-emotional impairment and social function : 0.96 ; 95 % CI , 0.03 - 1.90 ; P = .04 ) . Adverse effects of escitalopram ( P were fatigue or somnolence ( 35 patients [ 41.1 % ] ) , sleep disturbance ( 12 [ 14.1 % ] ) , and urinary symptoms ( 8 [ 9.4 % ] ) . CONCLUSIONS Older adults with GAD r and omized to escitalopram had a higher cumulative response rate for improvement vs placebo over 12 weeks ; however , response rates were not significantly different using an intention-to-treat analysis . Further study is required to assess efficacy and safety over longer treatment duration s. TRIAL REGISTRATION clinical trials.gov Identifier : NCT00105586"
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OBJECTIVE We conducted a systematic review to investigate the cross-sectional and prospect i ve associations of accelerometer-measured total sedentary time and breaks in sedentary time with individual cardiometabolic biomarkers in adults ≥18years of age . METHODS Ovid Medline , Embase , Web of Science and the Cochrane Library were search ed for studies meeting the inclusion criteria . Due to inconsistencies in the measurement and analysis of sedentary time , data was synthesis ed and presented narratively rather than as a meta- analysis . RESULTS Twenty-nine studies were included in the review ; twenty-eight reported on total sedentary time and six on breaks in sedentary time . There was consistent evidence from cross-sectional data of an unfavourable association between total sedentary time and insulin sensitivity . There was also some evidence that total sedentary time was unfavourably associated with fasting insulin , insulin resistance and triglycerides . Furthermore , there was some evidence from cross-sectional data of a favourable association between breaks in sedentary time and triglycerides . CONCLUSION Total sedentary time was consistently shown to be associated with poorer insulin sensitivity , even after adjusting for time spent in physical activity . This finding supports the proposed association between sedentary time and the development of Type 2 diabetes and reinforces the need to identify interventions to reduce time spent sedentary
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"Purpose Imprecise measurement of physical activity variables might attenuate estimates of the beneficial effects of activity on health-related outcomes . We aim ed to compare the cardiometabolic risk factor dose-response relationships for physical activity and sedentary behaviour between accelerometer- and question naire-based activity measures . Methods Physical activity and sedentary behaviour were assessed in 317 adults by 7-day accelerometry and International Physical Activity Question naire ( IPAQ ) . Fasting blood was taken to determine insulin , glucose , triglyceride and total , LDL and HDL cholesterol concentrations and homeostasis model-estimated insulin resistance ( HOMAIR ) . Waist circumference , BMI , body fat percentage and blood pressure were also measured . Results For both accelerometer-derived sedentary time ( sedentary behaviour was associated with increased risk ( all p≤0.01 ) . However , for HOMAIR and insulin the regression coefficients were > 50 % lower for the IPAQ-reported compared to the accelerometer-derived measure ( p moderate-to-vigorous physical activity ( MVPA ) and risk factors were less strong than those observed for sedentary behaviours , but significant negative relationships were observed for both accelerometer and IPAQ MVPA measures with glucose , and insulin and HOMAIR values ( all p with triglyceride , total cholesterol and LDL cholesterol concentrations , BMI , waist circumference and percentage body fat , and a positive relationship was evident with HDL cholesterol ( p = 0.0002 ) . Regression coefficients for HOMAIR , insulin and triglyceride were 43–50 % lower for the IPAQ-reported compared to the accelerometer-derived MVPA measure ( all p≤0.01 ) . Conclusion Using the IPAQ to determine sitting time and MVPA reveals some , but not all , relationships between these activity measures and metabolic and vascular disease risk factors . Using this self-report method to quantify activity can therefore underestimate the strength of some relationships with risk factors",
"Background Physical activity ( PA ) and sedentary behavior ( SED ) may have independent effects on health and disease . This might be due to PA and SED having distinct effects on lipoprotein metabolism . The aim of this study was to determine associations between lipoprotein subclass particle concentrations ( -P ) and accelerometer-measured SED and moderate-to-vigorous PA ( MVPA ) in a sample of healthy adult subjects . Methods Lipoprotein subclass particle concentrations were determined by proton nuclear magnetic resonance spectroscopy , whereas SED and MVPA were measured using Agtigraph GT1 M and GT3X+ accelerometers . We obtained valid data in 73 subjects ( 30 men and 43 women , age 40.5 ± 10.6 years ; body mass index 24.0 ± 2.8 ) . Multiple regression analysis was used to determine associations ( partial correlations ) with lipoproteins . Results Positive associations were detected between SED and small VLDL-P , large LDL-P and TG ( partial r = 0.24 to 0.25 , p for MVPA ( partial r = -0.12 to 0.04 , p > .355 ) . On the contrary , MVPA was positively associated with large HDL-P , average HDL size , Apo A1 and HDL-cholesterol ( partial r = 0.28 to 0.50 , p .607 ) . Conclusion There might be a specific effect of SED versus MVPA on lipoprotein metabolism . However , our results must be interpreted carefully due to possible effect-modification by gender and a low sample size . Thus , our findings should be viewed as preliminary",
"BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health",
"OBJECTIVE Low levels of physical activity appear to be associated with insulin resistance . However , the detailed associations of these complex relationships remain elusive . We examined the prospect i ve associations between self-reported TV viewing time , objective ly measured time spent sedentary , at light-intensity activity , and at moderate- and vigorous-intensity physical activity ( MVPA ) with insulin resistance . RESEARCH DESIGN AND METHODS In 192 individuals ( 81 men and 111 women ) with a family history of type 2 diabetes , we measured physical activity and anthropometric and metabolic variables at baseline and after 1 year of follow-up in the ProActive UK trial . Physical activity was measured objective ly by accelerometry . Insulin resistance was expressed as fasting insulin and the homeostasis model assessment score ( HOMA-IR ) . RESULTS Baseline MVPA was a significant predictor of fasting insulin at follow-up ( β = −0.004 [ 95 % CI −0.007 to −0.0001 ] , P = 0.022 ) , and the association approached significance for HOMA-IR ( β = −0.003 [ −0.007 to 0.000002 ] , P = 0.052 ) , independent of time spent sedentary , at light-intensity activity , sex , age , smoking status , waist circumference , and self-reported TV viewing . Time spent sedentary and at light-intensity activity were not significantly associated with insulin resistance . The change in MVPA between baseline and follow-up was inversely related to fasting insulin ( β = −0.003 [ −0.007 to −0.0003 ] , P = 0.032 ) and the HOMA-IR score ( β = −0.004 [ −0.008 to −0.001 ] , P = 0.015 ) at follow-up , after adjustment for baseline phenotype in addition to the same confounders as above . CONCLUSIONS These results highlight the importance of promoting moderate-intensity activity such as brisk walking for improving insulin sensitivity and possibly other metabolic risk factors to prevent type 2 diabetes",
"AIMS The importance of reducing sedentary time is increasingly being recognized in the prevention of diabetes and cardiovascular disease . Despite this , the prospect i ve association between sedentary time and physical activity with insulin sensitivity and cardiometabolic risk factors has been little studied . METHODS In an analysis of data from the European RISC study , sedentary time and time spent in activity of moderate or vigorous intensity were assessed by accelerometry at baseline in 313 men and 414 women , aged 30 - 60 years , with insulin sensitivity as measured by euglycaemic-hyperinsulinaemic clamp . Three years later , cardiometabolic risk factors ( anthropometry , glucose , insulin , lipids ) were available for 549 participants . RESULTS In cross-sectional analyses using baseline data , after adjusting for age , gender , recruitment centre and time spent in activity of moderate or vigorous intensity , significant unfavourable associations were observed between higher sedentary time with body weight , HDL cholesterol , triglycerides , clamp-measured insulin sensitivity and insulin secretion ( all P(trend) Sedentary time remained significantly associated with insulin secretion after adjusting for insulin sensitivity ( P(trend)=0.02 ) . In longitudinal analyses , higher baseline sedentary time was associated with 3-year increases in fasting glucose , fasting insulin and the HOMA insulin-resistance index score for the 50 % of the study population who increased their BMI by at least 0.3 kg/m(2 ) ( all P(trend) increase in insulin secretion was lower in those spending more time doing activity of moderate or vigorous intensity ( P(trend)=0.03 ) . CONCLUSION These prospect i ve data suggest that less sedentary behaviour may partly counteract some of the negative effects of increasing body weight on glucose-insulin homoeostasis"
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In 2011 , the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology and Nutrition systematic ally review ed published evidence related to the safety and health effects of the administration of formulae supplemented with pro- and /or prebiotics compared with unsupplemented formulae . We up date d evidence on the effects of the administration of prebiotic-supplemented infant formulae ( IF ) compared with unsupplemented IF . Five data bases were search ed up to March 2017 for r and omised controlled trials . In all , forty-one publications were identified , including twenty-five new publications . The administration of currently evaluated prebiotic-supplemented formulae to healthy infants does not raise safety concerns with regard to growth and adverse effects . Some favourable clinical effects are possible , primarily stool softening , which may be beneficial in some infants . Currently , there is no existing robust evidence to recommend the routine use of prebiotic-supplemented formulae . The latter conclusion may reflect the small amount of data on specific prebiotics and outcomes , rather than a genuine lack of an effect . The efficacy and safety should be considered for each prebiotic(s)-supplemented formula
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"Objectives : The aim of the present study was to assess the mode of delivery and type-of-feeding impact on gut microbiota . We demonstrated higher fecal bifidobacteria in infants who were breast-fed ( BF ) or fed formula with prebiotics polydextrose ( PDX ) and galactooligosaccharides ( GOS ) versus formula without prebiotics . Here , we tested feces of that cohort for lactobacilli and Staphylococcus aureus , 2 types of bacteria present in breast milk . Methods : In a double-blind , r and omized study , 21- to 30-day-old term infants vaginally delivered and exclusively formula-fed received a cow 's milk – based formula ( control , n = 80 ) or the same formula with 4 g/L ( 1:1 ratio ) of PDX/GOS ( PDX/GOS , n = 77 ) . A reference BF group ( n = 71 ) was included . Stool sample s were obtained at baseline and after 30 and 60 days of feeding to assess fecal bacteria by quantitative real-time polymerase chain reaction . Results : Pairwise comparisons between baseline-adjusted means log10 colony-forming unit per gram feces of total lactobacilli counts ( 8.37 in control , 8.46 in PDX/GOS , and 8.42 in BF ) showed a significant difference only between PDX/GOS and control at 30 and 60 days combined ( P = 0.035 ) , utilizing generalized estimating equations method . Baseline-adjusted odds ratio ( OR ) of colonization with S aureus was lower in control ( OR 0.47 , 95 % confidence interval 0.22–1.00 , P = 0.049 ) and PDX/GOS ( OR 0.44 , 95 % confidence interval 0.21–0.94 , P = 0.03 ) groups versus the BF group . Conclusions : Bacteria found in breast milk , such as lactobacilli and S aureus can also be found in infant feces . S aureus , traditionally considered harmful , may aid in educating the coevolving immune system . Modifying formula by adding prebiotics may bring gut microbiota closer to that of BF infants in terms of beneficial microbes",
"In this double-blind , r and omized , placebo-controlled study , we investigated the effect of an infant milk formula with 6 g/L short-chain galacto- and long-chain fructo-oligosaccharides [ ( scGOS/lcFOS ) ratio 9:1 ] on the development of the fecal secretory immunoglobulin A ( sIgA ) response and on the composition of the intestinal microbiota in 215 healthy infants during the first 26 wk of life . The infants received breast milk or were r and omized to receive an infant milk formula with or without scGOS/lcFOS . Stool sample s were collected after 8 and 26 wk of intervention . The concentration of fecal sIgA was determined by ELISA , and the composition of the intestinal microbiota was determined by quantitative fluorescent in situ hybridization . The scGOS/lcFOS group and the control group were compared in the statistical analysis . A breast fed group was included as a reference . In total , 187 infants completed the study . After 26 wk of intervention , in infants that were exclusively formula fed , the concentration of sIgA was higher ( P percentages of bifidobacteria were higher in the scGOS/lcFOS group ( 60.4 % ) than in the control group ( 52.6 % , P = 0.04 ) . The percentages of Clostridium spp . were 0.0 and 3.27 % , respectively ( P = 0.006 ) . In conclusion , an infant milk formula with 6 g/L scGOS/lcFOS results in higher concentrations of fecal sIgA , suggesting a positive effect on mucosal immunity",
"Adding prebiotics or probiotics to infant formula to improve the intestinal flora of formula-fed infants is considered to be a major innovation . Several companies have brought relevant formulations onto the market . However , comparative data on the effects of pre- and probiotics on the intestinal microflora of infants are not available . The present study aim ed to compare the effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the composition and metabolic activity of the intestinal microflora . Before birth , infants were r and omised and double blindly allocated to one of three formulas . The prebiotic ( GOS/FOS ) group ( n 19 ) received regular infant formula supplemented with a mixture of galacto-oligosaccharides and fructo-oligosaccharides ( 6 g/l ) . The probiotic ( Bb-12 ) group ( n 19 ) received the same formula supplemented with 6.0x10(10 ) viable cells of B. animalis per litre . The st and ard group ( n 19 ) received non-supplemented regular formula . A group of sixty-three breast-fed infants was included as a reference group . Faecal sample s were taken at postnatal day 5 and 10 , and week 4 , 8 , 12 and 16 . Compared with the groups fed Bb-12 and st and ard formula , the GOS/FOS formula group showed higher faecal acetate ratio ( 69.7 % ( sem 2.7 ) , 69.9 % ( sem 3.9 ) and 82.2 % ( sem 5.3 ) ; P lactate concentration ( 11.3 ( sem 7.9 ) , 3.1 ( sem 2.3 ) and 34.7 ( sem 10.7 ) mmol/kg faeces ) and lower pH ( 6.6 ( sem 0.2 ) , 7.1 ( sem 0.2 ) and 5.6 ( sem 0.2 ) ; P percentage of bifidobacteria between the GOS/FOS ( 59.2 % ( sem 7.7 ) ) , Bb-12 ( 52.7 % ( sem 8.0 ) ) and the st and ard ( 51.8 % ( sem 6.4 ) ) groups were not statistically significant at 16 weeks . Feeding infants GOS/FOS formula result ed in a similar effect on metabolic activity of the flora as in breast-fed infants . In the Bb-12 group , composition and metabolic activity of the flora were more similar to those of the st and ard group",
"Objective : The aim of the study was to evaluate the effect of infant formula with polydextrose ( PDX ) and galacto-oligosaccharides ( GOS ) on fecal microbiota and secretory IgA ( sIgA ) . Material s and Methods : In the present double-blind , r and omized study , term infants received control ( Enfamil Lipil ) or the same formula with PDX/GOS ( 4 g/L , 1:1 ratio ; PDX/GOS ) for 60 days ; a reference breast-fed group was included . Formula intake , tolerance , and stool characteristics were collected via electronic diary and analyzed by repeated measures analysis of variance . Anthropometric measurements and stool sample s were obtained at baseline and after 30 and 60 days of feeding . Fecal sIgA was measured by enzyme-linked immunosorbent assay and fecal bacteria by fluorescent in situ hybridization and quantitative real-time polymerase chain reaction ( qPCR ) ; both were analyzed by Wilcoxon rank sum test . Results : Two hundred thirty infants completed the study . Infants consuming PDX/GOS had softer stools than control at all times ( P counts in PDX/GOS were closer to the breast-fed group , tended to be higher than control for total bifidobacteria ( P = 0.069 ) and Bifidobacterium longum ( P = 0.057 ) at 30 days , and were significantly higher for total bifidobacteria and B longum at 60 days and B infantis at 30 days ( P = 0.002 ) . No significant differences were detected between PDX/GOS and control in changes from baseline to 30 or 60 days for sIgA or total bifidobacteria by fluorescent in situ hybridization or qPCR ; however , significantly higher changes from baseline were detected between PDX/GOS and control for B infantis at 30 days and B longum at 60 days ( P ⩽ 0.035 ) . Conclusions : Infant formula with PDX/GOS produces soft stools and a bifidogenic effect closer to breast milk than formula without PDX/GOS ",
"The objective of the present study was to assess the effect of adding specific prebiotics to st and ard formula feeding on the number of fever episodes in the first year of life . In the present r and omised , double-blind , placebo-controlled trial in seven centres in five West European countries , 830 healthy term infants , without a first-degree family history of allergic disease , of mothers who indicated to give only formula feeding were r and omised either to receive a st and ard non-hydrolysed cows ' milk-based formula to which a mixture of specific oligosaccharides was added ( prebiotics group ( PG ) ) , or to receive a similar formula without oligosaccharides ( control group ( CG ) ) . A separate reference group consisted of 300 breast-fed infants . The primary outcome was the number of fever episodes prospect ively documented by the parents . There was no difference in the number of fever episodes between the PG ( median value 1·19 ; 25th-75th percentile 0·09 - 2·34 ) and CG ( 1·16 ; 25th-75th percentile 0·06 - 2·38 ) . The median number of fever episodes in the separate breast-feeding reference group was 1·24 ( 25th-75th percentile 0·51 - 3·45 ) . There was no effect of adding specific prebiotics to st and ard formula feeding in reducing the number of fever episodes in the present study",
"Background the addition of oligosaccharides to infant formula has been shown to mimic some of the beneficial effects of human milk . The aim of the study was to assess the tolerance and safety of a formula containing an innovative mixture of oligosaccharides in early infancy . Methodology /Principal Findings this study was performed as a multi-center , r and omized , double-blind , placebo-controlled trial including healthy term infants . Infants were recruited before the age of 8 weeks , either having started with formula feeding or being fully breast-fed ( breastfeeding group ) . Formula-fed infants were r and omized to feeding with a regular formula containing a mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides ( prebiotic formula group ) or regular formula without oligosaccharides ( control formula group ) . Growth , tolerance and adverse events were assessed at 8 , 16 , 24 and 52 weeks of age . The prebiotic and control groups showed similar mean weight , length and head circumference , skin fold thicknesses , arm circumference gains and stool frequency at each study point . As far as the anthropometric parameters are concerned , the prebiotic group and the control group did not attain the values shown by the breastfeeding group at any study point . The skin fold thicknesses assessed in the breastfeeding group at 8 weeks were strikingly larger than those in formula fed infants , whereas at 52 weeks were strikingly smaller . The stool consistency in the prebiotic group was softer than in the control group at 8 , 16 and 24 weeks ( p incidence of adverse events between the two formula groups . Conclusions our findings demonstrate the tolerability and the long term safety of a formula containing an innovative mixture of oligosaccharides in a large cohort of healthy infants . Trial Registration : drks-neu.uniklinik-freiburg.de DRKS",
"Background Human milk oligosaccharides have been shown to stimulate selectively the growth of Bifidobacteria and Lactobacilli in the intestine . In this study , the bifidogenic effect of an experimental prebiotic oligosaccharide mixture consisting of low-molecular-weight galactooligosaccharides and high-molecular-weight fructooligosaccharides was analyzed in 90 term infants . Methods Two test formulas were supplemented with either 0.4 g/dL or with 0.8 g/dL oligosaccharides . In the control formula , maltodextrin was used as placebo . At study day 1 and study day 28 , the fecal species , colony forming units ( cfu ) and pH were measured and stool characteristics , growth , and side effects were recorded . Results At study day 1 , the median number of Bifidobacteria did not differ among the groups ( 0.4 g/dL group , mean [ interquartile range ] 8.5 [ 1.9 ] cfu/g ; 0.8 g/dL group , 7.7 [ 6.1 ] cfu/g ; and the placebo group , 8.8 [ 6.1 ] cfu/g ) ( figures in square brackets are interquartile range ) . At the end of the 28-day feeding period , the number of Bifidobacteria was significantly increased for both groups receiving supplemented formulas ( the 0.4 g/dL group , 9.3 [ 4.9 ] cfu/g ; the 0.8 g/dL group , 9.7 [ 0.8 ] cfu/g ) versus the placebo group ( 7.2 [ 4.9 ] cfu/g , P The number of Lactobacilli also increased significantly in both groups fed the supplemented formulas ( versus placebo , P change in fecal pH ( P the stool frequency result ed in a significant difference between the placebo group and the group fed the 0.8 g/dL formula at day 28 ( P stool consistency ( 0.8 g/dL versus placebo , P incidence of side effects ( crying , regurgitation , vomiting ) or growth . Conclusions These data indicate that supplementation of a term infant 's formula with a mixture of galacto- and fructooligosaccharides has a dose-dependent stimulating effect on the growth of Bifidobacteria and Lactobacilli in the intestine and results in softer stool with increasing dosage of supplementation",
"Objective : The aim of the study was to compare infants ’ gastrointestinal tolerance of formulas supplemented with 2 different levels of galacto-oligosaccharides ( GOS ) versus a control formula ( CF ) or human milk . Methods : Healthy , full-term infants ( n = 180 ) were enrolled in this 3-group controlled , double-blind , multicenter study , and a concurrently enrolled , nonr and omized human milk – fed group ( HM ) by 8 days of age . Infants were r and omized to be fed formula supplemented with either 4 g ( EF4 ) or 8 g ( EF8 ) GOS/L or a CF until day of life ( DOL ) 119 . Infants were to be seen at DOL 14 , 35 , 56 , 84 , and 119 . Parents were to record detailed 24-hour information about intake , tolerance to feedings , and stool patterns and consistency each day from enrollment to DOL 35 , and for 3 days before DOL 56 , 84 , and 119 . Stool consistency was scored on a 5-point scale as watery ( 1 ) , loose/mushy , soft , formed , or hard ( 5 ) . Results : The mean stool consistency score was higher in the CF group throughout the study ( CF > EF8 and CF > HM for all study periods and CF > EF4 from DOL 15 to 35 , P percentage of watery stools in the EF8 versus the CF group from study day 1 ( SD 1 ) to DOL 14 ( P number of stools per day . The percentage of feedings with spit up and /or vomiting within 1 hour after feeding was significantly lower for HM versus EF8 and CF from SD 1 to DOL 14 ( P newborn infants through the first 4 months of life",
"Objectives : To come even closer to the functional composition of human milk , acidic oligosaccharides ( AOS ) from pectin were added to well known neutral prebiotics ( galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( FOS ) ) . The effect of AOS and GOS/FOS/AOS on intestinal flora , stool characteristics as well as acceptance and tolerance was investigated . Methods : Human milk contains 75 % to 85 % neutral and 15 % to 25 % acidic oligosaccharides . In this prospect i ve , r and omized , double blind study , a mixture of 80 % neutral oligosaccharides ( from long-chain galacto- and long-chain fructo-oligosaccharides ) with 20 % acidic oligosaccharides derived from pectin hydrolysis was investigated . Forty-six term infants were fed a st and ard formula supplemented with either maltodextrin as control ( n = 15 ) , or with 0.2 g acidic oligosaccharides ( n = 16 ) , or with the latter plus 0.6 g neutral oligosaccharides ( mixture of galacto- and fructo-oligosaccharides ; n = 15 ) . Fecal flora using plating technique and pH were measured . Stool characteristics and possible side effects ( crying , vomiting , and regurgitation ) were recorded . Results : There was no difference in the bifidobacteria counts between the control and the group supplemented with acidic oligosaccharides alone ( 8.75 ± 0.50 vs. 8.58 ± 0.94 log colony forming units [CFU]/g stool ) . In infants fed the combination of acidic and neutral oligosaccharides , bifidobacteria were increased ( 9.61 ± 0.70 log CFU/g stool ; P . Stool consistency was softest in infants fed the complete oligosaccharide mixture , but also in those fed formula supplemented with acidic oligosaccharides alone , the stool consistency was significantly softer compared with the control group . Fecal pH increased in the controls , remained constant in acidic oligosaccharides alone , and decreased in the complete mixture of oligosaccharides group . Conclusion : There was no difference in growth , crying , vomiting , and regurgitation patterns between the groups . In summary , acidic oligosaccharides from pectin hydrolysate are well tolerated as ingredient in infant formulae but do not affect intestinal microecology",
"Aims . To evaluate the impact of oligofructose (OF)-supplemented infant formula on fecal microbiota , stool characteristics , and hydration . Methods . Ninety-five formula-fed infants were r and omized to α-lactalbumin-enriched control formula ( CF ) or identical formula with 3.0 g/L OF ( EF ) for 8 weeks ; 50 infants fed human milk ( HM ) were included . Results . Eighty-four infants completed the study , 70 met per- protocol criteria . Over 8 weeks , bifidobacteria increased more in EF than CF group ( 0.70 vs 0.16 log10 bacterial counts/g dry feces , P = .008 ) ; EF was not significantly different from HM group ( P = .32 ) . EF group stool consistency was intermediate between CF and HM groups ; at week 8 , EF group had softer stools than CF ( 5-point scale : 1 = hard , 5 = watery ; consistency score 3.46 vs 2.82 , P = .015 ) without significant differences in stool frequency . Physician-assessed hydration status was normal for all infants . Conclusions . Infant formula with 3.0 g/L OF promoted bifidobacteria growth and softer stools without adversely affecting stool frequency or hydration",
"There is some evidence that early colonization of the intestine affects the composition of the intestinal microbiota after weaning . In the present study , the effect of prebiotics administered from the first day of life on fecal counts of bifidobacteria and lactobacilli were studied during and after the administration of the prebiotics . In this double-blind , r and omized , placebo-controlled , explorative study , 20 newborns of hepatitis C virus-infected mothers who decided not to breast feed due to their concerns regarding their plasma viral load were r and omly assigned to either a formula with 8 g/L of a specific prebiotic mixture ( short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides , ratio 9:1 ) or a formula containing the same amount of maltodextrin ( placebo ) . Clinical examination including anthropometric measurements , microbiological analysis of fecal sample s , and blood leukocyte population analysis were performed at birth and 3 , 6 , and 12 mo age . At the age of 12 mo , hepatitis B vaccine-specific IgG serum titers ( Hepatitis B virus surface antibodies ) were also measured . Prebiotic supplementation result ed in more fecal bifidobacteria ( P lactobacilli ( P = 0.0044 ) compared with the placebo group . These differences between the groups were maintained during the second half of the first year without any prebiotic supplementation . There was no influence of the different diets on anthropometric data or the measured immunological variables . The data from this small explorative study indicate that early colonization of the intestine might have long-lasting effects on the composition of the intestinal microbiota",
"Background To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants , advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available . This study was design ed to evaluate growth and tolerance in healthy infants who received one of two investigational cow ’s milk-based formulas with adjustments in carbohydrate , fat , and calcium content and supplemented with a prebiotic blend of polydextrose ( PDX ) and galactooligosaccharides ( GOS ) or GOS alone . Methods In this multi-center , double-blind , parallel- design ed , gender-stratified prospect i ve study 419 infants were r and omized and consumed either a marketed routine cow ’s milk-based infant formula ( Control ; Enfamil ® LIPIL ® , Mead Johnson Nutrition , Evansville , IN ) ( n = 142 ) or one of two investigational formulas from 14 to 120 days of age . Investigational formulas were supplemented with 4 g/L ( 1:1 ratio ) of a prebiotic blend of PDX and GOS ( PDX/GOS ; n = 139 ) or 4 g/L of GOS alone ( GOS ; n = 138 ) . Anthropometric measurements were taken at 14 , 30 , 60 , 90 , and 120 days of age . Daily recall of formula intake , tolerance , and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60 , 90 , and 120 days of age . Medically-confirmed adverse events were recorded throughout the study . Results There were no group differences in growth rate from 14 to 120 days of age . Discontinuation rates were not significantly different among study groups . No differences in formula intake or infant fussiness or gassiness were observed . During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher ( i.e. softer stools ) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group ( all P The overall incidence of medically-confirmed adverse events was similar among groups . Conclusions Investigational routine infant formulas supplemented with 4 g/L of either a prebiotic blend of PDX and GOS or GOS alone were well-tolerated and supported normal growth . Compared to infants who received the unsupplemented control formula , infants who received prebiotic supplementation experienced a softer stooling pattern similar to that reported in breastfed infants . Trial registration Clinical Trials.gov Identifier :",
" Purpose Currently , there is no consensus concerning the possible beneficial colonic and systemic effects of prebiotic-containing infant formula . This study assesses whether the feeding of a galactooligosaccharides (GOS)-containing infant formula ( 0.44 g/dl of GOS ) and the subsequent feeding of a GOS-containing follow-on formula ( 0.50 g/dl of GOS ) have a prebiotic effect on intestinal microbiota that helps to decrease infections and allergy manifestations in healthy infants during the first year of life . Methods A multicentre , r and omised , double-blind and placebo-controlled trial was carried out on 365 healthy term infants enrolled before 8 weeks of age and r and omly assigned to a formula with or without GOS , until 12 months of age . The incidence of infections and allergy manifestations , the antibiotics prescribed and faecal characteristics were recorded up to 12 months of age , while faecal sample s were collected up to 4 months for the measurement of secretory immunoglobulin A , short-chain fatty acids and microbiota . Results A prebiotic effect on the faecal analysis was observed at 4 months of life . The GOS group showed a lower faecal pH ( P = 0.019 ) , a lower decreasing trend in secretory immunoglobulin A ( P = 0.078 ) , lower butyric acid concentration ( P = 0.040 ) and an increase in Bifidobacterium counts ( P = 0.010 ) . Changes in faecal characteristics involved greater frequency ( P softer consistency ( P incidence of infections or allergic manifestations during the first year of life was similar in both groups , with no statistical differences ( P > 0.05 ) . Conclusions The feeding of GOS-containing infant formula produced a definite prebiotic effect consisting of changes in faecal composition and microbiota , and in faecal consistency and the frequency of defaecation . No changes in the incidence of infection or allergic manifestation during the first year of life were observed",
"AIM To investigate the effect of a new infant formula supplemented with a low level ( 0.24 g/100 mL ) of galacto-oligosaccharide ( GOS ) on intestinal micro-flora ( Bifidobacteria , Lactobacilli and E. coli ) and fermentation characteristics in term infants , compared with human milk and a st and ard infant formula without GOS . METHODS Term infants ( n = 371 ) were approached in this study in three hospitals of China . All infants started breast-feeding . Those who changed to formula-feeding within 4 wk after birth were r and omly assigned to one of the two formula groups . Growth and stool characteristics , and side effects that occurred in recruited infants were recorded in a 3-mo follow-up period . Fecal sample s were collected from a sub population of recruited infants for analysis of intestinal bacteria ( culture technique ) , acetic acid ( gas chromatography ) and pH ( indicator strip ) . RESULTS After 3 mo , the intestinal Bifidobacteria , Lactobacilli , acetic acid and stool frequency were significantly increased , and fecal pH was decreased in infants fed with the GOS-formula or human milk , compared with those fed with the formula without GOS . No significant differences were observed between the GOS formula and human milk groups . Supplementation with GOS did not influence the incidence of crying , regurgitation and vomiting . CONCLUSION A low level of GOS ( 0.24 g/100 mL ) in infant formula can improve stool frequency , decrease fecal pH , and stimulate intestinal Bifidobacteria and Lactobacilli as in those fed with human milk",
"Objectives : The intestinal flora of breast-fed infants is generally dominated by Bifidobacteria . We aim ed to investigate whether an infant formula supplemented with galacto-oligosaccharides and fructo-oligosaccharides ( GOS/FOS ) is able to establish a bifido-dominant microflora , not only in numbers but also with respect to the metabolic activity in the colon . Methods : Two groups of infants fed infant formula with 0.8 g/100 ml GOS/FOS in a ratio of 9:1 ( OSF group ) , or control formula ( SF group ) were evaluated in a r and omised , double blind , placebo controlled intervention study . A breast-fed group was studied in parallel . At study onset and after 4 and 6 weeks , faecal sample s were examined for the number of bifidobacteria , pH , short chain fatty acids and lactate . Results : After 6 weeks , the mean proportion of bifidobacteria was significantly higher in the OSF group ( 59.6 % versus 49.5 % in the SF group ; P stool mean pH and an increased proportion of acetate and a decreased proportion of propionate . The mean pH in the OSF and SF groups were 5.7 and 6.3 , respectively ( P GOS/FOS mixture to an infant formula has a stimulating effect on the growth of bifidobacteria and on the metabolic activity of the total intestinal flora . The changes in short chain fatty acids , lactate and pH in the prebiotic group represent a fermentation profile that is closer to that observed in breast-fed infants compared to infants fed control formula",
"BACKGROUND & AIMS The sterile newborn digestive tract is rapidly colonized after birth and feeding type could influence this process . Infant formulas try to mimic the bifidogenic effect of human milk using prebiotic supplementation . The aim of this study was to demonstrate the efficacy , safety and tolerance of a 0.8 g/dL Orafti( ® )Synergy1 ( oligofructose-enriched inulin ) supplemented infant formula during the first 4 months of life . METHODS In a double-blind , r and omized , placebo-controlled and parallel trial , formula fed healthy term newborns were r and omized to receive a control ( controls ) or SYN1 supplemented infant formula ( SYN1 ) . Breastfed newborns ( BF ) were also followed for comparison . Anthropometry , water balance , blood parameters , adverse events , stool frequency and characteristics and faecal microbiota were assessed . RESULTS A total of 252 formula fed infants were r and omized at birth ( n = 124 controls , n = 128 SYN1 ) and 131 BF infants were recruited ; after 4 months 68 controls , 63 SYN1 and 57 BF completed the study . SYN1 infants showed a microbiota composition closer to that of BF infants , with a trend towards higher Bifidobacterium cell counts , softer stools and a higher deposition frequency compared to controls . There were no differences between formulas in anthropometry and relevant adverse events , water balance or blood parameters . CONCLUSION A 0.8 g/dL SYN1-supplemented infant formula during the first 4 months of life is safe and effective , promoting a gut microbiota closer to that of breastfeeding . This clinical trial was registered at Clinical trials.gov as Study on Fermentable Carbohydrates in Healthy Infants ( number NCT00808756 )",
"BACKGROUND & AIM The addition of prebiotics to infant formula modifies the composition of intestinal microflora . Aim of the study was to test the hypothesis that prebiotics reduce the incidence of intestinal and respiratory infections in healthy infants . METHODS A prospect i ve , r and omized , placebo-controlled , open trial was performed . Healthy infants were enrolled and r and omized to a formula additioned with a mixture of galacto- and fructo-oligosaccharides or to a control formula . The incidence of intestinal and respiratory tract infections and the anthropometric measures were monitored for 12 months . RESULTS Three hundred and forty two infants ( mean age 53.7+/-32.1 days ) were enrolled . The incidence of gastroenteritis was lower in the supplemented group than in the controls ( 0.12+/-0.04 vs. 0.29+/-0.05 episodes/child/12 months ; p=0.015 ) . The number of children with more than 3 episodes tended to be lower in prebiotic group ( 17/60 vs. 29/65 ; p=0.06 ) . The number of children with multiple antibiotic courses/year was lower in children receiving prebiotics ( 24/60 vs. 43/65 ; p=0.004 ) . A transient increase in body weight was observed in children on prebiotics compared to controls during the first 6 months of follow-up . CONCLUSIONS Prebiotic administration reduce intestinal and , possibly , respiratory infections in healthy infants during the first year of age",
"AIM Effects of supplementing prebiotic oligosaccharides to formula for healthy infants were studied in this placebo controlled , r and omised , double blind study . METHODS Ninety-seven infants were included into the study ; among them 42 breast-fed infants , 14 infants fed formula supplemented with 0.4 g/100ml oligosaccharides ( 9 to 1 mixture of galacto- and fructooligosaccharides ) and 13 infants fed control formula were followed-up throughout the 12-week-long study period . The groups receiving formula were compared with statistical methods , whereas data of breast-fed infants served as reference values . RESULTS Infants fed the two formulae did not differ in nutrient intakes , growth , occurrence rate of feeding difficulties and atopic manifestations , or in calcium excretion . The intestinal flora did not differ between the two formula fed groups at the beginning of the study . In contrast , numbers of Bifidobacteriae were significantly higher in infants receiving the formula supplemented with prebiotic oligosaccharides both at the 14th day ( 9 x 1011 versus 5 x 1010 , colony forming units/g faeces , median , p infant formula with prebiotic oligosaccharides result ed in ameliorating the difference in intestinal flora between formula fed and breast-fed healthy infants",
"Objectives : This r and omized controlled trial involving 110 healthy neonates studied physiological and bifidogenic effects of galactooligosaccharides ( GOS ) , oligofructose , and long-chain inulin ( fructooligosaccharides , FOS ) in formula . Methods : Subjects were r and omized to Orafti Synergy1 ( 50 oligofructose:50 FOS ) 0.4 g/dL or 0.8 g/dL , GOS : FOS ( 90:10 ) 0.8 g/dL , or a st and ard formula according to Good Clinical Practice guidelines . A breast-fed group was included for comparison . Outcome parameters were weight , length , intake , stool characteristics , crying , regurgitation , vomiting , adverse events , and fecal bacterial population counts . Statistical analyses used nonparametric tests . Results : During the first month of life , weight , length , intake , and crying increased significantly in all of the groups . Regurgitation and vomiting scores were low and similar . Stool frequency decreased significantly and similarly in all of the formula groups but was lower than in the breast-fed group . All of the prebiotic groups maintained soft stools , only slightly harder than those of breast-fed infants . The st and ard group had significantly harder stools at weeks 2 and 4 compared with 1 ( P total number of fecal bacteria increased in all of the prebiotic groups ( 9.82 , 9.73 , and 9.91 to 10.34 , 10.38 , and 10.37 , respectively , log10 cells/g feces , P = 0.2298 ) and more closely resembled the breast-fed pattern . Numbers of lactic acid bacteria , bacteroides , and clostridia were comparable . In the SYN1 0.8 g/dL and GOS : FOS groups , Bifidobacterium counts were significantly higher at D14 and 28 compared with D3 and were comparable with the breast-fed group . Tolerance and growth were normal . Conclusions : Stool consistency and bacterial composition of infants taking SYN1 0.8 g/dL or GOS : FOS – supplemented formula were closer to the breast-fed pattern . There was no risk of dehydration",
"The aim of the study was to evaluate whether supplementation of milk-formulas with prebiotic fructo-oligosaccharides or a probiotic , Lactobacillus johnsonii La1 ( La1 ) , could modulate the composition of the fecal microbiota of formula-fed infants , compared to breastfed ( BF ) infants . Ninety infants close to 4 months of age were r and omized into one of three groups to be blindly assigned to receive for 13 weeks : a ) an infant formula ( Control ) , b ) the same formula with fructo-oligosaccharides ( Prebio ) , or c ) with La1 ( Probio ) . At the end of this period , all infants received the control formula for 2 additional weeks . Twenty-six infants , breastfed throughout the study , were recruited to form group BF . Fecal sample s were obtained upon enrolment and after 7 and 15 weeks . Bacterial population s were assessed with classical culture techniques and fluorescent in situ hybridisation ( FISH ) . Seventy-six infants completed the study . On enrolment , higher counts of Bifidobacterium and Lactobacillus and lower counts of enterobacteria were observed in BF compared to the formula-fed infants ; these differences tended to disappear at weeks 7 and 15 . No major differences for Clostridium , Bacteroides or Enterococcus were observed between the groups or along the follow up . Probio increased fecal Lactobacillus counts ( p excreted live La1 in their stools at week 7 but only 17 % at week 15 . Increased Bifidobacterium counts were observed at week 7 in the 3 formula groups , similar to BF infants . These results confirm the presence of higher counts of bifidobacteria and lactobacilli in the microbiota of BF infants compared to formula-fed infants before dietary diversification , and that La1 survives in the infant digestive tract",
"Objectives : The primary objective of this study was to determine the bifidogenic effect of galacto-oligosaccharides ( GOS ) in a follow-on formula and the effects on other intestinal bacteria . Secondary objectives were the effects on stool characteristics , growth , and general well-being . Participants and Methods : In a multicenter , double-blind study , 159 healthy infants , formula-fed at enrollment ( at 4–6 months ) , were r and omized to an experimental follow-on formula supplemented with 5 g/L ( GOS ) ( 77 infants ) , or to a st and ard follow-on formula ( control , 82 infants ) . Infants were evaluated at enrollment ( study day 1 = sd1 ) , after 6 weeks ( study day 2 = sd2 ) , and after an additional 12 weeks ( study day 3 = sd3 ) . At each study day , a fresh stool sample for the bacterial counts was collected , and the growth parameters were measured . At sd2 , urinary specimens were collected for the evaluation of urinary osmolarity . Results : At sd2 and sd3 , the GOS group had a higher median number ( colony-forming units per gram of stool ) of bifidobacteria than did the control group ( sd2 GOS 9.2 × 109 vs control 4.4 × 109 , P = 0.012 ) ; ( sd3 GOS 7.2 × 109 vs control 2.4 × 109 , P = 0.027 ) . Other bacteria did not show any significant differences between the 2 groups at all study days . The GOS produced softer stools but had no effect on stool frequency . The urinary osmolarity ( mOsm/L ) at sd2 was comparable in both groups . Supplementation had no influence on the incidence of gastrointestinal side effects or on the growth of the infants . Conclusions : These data indicate that the addition of GOS ( 5 g/L ) to a follow-on formula positively influences the bifidobacteria flora and the stool consistency in infants during the supplementation period at weaning . No local or systemic side effects were recorded",
"BACKGROUND Oligosaccharides in human milk may protect infants by improving the intestinal micro-flora and fermentation . This study was to investigate effects of infant formula milk consisting of galacto-oligosaccharide ( GOS ) on intestinal microbial population s and the fermentation characteristics in term infants in comparison with that of human milk . METHODS The test formula ( Frisolac H , Friesl and , Netherl and ) was supplemented with GOS at a concentration of 0.24 g/dl . Human milk and another formula without oligosaccharides ( Frisolac H , Friesl and , Netherl and ) were used as positive and negative control respectively . Growth , stool characteristics , and side effects of the recruited infants were recorded after 3 and 6 months ' follow-up , and the fecal species were collected for the analysis of intestinal micro-flora , short chain fatty acid ( SCFA ) and pH. RESULTS At the end of 3- and 6-month feeding period , intestinal Bifidobacteria and Lactobacilli were significantly increased in infants fed with GOS supplemented formula and human milk when compared with infants fed with negative control formula ; however , there was no statistically significant difference between GOS supplemented formula and human milk groups . Stool characteristics were influenced by the supplement and main fecal SCFA ( acetic ) , and stool frequency were significantly increased in infants fed with GOS supplemented formula and human milk , while the fecal pH was significantly decreased as compared with that of negative control ( P incidence of side effects ( including crying , regurgitation and vomiting ) . CONCLUSIONS Supplementing infant formula with GOS at a concentration of 0.24 g/dl stimulates the growth of Bifidobacteria and Lactobacilli in the intestine and stool characteristics are similar to in term infants fed with human milk ",
"BACKGROUND The intestinal flora of breast-fed infants is generally dominated by bifidobacteria which have beneficial properties . Their presence is due to various compounds of breast milk including prebiotic substances . AIM This prospect i ve , double blind , study compared the growth , acceptability and the proportion of bifidobacteria and clostridia in the stool flora of bottle-fed infants r and omized to receive a formula with a specific mixture of 0.4 g/100 ml prebiotic galacto- and long-chain fructooligosaccharides or the same formula without added prebiotics . METHODS Within 0 - 14 days after birth at term , healthy bottle-fed infants were enrolled to receive either a prebiotic formula or a st and ard formula . At recruitment anthropometric measurements were done . These were repeated at the age of 6 and 12 weeks . Stool sample s were taken at inclusion and at the age of 6 weeks . The number of bifidobacteria and clostridia was determined by fluorescent in situ hybridization . RESULTS There was good tolerance of the prebiotic formula . Somatic growth was similar in the two groups . Stool frequency was significantly higher in the prebiotic group ( P=0.031 ) . Infants in the prebiotic group had also softer stools as compared to the control group ( P=0.026 ) . Baseline values of microorganisms at study entry were similar . The percentage of faecal clostridia at the completion of the study was significantly lower in the prebiotic group ( P=0.042 ) , while the proportion of faecal bifidobacteria was higher in the prebiotic group as compared to the control group . However this difference did not reach statistical significance ( P=0.262 ) . The percentage of E. coli was lower in the prebiotic group but again this did not reach statistical significance ( P=0.312 ) . CONCLUSION An infant formula containing prebiotic oligosaccharides is well tolerated , leads to normal somatic growth and suppresses the numbers of clostridia in the faeces with a trend for higher percentage of stool bifidobacteria and lower percentage of E. coli",
"The aim of this study was to evaluate the effect of an infant formula supplemented with short-chain fructooligosaccharides ( scFOS ) on faecal concentration of bifidobacteria . Sixty-one healthy formula-fed infants participated in this double-blind controlled trial and were r and omized to receive either the scFOS-supplemented formula ( 4 g/L scFOS ) or the placebo-supplemented formula ( 4 g/L maltodextrins ) until the age of 4 mo . Stool sample s were analyzed for bifidobacteria at enrolment and at the age of 2 and 3 mo and for antipoliovirus IgA at the age of 4 mo . Parents completed a question naire to assess digestive tolerance . Change in faecal bifidobacteria after 2 mo were higher with scFOS compared to the placebo . At 4 mo , specific IgA tended to be higher with the scFOS group than with the placebo . Somatic growth and digestive tolerance were similar between groups . This study confirms that scFOS-supplemented formula can increase the concentration of faecal bifidobacteria while being well tolerated",
"The objective of the study was to investigate whether an infant formula supplemented with galacto-oligosaccharides ( GOS ; OM55N ) was able to stimulate the growth of indigenous bifidobacteria and to establish microbiota similar to that of breastfed infants . A r and omised , double-blind , placebo-controlled trial was performed using 35 healthy term infants ( 31 - 54 days of age ; 42±6 days ) to determine whether infant formula with 0.3 g/dl GOS ( OM55N ) stimulated the growth of bifidobacteria in the infants ' guts . At the trial onset and 2 weeks after , the infants ' faecal sample s were examined for microbiota composition ( bacterial abundance and α-diversity ) and faecal characteristics . Among the 35 infants , 5 were withdrawn and 8 were excluded from the final evaluation before breaking the blinding since the indigenous bifidobacteria were not detected at the trial onset . After 2 weeks , the abundance of Bifidobacteriaceae was significantly increased in the GOS feeding group compared to the control ( + 11.6±24.1 % vs -3.9±13.0 % ; P=0.043 ) . The Shannon index , which accounts for both abundance and evenness of the present species , was significantly decreased with GOS supplementation ( -0.1±0.4 vs + 0.4±0.4 ; P=0.014 ) . Faecal characteristics such as pH and organic acids were similar in both groups , with no statistical differences . No adverse side effects related to the formula consumption were reported . Although the concentration of GOS was relatively low , the infant formula with GOS increased the abundance of bifidobacteria and result ed in a reduced α-diversity of the microbiota ",
"This double-blind , r and omized , placebo-controlled study , aim ed to explore the effect of an infant milk formula ( IMF ) with 6 g/l short-chain galacto- and long-chain fructo-oligosaccharides ( scGOS/lcFOS , ratio 9:1 ) on basal immune parameters in 215 healthy , term infants during the first 26 wk of life . After birth , the infants received breast milk or were r and omized to receive an IMF with or without scGOS/lcFOS . Blood sample s were collected at the age of 8 wk and 26 wk for the analysis of serum immunoglobulins , lymphocyte sub population s , and cytokines . The scGOS/lcFOS group and the control group were compared in the statistical analysis . A breast fed group was included as a reference . In total , 187 Infants completed the study . No significant differences were observed between both formula groups in the different studied immune parameters at weeks 8 and 26 . This explorative study indicates that supplementation of infant formula with a mixture of prebiotic oligosaccharides did not change the basal level of the measured parameters of the developing immune system in healthy infants with a balanced immune system during the first 6 months of life in comparison to feeding a st and ard infant formula and in comparison to exclusive breastfeeding",
"Objectives : The present study was design ed to evaluate the effect of 2 different combinations of prebiotic ingredients , polydextrose ( PDX ) , galactooligosaccharides ( GOS ) , and lactulose ( LOS ) , at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age . Patients and Methods : Healthy , formula-fed , term infants ( n = 226 ) were r and omly assigned to 1 of 3 study formula groups : control group ( n = 76 ) , PG4 group ( control formula supplemented with 4 g/L of a prebiotic blend , n = 74 ) , or PGL8 group ( control formula supplemented with 8 g/L of a prebiotic blend , n = 76 ) . Anthropometric measurements were taken at 14 , 30 , 60 , 90 , and 120 days of age , and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30 , 60 , 90 , and 120 days of age . Adverse events were recorded throughout the study . Results : There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point . Significant differences in stool consistency were detected among the 3 formula groups at 30 , 60 , and 90 days of age ( P looser stools than the control group . The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age ( P = 0.021 and P = 0.017 , respectively ) , but all of the groups were similar at 60 , 90 , and 120 days of age . A statistical difference was detected among the formula groups in 3 categories of adverse events : diarrhea ( control vs PG4 , 4 % vs 18 % , P = 0.008 ) , eczema ( PG4 vs control , 18 % vs 7 % , P = 0.046 ; PG4 vs PGL8 , 18 % vs 4 % , P = 0.008 ) , and irritability ( control vs PGL8 , 4 % vs 16 % , P = 0.027 ) . Conclusions : Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula . A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics",
"Secretory immunoglobulin A ( SIgA ) plays an important role in the defence of the gastrointestinal tract . The level of faecal SIgA antibody is associated with increased neutralization and clearance of viruses . Formula-fed infants who lack the transfer of protective maternal SIgA from breast milk may benefit from strategies to support maturation of humoral immunity and endogenous production of SIgA. We aim ed at study ing the effects of st and ard , prebiotic and probiotic infant formulas on the faecal SIgA levels . At birth , infants of whom the mother had decided not to breastfeed were allocated to one of three formula groups in a r and omized , double-blind fashion . Nineteen infants received st and ard infant formula ; 19 received prebiotic formula containing a specific mixture of 0.6 g galacto-oligosaccharides (GOS)/fructo-oligosaccharides (FOS)/100 ml formula and 19 received probiotic formula containing 6.0 x 10(9 ) cfu Bifidobacterium animalis/100 ml formula . Faecal sample s were taken on postnatal day 5 , day 10 , wk 4 and every 4 wk thereafter until wk 32 . SIgA in faeces was determined by an enzyme-linked immunosorbent assay . During the intervention , infants fed on prebiotic formula showed a trend towards higher faecal SIgA levels compared with the st and ard formula-fed infants reaching statistical significance at the age of 16 wk . In contrast , infants fed on the probiotic formula showed a highly variable faecal SIgA concentration with no statistically significant differences compared with the st and ard formula group . Formula-fed infants may benefit from infant formulas containing a prebiotic mixture of GOS and FOS because of the observed clear tendency to increase faecal SIgA secretion . Adding viable B. animalis strain Bb-12 to infant formula did not reveal any sign for such a trend",
"OBJECTIVE Cholesterol is a nutrient of essential importance in infant feeding because it is necessary in membrane development . In adults with high lipid levels , high doses of inulin ( oligofructose ) inconsistently decreased levels of serum cholesterol . The aim of the present study was to evaluate cholesterol and triacylglycerol levels in infants receiving a formula with a specific mixture of 0.6 g/100 mL of galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( lcFOS ) in a ratio of 9/1 , a control formula , or breast milk . Because the level of lcFOS in the infant milk is low , we hypothesized that there would be no differences between the formula groups . METHODS Two hundred fifteen infants were included in a prospect i ve , r and omized , double-blinded , placebo-controlled trial during the first 6 mo of life . Formula-fed infants were r and omized to receive a st and ard infant formula with a specific mixture of 0.6 g/100 mL of GOS/lcFOS , in a ratio of 9/1 , or a control formula . Breast-fed infants were r and omized to receive one of these two formulas after the mother had decided to discontinue breastfeeding . Serum levels of cholesterol , high-density lipoprotein , low-density lipoprotein ( LDL ) , and triacylglycerol were determined at 8 and 26 wk of age and were provided for infants who received the GOS/lcFOS formula or control formula from birth or after cessation of breastfeeding and for the subgroups that were fully fed with breast milk and formula . RESULTS One hundred eighty-seven infants completed the study . Total cholesterol and LDL levels at 8 and 26 wk were significantly lower in the formula-fed groups than in the breast-fed infants . There were no significant differences between the formula-fed groups . Levels of triacylglycerols and high-density lipoprotein did not differ between groups . CONCLUSION Our study demonstrated no differences in total cholesterol and LDL cholesterol in infants receiving an infant formula with GOS/lcFOS from infants receiving a control infant formula . Furthermore , total cholesterol and LDL cholesterol levels were higher in breast-fed infants than in formula-fed infants",
"Objective : The objective of the study was to investigate the effects of a galacto-oligosaccharides (GOS)-supplemented formula on the intestinal microbiota in healthy term infants , with a specific consideration for gastrointestinal symptoms as colic , stool frequency and consistency , regurgitation . Methods : This was a r and omized , double-blind , controlled , parallel-group clinical trial performed simultaneously by 6 centers in Italy . Three groups were considered : breastfed , formula-fed , and GOS-supplemented formula-fed infants . Formula-fed infants were r and omized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding . The nutritional composition of the 2 formulas were identical , apart from the supplemented GOS ( 0.4 g/100 mL ) in the study formula . Four different types of bacteria were evaluated in order to assess the efficacy of GOS-supplemented formula on infants : Bifidobacterium , Lactobacillus , and Clostridium , Escherichia coli . Results : A total of 199 breastfed infants and 163 formula-fed infants were recruited . When considering stool frequency and consistency , GOS-supplemented formula presented normal and soft stools in the majority of episodes ( 89 % ) . In the supplemented group the incidence of colic was lower with respect to the control group . A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic . In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one . Conclusions : The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth , result ing in a significantly lower presence of colic"
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We search ed the MEDLINE , CINAHL , and Cochrane Library data bases for articles published between January 1995 and April 2011 . The up date of this clinical practice guideline is the result of review ing a total of 54 clinical trials and systematic review s on incentive spirometry . The following recommendations are made following the Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) scoring system . 1 : Incentive spirometry alone is not recommended for routine use in the preoperative and postoperative setting to prevent postoperative pulmonary complications . 2 : It is recommended that incentive spirometry be used with deep breathing techniques , directed coughing , early mobilization , and optimal analgesia to prevent postoperative pulmonary complications . 3 : It is suggested that deep breathing exercises provide the same benefit as incentive spirometry in the preoperative and postoperative setting to prevent postoperative pulmonary complications . 4 : Routine use of incentive spirometry to prevent atelectasis in patients after upper-abdominal surgery is not recommended . 5 : Routine use of incentive spirometry to prevent atelectasis after coronary artery bypass graft surgery is not recommended . 6 : It is suggested that a volume-oriented device be selected as an incentive spirometry device
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"BACKGROUND Patients undergoing coronary artery bypass graft ( CABG ) surgery have higher risk to develop pulmonary complications ( PCs ) such as atelectasis , pneumonia and pleural effusion . These complications could increase the length of hospital stay , re sources utilization and also are associated with reduced quality of life and functional capacity a long term . OBJECTIVE To test if the use of incentive spirometry ( IS ) associated with expiratory positive airway pressure ( EPAP ) , after CABG surgery improves dyspnea , effort perceived and quality of life 18 months after CABG . METHODS Sixteen patients su bmi tted to a CABG , were r and omized to a control group ( n=8 ) or IS+EPAP group ( n=8 ) . The protocol of IS+EPAP was applied in the immediate postoperative period and following for more 4 weeks in the patient 's home . Eighteen months after CABG , the strength of the respiratory muscle , the functional capacity , the lung function , the quality of life and the level of physical activity were evaluated . RESULTS After six minute walk test ( 6-MWT ) , the score of the dyspnea ( 1.6+/-0.6 vs 0.6+/-0.3 , P perceived effort ( 13.4+/-1.2 vs 9.1+/-0.7 , P IS+EPAP group . In quality of life evaluation , the domain related to the physical aspects limitations was better in IS+EPAP group ( 93.7+/-4.1 vs 50+/-17 , P IS+EPAP present reduction of dyspnea and lower effort sensation after the 6-MWT , and also a better quality of life 18 months after CABG",
"OBJECTIVE To compare the effects of deep breathing exercises ( DBE ) and the flow-oriented incentive spirometry ( IS ) in patients undergone coronary artery bypass grafting ( CABG ) through the following variables : forced vital capacity - FVC , forced expiratory volume in 1 second - FEV(1 ) , maximal respiratory pressures and oxygen saturation . METHODS Thirty six patients in CABG postoperative period underwent thirty minutes of non-invasive ventilation during the first 24 hours after extubation and were r and omly shared into two groups as following : DBE ( n=18 ) and IS ( n=18 ) . The spirometric variables were assessed on the preoperative period and seventh postoperative day ( POD ) . The respiratory muscle strength and oxygen saturation were assessed on the preoperative period , first , second and seventh POD . RESULTS The groups were considered homogeneous in relation to the demographic and surgical variables . It has been noted fall in the values of FVC and FEV(1 ) between the preoperative period and the seventh POD , but without significant differences between groups . The maximal respiratory pressures showed drop in the first POD but with and partial recovery until the seventh POD , also without significant differences between groups . The oxygen saturation was the only variable that was completely recovered on the seventh POD , also without significant differences between groups . CONCLUSION There were not observed significant differences in maximal respiratory pressures , spirometric variables and oxygen saturation in patients undergone deep breathing exercises and flow-oriented incentive spirometry after coronary artery bypass grafting",
"STUDY OBJECTIVES The study evaluated the impact of the additional imposed work of breathing ( WBimp ) generated by two different spirometers on postoperative incentive spirometry performance in patients at high risk and moderate risk for postoperative pulmonary complications ( PPCs ) . Additionally , we investigated whether maximal inspiratory pressure ( PImax ) is an easy estimate of the WBimp imposed by incentive spirometers . DESIGN Prospect i ve , r and omized , single-blind clinical trial . SETTING ICU of a university hospital . INTERVENTIONS AND MEASUREMENTS Thirty male patients were assigned to a group at high risk for PPCs ( group A ; inspiratory capacity [ IC ] , On the first or second postoperative day WBimp , IC , and PImax were recorded without spirometers ( baseline ) and during incentive spirometry with the Mediflo spirometer ( Medimex ; Hamburg , Germany ) ( high WBimp ) and the Coach spirometer ( Kendall ; Neustadt , Germany ) ( low WBimp ) using a pneumotachograph . In group A , the baseline and the ICs for both spirometers only differed slightly . In group B , the IC was significantly reduced for the Mediflo ( p PImax was significantly increased for both the Mediflo and the Coach ( p PImax was positively correlated with WBimp ( r = 0.8 ) . CONCLUSIONS Incentive spirometers differ considerably in their additional Wbimp with a potential impact on the efficacy of postoperative incentive spirometry performance . PImax might be an easy clinical estimate for the WBimp during incentive spirometry . Incentive spirometers with low WBimp permit increased maximal sustained inspiration and , thus , enhanced incentive spirometry performance , and , therefore , it might be more suitable for use in postoperative respiratory care",
"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 Pulmonary infections can be life threatening for children with neuromuscular diseases who have impaired ability to clear secretions . Intrapulmonary percussive ventilation ( IPV ) is a pneumatic device that delivers air and aerosol to the lungs at frequencies of 200 to 300 cycles per minute at peak pressures from 20 to 40 cm H(2)O. Anecdotal reports and pilot studies show its safety and effectiveness in mobilizing secretions in patients with cystic fibrosis . OBJECTIVE To test the hypothesis that IPV used in a pulmonary program for adolescents with neuromuscular disease would reduce the number of days of antibiotic use for pulmonary infection . METHODS A r and omized , controlled study was conducted to compare efficacy of IPV with incentive spirometry ( IS ) in reducing number of days of antibiotic use in adolescents with neuromuscular disease . The secondary endpoints were the number of respiratory infections , hospitalizations , and school days missed . RESULTS A total of 18 patients were enrolled ( 9 IPV , 9 IS ) . Antibiotic use was significantly higher with IS ( 24/1000 patient-days ) compared with IPV ( 0/1000 patient-days ) , ( incidence rate ratio , 43 ; 95 % confidence interval , 6 - 333 ) . The IS group spent more days hospitalized ( 4.4/1000 patient-days vs 0/1000 patient-days ) than the IPV group ( incidence rate ratio , 8.5 ; 95 % confidence interval , 1.1 - 67 ) . The IPV group had 0 episodes of pneumonia or bacterial bronchitis compared with 3 events in the IS group , although this did not meet statistical significance . CONCLUSION Intrapulmonary percussive ventilation as part of a preventive pulmonary regimen reduced days of antibiotic use and hospitalization for respiratory illness in adolescents with neuromuscular disease",
"Abdominal binders are ordered by some surgeons postoperatively for patient comfort and to prevent wound complications . There has been some question as to the compressive effect that an abdominal binder has on pulmonary function . We prospect ively r and omized 54 patients undergoing a midline laparotomy incision to two groups : a “ binder ” group and a “ no binder ” group . Preoperative pulmonary function tests ( vital capacity and incentive spirometry ) were measured . Postoperatively , pulmonary function tests , pulse oximetry , oxygen requirement , pulmonary and wound complications , pain control , time to ambulation , and hospital length of stay were examined . Vital capacity as a per cent of preoperative values on postoperative Day 1 for the binder and nonbinder groups were 64.7 and 54.6 per cent , respectively , but this was not statistically significant . Average level of pain using the visual analog pain scale on postoperative Days 1 through 3 in the binder versus nonbinder groups was 4 versus 8 , 3 vs 6 , and 3 versus 7 , respectively . Time to ambulation was 18.6 hours in the binder group and 16.7 hours in the nonbinder group . Hospital length of stay in the binder and nonbinder groups was 3.9 days and 3.7 days , respectively . We conclude that abdominal binders in our patients with midline abdominal incisions had no significant effect on postoperative pulmonary function , but seemed to help with pain control",
"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",
"Background Even several days after surgery , obese patients exhibit a measureable amount of atelectasis and thus are predisposed to postoperative pulmonary complications . Particularly in ambulatory surgery , rapid recovery of pulmonary function is desired to ensure early discharge of the obese patient . In this study , we wanted to evaluate intensive short-term respiratory physical therapy treatment ( incentive spirometry ) in the postanesthesia care unit ( PACU ) and its impact on pulmonary function in the obese . Methods After ethics committee approval and informed consent , we prospect ively studied 60 obese patients ( BMI 30–40 ) undergoing minor peripheral surgery , half of which were r and omly assigned to receive respiratory physiotherapy during their PACU stay , while the others received routine treatment . Premedication , general anesthesia , and respiratory setting s were st and ardized . We measured arterial oxygen saturation by pulse oximetry on air breathing . Inspiratory and expiratory lung functions were measured preoperatively ( baseline ) and at 10 min , 1 , 2 , 6 , and 24 h after extubation , with the patient supine , in a 30 ° head-up position . The two groups were compared using repeated-measure analysis of variance and t test analysis . Statistical significance was considered to be P but , during the PACU stay , pulmonary function in the physiotherapy group was significantly better than the controls ’ ( p hort-term respiratory physiotherapy during the PACU stay promotes more rapid recovery of postoperative lung function in the obese during the first 24",
"The effect of three postoperative regimes of respiratory therapy on pulmonary complications and lung function was compared in high‐risk patients . Fifty‐one patients were r and omized to : 1 ) conventional chest physiotherapy alone ( PHYS ) , 2 ) chest physiotherapy and positive expiratory pressure ( PEP ) , or 3 ) chest physiotherapy with both positive expiratory pressure and inspiratory resistance ( RMT ) . Treatments were given twice daily by a physiotherapist and self‐administered . The incidence of postoperative pulmonary complications ( PPC ) was respectively , 71 % , 76 % and 65 % in the PHYS‐ , PEP‐ and RMT‐groups . The incidence of PPC requiring treatment with antibiotic , bronchodilator or supplementary oxygen according to the existing clinical practice was 47 % , 47 % and 29 % . The incidence of atelectasis was 65 % , 64 % and 60 % and of pneumonia 29 % , 35 % and 6 % . There was no difference between the groups , except for a tendency to a lower frequency of pneumonia in the RMT‐group . Postoperatively forced vital capacity ( FVC ) decreased to mean 54 % , forced expired volume in 1 s to 48 % and functional residual capacity to 76 % of preoperative values . Arterial oxygen tension ( Pao2 ) declined to mean 8.1 kPa and arterial saturation ( Sao2 ) to 89 % . There was no difference between the groups except for FVC , Pao2 and Sao2 ( P = 0.008 , P = 0.008 and P = 0.002 ) , which showed the least decrease in the RMT‐group . None of the regimens could be considered as satisfactory concerning the prevention of PPC , but RMT seemed to be the most efficient . Insufficient self‐administration of treatment was probably one of the causes of the overall high incidence of PPC in this study",
"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",
"BACKGROUND The pulmonary complication in sickle cell disease known as acute chest syndrome ( ACS ) has potential for high morbidity and mortality . A r and omized trial demonstrated that incentive spirometry ( IS ) reduces the rate of ACS , leading to a role for respiratory therapy in hospital management of sickle cell pain . However , use of IS can be limited by chest wall pain , or by difficulty with the coordinated inspiration in a young child . Intermittent positive expiratory pressure ( PEP ) therapy may be easier for a child 's coordination and more comfortable than IS for a child with chest wall pain . PURPOSE To compare PEP therapy with conventional IS for children hospitalized for sickle cell pain with respect to patient satisfaction , length of hospital stay , and progression to ACS . METHODS This pilot study enrolled 20 children upon hospitalization for sickle cell pain in the thorax , r and omly assigning them to either PEP ( n = 11 ) or IS ( n = 9 ) therapy , administered by a therapist hourly while awake . RESULTS The r and omization assigned an older distribution to PEP than IS ( 12.3 vs 8.8 y ) . Patient satisfaction was high for both respiratory care devices , and there was no difference between the PEP and IS groups ( 4.5 vs 4.4 , p = 0.81 ) . Length of hospital stay was similar ( 5 vs 4.3 d , p = 0.56 ) . No children in either group progressed to ACS . CONCLUSION These preliminary results show no difference in the primary outcomes in the 2 groups . Intermittent PEP therapy warrants further study as an alternative to IS for sickle cell patients at high risk for ACS , as effective preventive respiratory therapy",
"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 Chronic obstructive airway diseases ( COAD ) , characterized by mucus hypersecretion , lead to exercise intolerance . Incentive spirometry has been used to prevent postoperative pulmonary atelectasis . METHODS To compare the efficacy of two incentive spirometers , Coach ( volume-oriented ) and Triflo ( flow-oriented ) , in the work of breathing in COAD patients , 22 patients were r and omized in this study : 12 patients ( Triflo-II group ) initially used Triflo-II for 10 minutes and then Coach for the same period . In contrast , the Coach group , including 10 patients , started with Coach followed by Triflo-II . After receiving incentive spirometry , lung expansion and work of breathing were assessed . RESULTS Patients in the Coach group significantly increased chest wall expansion ( p = 0.041 ) , as compared with patients using Triflo-II . Similarly , there was also a significantly increased abdominal wall expansion in the Coach group ( p = 0.0056 ) , compared with that in the Triflo-II group . The need of accessory muscle assistance for breathing in the Coach group was significantly less than in the Triflo-II group ( p = 0.047 ) . It was easier for patients in the Coach group to start a breath ( p = 0.0058 ) than for those in the Triflo-II group . For the entire group , 17 patients ( 77.3 % ) preferred Coach to assist their breathing , and only 4 patients ( 18.2 % ) favored Triflo-II . CONCLUSION COAD patients achieved a larger expansion of the chest and abdomen with a Coach device . Our data provide a good rationale for an outcome study on the use of incentive spirometer in COAD patients",
"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",
"BACKGROUND This study was design ed to determine the incidence of thoracic bone infa rct ion in patients with sickle cell diseases who were hospitalized with acute chest or back pain above the diaphragm and to test the hypothesis that incentive spirometry can decrease the incidence of atelectasis and pulmonary infiltrates . METHODS We conducted a prospect i ve , r and omized trial in 29 patients between 8 and 21 years of age with sickle cell diseases who had 38 episodes of acute chest or back pain above the diaphragm and were hospitalized . Each episode of pain was considered to be an independent event . At each hospitalization , patients with normal or unchanged chest radiographs on admission were r and omly assigned to treatment with spirometry or to a control nonspirometry group . Each patient in the spirometry group took 10 maximal inspirations using an incentive spirometer every two hours between 8 a.m. and 10 p.m. and while awake during the night until the chest pain subsided . A second radiograph was obtained three or more days after admission , or sooner if clinical ly necessary , to determine the incidence of pulmonary complications . Bone scanning was performed no sooner than two days after hospital admission to determine the incidence of thoracic bone infa rct ion . RESULTS The incidence of thoracic bone infa rct ion was 39.5 percent ( 15 of 38 hospitalizations ) . Pulmonary complications ( atelectasis or infiltrates ) developed during only 1 of 19 hospitalizations of patients assigned to the spirometry group , as compared with 8 of 19 hospitalizations of patients in the nonspirometry group ( P = 0.019 ) . Among patients with thoracic bone infa rct ion , no pulmonary complications developed in those assigned to the spirometry group during a total of seven hospitalizations , whereas they developed during five of eight hospitalizations in the nonspirometry group ( P = 0.025 ) . CONCLUSIONS Thoracic bone infa rct ion is common in patients with sickle cell diseases who are hospitalized with acute chest pain . Incentive spirometry can prevent the pulmonary complications ( atelectasis and infiltrates ) associated with the acute chest syndrome in patients with sickle cell diseases who are hospitalized with chest or back pain above the diaphragm",
"OBJECTIVE Investigate the frequency of , and risks for postoperative pulmonary complications after surgery for non-malignant gynecologic disorders . METHOD A retrospective component included medical record data for one year . A prospect i ve component enrolled 300 patients consecutively who were scheduled for gynecologic surgeries . RESULT Postoperative pulmonary complications occurred in 1.22 % of 328 open abdominal procedures in the retrospective study , and 2.16 % of 232 in the prospect i ve study . Pooling the data yielded a frequency estimate of 1.61 % . Mean hospital length of stay ( pooled data ) increased 1.75 days in those with postoperative pulmonary complications . Smoking was the only significant risk factor ( relative risk=3.9 using pooled data ) . CONCLUSION Postoperative pulmonary complications after surgery for non-malignant gynecologic disorders are infrequent but increase hospital length of stay . Smokers are at increased risk",
"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",
"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",
"We undertook this study to characterize the postthoracotomy compartmental displacement and respiratory mechanical changes occurring during and after the performance of the incentive spirometry maneuver . We also evaluated the effect of recumbency angle on compartmental recruitment . Sixteen patients were r and omized to perform incentive spirometry either at 30 degrees or 60 degrees recumbency angle . They were studied using respiratory inductance plethysmography to measure tidal volume , respiratory frequency , inspiratory time , rib cage motion/tidal volume ratio , inspiratory duty cycle , and inspiratory flow . Patients were studied before surgery and on postoperative days 1 and 3 . Statistical analysis was accomplished using multiple measures ANOVA with post-hoc Student 's t-tests when appropriate . Preoperative incentive spirometry augmented VT by increasing both VT/TI and TI . Postoperatively , the incentive recruitment of VT was reduced , a result of a decrease in TI and TI/TTOT ; VT/TI was unchanged . There was postoperative decrease of AB and AB/VT during incentive spirometry , greatest in the 60 degrees group . Our results characterize the nature of the respiratory recruitment afforded by incentive spirometry , before and after thoracotomy . We also found evidence of postthoracotomy diaphragmatic derecruitment during incentive spirometry exacerbated by a high recumbency angle",
"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",
"Pulmonary complications are the leading cause of morbidity and mortality following major abdominal surgery . Chest physiotherapy aims to decrease the likelihood of these complications and hasten recovery . Exercises aim ed at maximising inspiratory effort are the most beneficial for the patients . The incentive spirometer is a h and held device that patients use to achieve effective inspiration . In a nonr and omised pilot study of 263 patients we have found that the addition of the incentive spirometer , as part of an intensive post-operative physiotherapy programme , decreased the occurrence of pulmonary complications ( 6 vs 17 % , p = 0.01 ) and length of stay on the surgical high dependency unit ( 3.1 vs 4 days p = 0.03 ) . The two groups were comparable when age , sex , smoking history , the need for emergency surgery and post-operative analgesia were compared",
"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"
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Aims To perform an up date d meta- analysis to assess efficacy , safety and technical performance of pulmonary vein isolation using cryoballoon or radiofrequency catheter ablation in patients with paroxysmal or persistent atrial fibrillation . Methods In June 2017 , data bases and websites were systematic ally search ed for systematic review s , r and omized controlled trials and observational studies reporting data on efficacy , safety and technical performance outcomes at follow-up at least 12 months . Research ers independently assessed records ’ eligibility , inclusion and method ological quality of included studies . Results Six r and omized controlled trials and 25 observational studies – 11 853 patients were included . Studies on paroxysmal atrial fibrillation were 29 and included 11 635 patients . Meta- analysis results showed no difference between cryoballoon and radiofrequency in terms of recurrent atrial fibrillation [ risk ratio 1.04 , 95 % confidence interval ( CI ) 0.98–1.10 ] or atrial tachyarrhythmias ( risk ratio 1.04 , 95 % CI 1–1.08 ) and fluoroscopy time ( mean difference −1.92 min , 95 % CI −4.89 to 1.05 ) . Cryoballoon ablation was associated with fewer reablations ( risk ratio 0.79 , 95 % CI 0.64–0.98 ) , lower incidence of pericardial effusion ( risk ratio 0.52 , 95 % CI 0.31–0.89 ) and cardiac tamponade ( risk ratio 0.33 , 95 % CI 0.18–0.62 ) and shorter total procedural time ( mean difference −23.48 min , 95 % CI −37.97 ; −9.02 ) but with higher incidence of phrenic nerve palsy ( risk ratio 5.43 , 95 % CI 2.67–11.04 ) . Prespecified subgroup analysis confirmed overall results as for freedom from atrial fibrillation and atrial tachyarrhythmias . Only two observational studies included patients with persistent atrial fibrillation , thus hindering any conclusion in this population . Conclusion In patients with paroxysmal atrial fibrillation , cryoballoon and radiofrequency ablation produce similar results in terms of freedom from recurrent atrial fibrillation or atrial tachyarrhythmias but with a different safety profile , being cryoballoon ablation less associated with cardiac complications but more likely to cause phrenic nerve palsy
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[
"Background —Pulmonary veins ( PVs ) play a pivotal role in initiating and perpetuating atrial fibrillation ( AF ) . We investigated if PV electrical isolation from the left atrium is required for curing AF . Methods and Result —Fifty-one patients with paroxysmal or persistent AF underwent circumferential radiofrequency ablation of PV ostia performed with an anatomic approach . The end point of the ablation procedure was the recording of low peak-to-peak bipolar potentials ( 41 patients ( 80.4 % ) were free of atrial arrhythmias . When patients with and without AF recurrence were analyzed , no significant difference was observed in the mean number of PVs in which the ablation end point was reached ( 3.4±1.2 versus 3.7±0.87 ) and PVs isolated ( 1.5±1.4 versus 1.6±1 ) . We noted that , although in 29 of 41 patients ( 71 % ) without AF recurrence , the ablation end point was reached in all PVs mapped , it was only possible to demonstrate the isolation of all PVs mapped in 2 patients . On the other h and , in 7 of 10 patients ( 70 % ) with AF recurrence , the ablation end point was reached in all PVs mapped , whereas one patient had all PVs isolated . Conclusions —Our findings show that with the use of a pure anatomic approach , it is possible to prevent AF in > 80 % of patients undergoing catheter ablation . Moreover , the isolation of PVs is not crucial for curing AF",
"BACKGROUND Although radiofrequency ( RF ) ablation has long been the st and ard of care for atrial fibrillation ( AF ) ablation , cryoballoon technology has emerged as a feasible approach with promising results . Prospect i ve multicenter registry data referring to both ablation technologies in AF ablation are lacking so far . OBJECTIVE The purpose of this study was to report data from the German ablation registry with respect to efficacy and safety in pulmonary vein ablation with different energy sources for paroxysmal AF after 1-year follow-up . METHODS A total of 2306 patients with symptomatic paroxysmal AF from the German ablation registry were included in this analysis . The cohort was divided into two groups according to the ablation energy source used : cryoballoon and RF ablation . MACCE was defined as a combination of death , myocardial infa rct ion , or stroke . RESULTS AF recurrence rate after a single ablation procedure at 1 year follow-up was not significantly different between the two groups ( 45.8 % after cryoablation and 45.4 % after RF ablation , P = .87 ) . Also , the rate of patients without AF recurrence and free of antiarrhythmic drug at 12-month follow-up was similar ( cryoablation 44.2 % and RF 41.4 % , P = .25 ) . MACCE occurred with an incidence of 0.7 % within 500 days after cryoablation and 1.4 % after RF ablation ( P = .30 ) . Persistent phrenic nerve palsy was more common after cryoablation compared to RF ablation ( 1.1 % vs. 0.3 % , P AF recurrence rate at 1-year follow-up was similar in RF ablation compared to cryoablation , whereas the spectrum and relevance of complications were significantly different between the two ablation methods . This finding might influence the choice of ablation method offered to the individual paroxysmal AF patient",
"Background Radiofrequency and cryoballoon pulmonary vein isolation are common approaches for paroxysmal atrial fibrillation treatment , showing similar results in recent multicenter studies , including heterogeneous tools and protocol s. The aim of this study is to compare prospect ively in a single , high-volume center the outcome of paroxysmal atrial fibrillation ablation performed specifically by second-generation cryoballoon or contact force radiofrequency ablation . Methods Consecutive patients scheduled for paroxysmal atrial fibrillation transcatheter ablation have been included and prospect ively followed up . Aim ing to reduce potential bias deriving from baseline characteristics , a propensity score matching analysis has been performed to analyze safety and efficacy outcomes . Results Out of consecutive patients undergoing atrial fibrillation transcatheter ablation between January 2015 and December 2016 , 46 patients approached by cryoablation were matched 1 : 1 by propensity score to a similar population treated by last-generation radiofrequency ablation . Freedom from atrial fibrillation after 12 months ( 76 vs. 78 % , P = 0.804 ) and incidence of complications ( 4 vs. 6 % , P = 0.168 ) did not differ between the two groups . Radiological exposure was higher for the cryoballoon group ( 11 vs. 4 min , P procedural duration did not differ ( P = 0.174 ) . Aim ing to assess the potential impact of a learning curve in patients undergoing cryoablation , the first-third of patients ( n = 15 ) were compared with the remaining , reporting longer radiological exposure ( P safety and efficacy . Conclusion In this propensity score analysis , last-generation cryoballoon and radiofrequency catheters for atrial fibrillation ablation present similar efficacy and safety . Cryoablation requires longer fluoroscopy exposure compared with radiofrequency , although this is reduced by increased experience",
"INTRODUCTION There are limited comparative data on catheter ablation of atrial fibrillation ( CAAF ) using the second-generation cryoballoon ( CB-2 ) versus point-by-point radiofrequency ( RF ) . This study examines the acute/long-term CAAF outcomes using these 2 strategies . METHODS AND RESULTS In this multicenter , retrospective , nonr and omized analysis , procedural and clinical outcomes of 1,196 patients ( 76 % with paroxysmal AF ) undergoing CAAF using CB-2 ( n = 773 ) and open-irrigated , non-force sensing RF ( n = 423 ) were evaluated . Pulmonary vein isolation was achieved in 98 % with CB-2 and 99 % with RF ( P = 0.168 ) . CB-2 was associated with shorter ablation time ( 40 ± 14 min vs. 66 ± 26 min ; P and procedure time ( 145 ± 49 minutes vs. 188 ± 42 minutes ; P greater fluoroscopic utilization ( 29 ± 13 minutes vs. 23 ± 14 minutes ; P transient ( 7.6 % vs. 0 % ; P persistent ( 1.2 % vs. 0 % ; P = 0.026 ) phrenic nerve palsy occurred exclusively with CB-2 , other adverse event rates were similar between CB-2 ( 1.6 % ) and RF ( 2.6 % ) ; P = 0.207 . However , freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 ( 76.6 % ) versus RF ( 60.4 % ) ; P patients with paroxysmal AF ( P Additionally , CB-2 was associated with reduced long-term need for antiarrhythmic therapy ( 16.7 % vs. 22.0 % ; P = 0.024 ) and repeat ablations ( 14.6 % vs. 24.1 % ; P CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated , non-force sensing RF , alone",
"AIMS The second-generation cryoballoon ( CB2 ) with increased surface cooling has recently become available . The aim was to investigate the incidence and characteristics of phrenic nerve palsy ( PNP ) during pulmonary vein isolation ( PVI ) using the CB2 as compared with the first-generation balloon ( CB1 ) . METHODS AND RESULTS A total of 360 consecutive patients with atrial fibrillation underwent PVI with the CB1 ( 106 patients ) or the CB2 ( 254 patients ) . Right PN function was monitored by continuous stimulation and palpation during septal PV ablation . Persistent PNP ( present at discharge ) occurred in 2.8 and 1.9 % ( P = 0.63 ) of patients , transient PNP ( full recovery before discharge ) in 5.9 and 3.8 % ( P = 0.41 ) of patients in the CB2 and CB1 group , respectively . Phrenic nerve palsy during ablation at the right inferior PV was observed in 0 % ( CB1 ) and 4.3 % ( CB2 , P = 0.03 ) of patients . Using the CB2 , a trend of reduced incidence of persistent PNP over quartiles of consecutive patients was observed [ 4.8 % ( Q1 ) vs. 0 % ( Q4 ) ; P = 0.077 ] . At the culprit PV , PNP occurred after 3.5 ± 2.1 ( CB1 ) and 1.1 ± 0.4 applications ( CB2 ; P = 0.036 ) . Complete recovery of PN function occurred after 29 ± 11 ( CB1 ) and 259 ± 137 days ( CB2 ; P = 0.004 ) . CONCLUSIONS The rate of transient/persistent PNP associated with the use of the CB2 was 5.9 and 2.8 % , respectively . Time to restitution of PN function was longer using the CB2 ",
"BACKGROUND Catheter ablation is an established treatment for atrial fibrillation ( AF ) . Cryoballoon ablation ( CBA ) has emerged as an alternative to radiofrequency ablation ( RFA ) . However , there are few data comparing these modalities for treatment of paroxysmal AF ( pAF ) in the U.S. POPULATION The purpose of this study was to compare procedural times , safety , and efficacy of CBA against RFA . METHODS A single-center prospect i ve cohort study evaluated patients who underwent catheter ablation for pAF using CBA or RFA between January 1 , 2010 and October 31 , 2013 . Patients with prior ablation and those without rhythm follow-up for at least 3 months were excluded . The primary end point was freedom from AF , atrial flutter , and atrial tachycardia ( FFAF ) > 30 seconds after a 3-month blanking period without requirement for antiarrhythmic drugs . We also compared rates of successful pulmonary vein isolation ( PVI ) , fluoroscopy and procedure times , and major complication rates . RESULTS A total of 201 patients were included ( CBA = 101 , RFA = 100 ) . The rate of successful PVI was 99.3 % in CBA versus 97.4 % in RFA ( P = 0.08 ) . Procedure times were shorter with CBA ( 192.9 ± 44.0 minutes vs 283.7 ± 78.0 minutes , P total fluoroscopy times ( 46.0 ± 22.4 minutes vs 73.0 ± 30.1 minutes , P 0.001 ) . Overall complication rates were equivalent ; however , fewer cardiac perforations occurred with CBA ( 0 % vs 4 % , P = 0.042 ) . The 1-year FFAF rates were 60.3 % for CBA and 61.1 % for RFA ( log rank P = 0.93 ) . CONCLUSION CBA was associated with equivalent 1-year FFAF rate as RFA for pAF . Procedure and fluoroscopy times were shorter for CBA and fewer cardiac perforations occurred",
"Purpose Recent data show no benefit of additional ablation beyond pulmonary vein isolation ( PVI ) in persistent atrial fibrillation ( AF ) . Evidence suggests that radiofrequency energy ( RF ) and cryoballoon ( CRYO ) have comparable efficacy for PVI . We aim ed to assess the outcomes after a single catheter ablation procedure , comparing PVI using CRYO vs. RF ablation for PVI plus additional ablation in a cohort of patients with persistent AF . Methods In this prospect i ve multicenter propensity score-matched comparison , 59 consecutive patients undergoing CRYO ablation of persistent AF were matched to 59 patients treated with RF from November 2010 to June 2012 . Results During a mean follow-up of 15.6 ± 11.5 months , 43.2 % of patients presented atrial arrhythmia relapse after a blanking period of 3 months , which was comparable between the two groups ( 40.7 % in CRYO vs. 45.8 % in RF , Log rank P = 0.14 ; HR = 0.67 , 95 % CI 0.38–1.16 , P = 0.15 ) , despite the fact that 52.5 % of RF patients add additional complex fractionated atrial electrogram ablation , as well as left atrial linear ablation in over two-thirds ( roof line in 67.8 % and mitral isthmus in 32.2 % ) . On multivariate Cox regression , only AF duration in years ( HR = 1.10 , 95 % CI 1.01–1.10 , P = 0.04 ) was a predictor of relapse . Patients undergoing RF ablation presented a numerically , but non-significantly , lower complication rate ( 6.8 vs 10.2 % , P = 0.51 ) . Conclusion In our multicenter experience , freedom from atrial arrhythmias was comparable among matched patients treated with CRYO and RF , despite non-significant trends in favor of RF in terms of complications , at the cost of longer procedure times",
"INTRODUCTION Data on long-term outcomes of cryoballoon ( CB ) ablation for treatment of persistent atrial fibrillation ( AF ) are sparse . Here , we report the first 3-year follow-up results and predictors of success for catheter ablation using the second-generation CB in patients with persistent AF . METHODS AND RESULTS For this prospect i ve observational study , we enrolled 101 patients ablated with the second-generation CB at our institution . The endpoint was the first documented recurrence ( > 30 seconds ) of AF , atrial flutter , or atrial tachycardia after a 3-month blanking period . Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings . The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models . After a median follow-up of 37 ( 31 of 42 ) months , recurrence was documented in 30 patients ( 29.7 % ) . The median procedure and fluoroscopy times were 120 ( 102 of 147 ) and 20 ( 16 of 27 ) minutes , respectively . Phrenic nerve palsy occurred in 2.0 % of the patients . Among the 30 patients who experienced recurrence , 16 underwent repeat ablation in radiofrequency technique . Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence . CONCLUSIONS Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation . Patients with a nonenlarged left atrium and short AF history had the best outcome",
"Background — Several approaches have been developed for radiofrequency catheter ablation of atrial fibrillation , but the correct intraprocedural end point is still under debate , and few data exist about the destiny of ablation lesions over time . The aim of the present study was to evaluate the long-term maintenance of intraprocedural end points of ablation procedures . Methods and Results — Inclusion criteria were ( 1 ) a previous ablation procedure of pulmonary vein ( PV ) encircling performed for drug-refractory persistent atrial fibrillation ; ( 2 ) a “ complete ” intraprocedural end point , which consisted of voltage abatement inside the lesions , PV disconnection , and exit-block pacing from inside the lesions , attained in all PVs ; and ( 3 ) stable sinus rhythm documented during a minimum follow-up of 2.5 years after the procedure . Twenty volunteers were selected ( 12 males , mean age 59±7 years ) and underwent a repeat electrophysiological study . After a follow-up of 36.4±4.7 months , complete voltage abatement was maintained around 32 PVs ( 40.0 % ) , PV disconnection persisted in 12 ( 37.5 % ) of the previously isolated PVs , and exit block was present in 39 PVs ( 48.7 % ) . Ten patients who underwent a redo ablation procedure because of recurrences of atrial fibrillation were used as the control group . Differences in intraprocedural end-point maintenance between the 2 groups were not statistically significant . Conclusions — Common intraprocedural end points such as voltage abatement , PV disconnection , and exit block persist only in a limited number of patients , even when the outcome is favorable during follow-up . Further investigation will be required to determine whether such data will have implication s for ablation strategies",
"Background To prevent atrial fibrillation ( AF ) recurrence after catheter ablation , pulmonary venous isolation ( PVI ) at an antral level is more effective than segmental ostial ablation . Cryoablation around the pulmonary venous ( PV ) ostia for AF therapy is potentially safer compared to radiofrequency ablation ( RFA ) . The aim of this study was to investigate the efficacy of a strategy using a large cryoablation balloon to perform antral cryoablation with ‘ touch-up ’ ostial cryoablation for PVI in patients with paroxysmal and persistent AF . Methods Paroxysmal and persistent AF patients undergoing their first left atrial ablation were recruited . After cryoballoon therapy , each PV was assessed for isolation and if necessary , treated with focal ostial cryoablation until PVI was achieved . Follow-up with Holter monitoring was performed . Clinical outcomes of the cryoablation protocol were compared , with consecutive patients undergoing PVI by RFA . Results 124 consecutive patients underwent cryoablation . 77 % of paroxysmal and 48 % of persistent AF subjects were free from AF at 12 months after a single procedure . Over the same time period , 53 consecutive paroxysmal AF subjects underwent PVI with RFA and at 12 months , 72 % were free from AF at 12 months ( p = NS ) . There were too few persistent AF subjects ( n=8 ) undergoing solely PVI by RFA as a comparison group . Procedural and fluoroscopic times during cryoablation were significantly shorter than RFA . Conclusions PV isolation can be achieved in less than 2 h by a simple cryoablation protocol with excellent results after a single intervention , particularly for paroxysmal AF",
"AIM Real-time assessment of pulmonary vein ( PV ) disconnection is possible using an inner circular mapping catheter during cryoablation of atrial fibrillation ( AF ) . However , it has been recently demonstrated that such continuous monitoring may only be possible in PV disconnection during ablation . METHODS AND RESULTS Single-centre , prospect i ve observational study ( NCT01843465 ) including 34 consecutive eligible patients ( 128 PVs ) undergoing a first procedure of cryoballoon ablation of AF using the Artic Front Advance ( ® ) 28 mm catheter and a 20 mm diameter Achieve ( ® ) catheter ( AC ) in all cases . Monitoring of real-time entrance block was possible , when AC was maintained in the st and ard position ( distal to the tip of the Artic Front Advance ( ® ) catheter ) in 47 ( 36.7 % ) PVs . In an additional 63 cases ( 49.2 % ) , such monitoring was possible after moving AC to a more proximal position and using different torqueing movements . Finally , using supplemental systematic pacing manoeuvres to test exit block , real-time assessment of PV disconnection was possible in 15 ( 11.7 % ) more PVs . Overall , real-time assessment of PV disconnection was possible in 97.7 % of cases , after a mean duration of 48.6 ± 33.0 s. CONCLUSION Our results suggest that optimal use of the AC , with a systematic stepwise mapping approach , may dramatically improve the real-time monitoring of PV disconnection during AF cryoablation",
"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",
"BACKGROUND Although radiofrequency ( RF ) and cryoballoon ( CB ) based technologies for pulmonary vein isolation ( PVI ) have both individually been demonstrated to be effective and safe for the treatment of paroxysmal AF , head-to-head comparisons are lacking . The purpose of this study was to compare the outcome of cryoballoon versus radiofrequency ablation in patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation . METHODS Out of a prospect i ve registry of 327 patients undergoing PVI , 208 patients ( age 58±11 years , ejection fraction 59±6 % , left atrial size 39±6 mm ) with paroxysmal AF were identified . The presented data set was obtained by 1:1 propensity score matching and contained 142 patients undergoing CB-PVI or RF-PVI in conjunction with a 3D mapping system , respectively . We compared single procedure efficacy of the two methods using a Cox proportional hazards model . RESULTS After a mean follow-up of 28 months and a single procedure , AF recurred in 37 of 71 ( 52 % ) in the CB-PVI group and in 31 of 71 patients ( 44 % ) in the RF-PVI group ( HR [ 95 % CI]=1.19 [ 0.74 , 1.92 ] , p=0.48 ) . Recurrence of AF for PVI using solely the CB was observed in 23 of 51 ( 45 % ) patients and in 23 of 51 ( 45 % ) patients in the corresponding RF-PVI group ( HR [ 95 % CI]=0.93 [ 0.52 , 1.66 ] , p=0.81 ) . Complication rate was not different between the groups . CONCLUSION A propensity score matched comparison between CB-PVI and RF-PVI using a 3D-mapping system for AF ablation showed similar long-term success rates",
"BACKGROUND Inflammation plays a prominent role in the etiology of the early recurrence of atrial fibrillation ( ERAF ) . We prospect ively compared the proportion of ERAF and time-course patterns of biomarkers between radiofrequency ( RF ) and cryoballoon ( CB ) ablation . METHODS AND RESULTS We enrolled 82 consecutive paroxysmal AF patients undergoing pulmonary vein ( PV ) isolation , performed with either a 28-mm 2nd-generation CB and 3-min freeze technique or point-by-point RF ablation . Each group had 41 patients . In the RF group , all PVs were successfully isolated with 28.9 ± 6.5 min of RF delivery . In the CB group , a mean of 5.3 ± 1.4 applications/patient was delivered . The proportion of ERAF was similar between the groups . The time-course patterns significantly differed between the groups for high-sensitivity C-reactive protein ( hs-CRP ) value ( P=0.006 ) and myocardial injury markers ( P Greater myocardial injury was observed in the CB than in the RF group ( P peak hs-CRP value was comparable between the groups . The 2-day post-procedure hs-CRP value was the sole factor correlating with ERAF as identified by the multivariable analysis ( hazard ratio 1.697 ; 95 % confidence interval , 1.005 - 2.865 ; P=0.048 ) in the RF , but not the CB group . CONCLUSIONS The proportion of ERAF was comparable after RF and 2nd-generation CB ablation . Despite CB ablation exhibiting greater myocardial injury than RF ablation , the inflammatory responses were comparable between the groups . The inflammatory response extent predicted ERAF post-RF ablation but not post-CB ablation",
"AIMS To assess the 1 year efficacy of pulmonary vein isolation ( PVI ) as index procedure for persistent atrial fibrillation ( PersAF ) comparing conventional radiofrequency irrigated-tip catheter ablation ( RFCA ) using contact-force technology and ablation using the second-generation cryoballoon ( CB-AdvA ) . METHODS AND RESULTS One hundred consecutive patients ( 74 male , 74 % ; mean age 62.4 ± 9.6 years ) with drug-refractory PersAF undergoing PVI using RFCA and CB-AdvA were enrolled . Follow-up was based on outpatient clinic visits including Holter-electrocardiograms . Recurrence of atrial tachyarrhythmias ( ATas ) was defined as a symptomatic or documented episode > 30 s. Among 100 patients , 50 underwent RFCA whereas 50 CB-AdvA. Mean procedure and fluoroscopy times were 90.5 ± 41.7 vs. 140.2 ± 46.9 min and 14.5 ± 6.6 vs. 19.8 ± 6.8 min in the CB-Adv and in the RFCA group , respectively ( P BP ) , freedom from ATas off-drugs after a single procedure was 60 % ( 28/50 patients ) in the CB-Adv and 56 % ( 27/50 patients ) in the RFCA group ( P = 0.71 ) . Multivariate analysis demonstrated that PersAF duration ( P = 0.01 ) and relapses during BP ( P = 0.02 ) were independent predictors of ATa recurrences following the index procedure . CONCLUSION Freedom from ATas following PersAF ablation with RFCA and CB-Adv is comparable at 1 year follow-up after a single procedure . Ablation with the CB-Adv is associated with shorter procedure time and radiation exposure as compared with RFCA . Atrial tachyarrhythmias occurrence during BP and longer time of PersAF seem to be significant predictors of arrhythmia recurrences after the index procedure",
"AIMS The urge to facilitate the atrial fibrillation ( AF ) ablation procedure has led to the development of new ablation catheters specifically design ed as ' one-shot tools ' for pulmonary vein isolation ( PVI ) . The purpose of this study was to compare the efficacy , safety , and procedure times for two such catheters using different energy sources . METHODS AND RESULTS One hundred and ten patients , referred for ablation of paroxysmal or persistent AF , were r and omized to treatment with either the cryoballoon or the circular multipolar duty-cycled radiofrequency-based pulmonary vein ablation catheter ( PVAC ) . Complete PVI was achieved in 98 vs. 93 % patients in the cryoballoon and PVAC group , respectively , with complication rates of 8 vs. 2 % ( P = 0.2 ) . Complete freedom from AF , without antiarrhythmic drugs , after one single ablation procedure was seen in 46 % in the cryoballoon vs. 34 % after 12 months ( P = 0.2 ) . Procedure times were comparable , but fluoroscopy time was shorter for the cryoballoon ( 32 ± 16 min ) than for the PVAC procedures ( 47 ± 17 min ) ( P of quality of life ( QoL ) and arrhythmia-related symptoms was seen in both groups after ablation . CONCLUSION Both catheters proved comparably effective and safe in achieving acute PVI , apart from the shorter fluoroscopy times achieved with the cryoballoon . At follow-up , there was no statistically significant difference between the groups regarding freedom from AF and clinical success . The QoL increased to the same levels as for the general Swedish population in both groups",
"INTRODUCTION Catheter ablation of paroxysmal AF using the Cryoballoon ( CRYO ) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation ( RFCA ) , but r and omized data are lacking . Pilot data suggested a high success rate with a combined approach ( COMBINED ) using wide encirclement with RFCA followed by 2 CRYO applications to each vein . We compared these 3 strategies in a r and omized controlled trial . METHODS AND RESULTS Patients undergoing first time paroxysmal AF ablation were r and omized to RFCA , CRYO , or COMBINED . Patients were followed up at 3 , 6 , and 12 months with 7 days of ambulatory ECG monitoring . Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure . A total of 237 patients were r and omized . Success at 1 year was achieved in 47 % in the RFCA group , 67 % in the CRYO group , and 76 % in the COMBINED group ( P RFCA vs. CRYO , P Procedure time was 211 ( IQR 174 - 256 ) minutes for RFCA compared to 167 ( 136 - 202 ) minutes for CRYO and 278 ( 243 - 327 ) minutes for COMBINED ( P CRYO and results in a higher single procedure success rate than conventional point by point RFCA . The COMBINED approach was not superior to CRYO alone",
"AIMS Atrial fibrillation ( AF ) ablation still requires long procedural time and high radiation exposure with its related risk for the patient and the operators . This study was design ed to compare three different approaches of AF ablation to verify the hypothesis that image integration with electroanatomic mapping allows minimal use of fluoroscopy . Therefore , we evaluated the procedure and fluoroscopy times of ablation using three imaging modalities : conventional fluoroscopy , image integration electroanatomic mapping , and a new electroanatomic mapping system that provides visualization of multiple catheters . METHODS AND RESULTS One hundred and twenty patients with symptomatic refractory AF were enrolled in the study . Patients were r and omly assigned to fluoroscopy alone ( Group A , 40 patients ) , electroanatomic integration ( Cartomerge ® , Group B , 40 patients ) , and electroanatomic integration plus catheters visualization ( Carto ® 3 System , Group C , 40 patients ) guided procedures . The ablation procedure aim ed at isolating the pulmonary veins and creating lesion lines at the left atrial roof and left isthmus . Procedure and fluoroscopy parameters were recorded in all patients . Total procedure time and skin to catheter positioning time did not significantly differ between the groups . Total fluoroscopy time was statistically different between all three groups ( Group A , 18'09″±5'00″ ; Group B , 9'48″±3'41″ ; Group C , 2'28″±1'40″ ; P noted in ablation fluoroscopy time between all groups ( P shortened fluoroscopy time in Group B ( 7'34″±3'15″ ) and Group C ( 0'21″±0'31″ ) when compared with Group A ( 16'07″±5'04″ ) . CONCLUSION Image integration and , to a larger extent , visualization of multiple catheters allowed a minimal use of fluoroscopy in transcatheter AF ablation",
"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 Results from r and omized trials design ed to compare cryoenergy with radiofrequency for pulmonary vein ( PV ) isolation are lacking . OBJECTIVE To compare the efficacy of a simplified strategy for PV cryoablation ( group C ) vs PV isolation with open-irrigated radiofrequency catheters ( group R ) . METHODS Fifty patients with paroxysmal atrial fibrillation ( AF ) and 4 independent PVs received a Reveal XT implantable cardiac monitor and were r and omized to group C or group R. In group C , PV ablation was done with a single A rct ic Front balloon ( 23 or 28 mm ) per patient and two 300-second applications per PV . No further applications were delivered to close residual conduction gaps . In group R , bidirectional PV conduction block was pursued with Lasso and Navistar ThermoCool catheters and the CARTO system . The primary end point was the proportion of patients remaining free from AF recurrences ≥2 minutes without taking antiarrhythmic drugs 12 months after ablation . RESULTS The primary end point was met by 12 ( 48 % ) patients in group C and 25 ( 68 % ) patients in group R ( odds ratio 0.43 ; P = .05 ) . This difference disappeared after adjustment for acute procedural outcome . In patients for whom all 4 PVs were blocked at the end of the procedure , there was no difference between group C and group R in the primary end point ( 67 % vs 68 % ; P = .94 ) . CONCLUSIONS The efficacy of the simplified strategy for PV cryoablation tested in this study is inferior to PV isolation using open-irrigated radiofrequency catheters with electrophysiological and electroanatomical guidance . Complete PV conduction block is critical to the success of AF ablation",
"Background Effective treatment of paroxysmal atrial fibrillation ( AF ) is essential for reducing the risk of stroke and heart failure . Cryoballoon ( CB ) ablation has been developed as an alternative to the use of radiofrequency ( RF ) energy for electrical isolation of the pulmonary veins . Herein , we provide long-term data regarding the efficacy of CB ablation in comparison to RF . Methods FreezeAF was a r and omised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF . Procedural success for the long-term follow-up ( 30 months ) was defined as freedom from AF with an absence of persistent complications . Results Of the 315 patients that were r and omised and received catheter ablation , 292 ( 92.7 % ) completed the 30-month follow-up ( 147 in the RF group and 145 in the CB group ) . The baseline characteristics of the RF and CB groups were similar . Single-procedure success was achieved by 40 % of patients in the RF group and 42 % of the CB group ( p multiple procedure success rate was 72 % in the RF group and 76 % in the CB group . Conclusion The data provide long-term evidence that CB ablation is non-inferior to RF ablation , with high proportions of patients reporting freedom from AF 30 months after the index procedure . Trial registration Clinical Trials.gov Identifier : NCT00774566 ; first registered October 16 , 2008 ; first patient included October 20 , 2008",
"BACKGROUND Experimental data suggest that use of cryoablation in pulmonary vein isolation ( PVI ) is associated with less cell damage and less thrombus formation compared to radiofrequency ( RF ) energy . OBJECTIVE The purpose of this study was to test the hypothesis that cryoablation significantly reduces markers of cell damage , platelet activation , and inflammation in patients undergoing PVI for treatment of atrial fibrillation ( AF ) . METHODS Sixty patients with symptomatic drug-resistant AF ( age 56 ± 9 years , 48 males , 38 with paroxysmal AF ) were r and omly assigned to undergo PVI using either an open irrigated-tip RF catheter or a cryoballoon . Markers of cell damage ( high-sensitive troponin T [ hs-TnT ] , microparticles ) , platelet activation ( platelet reactivity by aggregometry , expression of platelet surface proteins P-selectin and activated glycoprotein [ GP ] IIb/IIIa ) , and inflammatory response ( high-sensitive C-reactive protein [ hs-CRP ] ) were determined before and up to 48 hours after the procedure . RESULTS PVI result ed in a significant rise in hs-TnT , microparticles , markers of platelet activation , and hs-CRP over time , with distinct temporal patterns for each parameter . However , after Bonferroni correction for repeated measurements , no significant differences were noted in these parameters between patients treated with cryoablation or RF energy . Procedural time was significantly shorter in patients treated with cryoballoon ( 177 ± 30 minutes vs 200 ± 46 minutes , P = .03 ) , with no differences in fluoroscopic time , periprocedural complications , or success rate . CONCLUSION Cryoablation and RF energy result in a comparable rise of markers of cell damage , platelet activation and inflammatory response . The data do not support the concept of an improved safety profile for cryoablation in PVI",
"INTRODUCTION Hemi-diaphragmatic paralysis is the most common complication associated with cryoballoon ablation for atrial fibrillation , yet the histopathology of phrenic nerve injury has not been well described . METHODS AND RESULTS A pre clinical r and omized study was conducted to characterize the histopathology of phrenic nerve injury induced by cryoballoon ablation and assess the potential for electromyographic ( EMG ) monitoring to limit phrenic nerve damage . Thirty-two dogs underwent cryoballoon ablation of the right superior pulmonary vein with the objective of inducing phrenic nerve injury . Animals were r and omized 1:1 to st and ard monitoring ( i.e. , interruption of ablation upon reduction in diaphragmatic motion ) versus EMG guidance ( i.e. , cessation of ablation upon a 30 % reduction in the diaphragmatic compound motor action potential [ CMAP ] amplitude ) . The acute procedural endpoint was achieved in all dogs . Phrenic nerve injury was characterized by Wallerian degeneration , with subperineural injury to large myelinated axons and evidence of axonal regeneration . The degree of phrenic nerve injury paralleled the reduction in CMAP amplitude ( P = 0.007 ) . Animals r and omized to EMG guidance had a lower incidence of acute hemi-diaphragmatic paralysis ( 50 % vs 100 % ; P = 0.001 ) , persistent paralysis at 30 days ( 21 % vs 75 % ; multivariate odds ratio 0.12 , 95 % confidence interval [ 0.02 , 0.69 ] , P = 0.017 ) , and a lesser severity of histologic injury ( P = 0.001 ) . Mature pulmonary vein ablation lesion characteristics , including circumferentiality and transmurality , were similar in both groups . CONCLUSION Phrenic nerve injury induced by cryoballoon ablation is axonal in nature and characterized by Wallerian degeneration , with potential for recovery . An EMG-guided approach is superior to st and ard monitoring in limiting phrenic nerve damage",
"Aims Cryoablation is an indicated therapy for the treatment of recurrent atrial fibrillation through pulmonary vein isolation ; however , the optimal time between first diagnosis of atrial fibrillation and cryoablation is still unknown . We aim ed to assess the clinical efficacy and safety of early versus later treatment of patients with paroxysmal atrial fibrillation by cryoablation . Methods Five hundred and ten patients underwent atrial fibrillation cryoablation and were prospect ively followed for at least 6 months in 43 Italian cardiology centers . The population was divided into two groups according to the time since the first diagnosis of atrial fibrillation until the index cryoablation procedure . An early-treatment group had an elapsed time of 15 months or less from atrial fibrillation diagnosis until cryoablation , and the late-treatment group had an elapsed time of greater than 15 months . During the evaluation , clinical efficacy was defined as atrial fibrillation recurrence outside a l and mark 90-day blanking period , and safety was defined as the reporting of all procedure-related complications . Results In the total cohort , cryoablation was performed after a median of 36 months from the point of the patient diagnosis with drug refractory symptomatic recurrent atrial fibrillation . The early-treatment group was composed of 130 ( 25 % ) patients , whereas the late-treatment group had 380 ( 75 % ) patients . Both cohorts had similar baseline clinical characteristics . Of 510 patients , 22 had a complication related to the procedure with no difference between the two groups . Multivariable analysis showed that the risk of atrial fibrillation recurrence was significantly higher in the late-treatment group ( hazard ratio : 1.77 ; 95 % confidence interval 1.00 - 3.13 ) Conclusion In our multicenter observational examination , cryoablation was well tolerated and effective in the treatment of patients with drug refractory symptomatic paroxysmal atrial fibrillation . Reducing the time between diagnosis and ablation brought about a treatment that had a lower risk of atrial fibrillation recurrence with no change in safety . ( Italian Clinical Service Project : NCT01007474 )",
"Aim Cryoballoon ablation ( Cryoballoon ) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation ( AF ) . Whether the results of Cryoballoon are more reproducible than those of radiofrequency ( RF ) ablation remains to be proved . Methods and results A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF ( 467 treated with RF and 393 treated with Cryoballoon ) were selected from a prospect i ve multicentre survey of AF ablation ( FrenchAF ) . Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety . During a median follow-up of 14 months ( interquartile range 8–23 ) , patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique ( 68–80 % at 18 months ) . However , in centres performing RF , a greater heterogeneity in procedural results was observed ( 46–79 % were free from atrial arrhythmia relapse at 18 months ) . On multivariate analysis , Cryoballoon ( HR = 0.47 , 95 % CI 0.35–0.65 , P AF ablation caseload ( HR = 0.87 per every 100 AF ablation procedures per year ; 95 % CI 0.80–0.96 , P = 0.003 ) were independent predictors of procedural success . However , on sensitivity analysis , according to the ablation method , annual AF ablation caseload predicted only sinus rhythm maintenance in the subgroup of patients treated with RF . Analysis of interoperator results with Cryoballoon and RF confirmed lower reproducibility of RF , but suggested that besides caseload , other operator-related factors may play a role . Conclusion Cryoballoon seems to be less operator-dependent and more reproducible than RF in the setting of paroxysmal AF ablation",
"BACKGROUND Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation . Radiofrequency ablation is the most common method , and cryoballoon ablation is the second most frequently used technology . METHODS We conducted a multicenter , r and omized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation . The primary efficacy end point in a time-to-event analysis was the first documented clinical failure ( recurrence of atrial fibrillation , occurrence of atrial flutter or atrial tachycardia , use of antiarrhythmic drugs , or repeat ablation ) following a 90-day period after the index ablation . The noninferiority margin was prespecified as a hazard ratio of 1.43 . The primary safety end point was a composite of death , cerebrovascular events , or serious treatment-related adverse events . RESULTS A total of 762 patients underwent r and omization ( 378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation ) . The mean duration of follow-up was 1.5 years . The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 34.6 % and 35.9 % , respectively ; hazard ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.76 to 1.22 ; P primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 10.2 % and 12.8 % , respectively ; hazard ratio , 0.78 ; 95 % CI , 0.52 to 1.18 ; P=0.24 ) . CONCLUSIONS In this r and omized trial , cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation , and there was no significant difference between the two methods with regard to overall safety . ( Funded by Medtronic ; FIRE AND ICE Clinical Trials.gov number , NCT01490814 . )",
"OBJECTIVE Atrial fibrillation is often asymptomatic , but outcomes require further characterization . The study objective was to investigate the clinical presentation , management , and outcomes in asymptomatic and symptomatic patients with atrial fibrillation who were prospect ively enrolled in the EurObservational Research Programme - Atrial Fibrillation ( EORP-AF ) Pilot General Registry . METHODS A total of 3119 patients were enrolled , and 1237 ( 39.7 % ) were asymptomatic ( European Heart Rhythm Association [ EHRA ] score I ) . Among symptomatic patients , 963 ( 51.2 % ) had mild symptoms ( EHRA score II ) and 919 ( 48.8 % ) had severe or disabling symptoms ( EHRA III-IV ) . Permanent atrial fibrillation was 3-fold more common in asymptomatic patients than in symptomatic patients . RESULTS On multivariate analysis , male gender ( odds ratio [ OR ] , 1.630 ; 95 % confidence interval [ CI ] , 1.384 - 1.921 ) , older age ( OR , 1.019 ; 95 % CI , 1.012 - 1.026 ) , previous myocardial infa rct ion ( OR , 1.681 ; 95 % CI , 1.350 - 2.093 ) , and limited physical activity ( OR , 1.757 ; 95 % CI , 1.495 - 2.064 ) were associated significantly with asymptomatic ( EHRA I ) atrial fibrillation . Fully asymptomatic atrial fibrillation ( absence of current and previous symptoms ) was present in 520 patients ( 16.7 % ) and was associated independently with male gender , age , and previous myocardial infa rct ion . Appropriate guideline -based prescription of oral anticoagulants was lower in these patients , and aspirin was prescribed more frequently . Mortality at 1 year was more than 2-fold higher in asymptomatic patients compared with symptomatic patients ( 9.4 % vs 4.2 % , P 1-year mortality was found in asymptomatic patients compared with symptomatic patients"
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4116e6e2-06ff-11f0-808a-c43d1ab1c353
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Objective Type 1 diabetes mellitus rates are rising worldwide . The health benefits of physical exercise in this condition are many , but more than 60 % do not participate , mainly from fear of hypoglycemia . This systematic review explores the effects of physical exercise modes on blood glucose levels in adults for hypoglycemia prevention . Research design and methods Predefined inclusion criteria were r and omized or non-r and omized cross-over trials of healthy non-obese adults with type 1 diabetes mellitus . Exercise interventions used st and ardized protocol s of intensity and timing . Outcomes included hypoglycemia during or after exercise , and acute glycemic control . Medline , Cumulative Index to Nursing and Allied Health Literature , Allied and Complementary Medicine Data base , SPORTD iscus , Cochrane CENTRAL ( 1990 to 11 January 2018 ) , and Embase ( 1988 to 9 April 2018 ) were search ed using keywords and Medical Subject Heading ( MeSH ) terms . Inclusion s , data extraction and quality assessment using the Critical Appraisal Skills Programme checklists were done by one research er and checked by a second . Review Manager ( V.5.3 ) was used for meta- analysis where four or more outcomes were reported . Results From 5459 citations , we included 15 small cross-over studies ( 3 non-r and omized ) , 13 assessing aerobic ( intermittent high-intensity exercise ( IHE ) vs continuous , or continuous vs rest ) and 2 assessing resistance exercise versus rest . Study quality was good , and all outcome measures were reported . Thirteen gave hypoglycemia results , of which five had no episodes . Meta- analysis of hypoglycemia during or after IHE compared with continuous exercise showed no significant differences ( n=5 , OR=0.68 ( 95 % CI 0.16 to 2.86 ) , I2=56 % ) . For blood glucose there was little difference between groups at any time point . Conclusion IHE may be safer than continuous exercise because of lesser decline in blood glucose , but more research needs to demonstrate if this would be reflected in hypoglycemic episode rates . Trial registration number CRD42018068358
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[
"OBJECTIVE To compare the response of blood glucose levels to intermittent high-intensity exercise ( IHE ) and moderate-intensity exercise ( MOD ) in individuals with type 1 diabetes . RESEARCH DESIGN AND METHODS Seven healthy individuals with type 1 diabetes were tested on two separate occasions , during which either a 30-min MOD or IHE protocol was performed . MOD consisted of continuous exercise at 40 % Vo(2peak ) , while the IHE protocol involved a combination of continuous exercise at 40 % Vo(2peak ) interspersed with 4-s sprints performed every 2 min to simulate the activity patterns of team sports . RESULTS Both exercise protocol s result ed in a decline in blood glucose levels . However , the decline was greater with MOD ( -4.4 + /- 1.2 mmol/l ) compared with IHE ( -2.9 + /- 0.8 mmol/l ; P glucose levels remained higher in IHE compared with MOD ( P glucose levels remained stable during recovery from IHE , while they continued to decrease after MOD ( P blood glucose levels with IHE was associated with elevated levels of lactate , catecholamines , and growth hormone during early recovery from exercise ( P free insulin , glucagon , cortisol , or free fatty acids between MOD and IHE . CONCLUSIONS The decline in blood glucose levels is less with IHE compared with MOD during both exercise and recovery in individuals with type 1 diabetes",
"The lack in control of insulin release combined with an inadequate carbohydrate ( CHO ) ingestion accounts for the occurrence of frequent metabolic unbalances during exercise in type 1 diabetic patients . The aim of the study was to quantify , in these patients , the CHO requirement to prevent hypoglycemia during moderate exercise performed at different time intervals after morning subcutaneous insulin injection . Twelve type 1 diabetic patients and 12 well-matched healthy subjects cycled 4 times for 1 hour at a constant workload . The rate of glucose oxidation was calculated continuously by indirect calorimetry throughout the exercise , while blood parameters were assessed periodically and orally given CHO were checked . CHO needed by the patients to prevent hypoglycemia decreased as the time elapsed from insulin administration increased , amounting to 0.63 + /- 0.30 , 0.44 + /- 0.32 , 0.28 + /- 0.24 , and 0.14 + /- 0.18 g/kg after 1 , 2.5 , 4 , and 5.5 hours , respectively . Total glucose requirement during moderate exercise ( sum of alimentary and extracellular source ) was correlated ( r = 0.739 , P plasma insulin concentration , but not with fitness level . Time elapsed from last insulin dose is not a factor influencing the risk of hypoglycemia during exercise when a proportional , appropriate amount of CHO is ingested",
"Introduction We investigated blood glucose ( BG ) and hormone response to aerobic high-intensity interval exercise ( HIIE ) and moderate continuous exercise ( CON ) matched for mean load and duration in type 1 diabetes mellitus ( T1DM ) . Material and Methods Seven trained male subjects with T1DM performed a maximal incremental exercise test and HIIE and CON at 3 different mean intensities below ( A ) and above ( B ) the first lactate turn point and below the second lactate turn point ( C ) on a cycle ergometer . Subjects were adjusted to ultra-long-acting insulin Degludec ( Tresiba/ Novo Nordisk , Denmark ) . Before exercise , st and ardized meals were administered , and short-acting insulin dose was reduced by 25 % ( A ) , 50 % ( B ) , and 75 % ( C ) dependent on mean exercise intensity . During exercise , BG , adrenaline , noradrenaline , dopamine , cortisol , glucagon , and insulin-like growth factor-1 , blood lactate , heart rate , and gas exchange variables were measured . For 24 h after exercise , interstitial glucose was measured by continuous glucose monitoring system . Results BG decrease during HIIE was significantly smaller for B ( p = 0.024 ) and tended to be smaller for A and C compared to CON . No differences were found for post-exercise interstitial glucose , acute hormone response , and carbohydrate utilization between HIIE and CON for A , B , and C. In HIIE , blood lactate for A ( p = 0.006 ) and B ( p = 0.004 ) and respiratory exchange ratio for A ( p = 0.003 ) and B ( p = 0.003 ) were significantly higher compared to CON but not for C. Conclusion Hypoglycemia did not occur during or after HIIE and CON when using ultra-long-acting insulin and applying our method ological approach for exercise prescription . HIIE led to a smaller BG decrease compared to CON , although both exercises modes were matched for mean load and duration , even despite markedly higher peak workloads applied in HIIE . Therefore , HIIE and CON could be safely performed in T1DM . Trial Registration Clinical Trials.gov NCT02075567 http://www . clinical",
"OBJECTIVE To study the effects of exercise on the absorption of the basal long-acting insulin analog insulin glargine ( Lantus ) , administered subcutaneously in individuals with type 1 diabetes . RESEARCH DESIGN AND METHODS A total of 13 patients ( 12 men , 1 woman ) with type 1 diabetes on a basal-bolus insulin regimen were studied . (125)I-labeled insulin glargine at the usual basal insulin dose was injected subcutaneously into the thigh on the evening ( 2100 ) before the study day on two occasions 1 week apart . Patients were r and omly assigned to 30 min intense exercise ( 65 % peak oxygen uptake [ Vo(2peak ) ] ) on one of these visits . The decay of radioactive insulin glargine was compared on the two occasions using a thallium-activated Nal gamma counter . Blood sample s were collected at regular intervals on the study days to assess plasma glucose and insulin profiles . RESULTS No significant difference was found in the (125)I-labeled insulin glargine decay rate on the two occasions ( exercise vs. no exercise ; repeated- measures ANOVA , P = 0.548 ) . As expected , a significant fall in plasma glucose was observed over the exercise period ( area under curve above fasting [ DeltaAUC ] glucose : -0.39 + /- 0.11 vs. -1.30 + /- 0.16 mmol . l(-1 ) . h(-1 ) ; nonexercise vs. exercise ; P = 0.001 ) , but insulin levels did not differ significantly on the two occasions ( DeltaAUC insulin : -2.1 + /- 3.9 vs. 1.5 + /- 6.2 pmol . l(-1 ) . h(-1 ) ; nonexercise versus exercise ; P = 0.507 ) . CONCLUSIONS An intense 30-min period of exercise does not increase the absorption rate of the subcutaneously injected basal long-acting insulin analog insulin glargine in patients with type 1 diabetes",
"OBJECTIVE To evaluate and vali date appropriate premeal insulin dose reductions for postpr and ial exercises of different intensities and duration s to minimize the risk of exercise-induced hypoglycemia in type 1 diabetic subjects . RESEARCH DESIGN AND METHODS Eight male type 1 diabetic patients on a basal-bolus insulin regimen of ultralente ( UL ) as basal insulin and lispro ( LP ) as premeal insulin were tested in a r and omized , crossover fashion during postpr and ial exercise at 25 % VO2max for 60 min , 50 % VO2max for 30 and 60 min , and 75 % VOmax for 30 min starting 90 min after a st and ardized mixed breakfast ( 600 kcal , 75 g carbohydrates ) . Each subject served as his own control and was rested after a full dose of insulin LP ( LP 100 % ) and /or 50 % ( LP 50 % ) and /or 25 % ( LP 25 % ) of the current dose . RESULTS At all intensities , the full premeal insulin dose was associated with an increased risk of hypoglycemia . At 25 % VO2max for 60 min , a 50 % reduction in the premeal insulin dose result ed in plasma glucose of -0.62 mmol/l compared with baseline at the end of exercise . At 50 % VO2max for 30 and 60 min , 50 and 75 % reductions of the premeal insulin dose were associated with plasma glucose of -0.39 and + 0.49 mmol/l , respectively , at the end of the exercise . At 75 % VO2max , a 75 % reduction of the premeal insulin dose was required to achieve appropriate postexercise plasma glucose ( + 0.71 mmol/l ) . Such reductions in the premeal insulin dose result ed in a 75 % decrease in the incidence of exercise-induced hypoglycemia . CONCLUSIONS In well-controlled type 1 diabetic subjects on intensive insulin therapy with the basal-bolus ( UL-LP ) insulin regimen , risk of hypoglycemia can be minimized during postpr and ial exercises of different intensities and different duration s by appropriate reduction of premeal insulin LP",
"INTRODUCTION The effects of glargine/glulisine insulin regimen on exercise blood glucose ( BG ) and strategies to limit exercise-induced hypoglycemia are not well documented . Intermittent high-intensity exercise has been proposed to prevent hypoglycemia , but its effect in participants with type 1 diabetes using glargine/glulisine is unknown . METHODS The study used a repeated- measures design with three r and omly ordered exercise conditions . Eleven participants completed 60 min of moderate-intensity exercise at 50 % VO(2peak ) for all conditions . These conditions varied as follows : participants ingested 0 g of glucose preexercise ( 0 G + MOD ) , 30 g of glucose preexercise ( 30 G + MOD ) , or 0 g of glucose preexercise but performed brief high-intensity intervals interspersed every 2 min ( 0 G + MOD/INT ) during exercise . If BG fell 20 % dextrose solution was started to maintain BG between 4 and 5 mmol·L(-1 ) . RESULTS Consuming 30 g of glucose before exercise ( 30 G + MOD ) result ed in a higher preexercise BG ( 11.7 ± 2.7 mmol·L(-1 ) ) compared with 0 g of glucose before exercise ( 0 G + MOD , 7.8 ± 4.0 , and 0 G + MOD/INT , 9.2 ± 3.5mmol·L(-1 ) ) , P A dextrose infusion was required in 7/11 , 4/11 , and 1/11 participants for 0 G + MOD , 0 G + MOD/INT , 30 G + MOD conditions , respectively , P were greatest in the 0 G + MOD condition , moderate in the to 0 G + MOD/INT condition , and minimal in the 30 G + MOD condition , P a 30-g preexercise glucose beverage or interspersed with intermittent high-intensity sprints may be safe strategies to prevent hypoglycemia in glargine/glulisine users",
"OBJECTIVE Exercise is a cornerstone of diabetes therapy in type 1 diabetes mellitus ( DMT1 ) patients . The type of exercise is important in determining the propensity to hypoglycemia . We assessed , by continuous glucose monitoring ( CGM ) , the glucose profiles during and in the following 20h after a session of two different types of exercise . RESEARCH DESIGN AND METHODS Eight male volunteers with well-controlled DMT1 were studied . They underwent 30min of both intermittent high-intensity exercise ( IHE ) and moderate-intensity exercise ( MOD ) in r and om order . Expired air was recorded during exercise , while metabolic and hormonal determinations were performed before and for 120 min after exercises . The CGM system and activity monitor were applied for the subsequent 20h . RESULTS Blood glucose level declined during both type of exercise . At 150 min following the start of exercise , plasma glucose content was slightly higher after IHE . No changes were observed in plasma insulin concentration . A significant increase of norepinephrine concentration was noticed during IHE . Between midnight and 6:00 a.m. the glucose levels were significantly lower after IHE than those observed after MOD ( area under the curve , 23.3 ± 3 vs. 16 ± 3 mg/dL/420 min [ P = 0.04 ] ; mean glycemia at 3 a.m. , 225 ± 31 vs. 147 ± 17 mg/dL [ P ] ) . The number of hypoglycemic episodes after IHE was higher than that observed after MOD ( seven vs. two [ P ( 1 ) CGM is a useful approach in DMT1 patients who undergo an exercise program and ( 2 ) IHE is associated with delayed nocturnal hypoglycemia "
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